Pictured: Biogen/The Boston Globe via Getty, John Tlumacki With full FDA approval and CMS coverage for Leqembi in hand, Biogen is ramping up its launch efforts for the Alzheimer’s drug and executing a massive cost reduction program. The biotech company announced second-quarter earnings and its new cost-savings plan on Tuesday. The “Fit for Growth” program is expected to generate around $1 billion in operating expense savings by 2025, which includes a headcount reduction of approximately 1,000 jobs, or about 11% of Biogen’s workforce. Around $300 million will be reinvested into product launches and R&D programs for a net savings of $700 million. The staff reduction will be completed by 2025. The company had more than 8,700 employees in 2022, according to Statista. Biogen CFO Michael McDonnell told investors on Tuesday’s earnings call that a “substantial portion” of the $700 million in net operating expense savings are expected to come from cutting ...
New research from Duke found that people who imagined being a thief scouting a virtual art museum in preparation for a heist were better at remembering the paintings they saw, compared to people who played the same computer game while imagining that they were executing the heist in-the-moment. These subtle differences in motivation—urgent, immediate goal-seeking versus curious exploration for a future goal—have big potential for framing real-world challenges such as encouraging people to get a vaccine, prompting climate change action, and even treating psychiatric disorders. The findings appeared online July 25 in the Proceedings of the National Academy of Sciences. Alyssa Sinclair, Ph.D. ’23, a postdoctoral researcher working in the lab of Duke Institute for Brain Sciences director Alison Adcock, Ph.D., M.D., recruited 420 adults to pretend to be art thieves for a day. The participants were then randomly assigned to one of two groups and received ...
Photo: Kiyoshi Ota/Bloomberg, via Getty Images Astellas Pharma is far from alone in viewing cancer as a major growth area, but the Japanese drugmaker has specifically identified a type of therapy called targeted protein degradation as one of the key areas for increasing revenue. It just struck its second deal in the past two months to help it execute on that strategy and perhaps stand apart from others pursuing the same type of drugs. Under a partnership announced Tuesday, Astellas will work with PeptiDream to discover new protein degraders using the technology of that company. Specific targets were not disclosed, but they will be selected by Astellas. The deal also grants Tokyo-based Astellas the option to select up to three additional targets for inclusion in the collaboration. Astellas will pay PeptiDream 3 billion yen (about $21 million) up front. PeptiDream, based in Kawasaki, Japan, is eligible to receive up to ...
Pictured: Person undergoing an eye exam/iStock, Jacob Wackerhausen Kodiak Sciences shares fell over 50% on Monday after the company announced that its late-stage biologic failed to sufficiently improve the vision of patients with diabetes macular edema and that it would not be pursuing this program any further. The California-based company was testing tarcocimab tedromer, a novel antibody-polymer conjugate developed by the company for the treatment of vision loss. Kodiak had three Phase III trials: DAYLIGHT, GLEAM, and GLIMMER. The DAYLIGHT trial investigated the safety and efficacy of tarcocimab tedromer in a high-intensity dosing regimen for patients with wet age-related amcular degeneration (AMD). Not only was the drug “safe and well tolerated,” but it met the clinical target of “non-inferior visual acuity gains” relative to aflibercept, sold commercially as Eylea and Zaltrap. But the next two Phase III trials, GLEAM and GLIMMER, were far less promising. These were identical studies investigating ...
Pictured: Respiratory syncytial virus vial and syringe/iStock, Manjurul Bavarian Nordic’s portfolio has taken a hit as the company announced Saturday its respiratory syncytial virus vaccine candidate did not meet all primary endpoints in a Phase III study in older adults. While the vaccine candidate showed 59% efficacy in preventing at least two pre-defined lower respiratory tract disease (LRTD) symptoms from RSV, that number dropped to below the co-primary endpoint for severe LRTD in patients 60 and older. With the miss, Bavarian Nordic is discontinuing its RSV program. The decision also terminates its partnership with Nuance Pharma and chance for the coupled milestone payments of 195 million Danish kroner for developing and launching in select Asian markets. Bavarian Nordic CEO Paul Chaplin said in the release that the outcome was “unexpected” and will impact short-term growth expectations. However, the company said there is no impact on the financial guidance ...
