News Alert

Elanco has agreed to buy Bayer's veterinary drugs unit in a cash and stock deal valued at $7.6 billion, creating the second largest maker of medicines for pets and livestock and expanding Elanco's reach online. The deal is the latest in the fast-growing animal health market, which has recently seen Elanco floated by Eli Lilly and Co and rival U.S. drugmaker Pfizer also spinning off its veterinary medicine business. It also adds to the list of assets sold by Bayer, as the German company looks to slash debt from its $63 billion takeover of seed maker Monsanto last year and as it braces for a potential settlement of lawsuits over an alleged cancer-causing effect of weed killer Roundup. Learn More

Moderna has secured fast track designation from the US FDA for its investigational Zika vaccine, mRNA-1893. At present, the mRNA-1893 vaccine is being assessed in a phase 1 study to prevent Zika virus infection in healthy adults. The mRNA-1893 included an mRNA sequence that encodes for the structural proteins of Zika virus. It is designed to help cells to secrete virus-like particles, helping to mimic the response of the cell after natural infection. Earlier, Moderna secured fast track designation for its methylmalonic acidemia (MMA) program, mRNA-3704, which is currently enrolling patients under the phase 1/2 clinical study. Learn More

The costs associated with navigating a new therapeutic through the regulatory process to final approval and subsequent marketing continue to rise despite industry's collective efforts to speed up the process of drug discovery and development in order to rein in those burgeoning expenses. Last year, the top ranked 100 public biopharmaceutical companies by market cap, not including big pharma companies, invested well in excess of $33 billion. At the halfway point of this year, it appears that R&D spending is not slowing down. From an analysis of the second-quarter 2019 financial reports filed by the top 100 public biopharmaceutical companies ranked by market cap, the amount invested in R&D has increased by more than 4%, well in excess of $18 billion. Learn More

Roche this week named Eli Lilly executive Levi Garraway to succeed Sandra Horning as chief medical officer and head of global product development. Garraway, most recently Eli Lilly's senior vice president, oncology research and development and Lilly research laboratories novel target research, will take up the post as of October 1st and be based in South San Francisco. Horning, who joined Genentech nearly a decade ago and has been chief medical officer since 2014, will retire as of the end of 2019. She led the product development organization, oversaw late-stage clinical development, and was co-chair of the committee that invests in pivotal trials. Learn More

In an unexpected decision, the US FDA rejected Sarepta Therapeutics' experimental drug for Duchenne muscular dystrophy, issuing a Complete Response Letter to the rare disease biotech this week. According to Sarepta, the agency cited in its refusal the infection risk tied to the drug's delivery as well as preclinical signs of kidney toxicity. Called Vyondys 53, the medicine is designed for roughly 8% of Duchenne patients with a specific genetic mutation. Approval of the drug was widely anticipated, making the rejection a setback in Sarepta's ambitions to treat a wider pool of Duchenne patients. Learn More

Seen as a source of affordable and quality generic medicine for the world, India's pharmaceutical industry has found its credibility questioned by a new book alleging widespread violation of established manufacturing norms by its companies, leading to the production of medicines that potentially risk patients' lives. Bottle Of Lies - Ranbaxy And The Dark Side Of Indian Pharma, by American investigative journalist Katherine Eban, lays bare instances of cooked-up and plagiarised data, the presence of impurities and foreign particles, and unsanitary manufacturing conditions, among other egregious violations. Learn More

Celgene has won U.S. approval for Inrebic, a treatment for myelofibrosis that is one of five drugs Bristol-Myers Squibb regarded as particularly valuable in its $74 billion deal to buy Celgene. Before Inrebic's approval, only one other drug was cleared in the U.S. to treat myelofibrosis, a rare bone marrow disorder that disrupts the production of blood cells. Celgene paid just over $1 billion upfront in January 2018 to acquire Inrebic's latest developer, Impact Biomedicines. As part of that deal, Impact shareholders are entitled to up to $1.4 billion in milestone payments for regulatory approvals in myelofibrosis and other indications. Learn More

The Federal Circuit court has denied Genentech's motion seeking an injunction against Amgen's biosimilar to Avastin known as MVASI. In its ruling, Genentech was found by the court to have failed to establish that an injunction pending appeal was warranted under the relevant four-factor standard commonly applied. For its part Genentech argues that the FDA's approval of several supplements to the MVASI filing obliged Amgen to provide Genentech with a new notice of commercial marketing at least 180 days before launching its biosimilar in the United States. A position the court dismissed in its ruling. Learn More

The US Securities and Exchange Commission (SEC) has fined Lorenz Erne, a former senior executive at Roche, for insider trading and ordered him to pay back the ill-gotten profits. Erne accepted the accusations and agreed to the terms of a settlement with the SEC, according to an SEC document external link made public. The case concerns insider trading in the shares of Spark Therapeutics ahead of a February 25, 2019, announcement that a Roche affiliate company and Spark had reached a merger agreement. At the time of the trading, Erne was head of the Strategy Office at Roche Global Technical Operations in the Pharmaceuticals Division. Learn More

The U.S. FDA has approved Roche's personalized cancer treatment, which targets tumors with specific genetic mutations, irrespective of where in the body the disease started. The treatment, Rozlytrek, is a tyrosine kinase inhibitor that targets patients who must be identified via genetic profiling. It is approved to treat certain types of solid tumors, which show rare genetic anomalies called NTRK fusions. Individually, the mutations are rare and it is difficult to run dedicated tests for each. They have been identified in a broad range of solid tumor types, including breast, colorectal, pancreatic and non-small cell lung cancers, the company says. Learn More

A federal appeals court this week delivered a double dose of good news to Sanofi-Aventis U.S., affirming the validity of its first patent on the prostate-cancer drug Jevtana and overturning a ruling against a later patent on a method of administering it. The U.S. Court of Appeals for the Federal Circuit said a trial judge in New Jersey had properly rejected "convoluted" arguments against the first patent by Mylan Laboratories, Actavis LLC and several other generic drugmakers that Sanofi had sued for infringement. Learn More

The Colorado Economic Development Commission agreed this week to offer up to $24.8 million in tax and other incentives in hopes of persuading an unnamed biotech company to open a campus in Boulder County and create 1,000 well-paid jobs. According to reports the unidentified company already operates at four sites in Colorado, but if it accepts Colorado's tax credit offer it would consolidate in Boulder County. Estimates value the project at upwards of $130 million. However, other states are being considered as potential locations for the site including Minnesota, Tennessee and Texas. Learn More

