By Tristan Manalac Pictured: A Biogen building/courtesy of PictureDesignSwiss/shutterstock After a June 12 shakeup of Biogen’s board of directors that included three directors foregoing their re-election, the company announced Monday that shareholders elected Susan Langer, who currently serves as president of Souffle Therapeutics, to the board. Langer will serve on the board for a one-year term, according to the press release. She was nominated by Alex Denner, a former member of the board who did not stand for re-election. According to reporting by Endpoints News and STAT News, Langer is Denner’s romantic partner and the mother of his child. BioPharma Dive reported that during Monday’s annual meeting of stockholders, Biogen management was asked why the company didn’t disclose this potential conflict of interest. Caroline Dorsa, the new chair, replied that Langer’s “personal matters obviously are much less relevant than what she brings to this board.” Langer has previously worked at ...
US-based amyloid diseases treatment solutions developer AltPep has raised $52.9m in its Series B investment round led by Senator Investment Group. Former investors such as Matrix Capital Management Company and Alexandria Venture Investments, who took part in the firm’s Series A round, joined the latest fundraise along with new backers. The new investors in Series B include Eli Lilly and Company, Partners Investment, and Section 32. As part of the deal, Senator Investment Group’s Rohit Vanjani will join the AltPep board. Besides, Lilly’s senior vice president and chief scientific officer for Neurobiologicals Ronald DeMattos will become a member of the Scientific Advisory Board at AltPep. Vanjani noted: “We believe AltPep is in an excellent position to optimise the value of its unique technology. “With scientific application for both therapeutics and diagnostics in a wide range of amyloid diseases, the potential for the company’s pipeline is vast and extremely promising.” The ...
New analysis of official records from the National Institute of Health (NIH) have revealed that just 365,000 people took part in a clinical trial for Type 2 Diabetes in 2021, despite 37.3 million people in the US living with the condition – or more than 11% of the population. By taking part in a clinical trial, people affected by conditions like diabetes can access innovative new treatments and drugs and help bring the medicines to market much faster, benefiting millions of others. The new findings were uncovered by Lindus Health, a clinical trials start-up, who analyzed the official clinical trial records across multiple diseases and found that diabetes was clearly being under-represented – with the equivalent of fewer than 1% of people affected by the disease being involved in a trial. Despite the number of people affected by diabetes, the condition is frequently overlooked in clinical trials. This is despite ...
By Tristan Manalac Pictured: A Biogen building/courtesy of PictureDesignSwiss/shutterstock Biogen announced Monday that three of its directors—Alexander Denner, William Jones and Richard Mulligan—will not stand for re-election at the company’s annual stockholder meeting Wednesday. Instead, Susan Langer will be up for election to Biogen’s board of directors. This latest shake-up comes after board chair Stelios Papadopoulos announced he was stepping down from his post after the annual meeting. Papadopoulos will be succeeded by Caroline Dorsa, a long-standing member of Biogen’s board who had previously served for more than two decades at Merck. Meanwhile, Langer is currently serving as president of Souffle Therapeutics, a privately held start-up that has most recently scored $50 million in investments, according to PitchBook. Before that, Langer was also the founding president of Kojin Therapeutics and the founding chief business officer of Paratus Sciences. She also previously worked at Biogen in posts of increasing responsibility. Endpoints ...
After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen’s Leqembi is heading into the final stretch of its regulatory review on strong footing.During a Friday meeting, members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee took a careful look at the data behind the partners’ Alzheimer’s disease drug. Ultimately, the group voted 6 to 0 that the drug’s Clarity AD study verify its clinical benefit. In the discussion portion of the meeting, advisory committee members described the trial results as “robust,” “meaningful,” “consistent” and “significant.” Now, it’s up to the FDA to decide whether to follow the advisory committee’s guidance. The agency is expected to decide on the application by July 5. Before the Friday discussion, the FDA released its own briefing document that appeared to outline agency support for a full approval. During the meeting, the FDA’s acting director of the ...
