News Alert

China-based biotechnology startups looking to go global are poaching talent from the biggest American pharmaceutical companies, promising managers and medical chiefs lucrative pay packages and a more entrepreneurial work environment-all without asking them to uproot their lives in the U.S. At least a half-dozen Chinese biotech startups have established offices from Greater Boston to Silicon Valley in recent years, looking to commercialize their treatments in the world's largest drug market by sales.  Learn More

The Bureau of Pharma PSUs of India (BPPI), which implements the Centre's flagship affordable medicine scheme PMBJP, has found 25 batches of drugs of 18 different pharmaceutical companies to be of substandard quality since January 2018, according to an official document. While 17 out of the 18 companies are private, one is a public sector unit (PSU) -- Indian Drugs and Pharmaceuticals Limited (IDPL), according to the document. Both the BPPI and the IDPL work under the Department of Pharmaceuticals of the central government. Learn More

A recent article published by Business Insider shares the experience of attending a $1,325, two-day class called "Biotech for Non-Scientists". Which teaches executives, web designers, investors and others who work in or around the healthcare industry about the science at its very core. Attendees come from some of the biggest healthcare companies around, like Merck, Pfizer and Roche. Some haven't taken science classes since high school. Founder Stacey Hawkins came up with the idea and her company, Maryland-based Biotech Primer, nearly 20 years ago when she realized that even people in the burgeoning biotech field were having trouble keeping up with the complex, ever-changing science. Learn More

A heavily researched, well written article in Bloomberg Businessweek published this week, sheds light on the efforts of the NIH and FBI to target ethnic Chinese scientists, including U.S. citizens, searching for a cancer cure. The article provides the first in-depth account of what happened to Xifeng Wu, former Director of the Center for Public Health and Translational Genomics at the University of Texas MD Anderson Cancer Center in Houston. There is even a term that has been coined to refer to cancer researchers identified by the NIH as possibly having too close of ties to China, "oncological double agent". Learn More

GSK has announced that it will team up with some of the nation's most prominent CRISPR researchers to use the gene-editing technology in a search for new medicines, establishing a new lab in San Francisco and spending up to $67 million over five years. Jennifer Doudna, the University of California, Berkeley, researcher who co-invented the CRISPR enzyme technology, will help lead the effort, along with Jonathan Weissman, a UC San Francisco researcher who has been using CRISPR to understand the function of individual human genes and how they work together. The lab will be called the Laboratory for Genomic Research and will be based near UCSF's Mission Bay campus. Learn More

Peter Marks, head of the FDA's Center for Biologics Evaluation and Research, said his top concern for gene therapy's future is manufacturing, and how companies will scale up production to match scientific advances. "When the cost of goods are very high, they help justify when people charge astronomical prices," Marks said in a recent interview with BioPharma Dive. "If we can help see cost of goods and ability to manufacture reproducibly improve, I think that'll be a big thing. That's something we're working on but something that keeps me up at night." The FDA aims to finalize six draft guidance documents by the end of 2019 related to gene therapy, including some that will address specific manufacturing issues, Marks said. Learn More

A sweeping antitrust lawsuit, filed last month by 43 state attorneys general accusing the world's biggest generic drug manufacturers of fixing prices on dozens of drugs, has identified the alleged key player. Maureen Cavanaugh, a former senior vice president at Teva Pharmaceuticals, is accused of colluding to raise prices, as much as 1,000% in some cases, on 107 different generic drugs. While not identified as the mastermind behind the five-year-long price-fixing conspiracy, Cavanaugh stands out due to the sheer number of drugs she is alleged to have colluded on to fix prices.  Learn More

Catalyst has filed a lawsuit against the U.S. FDA claiming the regulator's recent approval of a new drug is illegal and should be thrown out. The lawsuit is the latest chapter in a bizarre competition between Catalyst Pharmaceuticals and Jacobus Pharmaceutical, two small biotechs that both have FDA-approved drugs for a rare disease called Lambert-Eaton Myasthenic Syndrome, or LEMS. At the core of Catalysts lawsuit are two claims, the first being that the labeling of the drug from Jacobus is illegal. The second claim being that the the FDA violated the orphan drug exclusivity period by approving a competitor after just a few months had passed. Learn More

Swedish Orphan Biovitrum (Sobi) has agreed to buy the drug emapalumab from Novimmune for $519 million per the terms of a licensing agreement signed in 2018. The deal includes the staff involved with the drugs development as well as a priority review voucher from the U.S. FDA. This comes as Sobi has announced that it is reorganizing to increase its focus on late-stage development in hematology and immunology, resulting in the elimination of roughly 90 jobs in R&D. Moving forward Sobi's R&D efforts will be split between Sweden and Switzerland, the latter being home to Novimmune. Learn More

An explosion at the Pusilin Biotechnology facility outside New Delhi, an Indo-Chinese joint venture, has killed three. While the exact cause of the explosion is unknown, it is understood that the three men, one a welder and the other two engineers, were repairing a boiler adjacent to the oven used to dry the company's primary product, chondroitin sulfate, when the fatal blast occurred. Amid allegations of negligence authorities have issued arrest warrants for the company director and two senior executives. However, their whereabouts are unknown as of this writing. Learn More

Genentech's blood cancer drug Polivy earned an accelerated approval from the U.S. FDA due to the complete response rate shown during clinical trials. This marks the fifth blood cancer drug approved for Genentech. Polivy, which was also granted Breakthrough Therapy designation, uses ADC technology developed by Seattle Genetics and licensed to Genentech. The FDA's Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition. Polivy was approved two months ahead of its August PDUFA date. However, the FDA noted that further clinical trials are required. Learn More

AstraZeneca's new global headquarters in Cambridge, UK is now estimated to cost $950 million. That is roughly twice the estimated cost when the project kicked-off several years ago. According to AZ's latest annual report, the increased costs can be attributed to the complexity of the architecture, general inflation in construction costs and "increased investment in new technologies and equipment". While occupancy of the new site was originally planned for 2016, the latest schedule has occupancy starting in 2020 with the site not being fully operational until after 2020. Learn More

This week, Roche said it received a request for additional information and documentary material from the U.S. Federal Trade Commission in connection to the agency's review of the pending $4.8 billion acquisition of Spark. However, it isn't just U.S. regulators who are now closely examining the deal. Roche has also let it be known that the U.K. Competition and Markets Authority has opened an investigation in order to obtain further information in relation to Roche's proposed acquisition of Spark. This brings the total number of delays to date to four and counting. Learn More