Novartis has replaced both the chief scientist and R&D head of AveXis and announced the appointment of a veteran Novartis executive to both roles at the biotech developer of the gene therapy Zolgensma. Neither Brian Kaspar nor his brother Allan Kaspar have been involved in operations at Avexis since early May, when Novartis confirmed internally the manipulation of preclinical data used to support the approval of Zolgensma. Both were placed on administrative leave and are now no longer with the company. In their place, Page Bouchard, most recently head of preclinical safety at Novartis' research institute, assumed the positions of senior vice president of research and chief scientific officer at AveXis. Learn More

For many the question has not been if, but when will biopharma step into medical cannabis. A recently published article delved into that question and the conclusion could perhaps best be summarized in one word, now.  According to the authors, leading biopharma's Sanofi (38), Pfizer (4), AstraZeneca (2) and GSK (1) have cannabis related clinical trials registered with the FDA. However, perhaps a far more important indicator of what lies ahead for biopharma's role in cannabis, is the number of cannabis patents. Leading the list is Abbvie (59), Sanofi (39), Merck (35). BMS (34), Pfizer (25), Novartis (21), Roche (17) and the list goes on. Learn More

Regeneron is planning to build a four-story, 256,000+ sq. ft. structure known as the Science Building at its Tempel Lane campus in Albany, New York. The building, which will house both labs and offices, would be the third and final phase of expansion at Regeneron's campus. The project will be managed by the Boston office of the engineering and construction firm Jacobs. Alert readers will recall that Regeneron has been investing heavily into its Albany site. This includes construction of a 212,000 sq. ft. warehouse and the ongoing project to build a 346,000 sq. ft. manufacturing facility at the site. This latest project is expected to take 30-36 months to complete. Learn More

Deciphera Pharmaceuticals shares more than doubled this week after the drugmaker said its treatment helped stomach cancer patients live longer without their disease worsening in a late-stage study. The treatment, ripretinib, was tested against placebo in 129 patients with advanced gastrointestinal stromal tumors (GIST), a rare cancer affecting the digestive tract, who had received at least 3 prior therapies. Ripretinib demonstrated a median progression-free survival rate of 6.3 months compared with a month in case of placebo, the company said, adding that the drug significantly reduced the risk of disease progression or death by 85%. Learn More

While noting that tens of thousands of drug listing records have not been updated in the past year, the US FDA this week announced that it will begin inactivating drug and manufacturing establishment listings that are not current in one month. The announcement is part of FDA's push to encourage drugmakers to ensure that their listed human drugs and any information in their drug listings, including drug establishments, are accurate. FDA Commissioner Ned Sharpless noted in a statement that although there have not been any public health consequences as a result of the outdated listings, "inaccurate information has the potential to compromise the integrity of the FDA's database..." Learn More

Aldevron has been granted the $5 million tax break it sought to help facilitate the expansion of its existing facility and the building of a new facility. Specifically, the building of a new, state-of-the-art, 180,000 square foot biologics manufacturing facility and a 20,000 square foot expansion of their existing facility in Fargo, North Dakota. According to published reports, the estimated budget for the project is $72 million, which includes both construction of the buildings as well as procurement of associated equipment. This is a big win for Fargo which faced competition from others seeking to be the site of Aldevon's new facility. Learn More

A US District Court Judge in New Jersey has upheld the validity of two of Amgen's patents for its blockbuster arthritis treatment Enbrel, preventing the launch of a biosimilar developed by Novartis' Sandoz division. So far, the US FDA has approved two Enbrel biosimilars, Sandoz' Erelz in August 2016 and Samsung Bioepis' Eticovo last April, but neither have launched commercially due to ongoing litigation. Enbrel was first approved by FDA in 1998. While the FDA has approved more than 20 biosimilars since approving its first in 2015, only about one-third have launched, in large part due to complicated intellectual property litigation that often takes years to resolve. Learn More

The US FDA has issued a Form 483 to Natco Pharma after an inspection of the biopharma's API manufacturing facility in Hyderabad, India. The inspection, which was conducted between August 5th and 9th, 2019 made 6 observations. According to the company, most of the observations were procedural in nature including gowning, revalidation and approval process for alternate suppliers. Other notable observations by FDA inspectors included stains in some early stage reactors that had not been adequately investigated and missing 'status tags' on certain equipment used in the drying process. Learn More

Boehringer Ingelheim and The University of Texas MD Anderson Cancer Center have  announced a new multi-year partnership to conduct collaborative research to rapidly advance therapies for various types of cancers. The establishment of a joint Virtual Research and Development Center will enable effective data sharing and analysis between the organizations. The partnership is built on a flexible framework, allowing for projects to enter at different stages (research, development and/or clinical stage) over several years. It further combines the unique patient-driven drug-development capabilities of MD Anderson's Therapeutics Discovery division with the innovative pipeline of novel medicines from Boehringer Ingelheim. Learn More

Shares in Nektar Therapeutics plunged following the company's disclosure that it administered inactive doses of its experimental drug bempegaldesleukin in clinical trials due to manufacturing issues. Cancer patients in a combination trial with Bristol-Myers Squibb's Opdivo progressed more quickly after receiving the suboptimal doses than those treated with active bempegaldesleukin. The ineffective drug also was used in a lung cancer trial in combination with Merck & Co.'s Keytruda. Nektar executives also announced that Bristol-Myers has cut back its commitment to the partnership. Alert readers will recall that Bristol-Myers paid nearly $1.9 billion up front to secure rights to the agent. Learn More

A star scientist at La Jolla's Scripps Research has left the elite biomedical institute, where he had been investigated for a possible violation of Title IX, a law prohibiting sex discrimination in education programs that get federal financial assistance. Floyd Romesberg, known internationally for developing a partly artificial life form with an expanded genetic code, left Scripps Research in mid-June, the institute says but has declined to elaborate. Romesberg, 53, gained world attention in 2014 when he and fellow Scripps Research scientist Denis Malyshev successfully engineered bacteria to replicate using two synthetic letters of DNA, in addition to the four natural ones. Learn More

Amid fears that the U.K.'s withdrawal from the European Union could doom its stature in life sciences, the country's new government plans to revamp immigration laws in an effort to make it more attractive and accessible to scientists. Prime Minister Boris Johnson instructed the Home Office and Department for Business, Energy and Industrial Strategy to develop a fast-track visa system to be launched later this year designed to attract "elite" science, engineering and technology specialists. The new system would streamline and simplify many of the requirements that such professionals currently must meet. Learn More

Allergan has gone to great lengths to guard the secret of how it makes Botox, its $2 billion  a-year wrinkle treatment. Metal-enclosed workstations, security guards and private jets are part of the effort. And now it is challenging a trade judge's order to reveal details of the manufacturing process, which it calls one of its "most valuable and highly protected assets." An U.S. International Trade Commission judge told Allergan to give lawyers for Daewoong Pharma and Evolus the information as part of a legal dispute over processes to make the next generation of Botox. While Allergan has obtained some patents on Botox, it has maintained the Botox manufacturing process confidential for three decades. Learn More

