News Alert

University of Pittsburgh School of Medicine scientists have announced a potential vaccine against SARS-CoV-2, the new coronavirus causing the COVID-19 pandemic. When tested in mice, the vaccine, delivered through a fingertip-sized patch, produces antibodies specific to SARS-CoV-2 at quantities thought to be sufficient for neutralizing the virus. The paper appeared this week in EBioMedicine, which is published by The Lancet, and is the first study to be published after critique from fellow scientists at outside institutions that describes a candidate vaccine for COVID-19. The researchers were able to act quickly because they had already laid the groundwork during earlier coronavirus epidemics. Learn More

An international team led by University of British Columbia researcher Dr. Josef Penninger has found a trial drug that effectively blocks the cellular door SARS-CoV-2 uses to infect its hosts. "Our new study provides very much needed direct evidence that a drug -- called APN01 -- hrsACE2 -- soon to be tested in clinical trials by the European biotech company Apeiron Biologics, is useful as an antiviral therapy for COVID-19," says Dr. Art Slutsky, a scientist at the Keenan Research Centre for Biomedical Science of St. Michael's Hospital and professor at the University of Toronto who is a collaborator on the study. The findings are published this week in Cell. Learn More

Pfizer, Merck, and Eli Lilly are allowing the thousands of licensed medical professionals they employ to volunteer to go back to serving patients during the COVID-19 pandemic. And those who do so will keep receiving their base pay from the companies. Merck said it's supporting employees worldwide who want to serve medical needs in their communities. In the U.S., the company is working with The Health Management Academy to send volunteers to the areas with the greatest need. Pfizer has created a new Global COVID-19 Medical Service Program to help its employees' transition into positions where they can treat patients. Some of Eli Lilly's medical professionals are already running a free drive-through COVID-19 testing facility at its corporate headquarters in Indianapolis. Learn More

The coronavirus pandemic is disrupting clinical trials of experimental medicines, but it hasn't prevented one of Massachusetts leading venture capital firms from raising more than $1 billion to create more biotech startups. Flagship Pioneering, among the biggest creators of life sciences firms in Massachusetts, said it started raising money for its seventh "origination fund" in mid-January and closed it last month after it totaled $1.1 billion. The Cambridge firm has created 41 companies since the venture capital firm was founded in 2000, all but one in Massachusetts. They include Cambridge-based Moderna, which helped develop the first potential COVID-19 vaccine to enter clinical trials. Learn More

Novartis has made public its decision to scrap the sale of its U.S. dermatology and generic pill assets to India's Aurobindo Pharma. This comes after the biopharma giant failed to obtain approval for the deal from the U.S. Federal Trade Commission (FTC) within anticipated timelines. The sale termination comes about one and a half years after Novartis said it would sell the generic oral solids and dermatology businesses assets for up to $1 billion to Aurobindo under Chief Executive Officer Vas Narasimhan's plans to reshape the Swiss drugmaker. According to reports Sandoz will continue to operate the assets as part of the Sandoz U.S. business. Learn More

Bristol Myers Squibb and Gilead Sciences have been locked in a CAR-T patent fight, with BMS scoring a lucrative victory following a trial late last year. Now, Gilead has failed to persuade a judge to overturn the $752 million verdict-and the company could face bigger damages down the line. In an order unsealed this week, Judge James Otero rejected numerous arguments from Gilead's Kite Pharma unit that patents held by BMS' Juno Therapeutics are invalid, plus that procedural flaws in the legal process warrant a new trial. Kite's "current arguments largely mirror its previous arguments," the judge wrote in the March 24 order. Learn More

The crowded race to develop a vaccine against the new coronavirus just received a potential billion-dollar boost: Johnson & Johnson and the U.S. government, through a military research agency, will together devote up to $1 billion to move a candidate product made by its Janssen division across the finish line. Janssen's vaccine is built around an engineered version of adenovirus 26 (Ad26), which normally causes common colds but has been disabled so that it cannot replicate. Company scientists stich into this Ad26 "vector" a gene for the surface protein from the new coronavirus spreading around the world. Janssen is testing this same Ad26 platform in vaccines against Ebola, HIV, respiratory syncytial virus, and Zika. Learn More

Following an inspection last August and September, the US FDA sent a warning letter to Pfizer's injectable product manufacturing site in Visakhapatnam, India. The letter, dated March 25th and released this week, explains how the site did not adequately investigate root causes and implement corrective and preventive action (CAPA) to address deficiencies with its sterility testing. The FDA also notes microbial contamination and how the site "did not adequately investigate serious deficiencies in microbiology laboratory conditions and practices." In addition, the site invalidated microbial results without adequate scientific justification. Learn More

Eli Lilly and Oxford, England-based Sitryx have entered into an exclusive global licensing and research collaboration. The two companies will work to develop up to four preclinical compounds discovered by Sitryx for autoimmune diseases. Under the terms of the deal, Lilly is paying Sitryx $50 million up front. Lilly will also make a $10 million equity investment in the company. For its part, Sitryx grants Lilly exclusive, worldwide license to develop and commercialize up to four immunometabolism targeted compounds, including Sitryx's two lead projects. The partnership will run for five years, with Sitryx taking on drug discovery and Lilly paying for and handling clinical development and commercialization. Learn More

Amarin shares plummeted in value this week after a federal judge ruled that key patents covering its heart drug Vascepa were invalid. The decision is a victory for two drug makers, Hikma Pharmaceuticals and Dr. Reddy's Laboratories, seeking to make and sell generic versions of Vascepa. The ruling came as a surprise to many financial analysts who had expected a ruling in Amarin's favor, sending the company's share down nearly 70% in after-hours trading. Amarin's CEO John Thero says the company will vigorously pursue all available remedies, including an appeal of the Court's decision, to prevent the launch of generic versions of Vascepa in the U.S. Learn More

Opening the door to the wider use of unapproved but potential COVID-19 treatments, the US FDA has issued an emergency use authorization (EUA) to allow BARDA to distribute donated hydroxychloroquine sulfate and chloroquine phosphate products to doctors, who can decide whether to prescribe them to hospitalized teen and adult patients with COVID-19 when a clinical trial is not available or feasible. This is FDA's first EUA for a therapeutic product to potentially treat COVID-19. The donations to be distributed include 30 million doses of hydroxychloroquine sulfate from Sandoz and one million doses of chloroquine phosphate from Bayer. Learn More