Insys Therapeutics filed for bankruptcy this week and will sell most of its assets, just days after agreeing to pay $225 million to settle charges of bribing doctors to boost prescriptions of its addictive painkiller. The filing, which was widely signaled, also comes weeks after a federal jury in Boston convicted Insys founder and former billionaire John Kapoor, along with four other former executives, of racketeering charges that contributed to the opioid crisis ravaging the U.S. The move marks a striking reversal of fortunes for a company that reportedly was responsible for the best-performing initial public stock offering in 2013. Learn More

Merck & Co has announced its agreement to acquire privately held Tilos Therapeutics for up to $773 million, bolstering its pipeline of drugs to treat cancer and autoimmune diseases. The deal includes an upfront payment and contingent milestone payments but the details of which have not been made public as of this writing. Massachusetts based Tilos was founded in part by the  Boehringer Ingelheim Venture Fund based on discoveries by the laboratory of Dr. Howard Weiner at Brigham and Women's Hospital and Harvard Medical School. Learn More

Vertex is committing $420 million in a pair of deals that expand the company's research scope to experimental genetic treatments for two forms of muscular dystrophy. The biotech has announced that it reached an agreement to pay $245 million up front to acquire Exonics, a company using gene editing techniques to develop a treatment for Duchenne muscular dystrophy and myotonic dystrophy type 1. Vertex also said it is paying CRISPR Therapeutics $175 million up front to expand an existing research collaboration to include Duchenne and myotonic dystrophy type 1. Learn More

Lilly has filed a petition with the U.S. Supreme Court asking it to reconsider the opinion of the lower federal court which invalidated Cialis' BPH patent. The opinion of the lower court stems from a challenge back in 2011 by a German company which Lilly claims represented a "particularly egregious example of functional claiming," a challenge the company said violated SCOTUS precedent. This latest legal maneuver comes amid an ever-growing chorus of drug companies announcing plans to bring to market generic challengers to Cialis, the effect of which has been an increasing headwind for global sales. Learn More

Tergus Pharma has announced plans to build a state-of-the-art commercial manufacturing facility in the Raleigh-Durham, NC area and will begin construction in July 2019. The new 100,000 square foot facility will have Clinical Trial Material (Phases I thru III) Supplies and commercial manufacturing capabilities and expand current capacity by over 400%. Tergus plans to open the new facility in early 2020, enabling the company to act as a CDMO by providing comprehensive services from development through manufacturing. This expansion comes as Targus announces a partnership with Great Point Partners which will provide the requisite funding. Learn More

Sanofi is poised to appoint Paul Hudson, a top executive with Switzerland's Novartis, to become the French drugmaker's next CEO effective September 1stof this year. Current Sanofi SA CEO Olivier Brandicourt will leave the company to retire, according to a source who asked not to be named because of the sensitivity of the matter. Reuters had reported on March 18ththat Sanofi was working to find a successor to Brandicourt. Hudson, born in 1967 according to Novartis' website, has been CEO of Novartis Pharmaceuticals unit since 2016. He is a member of Novartis' executive committee. Learn More

FUJIFILM has announced an initial $10 million investment to establish a full scale, fully integrated continuous processing facility for non-GMP manufacture of biopharmaceuticals at its FUJIFILM Diosynth Biotechnologies, Billingham, UK location. This perfusion-based facility represents the culmination of 3 years of in-house innovation by Fujifilm group companies and includes the introduction of patented, disruptive downstream bioprocessing technology to the biopharmaceutical industry. The new facility will include a 500L single use perfusion bioreactor and 7 patented downstream processing units which are expected to be available for process development services this Fall. Learn More

A former GSK R&D site near Philadelphia is being redeveloped into a WeWork-styled campus for healthcare and life sciences firms, part of a plan to turn Pennsylvania into a more attractive research hub for the industry. The site was bought last year for a reported $50 million, and spans 1.6 million square feet. The bulk of that is in Upper Merion, where GSK has leased back space, while 640,000 square feet will be dedicated as a "coworking ecosystem."
Efforts to establish new R&D centers outside of the industry's traditional hubs in the Bay Area near San Francisco and Cambridge, Massachusetts, have been mostly mixed. Learn More

A team of researchers inside Pfizer made a startling find in 2015: The company's blockbuster rheumatoid arthritis therapy Enbrel appeared to reduce the risk of Alzheimer's disease by 64 percent. The results were from an analysis of hundreds of thousands of insurance claims. Verifying that the drug would actually have that effect in people would require a clinical trial costing as much as $80 million - and after several years of internal discussion, Pfizer opted against further investigation and chose not to make the data public. However, for its part, Pfizer makes clear that it was purely a scientific decision based on facts and not an ecomomic one. Learn More

A draft bill in the U.S. Congress that would overturn a landmark U.S. Supreme Court decision that barred the patenting of human genes and ease other restrictions on patenting software and biomedical inventions is drawing fierce criticism from some scientific societies and patient advocates. This week, the ACLU along with more than 100 other signatories from research institutes and advocacy groups, released a letter to lawmakers arguing the changes would stifle medical research and hinder patients' access to diagnostic tests. The bill aims to address the complaint that recent Supreme Court decisions have created confusing and overly stringent patent eligibility rules. Learn More

Amgen released data this week from its phase 1 study on an investigational bispecific T cell engager molecule, updated with investigational AMG 420 results for the treatment of refractory multiple myeloma. The company said that 19 of the 42 patients in the study showed serious adverse events to the treatment, with 16 of those patients requiring hospitalization. Dr. David M. Reese, executive vice president of research and development at Amgen stated "As a leader in the development of targeted immuno-oncology therapies, we continue to investigate and advance more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumors."  Learn More

A Samsung Electronics executive was arrested overnight on allegations of ordering destruction of evidence related to a suspected accounting fraud at a Samsung affiliate. The executive, who was arrested around midnight, is accused of ordering the destruction and manipulation of accounting data and other internal documents of Samsung BioLogics and Samsung Bioepis in 2018. Eight employees from Samsung and its affiliates have now been arrested in recent weeks. The latest arrest comes after prosecutors last month raided a Samsung BioLogics factory, uncovering a cache of hidden electronic devices they believe are linked to the case. Learn More

China will audit the finances of 77 major biopharma companies, including Sanofi, Lilly and BMS after one of its largest listed drugmakers was found to have overstated its cash position by $4.3 billion. The list of drugmakers to be audited in June and July was randomly chosen, says China's Ministry of Finance. It also includes China's biggest domestic drug firms, among them Jiangsu Hengrui and Shanghai Fosun. The audit comes weeks after Kangmei Pharmaceutical, a producer of traditional Chinese medicines, said after a regulatory probe that it had used false documents and transaction records to overstate its cash holdings. Learn More