Shares of Sarepta Therapeutics plunged after a notice from the U.S. FDA showed a patient in an ongoing study of the company's gene therapy for Duchenne muscular dystrophy (DMD) was reported to have developed a serious illness. The incident, which occurred in February, involved a seven-year-old boy who developed rhabdomyolysis, a serious condition that can lead to complications such as kidney failure. In June, Pfizer, which is racing Sarepta Therapeutics to be first to market with a gene therapy for DMD, reported results from a tiny early study of its experimental treatment. At the time, Pfizer said two of the six patients in its trial experienced side effects that landed them in the hospital. Learn More

Versant Ventures and Bayer have started several biotechs together. But this week marks the first time the German drug maker took a step further and bought one of them: cell therapy developer BlueRock Therapeutics. Bayer already owns a 40.8 percent stake in BlueRock through its Leaps by Bayer venture arm. But it will pay $240 million up front for the rest of the company, which includes Versant's similar-sized stake and the remaining shares owned by management. Bayer could shell out another $360 million for BlueRock, but those payments are tied to the progress of various programs and may not materialize. The deal values BlueRock at $1 billion and should close during the third quarter. Learn More

Cambrex has made public its decision to be acquired for $2.4 billion acquisition by an affiliate of the private equity firm Permira. Under the agreement, Cambrex has 45 days to solicit a better deal. The company said it won't disclose any developments during this "go-shop" period unless the board decides on a different agreement. The purchase is the latest in a run of mergers in the CDMO field. In March, Thermo Fisher agreed to buy Brammer Bio for $1.7 billion. A month later, Catalent nabbed Paragon Bioservices for $1.2 billion. Alert readers will recall that Thermo Fisher CEO Marc Casper recently highlighted the growth potential in the industry, calling it "the golden age for the CDMO space." Learn More

Allergan has confirmed that it will divest experimental inflammatory bowel disease therapy brazikumab and marketed drug Zenpep ahead of its $63 billion acquisition by AbbVie. The news comes in the company's latest financial filings. According to published reports, Allergan decided to divest brazikumab and Zenpep regardless of whether getting rid of them is required for clearance of the AbbVie takeover by antitrust regulators such as the FTC. That seems prudent, given the FTC seems to be raising the bar for antitrust approvals in biopharma at the moment. Case in point Roche's much-delayed $4.3 billion Spark takeover and BMS's forced divestiture of psoriasis Otezla to seal its $74 billion acquisition of Celgene. Learn More

Adaptive Biotechnologies has announced plans to lease a new 100,000 sq. ft. corporate headquarters with a state-of-the-art office space and research facility that will triple the company's Seattle footprint.  The biotech's current headquarters, 1551 Eastlake Avenue East, also part of The Eastlake Life Science Campus by Alexandria, is a short distance from the future facility. Shell construction of the new building is expected to be completed in 2020 and Adaptive plans to occupy the new building in 2021 once interior construction is finished. Learn More

Safety concerns at a prominent military germ lab have led the government to shut down research involving dangerous microbes like the Ebola virus. "Research is currently on hold," the United States Army Medical Research Institute of Infectious Diseases, in Fort Detrick, Md., said in a statement. The shutdown is likely to last months, Caree Vander Linden, a spokeswoman, said in an interview. The statement said the Centers for Disease Control and Prevention decided to issue a "cease and desist order" last month to halt the research at Fort Detrick because the center did not have "sufficient systems in place to decontaminate wastewater" from its highest-security labs. Learn More

In a statement issued this week, Peter Marks, director of the US FDA's CBER, said the agency is investigating data manipulation submitted in the BLA for Novartis' gene therapy Zolgensma, a drug developed by AveXis. Alert readers will recall that AveXis was acquired by Novartis in an $8.7 billion deal in April 2018 and was approved last May. The gene therapy is considered to be the world's most expensive drug at $2.1 million. According to Marks, the FDA was informed by AveXis on June 28ththat some of the nonclinical data included in the BLA for Zolgensma was manipulated. Marks also said that AveXis was aware of the data manipulation and warned that the company could be subject to civil or criminal penalties. Learn More

CSL has made public plans to move into a new 16 story corporate headquarters, complete with state-of-the art laboratories, near the Parkville biomedical precinct which includes the University of Melbourne, several hospitals and top research facilities such as the Doherty Institute for Infectious Disease. The 376,000 sq. ft. development, which is yet to be given final planning approval, will accommodate more than 800 CSL employees including early stage research and product development teams and its commercial and corporate staff across seven floors of office space and nine floors of laboratories and research and clinical phase production suites. Learn More

Boston-based venture capital firm Vida Ventures has raised $600 million more to invest in early-stage biotech companies in a second fund. That fund should bolster the firm's attempts to become a more significant player in the relatively cottage industry of biotech venture capitalists. If you are not familair with the company its not your fault, Vida has only formally invested in 14 companies since its launch in April 2018. However, one such investment, Allogene, has already gone public and Merck bought another, Peloton Therapeutics, for $1 billion upfront. Learn More

Pfizer has announced that its Phase III RESET clinical trial evaluating rivipansel in sickle cell disease (SCD) failed to meet its primary and key secondary efficacy endpoints. Pfizer licensed the drug from GlycoMimetics in 2011 in a $340 million deal. GlycoMimetics' stock plunged at the news, dropping almost 43%. On July 29th, CRISPR Therapeutics reported progress in SCD in its ongoing Phase I/II trial of CTX001 in patients with transfusion-dependent beta thalassemia (TDT) and severe SCD. The company plans to report preliminary safety and efficacy data later this year. Learn More

Sanofi's decision to exit its development deal with Lexicon has left the management of the latter claiming breach of contract and hinting at litigation. Alert readers will recall that Sanofi entered into a development partnership with Lexicon around the drug Zynquista by paying $300 million upfront. However, it was recently made public that the drug had underperformed in clinical trials resulting in the decision by Sanofi to end the partnership. As for the possible litigation, speculation is that Lexicon has neither the time or money for such an effort and may instead be positioning itself for a settlement involving payment of select milestones and the return of rights to Zynquista. Learn More

In a company email to employees on Friday, Purdue Pharma CEO Craig Landau announced the drug manufacturer has sold its Treyburn plant in Durham North Carolina to Novo Nordisk. Purdue, which makes pain products such as OxyContin and Butrans, opened the facility in 2015 at a cost of roughly $59 million as a backup and overflow to its Wilson facility, employing more than 100 employees. Following the close of purchase, Landau says Perdue plans to lease back the space from Novo Nordisk and occupy it through the fall. Management plans to meet with employees today to discuss their options, which are expected to include jobs at the Wilson site and with Novo Nordisk. Learn More