Sun Pharmaceutical has made public a decision by the US FDA to classify its facility in Halol as "Official Action Indicated", or OAI, after conducting an inspection. The Halol facility, Sun's largest supplying to the U.S. market, had barely got a clean chit from the U.S. FDA in 2018 after coming under a warning letter in 2015. The plant is also important to Sun's research arm Sun Pharma Advanced Research, which makes some of its key drugs there. This latest move comes after an inspection of the Halol facility in December resulted in questions from the FDA about the robustness of its data as well as highlighted deficiencies in its test results. Learn More

A spate of mysterious second-time infections is calling into question the accuracy of COVID-19 diagnostic tools even as China prepares to lift quarantine measures to allow residents to leave the epicenter of its outbreak next month. It's also raising concerns of a possible second wave of cases. This comes as some Wuhan residents who had tested positive earlier and then recovered from the disease are testing positive for the virus a second time. Based on data from several quarantine facilities in the city, which house patients for further observation after their discharge from hospitals, about 5%-10% of patients pronounced "recovered" have tested positive again. Learn More

Evox Therapeutics has snared an $882 million partnership with Takeda for up to five rare disease programs. The alliance, which includes $44 million in upfront fees, near-term milestones and research funding, is focusing on the development of protein replacement and mRNA therapies that will be delivered using the Oxford University spin-out's exosome delivery platform. The Takeda alliance is the first with a big pharma company for Evox, although it has other partnerships in place, including a program with medical charity Duchenne UK looking at using exosomes to deliver dystrophin, a protein deficient in people with Duchenne muscular dystrophy. Learn More

Plans are moving forward for Selkirk Pharma's $30 million manufacturing facility on the West Plains near Spokane, Washington The company, a contract manufacturing biopharma startup, filed an environmental review for the project with the Washington state Department of Ecology last week. The company intends to build a 65,000-square-foot manufacturing facility at 9110 W. Granite Ave. in the Pacific Northwest Technology Park, according to an application filed with the city of Spokane. Construction is expected to begin in August and is slated for completion in December 2021, according to the environmental review. Spokane-based Bernardo|Willis Architects is designing the project. Learn More

A consortium of life sciences companies are collaborating to develop and manufacture vaccines, diagnostics and treatments for COVID-19 in a response to the coronavirus pandemic. The 15 companies have agreed to share their proprietary libraries of molecular compounds that already have some degree of safety and activity data following a conference call with the Gates Foundation earlier this month. Companies participating include Boehringer Ingelheim, Eli Lilly, Gilead, GlaxoSmithKline, Johnson & Johnson, Merck & Co (MSD), Merck KGaA, Novartis, Pfizer, and Sanofi. Learn More

Mylan this week waived its exclusive U.S. distribution rights to its generic version of HIV treatment Kaletra, which is currently being tested against the coronavirus. The move would make other drugmakers eligible to seek U.S. approval for their generic versions of the drug and boost supply, which would help in case studies find that Kaletra is effective in treating COVID-19, the disease caused by the virus, Mylan said. Kaletra, a combination HIV treatment sold by AbbVie, has been considered a potential treatment for the virus, although Chinese investigators have reported that it failed to improve outcomes for seriously ill patients. Learn More

A well written article published in STAT this week explored just what it is like going into the lab at a biopharma amid the coronavirus pandemic. Amid the questions being addressed daily include concerns about infection, which research and manufacturing projects can wait, which can't and what additional safeguards can be implemented to protect on-site workers. For the latter the article cites some novel approaches such as a survey about their symptoms that must be completed to unlock the lab doors and the less novel practice of alternating shifts in an effort to reduce the number of people in the facilities at any given time. Learn More

In a reversal, Gilead has submitted a request to the US FDA to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19. Earlier this month, Gilead was granted the designation because the potential antiviral would help to treat COVID-19, which currently affects fewer than 200,000 patients in the US. If the company had kept the designation and remdesivir won approval, the treatment would have received seven years of orphan drug and tax credits for some of the research done on remdesivir. Learn More

Vir Biotechnology has announced that laboratory testing showed two of its antibody drugs appeared to neutralize the coronavirus that causes Covid-19 and that it would pursue testing them in people. The company said that human tests of the drugs could begin in three to five months, putting it roughly in line with two other efforts to produce anti-coronavirus antibodies. Regeneron has said that its antibodies could enter trials by early summer - and that its treatment, if it proves effective, could be available for some uses in the fall. Eli Lilly, which is developing anti-SARS-CoV-2 antibodies with AbCellera has said it hopes to begin human tests in four months. Learn More

BeiGene has announced that the China National Medical Products Administration (NMPA) suspended the importation, sales and use of ABRAXANE® in China supplied to BeiGene by Celgene Corporation, a Bristol Myers Squibb company. This suspension is based on inspection findings at CMO Fresenius Kabi's site in Melrose Park, Illinois. As a result, BeiGene expects a disruption in ABRAXANE supply in China and is working closely with BMS to restore supply as soon as possible, including through BMS's remediation efforts at the current manufacturing site and application to qualify an alternative manufacturing site for China supply. Learn More

As Gilead begins to streamline the process for COVID-19 patients to receive its experimental antiviral remdesivir on a wider basis, the company also raised some eyebrows this week by obtaining an orphan drug designation for the potential COVID-19 treatment. Orphan designations are meant to help companies developing treatments for limited populations and they provide incentives like tax credits for research and seven years of exclusivity for the sponsors of such drugs. Although the number of COVID-19 cases is currently below 200,000, some have begun to criticize this designation as just the latest in a series of orphan drug abuses. Learn More

As the world goes into lockdown to try and limit the spread of the novel coronavirus that causes COVID-19, there is some hope that warmer weather will cause the virus to dwindle, like what happens with seasonal influenza. The bad news there is that it could be seasonal, returning in the fall. Four separate research groups in the U.S., Australia and China analyzed how temperature and humidity affect the coronavirus and they predict that hot summer months could decrease the presence of the virus in the Northern Hemisphere. But they also predicted it would come back in autumn, when the humidity drops and temperatures cool down. Learn More

CytomX Therapeutics is teaming up with Astellas Pharma in a research and development alliance focused on developing new cancer immunotherapies based on its antibody technology. Under the terms of the deal announced this week, Astellas is paying CytomX $80 million up front. For its part, CytomX will conduct and finance the research up to the selection of drug candidates. Astellas will take the lead from there, funding preclinical and clinical research. Depending on the progress of those programs, Astellas could pay CytomX up to $1.6 billion more, plus royalties from sales of any approved products. Learn More

Gilead has announced that it will stop granting individual access to its experimental treatment for COVID-19, citing an "exponential increase" in compassionate use requests for the antiviral drug, called remdesivir. Instead, the biotech plans to transition to an expanded access program that it says will speed the process for severely ill patients while allowing for better data collection. Five clinical studies testing remdesivir in patients infected by the new coronavirus are currently ongoing, and could begin to yield results by next month. So far, the biotech has provided remdesivir to "several hundred" patients sick with COVID-19 in the U.S., Europe and Japan. Learn More