Bayer has signed an alliance with Arvinas to gain access to the U.S. biotech firm's experimental protein drugs and crop protection technology in a deal worth up to $750 million. Under the pact, Arvinas will receive an upfront payment, pharmaceutical research and development support and a direct equity investment of more than $60 million. In addition, milestone payments linked to development achievements and commercial royalties could add up to slightly more $685 million according to Bayer which is cutting jobs and revamping its drug development activities to rely more on external partners. Learn More

Bio-analytical testing biz Eurofins Scientific has made public that it was the subject of a ransomware attack over the weekend. The company said in a statement that its tech security team had detected the malware and that in accordance with its incident management procedures, many systems and servers were taken off line by the group's IT teams to contain the activity of this new version of malware. The company has noted that "at this time there is no evidence of unauthorized transfer or misuse of data." However, the company notes that select labs and sites may be impacted, creating temporary disruption and delays to some of its services. Learn More

Bayer's animal health unit is attracting attention from several private equity bidders in a deal that could be worth up to $9 billion. If it goes through, the transaction would mark one of the largest European buyouts of the last decade. BC Partners has reportedly emerged as a potential front-runner as it is said to be considering partnering up with another investor to make an offer for the business. The sale of Bayer's animal health products division was originally announced last year as part of a cost-cutting drive that would also see the German giant scrap 12,000 jobs. Bayer's quest to slash costs follows its $63 billion acquisition of Monsanto. Learn More

Aldevron has announced plans to build a 14-acre gene therapy manufacturing campus at its headquarters in Fargo, North Dakota. Phase one of the construction project will start in August. Once completed, its annual capacity will be more than $1 billion of plasmid DNA, RNA, gene editing enzymes and other biologics. The expansion will increase biotech production capacity 10-fold, grow its warehouse space by more than four times, and develop a research and development center. The new construction will include three new buildings totaling 189,000 square feet. The first building is expected to be fully operational by the first quarter of 2021. Learn More

Drugmakers and industry groups are calling for changes to the U.S. FDA's recently released draft guidance, Quality Considerations for Continuous Manufacturing. The 27-page draft guidance was released for comment in February and is part of FDA's effort to encourage the adoption of continuous manufacturing, which the agency believes can improve consistency and reduce the risk of drug shortages. While there is great interest in continuous manufacturing at the FDA, drugmakers have been slow to transition to continuous manufacturing processes. To date only a handful of drugs are manufactured using continuous manufacturing. Learn More

Imprisoned "Pharma Bro" Martin Shkreli has sued three former colleagues over his ouster from the unethical pharmaceutical company he founded, alleging they were "driven by their egos, jealousy, and greed." The notorious Brooklyn-born troll is serving seven years for securities fraud. His lawsuit describes a Bizarro Shkreli who was a "brilliant leader" and entrepreneur who founded his company after being "particularly moved" by a young boy suffering from a rare disease. Shkreli, 36, alleges that Retrophin execs Stephen Aselage, Margaret Valeur-Jensen and Gary Lyons conspired to oust him from his beloved company, screwing him out of over $30 million. Learn More

Merrimack Pharmaceuticals will lay off its entire staff, including its leadership team, as the Cambridge, Mass.-based company looks to be in the midst of shutting down. Late last week the company announced the results of a months-long strategic review that include the job cuts, as well as a deal with startup 14ner Oncology, Inc. Merrimack will sell its anti-Her3 monoclonal antibody programs, MM-121 and MM-111, for up to $58 million. The deal includes $3.5 million in upfront cash and to $54.5 million in contingent milestone payments. A potential plan to rebuild will be announced at the company's next annual meeting of shareholders. Learn More

Our friends over at BioPharma Dive have published a thoroughly researched, well written article on one of the most taboo topics in our industry, compensation. In it we learn that the average wage increase for CEO's last year was 39% to $7.2 million while employees saw an average increase of 6% to $177,560 and that less than 10% of biopharma CEO's are women. Their results were compiled from analyzing the filings of nearly 200 biopharma companies, ranging in size from giant pharma's to small biotech's. Learn More

Amarin will get a regulatory decision sooner than expected on an important label expansion for its fish oil-based pill, Vascepa. The company announced this week that the U.S. FDA will decide by September 28th on approving the drug for treating heart risk. The sped-up timeline comes courtesy of a priority review granted by the FDA, setting up a potential approval in late 2019 rather than early 2020. The biotech is still waiting, however, on further word from the agency on whether its application will require an advisory committee review, a critical step in the process that could bring heightened scrutiny on Vascepa. Learn More

Just a day after the announcement of his resignation from Atara comes word that Dietmar Berger has joined Sanofi as head of development. Berger spent almost 20 years rising through the oncology ranks at Amgen, Bayer and Genentech, culminating in him holding a senior vice president position at the Roche unit. One year ago, Berger joined the exodus from Big Pharma to biotech by accepting the position of global head of R&D at Atara, an off-the-shelf cell therapy player. The appointment reunites Berger with John Reed, his former co-worker at Roche, now Sanofi's global head of R&D. Learn More

AstraZeneca has decided to trim back its 2015 alliance with Inovio Pharmaceuticals, which focused on combining the biotech's DNA cancer vaccines with AZ's cancer immunotherapies. In an SEC filing, Inovio has revealed that AZ's Medimmune subsidiary has decided to cut the collaboration down to one vaccine that has already reached the phase 2 testing stage, forgoing rights to two other candidates. The original agreement included a $27.5 million upfront fee plus development and commercial milestone payments of up to $700 million. Shares of Inovio lost almost 17% of their value pre-market as news of the scaled down deal reached investors. Learn More

Atara Biotherapeutics has announced the appointment of Pascal Touchon as President, Chief Executive Officer and member of the Board of Directors. Prior to joining Atara, Dr. Touchon was most recently at Novartis Oncology serving as Global Head, Cell & Gene and member of the Oncology Executive Committee. Included in the announcement of Dr. Touchon's arrival at Atara is the announcement that Dietmar Berger, global head of R&D, has resigned from the company to "pursue other opportunities". Speculation is that Mr. Berger wanted the CEO position and has opted to leave as a result of not getting the job. Learn More