(Collaborative Research and Development Agreement) with the U.S. FDA on behalf of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). The institute has more than 120 partners, including private companies, academic institutions and nonprofits, and will open its headquarters in 2020 at UD's Science, Technology and Advanced Research (STAR) Campus. According to the agreement, known as a CRADA, as of July 15th, 2019, the FDA and NIIMBL have the ability to collaborate in a pre-competitive environment to strengthen research, innovation, training and collaboration in the biopharma manufacturing industry. Learn More

Janssen has decided to hand back the rights to an experimental CD40 agonistic antibody to Alligator Bioscience as it reassesses its research priorities, sending the latter's shares tumbling by 40%. ADC-1013, as the candidate is known, is currently in development at Phase 1 in the treatment of metastatic cancer. It was originally handed over to Janssen as part of a 2015 agreement which featured an upfront payment of $35 million and milestone payments of up to $695 million in addition to tiered sales royalties. Alligator Bio confirmed it had received the upfront payment as well as $11 million in milestone payments throughout the partnership. Learn More

The Broad Institute of MIT and Harvard lied about who invented the use of CRISPR genome editing in animal cells, and its lead CRISPR scientist Feng Zhang made statements to the patent office that he knew were "untrue," according to attorneys for the University of California and its partners in legal documents filed this week with the U.S. Patent and Trademark Office. In strikingly tough language, the lawyers accused the Broad of trying to "deceive the Office" in order to win patents and claimed that another Broad scientist made a "materially false declaration" about when Zhang's lab got CRISPR to work which makes Zhang's work "unpatentable." Learn More

Every year, fishermen net hundreds of thousands of the creatures off the U.S. East Coast and in Asia before their prized milky-blue blood is drained for use in medical safety tests. Swiss biotech Lonza and U.S. based Charles River Labs are the biggest suppliers of crab blood-based endotoxin tests, which detect bacterial contamination in intravenous drugs and medical implants. They are now at odds over the future of this testing, as Lonza urges adoption of a synthetic alternative called recombinant Factor C (rFC), amid pressure from wildlife campaigners and worries about supply reliability. Meanwhile Charles River, which is still studying rFC, argues moving too quickly could compromise patient safety. Learn More

Rafael Amado, who previously worked at Amgen and GSK, has handed in his notice at Adaptimmune. The R&D chief is set to leave Adaptimmune in less than two weeks, "to pursue other opportunities", triggering a search for a new clinical leader. Amado joined Adaptimmune as chief medical officer in 2015 before transitioning to the role of president of R&D last year. The new position expanded Amado's responsibilities, giving him oversight of all research and clinical activities from target identification through regulatory filings. Adaptimmune is recruiting a CMO to cover the clinical part of Amado's duties but may have to rely on its existing employees to handle the work in the near term. Learn More

Organization psychologist Jane Piper has worked with biopharma companies around the world to help them increase productivity and increase employee wellbeing. In this article she outlines the steps needed to increase productivity. In the biopharma manufacturing industry, where quality, hygiene and safety are essential, distractions can be costly. Errors, accidents and quality problems all increase when GMP procedures and SOP's are not followed because someone is not concentrating on their job. Helping your team to focus and concentrate will pay off in improvements in quality and safety. Learn More

The Trump administration this week proposed allowing the importation of lower-priced drugs from foreign countries in its latest bid to lower patient out-of-pocket costs. The proposal rests on the belief that manufacturers would offer imported drugs at a lower price if they sold them under a different National Drug Code than products designated for the U.S. market, a claim that analysts disputed. The pharmaceutical sector's leading trade group, meanwhile, opposed the plan on safety grounds. The reimportation plan comes after several recent setbacks for the administration in its efforts to drive down drug prices. Learn More

Bayer announced this week that the U.S. FDA has approved under priority review the prostate cancer drug daroluramide, which Bayer had co-developed with Orion. This decision by the regulator makes Orion eligible for a $50 million milestone payment from Bayer upon a commercial sale. According to the 2014 deal Bayer has the right to commercialize daroluramide globally while Orion will manufacture the product and receive milestone payments upon first sale in different markets. Bayer has filed for approval of the compound also in the European Union, Japan and with other health authorities. Learn More

The Federal Trade Commission (FTC) is investigating whether a Johnson & Johnson subsidiary violated antitrust laws with the contracting practices used for its anti-inflammation drug Remicade. J&J disclosed the legal challenge this week in a regulatory filing, saying the FTC issued a Civil Investigative Demand in June. Remicade is a long-time blockbuster biologic for J&J, initially approved in the U.S. in 1998. While Pfizer launched a biosimilar in 2016, uptake has been minimal with recent prescription statistics showing J&J has kept more than 90% of the market. Learn More

The US FDA has sent a Form 483 to API manufacturer Dr. Reddy's Bollaram, India site, raising concerns about the company's failure to respond to customer complaints about out-of-specification (OOS) results. According to the FDA, Dr. Reddy's received three complaints related to microbiological failures that did not meet the customer specifications for certain API lots, and Dr. Reddy's testing confirmed the OOS microbiological failures but did not determine a root cause. The site also failed to evaluate whether the finished APIs and retention samples stored in areas where relative humidity is not controlled or monitored were affected by extreme fluctuations in humidity, the FDA says. Learn More

Unusually high numbers of U.S. lymphoma patients are choosing experimental treatments over expensive cell therapies sold by Gilead and Novartis, new data shows, helping explain why sales of the two products have not met rosy expectations. Both Gilead's Yescarta and Novartis's Kymriah were approved in 2017. But government and private health plans have balked at their high price of at least $373,000 for a one-time treatment before hospital costs, which can bring the bill for a single patient to over a million dollars. Sales of both drugs billed as potential blockbusters at their launch, have been slow to ramp up. Learn More

Sanofi this week admitted its hopes for a hemophilia drug acquired in last year's $11 billion buy of Bioverativ were too optimistic, taking a roughly $2 billion impairment charge on Eloctate due to slowing sales in the U.S. and revised revenue projections. The write down acknowledges the substantial pressure Roche's rival Hemlibra has exerted on the market for hemophilia medicines, particularly older and less convenient therapies like Eloctate. For Sanofi, Hemlibra's success has cast some doubt on its push into hemophilia via Bioverativ. When the drugmaker bought Bioverativ last year, executives knew Hemlibra would present a competitive challenge, but thought any effect would be largely limited. Learn More