IBM has announced that it has teamed up with the White House to form the COVID-19 High Performance Computing Consortium. The working group, which also includes Amazon and Microsoft, was created to bring together an "unprecedented" amount of computing power to help researchers better understand COVID-19, treatments, and cures.  Through the consortium, researchers will have access to 16 systems with more than 330 petaflops, 775,000 CPU cores, and 34,000 GPUs -- and growing. The consortium is already accepting and evaluating proposals from researchers and will provide supercomputing access to those efforts that make a difference immediately. Learn More

India will set up a nearly $1.3 billion fund to encourage companies to manufacture active pharmaceutical ingredients domestically after supply chain disruptions due to the coronavirus pandemic exposed the country's dependence on China and raised the specter of drug shortages. The program includes spending on infrastructure for drug manufacturing centers, and financial incentives of up to 20% of incremental sales value over the next eight years, according to a government statement. India imports almost 70% of its APIs from China. A number of those chemicals are sourced from Hubei province, the epicenter of the coronavirus outbreak. Learn More

As the US FDA re-gears to respond to the coronavirus disease (COVID-19) pandemic, the agency's Center for Biologics Evaluation and Research (CBER) says it will "significantly scale back" lot release activities. In a letter to biological product manufacturers, CBER's Office of Compliance and Biologics Quality (OCBQ) advises that it will no longer accept biological product samples or lot release protocols in physical form (paper or CD-ROM) at the agency's headquarters in Silver Spring, MD until further notice. Despite the pause in other lot release activities, CBER says it will continue to prepare reagents for the 2020/2021 influenza season. Learn More

The German Constitutional Court has published its decision that the German Act implementing the Unified Patent Court (UPC) system is unconstitutional. In doing so the court has effectively ended, for the foreseeable future, an effort to create a single European court in which to hear all patent related matters. This decision is being celebrated by many in biopharma as it allows the continuation of the practice of litigating IP such as patents by jurisdiction and not universally. The decision by the German court comes after the government of the United Kingdom expressed that it would no longer seek to participate in the UPC. Learn More

Dover, a diversified global manufacturer with annual revenue of over $7 billion, has announced its agreement to acquire the flow measurement firm Em-Tec, perhaps best known in our community for its manufacture of non-invasive flow meters used on single-use tubing. According to details of the deal, Dover intends to place Em-Tec under its PSG business unit, itself perhaps best known to many of us for its innovative Quattroflow pumps. As of this writing no financial details on the deal, which is expected to close in Q2' 2020, have been made public. Learn More

Danaher announced Thursday night that the U.S. Federal Trade Commission has accepted the proposed consent order in connection with Danaher's definitive agreement with General Electric Company to acquire the Biopharma business of GE Life Sciences. The acceptance by the FTC satisfies all required antitrust clearances needed to be obtained for the acquisition of GE Biopharma by Danaher. In addition to the FTC, the transaction has also been cleared by the European Commission and the Brazilian, Chinese, Israeli, Japanese, Korean and Russian antitrust authorities. Danaher currently expects that the acquisition will be completed on March 31, 2020. Learn More

Biogen sued Creative Biolabs in Boston federal court this week for allegedly selling illegal copies of its aducanumab antibody, which is being investigated to treat early Alzheimer's disease. CB's version of Biogen's patented antibody would hurt both Biogen and the investigators who use the copycat product in research, the complaint says. According to published reports Biogen licensed aducanumab from the Swiss biopharma Neurimmune Therapeutics to collaborate on developing the antibody to treat Alzheimer's and licenses a U.S. Patent covering the treatment from the University of Zurich. Learn More

The Health Products Regulatory Authority (HPRA) of Ireland has joined the US FDA in canceling what it terms "routine compliance inspections". These initial cancelations are scheduled to last through March 29th. However, with the rate of new daily cases in Ireland still increasing, it is being speculated that the cancellations may continue well beyond this date. No word as of this writing what, if any, changes might be coming to the site inspection plans of other European regulators such as the United Kingdom's MHRA. Learn More

The US FDA has formally announced that it has temporarily postponed all domestic routine surveillance facility inspections. The decision, which the FDA said is for "the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors". FDA Commissioner Stephen Hahn said in a statement: "I want to assure the American public that we have full confidence in the safety and quality of the products we all use every day and that the FDA will continue to leverage all available authorities to continue to ensure the integrity of the products we regulate." Learn More

An article in STAT explains that as more regional governments consider ordering residents to largely stay inside their homes to try to slow the spread of the coronavirus, drug industry trade groups are pushing to ensure such orders make exceptions to allow the employees of biotech and pharma companies to travel to and from work. The first "shelter-in-place" orders in the U.S. have come over the past few days in the Bay Area and other parts of Northern California. Local governments in Massachusetts and New York have called for similar directives. The Bay area order specifically allows for employees of pharma and biotech firms to travel to and from work. Learn More

Amid allegations to the contrary, the novel SARS-CoV-2 coronavirus that emerged in the city of Wuhan, China, last year and has since caused a large scale COVID-19 epidemic and spread to more than 70 other countries, is the product of natural evolution, according to findings published this week in the journal Nature Medicine. The analysis of public genome sequence data from SARS-CoV-2 and related viruses found no evidence that the virus was made in a laboratory or otherwise engineered. By comparing the available genome sequence data for known coronavirus strains, we can firmly determine that SARS-CoV-2 originated through natural processes," said Kristian Andersen, PhD, an associate professor of immunology and microbiology at Scripps Research and corresponding author on the paper. Learn More

According to Regulatory Focus the US FDA appears to have halted its domestic inspections of biopharma facilities, although not before attempting to inspect a CDMO on Monday and subsequently deciding to end the inspection early and announce the halt. The CEO of the CDMO, who requested that he and his firm remain anonymous, explained to Focus via email that the FDA inspector arrived alone on Monday morning, performed an inspection for between two and three hours and then received a phone call to end the inspection. At which time the inspector reportedly said that the FDA was suspending all domestic inspections. As of this writing the FDA has not responded to a request for comment by Focus. Learn More

The virus that causes coronavirus disease 2019 (COVID-19) is stable for several hours to days in aerosols and on surfaces, according to a new study from National Institutes of Health, CDC, UCLA and Princeton University scientists in The New England Journal of Medicine. The scientists found that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was detectable in aerosols for up to three hours, up to four hours on copper, up to 24 hours on cardboard and up to two to three days on plastic and stainless steel. The results provide key information about the stability of SARS-CoV-2, which causes COVID-19 disease, and suggests that people may acquire the virus through the air and after touching contaminated objects. Learn More