Iovance Biotherapeutics announced this week that it will build a 136,000-square-foot facility in Philadelphia to produce cancer therapies using its tumor-infiltrating lymphocyte (TIL) technology. While construction will take about two years, the California biotech expects to spend some $75 million over three years on the overall project, creating "several hundred" jobs in Philadelphia. Iovance received undisclosed financial incentives from the state, city and PIDC, a public-private economic development corporation, for the new site. It also has a letter of intent from PIDC for a five-year option to expand further. Learn More

The U.S. FDA has approved a new way for cancer drugs to be approved more quickly. The approval for the breast cancer treatment Piqray in combination with fulvestrant and alongside a companion diagnostic - came more than three months ahead of its PDUFA deadline and a little more than five months after it was submitted thanks to FDA's Real-Time Oncology Review (RTOR) pilot and Assessment Aid (AAid) programs. Up until now, the FDA had only approved supplemental new drug applications (sNDAs) and supplemental biologics license applications (sBLAS) under the RTOR pilot. The FDA had never even publicly said that it was expanding the RTOR pilot to NDAs until announcing that Piqray's NDA had been approved. Learn More

Emory University fired two neuroscientists after they were accused of failing to disclose foreign research funding and connections with China. Li Xiao-Jiang told Science magazine that the university fired him and his wife, Li Shihua--with whom he led a laboratory at the Atlanta university's medical school. The university also shut down their laboratory. Four Chinese postdoctoral students working in the lab were told to leave the U.S. within 30 days, Li said. Li and his wife are best known for studying Huntington disease. They are denying the allegations and suggested that their firing was part of a problem with hostility toward Chinese students and faculty on campus. Learn More

Longmont city council members this week voted their unanimous initial approval of an ordinance authorizing the offer of an estimated $1.9 million in incentives to AveXis to get the company to expand its presence in Longmont. AveXis, a subsidiary of Novartis, recently bought the 64.12-acre former AstraZeneca property at 4000 Nelson Road, rehired 150 full-time former AstraZeneca employees and has begun operations there. Longmont's proposed $1.9 million incentives package would include rebates on certain costs and taxes on property, machinery and equipment. Learn More

The U.S. FDA has approved Zolgensma, the first gene therapy for a type of spinal muscular atrophy. The disease is caused by a defect in a gene that makes SMN, a protein necessary for the survival of motor neurons. Zolgensma uses a re-engineered virus to deliver a functional copy of the defective gene so that SMN protein can be produced. Launching Zolgensma, which at $2.1 million will be the world's most expensive drug, promises to be a big test for Novartis. Alert readers will recall that the biopharma giant spent $8.7 billion to acquire AveXis last spring based in large part on the potential of Zolgensma. Learn More

Dynavax Chief Executive Officer Eddie Gray will step down from his role on Aug. 1 as the Bay Area company undergoes restructuring to move away from immuno-oncology and prioritize its vaccine business. The company announced the restructuring plan late last week. With the turning away from immuno-oncology, the company said it will reduce its workforce in order to focus resources on Heplisav-B. Dynavax will cull 82 positions, about 37 percent of its workforce. The positions eliminated are primarily related to research and clinical development for the immuno-oncology programs and general and administrative functions. Learn More

A new U.S. law intended primarily to curb Chinese investment is threatening the U.S. biotechnology industry. After passing Congress 400 to 2, the updated version of this little-known law, administered by a government committee called CFIUS, immediately triggered layoffs and reduced international fund flows into biotech companies. Because of its overly broad implementation and lack of an appeal mechanism, CFIUS is not only drastically reducing Chinese investment into US biotech. It is also threatening our country's drug discovery engine. With no route of appeal, CFIUS risks costing further jobs, hurting innovation and downgrading the United States as an innovator country. Learn More

Aspen Brook is closed today so that we may observe Memorial Day here in the States with family and friends. The Alert will return tomorrow, Tuesday, May 28th, at its regular time.

After a four-year decline that erased 65% from the value of Sun Pharma, comes word that the world's biggest generic drug manufacture will pursue branded drugs. That won't be easy, especially when the multinationals that dominate the pharmaceutical business have already seen the payoffs from their massive research and development spending become more uncertain. Those giants are increasingly turning to acquisitions to fill out their pipelines, and that's where Sun Pharma sees an opening. Sun Pharma thinks the company can eventually pick up enough early-stage innovations and key personnel to generate half its revenue from patented medicines. Learn More

Boehringer Ingelheim has announced a multi-million-dollar investment that will see the expansion of its manufacturing capacity in Mexico over the next two years. The majority of the investment, $52 million will be at the biopharma giants site in Xochimilco which specializes in oral dosage anti-diabetic drugs. The Xochimilco plant is one of three sites that Boehringer has in Mexico, and the capital injection will be destined to increase the production capacity by at least 50%. The expansion at the Xochimilco plant is part of an investment plan to invest $84 million by 2023 to boost production at all three of its production sites in the country. Learn More

Scott Gottlieb, who recently stepped down as the head of the U.S. FDA, has rejoined venture capital firm New Enterprise Associates as a full-time investing partner. Gottlieb had been a venture partner with NEA for 10 years before President Trump tapped him to lead the FDA. He's expected to lead investments in life sciences startups and take board seats on behalf of the firm. Gottlieb also recently rejoined the American Enterprise Institute as a resident scholar, and he plans to maintain that position. Alert readers will recall that Mr. Gottlieb resigned abruptly from his leadership position at the FDA just months ago. Learn More

Ram Sasisekharan, PhD, a professor of biological engineering at MITwas accused of plagiarism in a report published this week in the journal mAbs. The report, from a group of outside researchers, concluded that published work from labs led by Dr. Sasisekharan presented antibody therapies that bore overwhelming resemblances to those previously published by other labs. For his part, Dr. Sasisekharan called the report's claims "inaccurate and slanderous." Before coming under this scrutiny, his work earned countless prestigious accolades and led him to start three biotech companies, which have together earned hundreds of millions of dollars in funding. Learn More

Amgen this week agreed to buy Scandinavian biopharmaceutical company Nuevolution AB for $167 million to boost its position in drug discovery. Nuevolution has a patent protected drug research platform to identify small-molecule drug candidates to be taken as pills against cancer and inflammatory diseases. Since its founding in 2011, Nuevolution has entered into partnerships with a number of leading biopharma's including Novartis, J&J, Boehringer Ingelheim, GSK and Merck. Amgen, which is grappling with competition to its new migraine treatment Aimovig and cholesterol fighter Repatha, says it had collaborated with Nuevolution since 2016. Learn More