California Attorney General Xavier Becerra has announced that Teva, Endo and Teikoku will pay roughly $70 million to settle four cases where generic versions of Provigil and Lidoderm were delayed from entering the market. As part of this $69 million settlement, California will set up a more than $25 million consumer fund for California residents who purchased Provigil, Nuvigil or modafinil. This comes after an FTC report in May found that FY 2016 had the lowest number of pay-for-delay agreements since 2004. The U.S. Congress, meanwhile, has sought to halt the tide of pay-for-delay agreements, although legislation to crack down on such practices has stalled. Learn More

Cytokinetics has signed a 12-year lease on 235,000-sq. ft. at Kilroy Oyster Point, a 2.5-million-square-foot South San Francisco development project. The deal was closed just four months after construction commenced on the 40-acre, fully entitled, waterfront site. The first of four phases was launched in March 2019. Kilroy Oyster Point Phase I is expected to be delivered in the second half of 2021. Phase I consists of three state-of-the-art laboratory and office buildings. The three buildings, situated at the entrance to the project, are within walking distance to the ferry terminal and near Highway 101. Learn More

Pfizer is understood to be in talks to merge its off-patent drugs business with Mylan in a stock deal. Mylan shareholders would receive a little more than 40% of the newly formed entity, with Pfizer shareholders receiving the remainder. Additionally, Pfizer would receive roughly $12 billion in proceeds from a new sale of debt. Alert readers will recall that last year Pfizer said it was planning to reorganize into three units, separating its consumer healthcare business. At the time analysts speculated that such a move could lead Pfizer to sell or spin off its off-patent drugs. Learn More

Some of Switzerland's top university hospitals are teaming up to take on the soaring cost of cancer cell therapy offered by big pharma. The hospitals are hoping to offer the treatment for roughly $150,000 to $200,000. That's about one-third cheaper than the commercialized process offered by the biopharma industry. They expect to reduce costs by treating cells in Switzerland instead of sending them abroad for genetic processing. Pilot projects have started in Lausanne and Bern and university hospitals in Basel and Zurich are also planning to join according to published reports. Learn More

Tasuku Honjo, a distinguished professor at Kyoto University who helped develop the cancer immunotherapy drug Opdivo, plans to file a $138 million lawsuit against Ono Pharmaceutical, which markets the product. Honjo, who won the Nobel Prize in Physiology or Medicine last year for research that contributed to the development of Opdivo, has been at odds with the drugmaker over patent compensation. Sales of the drug have exceeded ¥1 trillion worldwide. Alert readers will recall that back in 2014 Honjo, who owns the patent, helped Ono Pharma with a patent infringement lawsuit against U.S. biopharma giant Merck & Co. for its sales of a product similar to Opdivo. Learn More

Merck, known outside the United States and Canada as MSD, has announced plans to invest roughly $680 million and create more than 400 jobs in North Carolina. The biopharma industry leader will build a new production facility at its Maurice R. Hilleman Center for Vaccine Manufacturing in Durham and expand its packaging operations in Wilson. Merck's project to expand its North Carolina facilities includes plans to design, build, and win qualification from the FDA for a new 225,000 square foot manufacturing facility to produce active ingredient for the vaccine. The new facility will be located at Merck's current manufacturing center in Durham. Learn More

Vertex will promote Reshma Kewalramani, its chief medical officer, to president and CEO on April 1, the company announced this week. She will succeed Jeffrey Leiden, who said he would step down as president and CEO after seven years in those roles. Leiden, who has also served as chairman, will become executive chairman, a position he will hold through the first quarter of 2023. Kewalramani, 46, will become the first woman to run a large biotechnology firm, a watershed moment for an industry that in 2018 had more men named "Michael" than women speak at its largest conference. Learn More

Italian biopharma Zambon is acquiring Breath Therapeutics for $156 million up front to expand its respiratory pipeline and establish a foothold in the U.S. The terms of the deal give Zambon ownership of Breath's sole asset, liposomal cyclosporine A for inhalation. For its part, Breath is eligible for roughly $400 million in well-defined milestones. The acquisition of Breath follows its spin-out from Pari in 2017 with $46 million in initial financing.  According to published reports, investors had planned to raise additional monies and seek a listing on the exchange had the acquisition not occurred. Learn More

Industry leading biopharma Roche, along with a host of others, made public this week that they had been victims of cyber-attacks, confirming a German media report which said the likely culprit was a state-backed Chinese group. According to reports, hackers used a type of malware called Winnti, which allows attackers to remotely access a victim's computer network. An analysis of the malware code showed which companies were targeted by a group likely working for the Chinese government. All said that no sensitive information was lost, while none of the companies commented on whether the attacks had been launched by Chinese hackers. Learn More

The Fortune 500 list is compiled of the 500 U.S.-based companies that generate the most revenue. In the latest ranking, one dozen biopharma companies were included, with one, Johnson & Johnson, breaking into the top 50 and only four in the top 100. Just behind J&J, at #61, is Pfizer. Followed by Merck at #76 and AbbVie at #96. Although not in the Fortune 500, three other biopharma companies did make the top 1000. Alexion came in at #614, Vertex at #752 and Catalent at #865. Alert readers will recall that 2018 saw three biopharma firms make the list of top 100. Learn More

Lonza has announced the start of an expansion to its bioconjugation facility in Visp, Switzerland that is expected will take two years. The stated purpose of the expansion is to meet the development and manufacturing needs of pharma and biotech companies developing a new generation of therapies. Lonza's Visp site completed a successful FDA inspection for commercial manufacture of a recently approved ADC, the third to be commercialized from the bioconjugation facility. The existing capacity at the Visp facility will cover the current needs for production of this fast-tracked therapy. Learn More

Jounce Therapeutics has announced an update on its strategic collaboration with Celgene, originally established in July 2016. Under the terms of a new license agreement, Celgene has licensed worldwide rights to JTX-8064. Jounce retains full worldwide rights to its pipeline beyond JTX-8064, including vopratelimab, JTX-4014 and all discovery programs, as Jounce and Celgene have also entered into a mutual agreement to terminate their original strategic collaboration. Under the terms of the new license agreement, Jounce receives $50 million upfront and is eligible to receive from Celgene up to $480 million. Learn More

The US FDA this week approved the 22nd and 23rd biosimilars: Pfizer's Ruxience, which is the second biosimilar to Roche's Rituxan, and Merck's Hadlima, which could end up being the ninth biosimilar to AbbVie's Humira. Celltrion and Teva's Truxima was approved last November as the first biosimilar to Rituxan. Truxima has yet to launch in the US, but in the EU, adoption of Truxima and Sandoz's Rixathon has topped 60%. Sandoz has since said it will not pursue a US biosimilar for rituximab. Hadlima, meanwhile, which is expected to launch 30 June 2023, joins a crowded field of adalimumab biosimilars all gearing up for 2023 launch dates. Learn More