Janet Woodcock, Director of the FDAs Center for Drug Evaluation and Research (CDER) has co-authored an article for the blog Health Affairs citing the need for increased quality in our drug manufacturing operations. In the article, Director Woodcock notes that the vast majority of drug shortages are a result of quality issues (62%) for which the technology largely exists to address but in which an investment has not been made. The result the authors note is that while several non-pharma manufacturing industries operate above a six-sigma level, a large number of their biopharma counterparts operate closer to two or three sigma capability. However, the authors acknowledge that incentives are needed to drive adoption. Learn More

The U.S. Health and Human Services agency suffered a cyber-attack on its computer system, part of what people familiar with the incident called a campaign of disruption and disinformation that was aimed at undermining the response to the coronavirus pandemic and may have been the work of a foreign actor. The attack, which involved overloading the HHS servers with millions of hits over several hours, didn't succeed in slowing the agency's systems significantly, as was apparently intended, according to one of the people familiar with the matter. While a foreign state is suspected in the attack, the administration hasn't yet confirmed who it was. Learn More

The US biosimilar industry has lingered in the shadow of the European market since the US pathway for approvals was initiated in 2009. Ten years later, or less than five years since the first FDA approval of a biosimilar, and just 46% (12 out of 26) of FDA-approved biosimilars have launched. But in the next three months, a clutch of new biosimilars will hit the market, including new ones in oncology, hinting at a wave of uptake. These include biosimilars for Avastin, Rituxan and Herceptin being launched by Pfizer. The rising number of launches, combined with an increasing amount of quick uptake, may put biosimilar foes on their heels. Learn More

A well written article in the San Diego Union Tribune this week does a great job of telling the story of a biotech visionary in San Diego, California and the legacy he left behind in that community. Larry Bock, who passed away from cancer back in 2016, founded the likes of Illumina, Nanosys, Pharmacopeia, Idun and Caliper while also financing more than 40 others. But perhaps his greatest legacy is what would become the San Diego Science and Engineering Festival. An annual festival first began in 2009 which has grown to fill a baseball stadium in downtown San Diego. Each year the festival educates and informs tens of thousands of attendees, parents and children alike, on the wonders of science and engineering. Learn More

German officials are discussing a reported U.S. attempt to secure the rights to any coronavirus vaccine developed by a German biopharma company in crisis meetings today, the country's interior minister said, amid concerns that the Trump administration was trying to monopolize the market. Interior Minister Horst Seehofer, when asked to confirm a report the Trump administration was attempting to secure exclusive rights to any vaccine created by the German biopharmaceutical firm CureVac, said he had "heard from several other members of government today that is the case." Germany's Welt am Sonntag newspaper reported Sunday that the administration wanted to secure the rights and move R&D to the United States. Learn More

Scientists who study coronaviruses or design antiviral therapies are grinding away at their research like never before. But some of their counterparts in other academic laboratories are winding their work down, as the coronavirus pandemic leads to institutional shuttering and people avoiding working in close contact. In an email to staff Saturday morning the Broad Institute of MIT and Harvard, wrote announcing that "non-critical" work at the institute had to wrap up by this coming Wednesday. While this degree of closure appears to be limited as of this writing, researchers at other universities say they have started preparing should they need to close. Learn More

In response to the substantial interest on the part of our community for the content featured in the Solution portion of Friday's Alert, we have elevated the product in question and the program associated to ensure its availability, to this News Alert space. Apprentice has prepared kits for the immediate deployment of their Tandem platform to address the rapidly changing work environment being experienced by our industry attributable to COVID-19. The Tandem platform enables in-suite operators to connect with remote Co-Workers, SMEs, CROs/CMOs, Vendors and the like. These kits are customizable and come with the enterprise ready Tandem platform pre-loaded on hands-free, clean room compliant, augmented reality smart glasses and accessories. Learn More

Not surprising, biopharma plastic recycling isn't as simple as recycling ordinary plastic. One of the key reasons for this lack of recyclability is that biopharma plastics often contain a mixture of silicon, polyethylene and polypropylene - materials that are difficult to separate. In addition, purifying these types of plastics has also proven to be very difficult. However, according to Jacqueline Ignacio Hollands, global manager, customer sustainability solutions, at MilliporeSigma "When the program launched in 2015, many others in the industry said that this plastic waste could not be recycled. Five years later, we've engaged 15 biopharma companies and recycled over 4,400 tons -and the industry is starting to take notice. In fact, many biopharma manufacturers are asking how and when they can get the process closer to their operations." Learn More

A Stanford University professor and stem cell pioneer whose first job in science paid $25 a month is poised to receive a $191 million windfall from the sale of the immunotherapy biotech firm he co-founded. Irv Weissman, 80, owns 4.2% of Forty Seven Inc., which Gilead Sciences Inc. agreed to buy for about $4.9 billion, a remarkable amount considering the company's market value was less than $250 million just five months ago. Weissman, a native of Great Falls, Montana, is a leader in stem cell research and was the first to identify and isolate blood-forming stem cells from mice. Learn More

Rubius Therapeutics will end development of its most advanced drug as it looks to save money by moving away from rare disease research. The decision, according to Rubius, is partially due to setbacks that stung its lead drug, an experimental treatment for the uncommon metabolic disorder phenylketonuria, or PKU. An early study of the drug had a delayed start, and then results from the first patient were "uninterpretable," the biotech said. Rubius expects the costs saved by shuttering its rare disease programs will give it enough cash to operate into 2022. The news sent the company's share price tumbling 50% in an already difficult financial market. Learn More

President Trump has announced a 30-day ban on most visitors from continental Europe to the United States beginning this Friday, March 13th at Midnight. As of this writing the ban does not apply to the U.K. nor does it apply to cargo. However, it does apply to foreign nationals who have been in certain European countries at any point during the 14 days prior to their scheduled arrival in the United States. For Americans seeking to return home, the US government will issue a notice in the next 48 hours requiring them to travel through select airports where they will be subject to enhanced screening procedures. No word yet on which airports these will be. Learn More

Growing concerns about the health and safety of attendees have resulted in the decision by their respective organizers to reschedule the World Vaccine Congress and cancel the Spring Meeting of ISBiotech. As of this writing, the rate at which industry conferences are being rescheduled has begun to increase significantly so attendees and exhibitors alike are being urged by organizers to check back often on the status of the respective conferences they are planning to attend. 