Chugai, a business unit of Roche, announced this week a decision to construct a centralized research laboratory. The new facility, to be known as the Chugai Life Science Park, is being constructed in Yokohama. The new facility will become home to both the Fuji Gotemba Research Laboratories and Kamakura Research Laboratories upon its completion. As for the future of the two research labs, both will be closed after the consolidation is complete. The new 380,000 sq. ft. facility is expected to cost roughly $1.15B with construction scheduled to begin in August of this year and be completed in Q3' 2022. Learn More

On the eve of its initial day of public stock trading, Dallas-based cancer drug developer Peloton Therapeutics was sold to biopharma giant Merck in a deal that could total $2.2 billion. Merck will pay $1.05 billion in cash now, plus $1.15 billion in additional payments based on how Peloton's experimental drugs are further developed. Peloton, founded by UT Southwestern Medical Center researchers, was set to go public today. UT Southwestern researchers were among the first to identify the problematic protein and its link to kidney cancer. That discovery led to the development of a pill that can fight advanced kidney cancer. Learn More

A trio of Kendall Square buildings that are home to big-name biopharma companies just traded hands for one of the steepest prices ever seen in Boston's office market. Chicago-based investment firm Harrison Street Real Estate and Boston-based developer Bulfinch agreed to pay the investment arm of Massachusetts Institute of Technology $1.1 billion for a long-term lease on the three buildings - 610 Main Street, 700 Main, and One Portland Street in Cambridge. The cluster of buildings, called the Osborn Triangle, is occupied by Pfizer, Novartis, and startup hub Lab Central, as well as a few smaller tenants. Learn More

WuXi Biologics has announced that it has entered into a strategic partnership Letter of Intent (LOI) with a global vaccine leader, pursuant to which WuXi Vaccines will build a dedicated facility and supply a commercial product for the global market. Under the LOI, WuXi Vaccines will build an integrated vaccine manufacturing facility including drug substance manufacturing (DS), drug product manufacturing (DP) as well as Quality Control labs (QC). The facility will be dedicated to manufacture 100% of the global market of one of our partner's vaccine products. The value of the 20-year manufacturing contract is estimated to be more than $3 billion USD. Learn More

A federal judge has ruled that a Dana-Farber Cancer Institute researcher and another scientist are among the inventors of a landmark cancer treatment and will share in six patents worth billions of dollars that had been granted to the researchers' former collaborator. District Court Judge Patti B. Saris ruled that Gordon J. Freeman, a Dana-Farber researcher and Harvard Medical School professor, and Clive Wood will be added to patents granted to Dr. Tasuku Honjo of Kyoto University and a handful of Japanese collaborators. Saris wrote that, after a bench trial, she found that "Dana-Farber has presented clear and convincing evidence that Dr. Freeman and Dr. Wood are joint inventors of the six Honjo patents. Learn More

Just Biotherapeutics has announced an agreement to be acquired by German biotech company Evotec for up to $90 million. Founded in 2014 by a group of former Amgen scientists, Evotech is paying all cash for the acquisition, with an unspecified portion of the $90 million price tag contingent upon Just Biotherapeutics reaching certain milestones over the next three years. The acquisition is expected to close in the second half of this year. Just Biotherapeutics has about 90 employees, most of them scientists, working at its facility in Seattle's South Lake Union neighborhood. Learn More

The University of Maryland BioPark is planning its next building as developer Wexford Science & Technology has revealed plans for a $200-plus million, 10-story, 333,000 sq. ft. office and biotech building at the northwest corner of Martin Luther King Blvd. and W. Baltimore St. The new building is Phase One of a two-phrase project that will redevelop a Poppleton/Hollins Market block that borders Martin Luther King Blvd., W. Baltimore St., W. Fayette St., and N. Fremont Ave. The project site currently includes green spaces, a parking lot, and several open spaces created by demolishing a Chinese carryout restaurant, rowhomes, and a former church. Learn More

Celltion Chairman Seo Jung-jin has announced that the biopharma group will invest roughly $34 billion and create some 110,000 jobs by 2030. These monies will be distributed so as to provide roughly $23 billion for its biopharma business, $4 billion for its APIs business and $7 billion for its U-Healthcare platform business which involves artificial intelligence and medical database services. The stated purpose of which being to build a bio-industrial valley capable of making South Korea the hub of the global biopharma industry. To realize this business plan, Celltrion says it will hire some 2,000 R&D professionals and 8,000 others for its expanded factories. Learn More

Parvus Therapeutics has entered into a global collaboration agreement with Genentech to develop, manufacture, and commercialize novel Navacim™ therapeutics for the treatment of autoimmune diseases. Under the terms of the Agreement, Parvus will conduct pre-clinical development and clinical development activities through Phase I. Genentech will be responsible for clinical development from Phase II and beyond, including global regulatory submissions and worldwide commercialization of products. Parvus will receive an undisclosed upfront payment and is eligible to receive milestone payments worth upwards of $800+ million. Learn More

AbbVie has announced that it has halted enrollment of patients in all ongoing studies testing its brain cancer treatment Depatux-M after the drug failed to meet the main goal in a late-stage trial. An independent data monitoring committee recommended the study be stopped due to "lack of survival benefit" for patients receiving the treatment compared with a placebo, AbbVie said. Depatux-M, when added to the standard regimen of radiation and temozolomide, failed to meet the main goal of achieving overall survival in newly diagnosed patients when compared to patients given a placebo along with radiation and temozolomide. Learn More

General Electric's deal to sell its Biopharma unit to Danaher might be in jeopardy, according to Gordon Haskett analyst John Inch, after several competitors posted weaker than expected results. That's not good news for General Electric. The company expects to receive $20 billion cash from the asset sale and investors expect GE to use that cash to pay down debt with deal proceeds. Any problems with the Danaher deal would certainly mean more volatility for GE shareholders. If something does scuttle the deal, GE would likely proceed with an IPO of its entire health care business. That was the company's original plan before Danaher emerged as a buyer for the business unit. Learn More

Thermo Fisher Scientific announced this week that it has entered into a definitive agreement to acquire a drug substance manufacturing site in Cork, Ireland, from GSK for approximately $100 million in cash. The Cork site will expand capacity to meet customer demand for the development and commercial manufacturing of complex APIs. Thermo Fisher will continue to produce APIs for GSK under a multi-year supply agreement and plans to expand use of the site to develop and produce complex APIs for other customers as well. The site contains 270,000 liters of reactor capacity, 10 production buildings, an R&D pilot plant and lab infrastructure. Learn More