The US FDA rejected an application from Biohaven for approval of its ALS drug, citing manufacturing quality issues with the active pharmaceutical ingredient used in a 2017 study, the biotech has disclosed. Biohaven said the sole issue raised by the FDA was over manufacturing concerns involving an Indian subsidiary of the Canadian generic drugmaker Apotex. Biohaven had sought approval for a sublingual version of riluzole that it dubbed Nurtec. Riluzole was first approved by the FDA in 1995 under the brand name Rilutek and remains standard treatment for ALS patients. Generic versions have dominated the market since the first copycat was OK'd in 2013. Learn More

After nearly seven years of failing to win fundamental patents on the genome-editing technology CRISPR, a unit of one of the world's largest life sciences companies has thrown a Hail Mary: Late last Friday, MilliporeSigma petitioned the U.S. Patent and Trademark office to open an interference proceeding between CRISPR-Cas9 patents that it applied for way back in 2012 and patents that the University of California has applied for or been awarded. The unusual move seems to be the company's last-ditch effort to pull out a CRISPR victory at the patent office, which it believes has treated its applications in a way that is inconsistent with how it has treated others. Learn More

Durect has inked a collaboration and license deal with Gilead to develop and market a long-acting injectable HIV therapy using Durect's SABER technology. Gilead picked up exclusive access to the SABER platform for HIV and Hepatitis B Virus (HBV) as well as an exclusive option to license more SABER-based products for HIV and HBV. Under the terms of the deal, Gilead is paying Durect $25 million upfront with another $75 million in development and regulatory milestones, another $70 million in sales milestones, and tiered royalties on any products that are sold. Learn More

An analysis done by Vantage finds that novel drug approvals could be heading for a down year. This after the US FDA green lit only 18 new medicines in the first half. However, a closer look at CDER finds that the department received eight "original novel drug" applications, as the regulator terms it, in the first quarter of 2019. This looks pretty much in line with the first-quarter average, since 2016 at least. Those monitoring biopharma's output of innovative medicines will also be encouraged to see that these novel filings have remained pretty constant, as a proportion of all types of submissions, over the past few years. Allowing one to conclude that 2019 could see a dip in novel drug approvals but not a slowdown. Learn More

The first anticancer biosimilars have arrived on the US market. Amgen and Allergan have announced the launch of Mvasi, a bevacizumab biosimilar referencing Avastin, and Kanjinti, a trastuzumab biosimilar referencing Herceptin, in the United States. According to the Amgen-Allergan partnership, the list price of both products will be 15% lower than their respective reference products. Notably, this week's launch of Kanjinti comes on the heels of news that Genentech had filed a motion for a temporary restraining order, and a motion for a preliminary injunction against Amgen but a judge denied Genentech's motions. Learn More

Catalent has signed a long-term agreement with Novartis' AveXis unit for manufacturing tied to Zolgensma, a gene therapy approved this year and launched at a price that makes it the most expensive drug ever brought to market. With the agreement, Novartis gains dedicated space at a new facility near the Baltimore-Washington International Airport built by Paragon Gene Therapy, a Catalent unit acquired in an April deal. Paragon Gene Therapy will also help with process development for clinical supply of viral therapies in AveXis' pipeline, Catalent says. Learn More

In a well written article recently published in Forbes, the argument is made that there is a need for a "Bio-Belt" to be created in rural America. In the article, the author cites a recent report from the USDA which finds that  although rural communities are home to 14 percent of the U.S. population, they have seen just 4 percent of the nations employment growth since 2013. Despite this economic pressure, rural America remains one of Americas most fertile regions, and recent advances in biotechnology are making it easier than ever to sustainably grow new kinds of valuable goods, from biopharmaceuticals to biomaterials. With the right strategic investments, rural America could see a biotech "bloom." Learn More

Martin Shkreli - the former biopharma CEO widely known as "Pharma Bro" - lost his bid to overturn a seven-year prison sentence for fraud this week. The U.S. Court of Appeals for the 2nd Circuit affirmed Shkreli's 2017 conviction. The appeals court judges ruled against Shkreli by a 3-0 vote. In addition to ordering him to stay in prison, the judges affirmed that he must forfeit more than $7.3 million, pay restitution of $388,336 and pay a $75,000 fine. Alert readers will recall that Shkreli gained a high profile in 2015 when, as the CEO of Turing Pharmaceuticals, he hiked the price of the lifesaving HIV drug Daraprim by more than 5,000%. Learn More

MyoKardia will spend up to $80 million to buy back U.S. royalty rights on mavacamten and MYK-224 from Sanofi, the last economic tie the two companies have retained since the French big pharma ended its collaboration in January. The transaction will put a dent into the cash reserves of MyoKardia, which amounted to $628 million as of March 31st. The company, which has no products on the market, says it has enough money to fund operations into the second half of 2021. MyoKardia will know soon enough whether its gamble was worth it, as the Phase 3 trial of mavacamten in obstructive hypertrophic cardiomyopathy is due to read out in the second quarter of 2020. Learn More

Investing in specialist waste management facilities would strengthen Ireland's hand in attracting more foreign investment, a global pharmaceuticals chief has said. Christophe Weber said there was a "huge critical mass" of pharmaceutical manufacturing in Ireland, "so I think having its own waste capability would be a big competitive advantage for the future for Ireland". Mr Weber, who is global chief executive of Japan's largest drug company Takeda, was in Ireland for the opening of its new state-of-the-art manufacturing facility for its blockbuster cancer drug, Ninlaro. The company has invested $45 million at Grange Castle to build the plant that will manufacture the drug for global supply. Learn More

Gilead as made public the planned departure of its chief scientific officer, chief patient officer and executive vice president of human resources within the next few months, as CEO Daniel O'Day continues to reshape the company's top ranks since arriving in March. John McHutchison, chief scientific officer and head of R&D, will step down on Aug. 2nd. The company describes his exit as a voluntary departure, and will pay $1.1 million to the outgoing executive. On Sept. 1, Katie Watson will leave her leadership position in HR, with an internal successor already named. Chief Patient Officer Gregg Alton will depart on Oct. 4 after two decades at Gilead. Learn More

Astellas Pharma and Frequency Therapeutics have announced that they have entered into an exclusive license agreement to develop and commercialize Frequency's regenerative therapeutic candidate, FX-322, for the treatment of sensorineural hearing loss, the most common type of hearing loss. At present, there are no approved therapeutic options for sensorineural hearing loss. Under the terms of the agreement, Astellas will pay Frequency $80 million upfront and be responsible for the development and commercialization of FX-322 outside of the U.S. and Frequency will be responsible for U.S. development and commercialization. Learn More