MassBio and Bayer have announced the Center for Regulatory Excellence, a first-of-its-kind forum for startups and academia to interact with and learn from regulatory experts. The Center for Regulatory Excellence will provide formal mentorship and regular seminars to ensure early identification and mitigation of regulatory issues and optimize the chances of regulatory success. The Center will host regular seminars that will be open to all startups in the biotech and digital health space. Each session will focus on specific areas of interest related to the regulatory process and will entail lectures, open dialogue, and networking. Learn More

Growing concerns about the health and safety of attendees have resulted in the decision by their respective organizers to reschedule InterphexBioprocessing Summit Europe and Analytica. Additionally, CDER organized meetings, conferences and workshops are being postponed or cancelled through April. As of this writing, the rate at which industry conferences are being rescheduled has begun to increase significantly so attendees and exhibitors alike are being urged by organizers to check back often on the status of the respective conferences they are planning to attend. 

As a precaution amid the global coronavirus outbreak, the US FDA this week canceled all foreign travel by agency officials and said it is limiting domestic travel to "mission critical only" through April. FDA Commissioner Stephen Hahn also said the agency will postpone most foreign inspections, though some "will still be considered on a case-by-case basis." Last month, the FDA stopped conducting inspections in China while the outbreak was mostly contained within the country. For her part, CDER Director Janet Woodcock said that CDER-organized meetings, conferences and workshops will be postponed or canceled through April. Learn More

Roughly a week after announcing that its CSO was leaving, and that over half its staff would be cut, Unum has made public a decision by the US FDA to place a partial clinical hold on its cancer drug ACTR707. This latest hold, which follows an FDA hold of a couple of years ago which resulted from two patient deaths, relates to a phase 1 test of ACTR707 in combination with Roche's Rituxan. According to the 8-K filing with the SEC that the company was required to submit, a patient in the latest trial experienced a Grade 3 serious adverse event possibly related to ACTR707. Learn More

Plastics are a victim of their own success, so inexpensive, easy to use and versatile that the world is awash in plastic waste. Now researchers from the University of Houston have reported a new method of producing polyolefins -- made from hydrocarbons and the most common building block of plastics -- structured to address one of the biggest stumbling blocks to plastics recycling. The process also would allow plastics to be produced from food oils and other natural substances. Eva Harth, director of the Welch-UH Center for Excellence in Polymer Chemistry, said the process addresses a long-standing need for industrial plastics producers, without requiring a new catalyst or expensive additives. "It's a very simple process," she said. Learn More

The U.S. Court of Appeals for the Federal Circuit has affirmed the lower court's denial of Genentech's motion for a preliminary injunction to enjoin sales of Amgen's Trastuzumab biosimilar, Kanjinti. According to published reports, Amgen launched Kanjinti in the United States in July 2019, after the U.S. District Court for the District of Delaware denied Genentech's motion, and both the District Court and the Court of Appeals denied Genentech's subsequent motions to for an injunction pending resolution of Genentech's appeal. The Court of Appeals issued its judgment without opinion, pursuant to Federal Circuit Rule 36. However, the patent litigation involving Kanjinti is still pending. Learn More

Pharming Group has made public a decision by the US FDA to approve their new production facility in the Netherlands. The facility, which will focus on the production of starting material, will support the company's lead product, RUCONEST®. With this latest approval product manufactured with material from the new site during the approval process is also immediately available for the US market. As previously announced, Pharming had already received approval for output from the new facility from the European Medicines Agency for commercial use in the European Union. Learn More

Amid increasing concerns about the health and safety of attendee's, both the BPI West conference and PDA Annual Meeting have been rescheduled by their respective organizers. As of this writing, industry conferences such as the 10th Spring Meeting organized by IS Biotech scheduled to begin March 23rd, the World Vaccine Congress scheduled for April 7th and Interphex scheduled for April 28th are planning to take place as scheduled. However, this remains a very fluid situation, so attendees and exhibitors alike are being urged by organizers to check back often on the status of the respective conferences they are planning to attend. 

FiercePharma reports that biopharma companies it spoke to late last month were simply limiting travel to hard-hit countries such as China, South Korea and Italy. Now, as more cases pop up across the U.S., Europe and Asia, their tone has shifted. GSK has "instructed all employees to postpone non-critical international business travel until further notice" while BMS has started restricting business travel and put the kibosh on workplace and company meetings until the end of March. And BMS' limits don't just apply to employees and contractors, but to partners, suppliers and vendors, too, a spokeswoman said. Learn More

The U.S. Federal Circuit court issued a Rule 36 affirmance of the district court's judgment of non-infringement in the litigation involving Celltrion's infliximab biosimilar.  The court heard oral argument in the appeal last week. This comes after Janssen had appealed the district court's order granting Celltrion's motion for summary judgment of non-infringement of U.S. Patent No. 7,598,083, covering Janssen's REMICADE.  Celltrion cross-appealed the district court's denial of Celltrion's motion to dismiss for lack of standing. Learn More

Three people who attended a two-day management meeting with roughly 175 Biogen co-workers at a hotel in Boston last week have tested positive for the coronavirus. According to published reports a number of attendees reported varying degrees of flu-like symptoms. Some attendees have been confirmed with influenza and three attendees have tested positive for COVID-19 to date. Everyone who attended the meeting, whether they have symptoms or not, have been directed by Biogen to work from home for the next two weeks. The company said it will also be taking other precautionary measures, including restricting travel through the end of March. Learn More

The Healthcare Information and Management Systems Society has canceled its annual health information and technology conference in the wake of the COVID-19 outbreak. The trade group confirmed cancellation of the event, which had been slated to run March 9-13 in Orlando, Fla., to exhibitors Thursday afternoon. "Made apparent by recent reports from the World Health Organization and the Centers for Disease Control and Prevention, the virus continues to spread globally and the situation is so dynamic that each day brings a new development," Elli Riley, senior director of exhibitor and meeting services at HIMSS, wrote in the email to exhibitors. "It is clearly necessary to cancel the 2020 HIMSS Global Health Conference & Exhibition." Learn More

A new study conducted by researchers at Bentley University in Waltham, Massachusetts, and at the University of New Mexico, finds that while the biopharma industry's profits outpace those of most sectors, they remain in line with those of industries that depend on research and development. The study found that the sector's profitability is similar to those in areas like tech, even while it outpaces most of the S&P 500. Its lead author said that policy solutions to high drug prices need to balance affordability with ensuring drugmakers can make medicines available. The study was published this week in the Journal of the American Medical Association. Learn More