The respiratory syncytial virus (RSV) vaccine arena lost a competitor on Saturday 21 July after Danish company Bavarian Nordic shelved its programme following missed endpoints in a Phase III trial. The candidate, named MVA-BN RSV, failed to meet the co-primary endpoint of severe lower respiratory tract disease (LRTD) based on at least three pre-defined symptoms, only demonstrating a 42.9% efficacy. The vaccine did, however, have a 59% efficacy in preventing at least two pre-defined LRTD symptoms. The randomised, double-blind Phase III trial (NCT05238025) involved 20,000 older adults across centres in the US and Germany. As a result of the programme termination, Bavarian Nordic has also ended its partnership with Nuance Pharma, a Chinese pharma company brought in to develop and launch the vaccine for Asian markets. Although Bavarian Nordic’s president and CEO Paul Chaplin said in a statement that the blow would impact short-term growth, ...
Johnson & Johnson on Monday said it plans to reduce by at least 80% its stake in Kenvue, the consumer health business it spun out as an independent company earlier this year, via a stock exchange offer. J&J owns 89.6% of Kenvue’s common stock, which amounts to more than 1.72 billion shares. The exchange offer, also known as a split-off, will allow J&J shareholders to swap all or a portion of their shares for Kenvue’s common stock at a 7% discount. The offer is expected to be tax-free, J&J said in a release. The company noted that the split-off is voluntary for investors and is slated to close on Aug. 18, which is far earlier than expected. J&J said it received a waiver that dismisses the share lockup period associated with Kenvue’s initial public offering in May. That lockup agreement would have required J&J to ...
Roche has entered into a new partnership with Alnylam Pharmaceuticals to develop and commercialise a potential treatment for high blood pressure, with the deal worth up to $2.8bn. The candidate, zilebesiran, is an investigational, subcutaneously administered RNAi therapeutic currently in phase 2 development to treat hypertension in populations with high-unmet needs. Under the terms of the agreement, which provides Roche with exclusive commercialisation rights to the therapy outside of the US and joint commercialisation rights within the country, Alnylam will receive an upfront payment of $310m and is also eligible to receive certain milestone payments. Hypertension, the leading cause of cardiovascular disease, affects more than 1.2 billion adults worldwide. While several therapies exist, a significant unmet need remains, especially for high-risk patients. Zilebesiran works by preventing the production of angiotensinogen, a protein that plays a key role in raising blood pressure, in the liver. ...
Sandoz, a Novartis division, has announced that its multiple sclerosis (MS) biosimilar has been recommended by the European Medicines Agency’s (EMA) human medicines committee as a single disease-modifying therapy in adults with highly active relapsing-remitting forms of the disease. The “first-of-a-kind” biosimilar natalizumab, developed by Polpharma Biologics, is a version of Tysabri (natalizumab). Biosimilars, according to the EMA, are biological products that are highly similar to a medicine already approved in the EU. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they could potentially lower healthcare costs. Pierre Bourdage, chief commercial officer, Sandoz, said: “Access to affordable, high-quality treatments like disease-modifying therapies – which are a cornerstone in the treatment of MS – remains limited for many people living with this disease.” Over 2.8 million people worldwide are affected by MS, a disabling and unpredictable ...
Snacking is becoming increasingly popular, with more than 70% of people reporting they snack at least twice a day. In a new study involving more than 1,000 people, researchers examined whether snacking affects health and if the quality of snack foods matters. Kate Bermingham (PhD, postdoctoral fellow, King’s College London) said, “Our study showed that the quality of snacking is more important than the quantity or frequency of snacking, thus choosing high quality snacks over highly processed snacks is likely beneficial. Timing is also important, with late night snacking being unfavorable for health.” Bermingham will present the findings at NUTRITION 2023, the annual flagship meeting of the American Society for Nutrition held July 22-25 in Boston. The work is part of the ZOE PREDICT project, a group of large in-depth nutritional research studies designed to uncover how and why people respond differently to the same foods. ...
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