Inovio Pharmaceuticals has announced a strategic restructuring to prioritize the development of its late-stage HPV assets and reallocate capital to develop fast-to-market product candidates. As part of this corporate strategy, the company reduced its annual burn rate by 25% and cut workforce by 28%. Inovio also decided to trim some early-stage R&D programs while terminating the phase I/II study evaluating INO-5401 in advanced bladder cancer. Alert readers will recall that in May of this year Inovio made public in a regulatory filing the decision by MedImmune to discontinue their R&D collaboration. Learn More

Swiss authorities made public this week their decision to extradite Gongda Xue to the United States where he is wanted on charges of corporate espionage. Mr. Xue is the brother of Yu Xue, a biochemist who last year pleaded guilty to stealing trade secrets from drugmaker GSK. Alert readers will recall that five people have been charged in the case to date, including three who formed a Chinese-based startup, Renopharma, in the hope of allegedly benefiting from GSK's stolen proprietary data. The prosecutors accuse Gongda Xue, who worked in Basel for the Friedrich Miescher Institute for Biomedical Research, of carrying out tests in Switzerland using data stolen from a GSK research center in Pennsylvania. Learn More

The U.S. FDA has warned Strides Pharma over good manufacturing practice (GMP) violations at its Puducherry facility that included uncontrolled shredding of documents and inadequate investigations into out-of-specification (OOS) test results. According to the warning letter, investigators found rampant shredding of uncontrolled documents, including "multiple bags of uncontrolled CGMP documents with color coding indicating they were from drug production, quality and laboratory operations" that were awaiting shredding as well as a binder of batch records that had been tossed in a barrel outdoors. Learn More

Kite has announced plans for a new 67,000-square-foot facility in Oceanside, California, dedicated to the development and manufacturing of viral vectors, a critical starting material in the production of cell therapies. The new site builds on Kite's existing state-of-the-art manufacturing capabilities to deliver innovative cell therapies for people with cancer. Kite's facility will be constructed within an existing Gilead biologics operations facility in Oceanside and will become part of Kite's growing commercial manufacturing network that includes sites in California, Maryland and the Netherlands. Learn More

DeepMind, the artificial-intelligence arm of Google's parent Alphabet Inc., has the potential to upend how drugmakers find and develop new medicines. It could also dial up pressure on the world's largest biopharma companies to prepare for a technological arms race. Already, a new breed of upstarts are jumping into the fray. In December, at the CASP13 meeting in Riviera Maya, Mexico, DeepMind beat seasoned biologists at predicting the shapes of proteins, the basic building blocks of disease. The seemingly esoteric pursuit has serious implications: A tool that can accurately model protein structures could speed up the development of new drugs. Learn More

Boehringer Ingelheim has announced its acquisition of all shares of AMAL Therapeutics, a private Swiss biotechnology company focused on cancer immunotherapy and advancing first-in-class therapeutic cancer vaccines derived from its technology platform KISIMA. AMAL's lead vaccine ATP128 is currently developed for stage IV colorectal cancer and is slated to begin first-in-human trials later this month. Boehringer Ingelheim plans to develop new therapies by combining assets from its cancer immunology portfolio with AMAL's proprietary KISIMA immunization platform. Learn More

Novartis has been streamlining its business since CEO Vas Narasimhan took over, and has continued that push with the divestment of three drugs to Recordati for $390 million upfront. The Italian drugmaker is taking control of Signifor and its long-acting follow-up Signifor LAR - both passed on the somatostatin analogue pasireotide - as well as an experimental drug called osilodrostat (LCI699) in late-stage development. The sale of the three drugs comes as Novartis is in the midst of a streamlining effort, second only to AstraZeneca in the number of divestments and out-licensing deals last year, according to analysts. Learn More

Gilead has announced that it has entered into a 10-year global research and development collaboration with Galapagos. Under the terms of the agreement, Gilead will gain access to no fewer than six molecules currently in clinical trials, more than 20 preclinical programs and a drug discovery platform. Galapagos will receive a $3.95 billion upfront payment and a $1.1 billion equity investment from Gilead. Galapagos will use the proceeds to expand and accelerate its research and development programs. Gilead will receive an exclusive product license and option rights to develop and commercialize all current and future programs in all countries outside Europe. Learn More

Amgen, Novartis and Banner Alzheimer's Institute have discontinued two pivotal Phase 2/3 trials in the Alzheimer's Prevention Initiative Generation Program after tests showed some patient's cognitive functions had declined. The sponsors concluded that the potential benefits for participants did not outweigh the potential risks. The decision comes as another disappointment in the area of Alzheimer's research. The drug, CNP520, was being assessed for safety and efficacy in preventing or delaying the onset of Alzheimer's in people at high risk of developing the disease. Learn More

A recently published study in The BMJ by officials from Germany's Institute of Quality and Efficiency in Healthcare (IQWiG) finds there is no evidence of added benefit for more than half of the drugs the institute assessed from 2011-2017. For the study, the authors looked at the outcomes of the 216 benefit assessments IQWiG conducted from 2011-2017. More than half (125/216, 58%) of IQWiG's assessments found no evidence of added benefit for the drug compared to the standard of care. A quarter (54/216, 25%) of the assessments found there was major or considerable added benefit and one-sixth (35/216, 16%) of the assessments determined there was only minor or non-quantifiable added benefit. Learn More

BioTek, privately held and operared by the Alpert family for the past 50 years, has made public its agreement to be acquired by Agilent for roughly $1.16 billion. According to published reports, Agilent plans to have BioTek retain its name and remain in Vermont. The Winooski, Vermont site is expected to become a center of excellence for Agilent's cell analysis division. This is good news for the roughly 300 people employed by the company in Vermont who are expected to keep their jobs after the acquisition closes later this year. Agilent was one of five bidders for BioTek which had initiated the search for a buyer earlier this year.  Learn More

New Zealand's defense force conducted a controlled explosion at a site owned by biotechnology company Blis Technologies this week after being called to deal with a hazardous chemical inciden. According to reports, Blis staff noticed the deterioration of a container holding hydrazine monohydrate, which had crystalized, during a review of their chemical inventory. This led police to cordon off several streets in the area to facilitate disposal of the hazardous chemical. Learn More

Stem cell scientists in California who have benefited from a $3 billion state research agency created in 2004, at the height of federal limits on working with cells from human embryos, have long known that it would eventually run out of money. That reality set in last month, when the California Institute for Regenerative Medicine (CIRM) in Oakland announced it is no longer taking grant applications. Ongoing payments for approved projects continue, but scientists are already tightening their belts for a funding gap. They are also contemplating the end of a boom in stem cell research in the state. Learn More