China's competition watchdog has ruled that Danaher must provide research and development resources for an unfinished project related to the separation and purification of biomolecules as a condition for buying GE's biopharma business. No word yet on exactly what this means from a practical sense as details have not been forthcoming. Alert readers will recall that, roughly a month ago, South Korea conditioned its approval of the acquisition on Danaher agreeing to sell off no fewer than eight bioprocessing product assets. This comes after the EU granted approval late last year on the condition that Danaher sell five business to address concerns about competition. Learn More

The Center for Drug Evaluation and Research (CDER) is understood to be planning to open a new manufacturing research lab near its headquarters in White Oak, Maryland. The lab, which is said to be focused on pushing advanced manufacturing adoption, is expected to open in 2021. Alert readers will recall that Janet Woodcock, Director of CDER, is a strong proponent of continuous manufacturing in biopharma, having spoken extensively on the subject for several years. However, as of this writing details about the lab have not been made publicly available. Learn More

The cost of the new global headquarters of Britain's biggest drugs company has risen to about $1.3 billion (£1 billion), more than three times the original estimate. Astrazeneca had planned to spend $425 million (£330 million) on the Cambridge site, which will also be its research and development center, but the costs have jumped for a third time to make it one of the most expensive corporate buildings in the country. It is also way behind schedule - it was due to open in 2016. The latest cost estimate comes after a review by Mace, which replaced Skanska as construction manager in 2018. Astrazeneca moved from Alderley Park in Cheshire to the new site on the biomedical campus in the south of Cambridge seven years ago. Learn More

Thermo Fisher Scientific has agreed to pay about $10.1 billion for Qiagen. Thermo Fisher, based in Waltham, Mass., and Qiagen, Venlo, the Netherlands, said in a joint release that a tie-up would expand the combined companies' specialty-diagnostics portfolio, improve their commercial and geographic reach and their life-sciences offerings. Including debt of $1.4 billion, the deal is worth $11.5 billion, Thermo Fisher said. The deal is expected to be completed in the first half of 2021, subject to regulatory approvals and other customary closing conditions. According to analysts the deal comes at a good time for Thermo Fisher as the market is experiencing ongoing consolidation. Learn More

U.S. biopharmaceutical companies spent about $1 billion to bring each of their new drugs to market between 2009 and 2018, according to a new analysis published in JAMA this week. The analysis, which accounts for projects that failed in clinical development, confirms similar numbers that have been published in the past, although it rebuts a more recent finding putting the costs as high as nearly $3 billion, which used confidential data provided by drugmakers. Between 2009 and 2018, the median cost of developing a new drug was $985 million, while the average sum totaled $1.3 billion, according to the researchers, led by Olivier Wouters, assistant professor of health policy at the London School of Economics. Learn More

The US FDA's Center for Biologics Evaluation and Research (CBER) is looking for ways to facilitate the development of more products intended to treat individual or small groups of patients, including cell and gene therapies, antisense oligonucleotides and phage therapies. At a workshop at the FDA's headquarters in Silver Spring, MD this week, CBER Director Peter Marks addressed some of the barriers to developing individualized therapies such as "customized products" with a single indication and a mode of action that are tailored to individual patients, or "created products" that could target different indications via different modes of action. Learn More

GSK is looking to divest some of its antibiotic medicines as part of refocus efforts at the British pharma company. According to people familiar with the matter, the proposed sale of certain antibiotics will fuel an increased attention on the company's core focus areas - including immuno-oncology. The proposed divestment, reported initially by Bloomberg, consists of GSK's cephalosporins franchise, including the Zinnat and Fortum brands. The sale of this portfolio of products is expected to rake in several hundred million US dollars, as the drugs make around $200M each year, according to Bloomberg. GSK has already attempted to sell these brands, but failed to successfully do so, two years ago. Learn More

AstraZeneca has picked up a $350m windfall after selling off five hypertension medicines to generics specialist Atnahs Pharma. The UK pharma has a strategy of selling off older drugs and reinvesting the proceeds in its research pipeline, and this is just the latest in a string of such deals. The five drugs in question are Inderal, Tenormin, Tenoretic, Zestril and Zestoretic. Inderal, Tenormin and Tenoretic are beta-blockers, Zestril is an angiotensin-converting enzyme (ACE) inhibitor and Zestoretic is a fixed-dose combination of lisinopril and hydrochlorothiazide. The deal was first made public in January and covers global commercial rights to the five drugs. Learn More

PBS Biotech, perhaps best know for its innovative bioreactors, has leased a 63,789-square-foot freestanding industrial facility in Camarillo, according to brokerage Newmark Knight Frank. The recently renovated property, located at 4721 Calle Carga, features four ground-level loading doors with a 22' clear height; open bullpen areas; multiple labs; and breakroom. The building lies next to the 101 freeway and its location between Santa Barbara and the Greater Los Angeles area made it ideal for PBS Biotech. The new property is four times larger than PBS' previous location, accommodating their current space needs as well as allowing room for growth. Learn More

Gilead Sciences has approached cancer therapy company Forty-Seven with a takeover offer, according to people with knowledge of the matter. The latter is working on cancer treatments that harness the immune system to fight tumors. Gilead has explored a number of options, including a partnership, said the people, asking not to be identified as the matter is private. Forty-Seven has received interest from other potential suitors as well, they said. No deal has been finalized and talks could fall through, they said. Forty-Seven has seen its share price increase 192% in the past year, giving it a market value of about $2.3 billion. Learn More

The US FDA has approved a generic version of Daraprim, the anti-infective treatment made famous when Martin Shkreli's company raised its price by more than 5,000%. The approval means Shkreli's company, now called Phoenixus, will no longer have a monopoly on Daraprim, which lost patent protection years ago. Cerovene, a U.S. generics company, will market an identical product. It was not immediately clear how much Cerovene would charge for its version, or when it would be available. Competition for Daraprim is bad news for Phoenixus, which has been saddled with declining revenue and internal strife. Learn More

Merck KGaA has partnered with German tech company AMCM to carry out clinical testing on tablets manufactured using 3D printing. The collaboration - which could be a "massive move towards digitalization of the industry," according to Merck's chief strategy officer Isabel de Paoli - will focus initially on formulation development and production of 3D printed tablets for clinical trials. Merck and AMCM - part of the metal and polymer 3D printing specialist EOS group - are working on the development of a prototype tablet printer that they hope will be ready for testing later this year. Learn More

In a deal potentially worth billions of dollars, Biogen and gene-editing company Sangamo Therapeutics are exploring whether the latter's technology can treat a range of neurological conditions, including Alzheimer's disease, by regulating DNA. Deal terms leave Sangamo responsible for early research activities, with costs split between the two biotechs. Biogen will then take control of development once the drugs are close to in-human testing. The big biotech agreed to pay Sangamo $350 million upfront and lined up nearly $2.4 billion in various milestones. Once the deal closes, Biogen gains exclusive rights to three drugs and retains the ability to nominate up to nine additional undisclosed targets over a period of five years. Learn More