The U.S. FDA recently finalized its guidance document intended to assist protein biosimilar manufacturers in demonstrating interchangeability, Considerations in Demonstrating Interchangeability With a Reference Product.  Interchangeability, as of now, is nothing more than a pipe dream; no biosimilar has been declared interchangeable and therefore fully substitutable for its reference product.  But FDA is hoping that this guidance will help address that.  This guidance finalizes FDA's expectations and updates the draft version of the guidance to provide more clarity.  Of note, this guidance document is directed specifically toward proposed therapeutic protein products. Learn More

Vertex will partner with Kymera Therapeutics in a four-year development deal that hands the small biotech $70 million in cash and equity investment. All told, the collaboration could be worth more than $1 billion for Kymera, which is one of several biotechs exploring whether a new type of small molecule drug can degrade disease-causing proteins in ways current technologies like antibodies cannot. With its deal, Vertex joins larger biopharma companies like Roche, Biogen and Pfizer in betting on what's termed targeted protein degradation, a field Kymera shares with C4 Therapeutics and Arvinas. Learn More

Civica Rx, a nonprofit drug company founded last year by a consortium of hospitals and foundations, says it has entered an agreement with Xellia to make available injected forms of vancomycin and daptomycin, two antibiotics that are often in short supply. Alert readers will recall that Civica Rx has plans to become an alternative source of generic drugs for hospitals and provide a steady supply of critical medicines at reasonable prices. The company's initial plan is to make 14 drugs and offer them to member health systems. The antibiotics are the first two that Civica Rx has publicly announced. Learn More

The news last month that IBM would stop selling Watson for Drug Discovery due to lackluster financial returns did not come as a surprise to some executives in the field of artificial intelligence-led drug discovery and development. But, they said, that doesn't mean the field as a whole is in trouble. For one such company, Recursion Pharma, the news did not come as a major surprise. "A key distinction is between analysis of data sets via AI that is prospective versus retrospective." says  Recursion CEO Christopher Gibson. For AI to work, Gibson says, data sets need to be tailored to it. Learn More

Back in the 1970s and 1980s, the U.S. FDA made clear that at least two adequate and well-controlled studies were necessary to establish a new drug's effectiveness, except in only the rarest of circumstances. Then in 1997, the FDA Modernization Act was passed, and Congress clarified that FDA may consider "data from one adequate and well-controlled clinical investigation and confirmatory evidence" to approve a new drug. However, recently IQVIA released a report finding that 25 of 59 (42%) novel drugs approved in 2018 were approved on the basis of only one trial. And one out of eight approvals relied only on Phase 1 or 2 trials, with no Phase 3 trials. Learn More

The last major legal standoff for a Humira biosimilar has ended, as AbbVie and Boehringer Ingelheim announced this week a settlement of patent litigation over the U.S. entry date. Boehringer can begin selling its copycat of the world's best-selling drug on July 1, 2023, paying royalties to AbbVie for the U.S. license, according to the settlement. Eight companies have now settled with AbbVie over Humira biosimilars. While Humira competition started this year in Europe, the deals reached in the U.S. give the giant biotech more than three years of stateside exclusivity, staving off all entries until 2023. Learn More

The Delaware Biotechnology Institute will expand into 70,000 square feet within the new six-story, $160 million Biopharmaceutical Innovation Building on the STAR Campus next February. The building, which includes labs, offices, collaborative space, and shared research facilities, will be the home of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a coalition of 150 companies, educational institutions, nonprofits and state governments. The Delaware Biotechnology Institute will take a little over two floors of the six-story building besides the 70,000 square feet it has in its current location at 15 Innovation Way. Learn More

ElevateBio has announced plans to create and build a broad portfolio of single and multi-product cell and gene therapy companies. Leveraging the roughly $150 million it has raised to date, Elevate Bio plans to provide centralized bench-to-bedside capabilities including world-class scientists, manufacturing facilities, drug development and commercialization expertise. All of which will be housed in a new 100,000 sq. ft. R&D and Manufacturing center in Waltham, Massachusetts to be known as BaseCamp which is on schedule to be fully operational in Q3/Q4 of 2020.  In the meantime, the company is leveraging its lab space in Cambridge, Massachusetts to launch collaborations. Learn More

Gilead's HIV blockbuster Truvada looks set to face generic competition in the US next year, a year earlier than expected, putting the bulk of the product's $3 billion annual sales at risk. The biopharma leader had been predicting the onset of generic competition to Truvada in 2021, but a recent SEC filing from Gilead suggests Teva - in pole position to bring a copycat version to market - is now able to launch in 2020. Gilead is already facing competition to Truvada in Europe, where patent protection extended by a supplementary protection certificate (SPC) was overturned last year and generics have already been launched - albeit at risk of damages if Gilead were to win an appeal of the ruling. Learn More

Purdue Pharma has removed the signs bearing its name outside its downtown headquarters, a move that could hint at the controversial OxyContin maker trying to reduce the visibility of a building increasingly targeted by protesters. For years, Purdue's ringed-and-underlined logo had adorned the front entrance and sidewalk markers around the One Stamford Forum building at 201 Tresser Blvd., where it has been based since 2000. But all those company-branded markers have come down in the past few weeks, and the firm has not said whether it would replace them. Learn More

In an exclusive interview with NBC News Massoud Motamed, a former inspector with the U.S. FDA, says the regulatory agency struggles to police overseas drug manufacturers who may hide problems in their production lines. Case in point, he cites the valsartan recall and the fact that more than a year before the notices went out, he had tried to sound the alarm on what he flagged as potential systemic problems at two facilities in China and India that produce the active ingredients in generic valsartan and other blood pressure medications. However, the FDA ultimately overruled his recommendation. Learn More

New Jersey state officials announced this weekend that law enforcement authorities from 43 other states have filed a civil lawsuit in federal court accusing 20 biopharma companies, including 15 biopharma executives, of conspiring to hike generic drug prices. The state officials say that costs for drugs were sometimes boosted by more than 10 times what they should have been. Twelve of the companies named in the lawsuit are currently, or will soon, have their U.S. headquarters in New Jersey. The conspiracy was allegedly hatched at trade shows, cocktail parties and golf outings, according to the states Attorney General. Learn More

BioPharma bosses have mounted a last-ditch effort to overturn government proposals to cap research and development tax credits - plans that could lay waste to the UK's life sciences industry, they claim. The Treasury has proposed laws that would restrict payments to loss-making companies through the R&D tax credit scheme. The changes are designed to prevent abuse of the system by "virtual companies", but industry figures say they will reduce the attractiveness of Britain as a place to develop life-saving medicines. A meeting of the government's Life Sciences Council this week will hear protests that biotech developers will be disproportionately affected. Learn More