Don't worry, biopharma industry: The FDA's still committed to accelerated drug development and approvals. That was the message from the director of the FDA's Center for Drug Evaluation and Research, Janet Woodcock, M.D., who appeared this week at the SVB Leerink Therapeutics Day in Boston. Woodcock said the "current elevated numbers" of new approvals would stay steady or even increase, according to a report SVB Leerink sent to clients today. "In fact, Dr. Woodcock believes that the drug industry is just beginning to see the fruits of the human genome sequencing and expects more and more approvals in future years," the report said. Learn More

Researchers in the University of California system this week lost subscription access to the major publisher Elsevier, the result of a closely watched fight between the two parties over how academic research should get read and paid for. The UC system, one of the largest in the country, has long paid Elsevier so that its affiliates could access hundreds of Elsevier journals. But negotiations broke down for a new contract that would have begun at the start of this year because of a dispute over payments for open-access research, which is made freely available to the public online. Learn More

Amneal Pharmaceuticals has made public plans to close its factory in Hauppauge, New York in October-December of 2020, eliminating 220 jobs. The manufacturer of generic prescription drugs, which is headquartered in New Jersey, will transfer production from Hauppauge to a larger factory in South Yaphank and to other facilities around the globe. According to regulatory filings, the job cuts are part of a restructuring plan initiated due to increased competition, declining sales and lower drug prices. In addition to the jobs being lost in New York, the company plans to eliminate 330 other positions at sites in the U.S., Europe and India. Learn More

Bayer has approached Elanco Animal Health to discuss a possible combination of their animal health businesses to create an industry giant, three sources familiar with the matter told Reuters. The two companies are working with banks to ensure any merger would secure regulatory approval, the sources said, speaking on condition of anonymity. Bayer has delayed the launch of an auction to private equity funds to clinch a bilateral deal with Elanco, the fourth-largest player in the animal health industry globally, the sources said. Bayer ranks fifth in veterinary medicine. Learn More

Following a more than one-month inspection last summer, the U.S. FDA this week released a warning letter for Akorn's Somerset, New Jersey manufacturing facility due to cGMP violations. The warning letter issued June 13th and discussed by Akorn on June 25th, echoes some of the observations made by the FDA in a Form 483 for the site last November. The FDA specifically raises concerns with the site's quality system, which "does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture." Akorn's data integrity issues led to the collapse of the merger agreement between Akorn and Fresenius Kabi. Learn More

Gulf Pharmaceutical Industries is looking to hire a restructuring adviser after cutting jobs as a ban on the medicine maker's exports to Saudi Arabia weighs on its finances. The company known as Julphar replaced most of its top management and appointed new board members as it comes under increasing financial strain. The United Arab Emirates-based firm also cut about 150 jobs, or 3 per cent of its workforce, according to a person with knowledge of the plans who asked not to be identified because they are private. Julphar is under growing pressure after Saudi Arabia's Food and Drug Authority in September banned its products for failing to meet regional standards. Julphar is working with the agency to get the ban lifted. Learn More

The U.S. wants Switzerland to extradite a Chinese researcher accused of helping his scientist sister steal secrets worth $550 million from GSK. Gongda Xue, who is fighting extradition, has been labeled a potential flight risk, according to a Swiss Federal Criminal Court verdict, keeping him in custody pending the extradition request's resolution. U.S. allegations against Gongda Xue, 49, underscore global fears that China is using networks of highly trained nationals abroad to smuggle trade secrets to the world's second-largest economy. Last year, prosecutors in Germany charged a Chinese-born engineer with industrial espionage in connection with secrets pilfered from chemical maker Lanxess. Learn More

Roche and Spark Therapeutics have made public the extension of the deadline to conclude the Swiss biopharma's $4.8 billion acquisition of Spark by three months, to April 30, 2020. The announcement comes shortly after the U.S. Federal Trade Commission initiated an unusual second request of the transaction to evaluate antitrust implications. In an email to Spark employees, Roche CEO Severin Schwan reiterated the group's intent to complete the acquisition. Roche-Spark is one of two recent biopharma transactions, the other being the BMS acquisition of Celgene, that has been the subject of FTC scrutiny. Learn More

Acer Therapeutics has announced both a corporate restructuring and update on its pipeline programs. Acer's headcount has been reduced from 48 to 19 employees and pre-commercial activities of EDSIVO™ (celiprolol) have been halted. The restructuring is expected to provide the resources needed for Acer to conduct its planned business operations through 2020. Acer intends to pursue discussions with the U.S. FDA regarding its previously announced Complete Response Letter (CRL) for Acer's New Drug Application (NDA) for EDSIVO™ and to continue the development of Acer's additional pipeline programs, including ACER-001 and osanetant. Learn More

GSK has officially opened its new $130 million pharmaceutical manufacturing facility in Singapore. The facility employs state-of-the-art technology that enables continuous manufacturing instead of the usual batch production. One of the site's production buildings was also expanded. The biopharma giant is reporting that the move to continuous manufacturing will reduce production time from roughly 180 days to just 42 and shrink the associated carbon footprint by 75%. GSK says that some staffers have already been trained on the new equipment and processes. They will in turn train the next group of workers. Learn More

Hanmi Pharmaceutical has taken a hit after Janssen handed back rights to a novel biologic being developed for weight loss and blood glucose control in certain patients with diabetes. According to the Korean drugmaker, while two Phase II trials carried out by Janssen achieved the primary target of weight reduction, "its blood glucose control in obese patients accompanying diabetes fell short of Janssen's internal standards". Janssen licensed exclusive global rights (excluding Korea and China) to the experimental drug in November 2015 in a deal valued at $915 million. Learn More

According to a University College London (UCL) report, British researchers are being shut out of major European research partnerships because of concerns over a no-deal Brexit. Apparently, if not being outright excluded from partnerships, UK researchers are being asked to keep a low profile because of fears a no-deal Brexit might make success less likely or that if a UK academic is heading an important partnership proposal, the research might not be funded. This is consistent with the last UCL report, which analyzed EU research funding. The data showed that UCL and eight other Russell Group universities had about 50 large European research collaborations in 2016, but only 20 in 2018. Learn More

Strides Pharma Science has made public, through a BSE filing, its receipt of a warning letter from the U.S. FDA for its Puducherry facility. The biopharma, however, did not provide any details of the contents of the warning letter received from the regulator. The company said its Puducherry site currently produces six products which will not get impacted by the current development. However, the 10 abbreviated new drug applications (ANDAs) pending approval from the Puducherry facility will get deferred till the site is reclassified, the company added. Strides says it will work collaboratively with the FDA to resolve all issues addressed in the warning letter. Learn More