Biocon announced this week that it has received a Form 483 letter from the US FDA related to an inspection at its insulin manufacturing plant in Malaysia, where the company will produce its insulin glargine product, referencing Sanofi's Lantus. In a filing with India's stock exchange, Biocon said the FDA conducted a pre-approval inspection of the facility between February 10th and February 21st. The notice includes "3 observations, which we believe are procedural in nature," the company wrote. With the latest notice, Biocon said it is confident of addressing the observations "expeditiously" and said it is committed to "global standards of Quality and Compliance." Learn More

2020 is going to be a big year for biotech in Thousand Oaks, city officials say. Los Angeles-based Westlake Village BioPartners, the venture firm founded two years ago by former Amgen executives Sean Harper and Beth Seidenberg, plans to bring six biotech startups to the city by the end of the year, Economic Development Manager Haider Alawami told attendees at the annual Thousand Oaks Rotary Economic Outlook Forecast Breakfast. The life-science startups are expected to land in the industrial area of Newbury Park north of the 101 Freeway, which the city is trying to fashion into a biotech hub. Learn More

Takeda has exercised its option to buy U.S.-based PvP Biologics after seeing Phase 1 data from its only candidate, a celiac disease drug called KumaMax that was invented by a University of Washington undergraduate team. The deal will be worth up to $330 million for PvP's owners, based on development and regulatory milestones for KumaMax, which will now be called TAK-062. Takeda signed PvP to an option deal in 2017, which provided $35 million to cover research costs and allowed the company to bypass traditional venture capital funding. In Takeda's pipeline, TAK-062 will join TAK-101 in clinical trials for celiac disease. The latter was in-licensed from COUR Pharmaceutical last year. Learn More

Cancer drugmaker Iovance Biotherapeutics is exploring a sale and has held preliminary talks with potential buyers, according to people familiar with the matter. The San Carlos, California-based company is working with a financial adviser after receiving takeover interest, said one of the people, who asked to not be identified because the matter isn't public. No final decision has been made and Iovance could opt to remain independent, they said. The company's share price, surging since the company released strong trial results for its cervical and skin cancer treatments in May, has risen 203% in the past year, including this week's gains. Learn More

FUJIFILM Diosynth Biotechnologies broke ground this week on its North Carolina facility expansion project. The 31,778 square foot addition includes the expansion of its cell culture and microbial manufacturing trains through the addition of new recover and purification suites. The North Carolina site will increase its cell culture manufacturing capacity by approximately 25% and microbial capacity by approximately 50%. A new receiving warehouse is also included in the project. FDB expects that the increased production capacity will be ready for cGMP manufacture by mid-2021. Learn More

For years, government research agencies have misinterpreted a law that requires them to collect and post clinical trial data, a federal judge ruled this week, leaving behind a 10-year gap in data that now must be made publicly available. Now, potentially hundreds of universities, drug companies, and medical device manufacturers are on the hook to release previously unpublished data. The ruling affects trials conducted for as-yet-unapproved drugs and devices in that 10-year stretch, according to a lawyer for the plaintiffs - meaning hundreds or even upwards of 1,000 noncompliant trials would be forced to post data. The ruling puts sponsors of clinical trials during that span out of compliance if they have not posted results. Learn More

Bicycle Therapeutics has entered into a strategic collaboration agreement with Genentech. Under the terms of the agreement, Genentech and Bicycle will collaborate on the discovery and pre-clinical development of novel Bicycle-based immunotherapies against multiple targets. Bicycle will be responsible for discovery research and early pre-clinical development up to candidate selection, and Genentech will be responsible for further development and commercialization upon the selection of candidates.to discover, develop and commercialize novel immuno-oncology therapies. For its part, Bicycle will receive a $30 million upfront payment with commercial-based milestone payments worth up to $1.7 billion. Learn More

This week the American Society of Retina Specialists issued a note to eye doctors warning about worrying side effects seen with Novartis' new macular degeneration treatment, Beovu. A drug which has been targeting the market share of Regenerons' Eylea. According to the warning, there have been several cases of a dangerous form of eye inflammation called vasculitis; although this was seen in Beovu's clinical program, these occurrences appear to confirm that this is a real issue for the product. Retinal vasculitis can lead to blindness and although only 14 cases were reported to the ASRS, 11 were classified as occlusive retinal vasculitis. Learn More

Sanofi will spin out some of its drug production activities into a new company, announcing plans this week to create a standalone contract manufacturer specializing in the active ingredients which compose pills or other medicines. Seeing an opportunity amid recurring shortages of critical generic drugs, Sanofi expects the new company could earn roughly $1.2 billion in sales by 2022, which would make it the world's second largest API producer according to the pharma. The planned spinout, which has yet to be named, will be sizable, employing 3,100 and holding a network of six API factories across France, Germany, Italy, Hungary and the U.K. Learn More

Mallinckrodt is widely understood to be finalizing a settlement proposal worth at least $1.6 billion that would place its U.S. generic-drug business into bankruptcy to address coming debt maturities and liabilities stemming from the opioid crisis, according to people familiar with the matter. The details of the proposed deal are said to include a chapter 11 bankruptcy filing covering its U.S. generics business and a resolution of claims from hundreds of state and local governments stemming from the cost of combating opioid addiction. Alert readers will recall that Mallinckrodt is one of several company's wrestling with the effects of their alleged role in the opioid crisis. Learn More

In early 2019, the FDA began accepting proposals for projects seeking to assist the regulator in meeting the 2023 requirements of the Drug Supply Chain and Security Act (DSCSA) - which requires the biopharma industry to track "legal changes in ownership of pharmaceuticals in the supply chain." This week the 25 leading biopharma manufacturers, distributors, logistic partners, and other representatives of the biopharma supply chain that make up the MediLedger working group have published a report arguing in favor of adopting blockchain technology to track and trace prescription drugs.  Among the groups members are Pfizer, AmerisourceBergen, Walgreens and FedEx to name a few. Learn More

A month before the long-anticipated transition of applications for certain biological products to be deemed to be licensed as biologics, the US FDA has issued a final rule amending its definition of "biological product." Effectively, on March 23rd, 2020, some 100 products approved under new drug applications (NDAs) will transition to biologics license applications (BLAs). Under the rule, the FDA is amending its definition of "biological product" in line with the statutory definition set by the BPCIA. As such, the FDA now interprets the term "protein" to mean "any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size." Learn More