For young people looking to find a career path, the pharmaceutical industry is a good one to go into, especially if salary is a major concern. A recent analysis from the Wall Street Journal highlighted some of the best-paying jobs in the biotech industry. At the top of the list of companies offering impressive compensation packages is New Jersey-based Celgene. According to the analysis, Celgene had the highest-paid median employee in the sector with annual compensation of $263,237. The Journal's analysis ranks Vertex as the number two company for best median compensation with a median salary of $232,178. Followed by Incyte and others. Learn More

Bayer has made public plans to invest $150 million into its site in Berekeley, CA to build a Cell Culture Technology Center. The new Cell Culture Technology Center will be built on Bayer's existing Berkeley campus. The new 40,000 square foot facility, which is expected to be ready for clinical production in late 2021, will support the development of emerging therapies in Bayer's portfolio with an emphasis on oncology, cardiology and additional specialty care therapeutic areas. Bayer has selected Fluor for design and construction, and GE Healthcare for the integration of its FlexFactory™ technology platform into the Center. Learn More

Novartis has signed off on a memorandum of understanding with Sudair Pharma for a technology transfer that would allow the Saudi Arabian company to produce a number of Novartis' "innovative" cancer drugs in the kingdom. In doing so, Novartis joins peers like Pfizer who just two years ago opened a 120,000 sq. ft., manufacturing and packaging facility in the kingdom at a cost of $50 million. Alert readers will recall that back in 2017 an 800,000 sq. ft. facility to manufacture generic drugs was built at a cost of $53 million. Learn More

Merck & Co., Inc., a publicly held global healthcare company known as MSD outside the United States and Canada, plans to invest up to $1 billion in stages over the next three years to expand its manufacturing operation in Elkton, Virginia. The company will add 120,000 square feet to its existing 1.1 million-square-foot operation in Elkton, Virginia to increase production of its Human Papillomavirus vaccines. Virginia successfully competed with other states for the project, which is anticipated to create approximately 100 new jobs in Rockingham County. As part of the expansion Blue Ridge Community College and James Madison University will collaborate to address Merck's short- and long-term workforce needs. Learn More

Novartis has agreed to pay $3.4 billion for eye-disease assets that Takeda is selling after its $62 billion acquisition of Shire Plc earlier this year. The main product in the deal is Xiidra, a prescription eye drop for adults with dry-eye disease that had about $400 million in sales last year. Along with $3.4 billion in cash upfront, Novartis says that it will pay as much as $1.9 billion in milestones. The deal is expected to close in the second half of the year and plans to bring over about 400 employees. The transaction is the first major deal for Takeda since Chief Executive Officer Christophe Weber said in January that the Japanese company plans to move quickly on disposals to reduce debt after its takeover of Shire. Learn More

Pfizer has announced that it has entered into a definitive agreement to acquire all the shares of Therachon, a privately-held clinical-stage biotechnology company focused on rare diseases, with assets in development for the treatment of achondroplasia and short bowel syndrome. Under the terms of the agreement, Pfizer will acquire Therachon for $340 million upfront with an additional $470 million in additional payments contingent on the achievement of key milestones in the development and commercialization of TA-46 for the treatment of achondroplasia, a genetic condition and the most common form of short-limbed dwarfism. Learn More

AstraZeneca has lost another manager to a small cancer biotechnology firm that has already poached the former head of the U.K. drugmaker's MedImmune unit and one of its top oncology researchers. Mohammed Dar is going to closely held Immunocore as chief medical officer to oversee development of drug candidates including tebentafusp, the company's most advanced. Dar, who was vice president of clinical biologics at MedImmune, contributed to the development of Imfinzi, an immune-based treatment for early lung cancer, and Lumoxiti, approved last year for a type of leukemia. His expertise will be crucial as Immunocore moves through late-stage testing of its lead drug. Learn More

Acacia Pharma has received a Complete Response Letter from the U.S. FDA regarding its New Drug Application (NDA) for Barhemsys. The letter marks the second for this particular submission and identified continuing deficiencies at the contract manufacturer of amisulpride, the active pharmaceutical ingredient used in Barhemsys. The same issue was raised initially in October 2018 when the company received their first Complete Response Letter from the FDA. Despite the rejection, no concerns were raised by the FDA on any of the clinical or non-clinical data in the NDA and no further studies or data analyses will be required for approval. Learn More

In response to the U.S. FDA proposal to not go back and rename certain biologics with nonsense suffixes, as it once said it would, Pfizer is calling on the agency to at least retroactively apply suffixes to biologics that serve as reference products for biosimilars. Such a compromise would reform the initial proposal and ensure the nonproprietary names of biosimilars, with their four-letter nonsense suffixes, would at least look similar to the nonproprietary names of their reference products. The FDA has said the decision to use the suffixes, which no other country in the world does, is part of the agency's focus on pharmacovigilance, but Pfizer made clear that the suffixes are not currently being used as intended. Learn More

Lundbeck, a manufacturer of neurology drugs, intends to grow its pipeline and U.S. footprint through the acquisition of Abide Therapeutics. For $250 million upfront, Lundbeck takes control of Abide and its drug discovery platform focused on serine hydrolases, a diverse enzyme class that accounts for roughly 1% of all proteins in mammals, according to Abide's CEO. The deal, expected to close before the end of June, also hands Lundbeck a research hub in La Jolla, California. Terms hold that Abide could receive as much as $150 million more upon completion of certain development and sales milestones. Learn More

Synthetic CBD from Zynerba Pharma has earned fast track status from the U.S. FDA for its Zygel transdermal CBD lotion to treat symptoms associated with the genetic condition Fragile X. There currently are no drugs to treat the symptoms of Fragile X syndrome, which include developmental problems from learning disabilities to cognitive impairment. Zynerba is in the final stages of a clinical trial of Zygel and hopes to have it on the market by late 2020. The FDA already had granted the gel orphan-drug status, which gives Zynerba a seven-year period to market the drug exclusively in the U.S. as well as granting the company tax credits for clinical research expenses. Learn More

The Centre for Process Innovation (CPI) has collaborated on a project to develop new research and testing capabilities to drive further scale-up and manufacture of next generation liquid formulated products. Working alongside the Universities of Birmingham, Leeds and Edinburgh, CPI has created an open-access facility to enhance SME and larger corporate partners' product development. Consisting of a series of scaled vessels, from one liter to 1,000 liters, with a sample flow loop to allow in-line and at-line monitoring of process parameters, the facility's configuration is highly flexible and can be adjusted to specific project needs. Learn More