By Rosemary Scott Pictured: Three side-by-side scans of a human brain/iStock, semnic The FDA released briefing documents Wednesday that signal it is likely to grant Eisai and Biogen’s Leqembi (lecanemab) full approval to treat Alzheimer’s disease on its decision date in July. The documents come just two days before an advisory committee is scheduled to vote on whether to recommend the drug’s approval. The FDA has asked the six members of the advisory committee to answer the following question: Do the results of a pivotal trial dubbed Study 301 (CLARITY AD) verify the clinical benefit of lecanemab for the treatment of AD? But it appears the agency may have already decided for itself. Both the briefing documents and the committee’s decision will be based on the Study 301results. In the documents, the FDA stated that the data from the trial showed “consistently favorable results for the primary and secondary endpoints,” ...
Nicole DeFeudis Editor Biogen is calling it quits on a late-stage Parkinson’s trial as part of an ongoing R&D reorganization. The Cambridge, MA-based biotech announced Monday morning that it’s discontinuing a Phase III program evaluating BIIB122 as a treatment for patients with Parkinson’s disease related to LRRK2 mutations with partner Denali Therapeutics. The study, dubbed LIGHTHOUSE, kicked off in September; it was slated for completion in 2031. Biogen said the decision was made in consideration of the study’s “complexity including the long timeline.” “These modifications are not based on any safety or efficacy data from studies of BIIB122,” the company said in a statement. “Denali and Biogen have a strategic collaboration to jointly develop and commercialize small molecule inhibitors of LRRK2 and remain committed to advancing the development of BIIB122.” Back in 2020, Biogen shelled out more than $1 billion upfront — including $560 million in cash and $465 million ...
After Lundbeck and Otsuka’s Rexulti cleared a key advisory committee hurdle, the FDA has given the drug the go-ahead to treat dementia-associated agitation in Alzheimer’s disease patients With the approval, Rexulti becomes the first drug approved for this use in the United States. The FDA granted the nod based on data from two 12-week studies in which patients showered statistically significant and clinically meaningful improvements on the Cohen-Mansfield Agitation Inventory scale, according to the FDA. The metric looks at the frequency and intensity of dementia-related agitation. In the studies, Rexulti demonstrated a 31% improvement from baseline agitation symptoms compared with placebo. Agitation symptoms cover a wide group of behaviors including pacing, gesturing, profanity, shouting, and physical outbursts, Otsuka said in a release. The symptoms are the leading causes of assisted living or nursing room placement and have been known to be associated with accelerated disease progression, Tiffany Farchione, director ...
Biogen has stopped or paused several drug programs as part of a larger effort to cut costs and prioritize certain research. The decision, disclosed Tuesday in the company’s latest earnings report, comes as sales of its marketed medicines for brain and nervous system disorders continue to fall. Biogen recorded $2.46 billion in total revenue between January and March, a 3% decline from the same period a year prior. Revenue was down across most business segments, with the company’s flagship multiple sclerosis franchise taking the biggest hit, decreasing by 19%. Christopher Viehbacher, the former chief executive at Sanofi and the recently minted CEO of Biogen, is now trying to reshape a research and development organization that, for many years, revolved around high-risk, high-reward neuroscience programs. ““Having a few of those projects in our pipeline is good,” he said in February, “having 100% … is challenging.” On Tuesday, Biogen ...
U.S. neurologists are “cautiously optimistic” about using Eisai’s Leqembi in Alzheimer’s disease as concerns about safety and the need for the FDA’s full green light for the drug remain high barriers to uptake. That’s according to a new survey and report out by drug launch analyst Spherix Global Insights, which in March asked 73 neurologists working in the U.S. about their use and receptivity of Leqembi, which was partially approved by the FDA at the start of the year. Now launched, the drug finds itself at a strange junction. It still does not have a full FDA approval; that isn’t set to come until early July. While there is another new drug on the market for Alzheimer’s—namely Aduhelm, which Eisai helped create with Biogen—that drug is commercially dead in the water. The Centers for Medicare & Medicaid Services (CMS) refused to cover payments of Aduhelm, which was ...
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