For the second time this month Gilead has suffered a loss in its high-profile feud with the US Government. Following a similar decision earlier this month, the U.S. Patent & Trademark Office's Patent Trial and Appeal Board decided not to strike up inter partes reviews (IPR) of patents held by the U.S. government. Gilead had challenged the patents in August, but for the second time this month, the board decided Gilead wouldn't be likely to succeed. Gilead "has not demonstrated a reasonable likelihood that it would prevail with respect to at least one of the claims," the PTAB said in its ruling. Alert readers will recall that the courts have demonstrated some aversion to ruling against the USPTO. Learn More

The U.S. FDA revoked the 'Voluntary Action Initiated' status issued to Aurobindo Pharma's plant in Hyderabad, days after indicating it might not pursue further regulatory action. The company has received a communication from the U.S. regulatory agency that the inspection conducted at its unit-IV - a general injectable formulation plant - "is still open and under review by way of rescindment of 90-day VAI letter", according to an exchange filing. This notification comes just days after Aurobindo informed the stock exchanges that it has received the VAI status-allowing the company to make voluntary changes to the unit if needed and shielding it from any adverse action by the regulator. Learn More

WuXi Vaccines has announced that it has entered into a strategic partnership with a global vaccine leader and signed a 20-year vaccine manufacturing contract valued approximately $3 billion. As part of the deal WuXi will build an integrated vaccine manufacturing facility including drug substance manufacturing (DS), drug product manufacturing (DP), Manufacture Science and Technology Labs (MS&T) as well as Quality Control labs (QC). The facility will be dedicated to manufacture one of its partner's vaccine products for the global market. The new facility is expected to be operational in 2022. Learn More

Immatics Biotechnologies has entered into a strategic collaboration agreement with GSK to develop novel adoptive cell therapies targeting multiple cancer indications. The companies will collaborate on the identification, research and development of next-generation T-Cell Receptor (TCR) Therapeutics with a focus on solid tumors. Under the terms of the agreement, Immatics will receive an upfront payment of $50 million for two initial programs and is eligible to receive over $550 million in development, regulatory and commercial milestones for each product as well as additional royalty payments. GSK obtains an option to select additional target programs to include in the collaboration. Learn More

A Teva Pharmaceutical drug in testing as a treatment for tics in pediatric patients with moderate-to-severe Tourette syndrome has failed two late-stage trials. The drug, deutetrabenazine, didn't beat a placebo in reducing motor and phonic tics-the main goals of the Phase 2/3 and Phase 3 trials. Teva, which partnered Nuvelution Pharma on the Tourette studies, said the most commonly reported side effects in the trials were headache, sleepiness, and fatigue. In 2017 Teva secured FDA approval for deutetrabenazine as a treatment for two conditions that involve involuntary movement. Both approvals were for adults with the conditions. Learn More

Five Prime Therapeutics has announced a global license agreement with Seattle Genetics to develop and commercialize novel antibody-drug conjugate (ADC) therapies using monoclonal antibodies developed by Five Prime. Under the terms of the agreement, Five Prime granted Seattle Genetics an exclusive worldwide license to a family of monoclonal antibodies that are directed to a single target for a $5 million upfront payment and Seattle Genetics will be responsible for research, development, manufacturing and commercialization of ADC products based on these antibodies. Learn More

Biotech venture capitalists make their money by seeing the future better than most of us, and three of them shared their insights at the STAT Summit. They talked about cell therapies and other efforts to harness the body's own disease-fighting abilities, but also how to more efficiently develop traditional small-molecule drugs using new technology. "I think there's actually an angle to making small molecules cool again," Dr. Krishna Yeshwant, a general partner at GV, Alphabet's venture capital investing arm, said during a panel called "Building the Next Big Thing." He said GV is investing in companies working to make clinical trials more efficient. Learn More

A new Innovation Center has been opened in Dublin, Ireland, by the National Institute for Bioprocessing Research and Training (NIBRT) and Boston Consulting Group (BCG) as part of the Biopharma 4.0 (B4.0) Alliance. The facility will be dedicated to biopharma operations and showcase the latest Industry 4.0 (I4.0) technologies in biopharma manufacturing, bioprocessing, quality control and training. According to the NIBRT, the technologies are integrated with core operating processes to enable proof-of-concept use cases on new discoveries and ways of working, situated in a good manufacturing practice (GMP) simulated environment. Learn More

Audentes Therapeutics, a gene therapy developer recently bought by Astellas, will invest about $110 million to build a manufacturing plant in North Carolina, joining a growing list of drugmakers choosing to locate new drug production facilities in the state. For Audentes, the decision to invest in a new facility emerged from planning for when the biotech outgrows the capacity it currently has in a South San Francisco plant, according to Donald Wuchterl, the company's head of technical operations. Audentes cast a wide net for where to place its newest facility, eventually choosing a small town southwest of Raleigh already home to one gene therapy plant, which Pfizer's now spending $500 million to expand. Learn More

Akebia Therapeutics has agreed to pay $10 million to its partner Vifor for the latter to agree to hold onto its newly procured Priority Review Voucher, or PRV, until the companies decide what to do with it. The details of the arrangement say that the two companies will either use the voucher on the approval application for Akebia's experimental anemia drug or resell it and share the proceeds. According to industry analysts, possession of the voucher could move up an FDA decision on Akebia's drug to the middle of 2021. That timeline would put Akebia and Vifor roughly just six months behind competitors AstraZeneca and Fibrogen. Learn More

Frank Reynolds, the CEO of Boston-based PixarBio Corp., was sentenced this week in federal court to seven years in prison for defrauding the company's investors and obstructing a federal investigation. Reynolds was also sentenced to three years of supervised release following his prison sentence. He was ordered to pay $280,000 in forfeiture and roughly $7.5 million in restitution, according to Lelling's office. Alert readers will recall that during the trial back in October jurors heard testimony that Mr. Reynolds had been cured of his paralysis by the company's lead drug, only to learn later that he in fact had never been paralyzed. Learn More

AI hit a big milestone in January as the first drug designed entirely using artificial intelligence entered human clinical trials. The compound, created by Exscientia, reached this stage in less than a year, five times faster than it usually takes to get a drug to this stage. It is the speed that made the rest of the biopharma industry sit up and take notice. It takes on average 10 to 12 years to bring a new drug to market. "AI could be a bigger revolution for the pharmatech industry than the development of DNA sequencing," says Andrew Hopkins, founder and chief executive of Exscientia. He believes that artificial intelligence could cut the cost of bringing a drug to market by 30%. Learn More