Gilead, which hired Roche veteran Daniel O'Day to be its new chief executive, has made public plans to have Kite Pharma become a separate business unit. O'Day, leading his first quarterly conference call since taking the Gilead helm on March 1, said the company has initiated a search for a new CEO at Kite, which Gilead bought for $12 billion. The new CEO said his first priority is strengthening Gilead's drug development pipeline, both internally as well as through acquisitions or partnerships. Kite is mainly known for Yescarta, a CAR-T cell therapy currently approved to treat certain types of lymphoma. Learn More

Vectura announced over the weekend that it has won a patent infringement litigation case against GSK in the U.S. and has been awarded $89.7 million in damages for the period from August 2016 through December 2018. A jury trial in a Delaware district court late Friday found that one of Vectura's U.S. patents was infringed by sales of three of GSK's Ellipta products in the United States. The jury found that GSK willfully infringed the patent, which Vectura says gives it the right to seek enhanced damages. Vectura started legal proceedings against GSK after a patent license agreement between the two companies expired and GSK declined to license additional patent families under the original agreement. Learn More

Biotechnology company Aldevron is expanding its Madison site, more than doubling the size of its space and, potentially, its staff over the next couple of years. The company currently occupies 8,000 square feet at 5602 Research Park Blvd., in University Research Park, and it will add nearly 10,000 square feet, moving into space being vacated by another biotech. Large fermentation equipment already has arrived to expand the site's biomanufacturing capacity. Aldevron's Madison labs culture bacteria, as well as mammal and insect cells, to manufacture proteins and enzymes. The expansion is expected to be completed and operating by this fall. Learn More

A modernization of the way the U.S. FDA reviews NDAs and BLAs will be instituted over the next two years, CDER Director Janet Woodcock told attendees of the Food and Drug Law Institute's annual conference this week. Six active initiatives related to this modernization are ongoing at CDER, including initiatives focused on integrated reviews for marketing applications, IND application review management, post-market safety management, assessing talent, reorganization management and administrative operations. The new integrated reviews, which are currently being phased in, will be used among all CDER divisions beginning in 2020. Learn More

Manufacturing issues have tripped up two experimental drugs, resulting in the U.S. FDA handing their respective makers Complete Response Letters this week. Heron Therapeutics disclosed this week that the regulator had rejected HTX-011, a non-opioid painkiller for postoperative pain. According to Heron, the FDA wants additional information on chemistry, manufacturing and controls to proceed, along with more non-clinical data. Nabriva Therapeutics, meanwhile, said this week that its drug for complicated urinary tract infections was turned down by the agency. Learn More

Takeda announced this week that it has opened a new research facility in San Diego. The new 165,000 square foot site is home to more than 250 employees focused on leveraging specialized drug discovery technologies and advancing discovery research in gastroenterology and neuroscience, the company said. In its announcement, Takeda said the San Diego site is home to four research platform groups -- structural biology, early target discovery, computational biology and biologics. The new San Diego facility complements Takeda's global Research & Development center in Cambridge, Mass. and its other global research site in Shonan, Japan. Learn More

Charles River Laboratories began notifying clients April 30 of a data breach that allowed an unauthorized third-party access to portions of its information systems. In a Securities and Exchange Commission filing, Charles River Laboratories indicated that it had discovered unusual activity within its information systems in mid-March. Charles River Laboratories estimates around 1 percent of its client data was copied by a "highly sophisticated, well-resourced intruder." The company is unsure which data was copied or the potential financial impacts related the indecent. The Boston Business Journal reported that Charles River Laboratories' biotech and pharmacy clients were affected by the data breach. Learn More

Merck & Co. filed with the U.S. Securities and Exchange Commission that it plans an extensive restructuring of its manufacturing and supply network. This will, it indicates, reduce its "global real estate footprint." The restructuring is expected to be mostly completed by the end of 2023 and is projected to incur pre-tax costs between $800 million and $1.2 billion. It expects to record GAAP charges of about $500 million related to the program this year, including $187 million in the first quarter. About 55% of the pretax costs will be in cash to pay for the shutdown of facilities and "employee separate expense." The company has not identified the specific plants it will shut down or indicated how many jobs it plans to cut. Learn More

GlaxoSmithKline has dumped a universal flu vaccine after getting a look at interim phase 1 data. The clinical data and other results persuaded GSK to stop development of the candidate once it finishes the ongoing study.  The influenza vaccine, GSK3816302A, combines the cHA technology and GSK's AS03 adjuvant in a bid to develop a shot that protects against all current and future circulating influenza strains, thereby eliminating the need to develop new jabs and administer them each year. The clinical trial was designed to compare the safety and tolerability of nine unadjuvanted and adjuvanted supra-seasonal universal flu vaccine formulations to placebo and GSK's quadrivalent seasonal influenza vaccine. Learn More

The Seoul Central District Prosecutors' Office has arrested an executive and another employee at Samsung Bioepis, the biosimilar division of Samsung Group, on suspicion of destroying evidence to mask an alleged accounting fraud. The move comes after South Korea's Securities and Future Commission ruled in November that Samsung Biologic violated accounting rules by intentionally inflating the value of Samsung Bioepis and the two employees have said they destroyed evidence on their own but prosecutors are reviewing whether there was an order from management or whether the group's strategic office orchestrated the process. Learn More

Novartis's Sandoz division has struck a deal with Taiwan's EirGenix Inc to market a biosimilar version of Roche's Herceptin that is now in late-stage development to treat some cancer tumors. Novartis said the accord covers the trastuzumab biosimilar in Phase III development for human epidermal growth factor receptor 2 positive (HER2+) breast and gastric tumors. EirGenix will receive an upfront payment, milestone payments as well as a share of profits from sales and be responsible for development and manufacturing. The deal, the third biosimilar collaboration for Sandoz in 18 months, expands the existing Sandoz cancer portfolio of four oncology biosimilar medicines. Learn More

Fujifilm Diosynth Biotechnologies has announced an expansion to its Billingham, United Kingdom location through the creation of a new BioCampus. The initial phase of this project will involve a new purpose-built facility. This will consist of approximately 42,000 square feet of space and will house roughly 250 existing staff and 50 new staffers. This latest investment is part of a major strategic growth plan. In September 2017 FDB announced the opening of the 10,000 square foot, state-of-the-art cell culture PD Labs in Wilton Centre, Teesside. In January 2019, the Wilton Laboratories were further expanded with the addition of 7,000 square feet of laboratory space increasing FDB's cell culture PD capacity. Learn More