Merck is back in Alzheimer's saddle with $1B+ Cerevance pact, years after dropping the BACE AstraZeneca ADC barrels forward as Keytruda combo data make case for lung cancer use Acadia culls painkiller rival to Vertex and cancer candidate over poor data Johnson & Johnson's head of R&D Mathai Mammen heads for the exit in surprise move Verona’s shares jump as COPD drug hits goal in phase 3, teeing up FDA filing After a series of clinical stumbles, Atara lays off 20% of staff and slims R&D focus GSK bets $1.3B on Mersana’s preclinical ADC and chance to expand portfolio beyond Blenrep After addressing FDA’s concerns, Reata's wait for ataxia drug decision extended by 3 months Eagle swoops down to nab chunk of BARDA-backed Enalare Therapeutics MacroGenics joins biotech layoff wave, slashing 15% of workforce after deaths reported in phase 2 trial Cyteir pauses development of cancer med, funnels cash towards lead asset Clovis, in need of cash or deals now to stem looming financial challenges, looks to pipeline for ideas How newly discovered vitamin K mechanism could have broad implications for treating diseases The rise of SkyWalker: FDA clears surgical robot for orthopedic procedures Featured Story | By Annalee Armstrong Another Big Pharma is entering—or rather re-entering—the Alzheimer’s ring. Merck & Co. has signed a billion-dollar biobucks deal with Cerevance to identify new therapies for the devastating neurodegenerative disease. read more |
| |
|---|
|
Top Stories By Nick Paul Taylor AstraZeneca and Daiichi Sankyo have delivered more evidence that their TROP2-directed antibody-drug conjugate (ADC) may have a future in non-small cell lung cancer, linking the candidate to a roughly 40% overall response rate when used as part of doublet and triplet combination therapies. read more By James Waldron Acadia ditched two candidates from its pipeline, including a one-time competitor to Vertex’s non-opioid painkiller. The biotech revealed it scrapped ACP-044 following an evaluation of the final phase 2 data on patients undergoing bunion removal, while a phase 1 cancer prospect will not move forward. read more By James Waldron Johnson & Johnson’s head of R&D is off. In a surprise post-market announcement yesterday, the company revealed that its executive vice president of pharma R&D Mathai Mammen, M.D., Ph.D, is leaving to “pursue other opportunities.” read more By Nick Paul Taylor Verona Pharma has hit the mark in its first of two phase 3 COPD clinical trials, keeping it on course to file for FDA approval of the inhaled PDE3 and PDE4 inhibitor in the first half of next year. Shares in Verona rose around 30% to the region of $9 in premarket trading. read more By Annalee Armstrong Just under a month after Atara Biotherapeutics’ multiple sclerosis cell therapy turned up inconclusive results in a mid-phase trial, the biotech is taking decisive action to reduce cash burn by laying off 20% of its staff. read more By Gabrielle Masson GSK has paid out $100 million cash to Mersana Therapeutics for the potential to add a second antibody-drug conjugate (ADC) to its pipeline. The new deal encompasses XMT-2056, Mersana’s preclinical ADC aimed at treating a range of HER-2 cancers. read more By James Waldron Reata Pharmaceuticals has done its homework in responding to the FDA’s concerns about an application for its nerve disorder drug. But now the biotech has to sit tight for an extra three months while the agency mulls things over. read more By Max Bayer Eagle Pharmaceuticals is not leaving M&A to the larger biopharma hawks, offering up to $55 million in equity to Enalare Therapeutics for its lead asset to treat respiratory depression. Eagle also has the opportunity to fully acquire the company later. read more By Gabrielle Masson MacroGenics has joined the pack of biotechs cutting staff, laying off 15% of its workforce after shuttering a phase 2 clinical trial for anti-cancer antibody enoblituzumab when seven patient deaths occurred. read more By Max Bayer Cyteir is pausing development of its a cancer med waiting in the wings. Instead, the company says it will focus resources on its lead asset and additional research work. read more By Annalee Armstrong Clovis Oncology needs cash—and fast. And so the company is making an appeal for some sort of deal or additional capital to ensure it can continue beyond February 2023 “as a going concern.” read more By Angus Liu Vitamin K has been widely used to reverse severe bleeding from overuse of the blood thinner warfarin. Now, an international team of scientists has identified the enzyme performing that task and, along the way, showed that vitamin K could suppress a type of cell death. read more By Andrea Park Not so long ago in our very own galaxy, the FDA saw fit to expand its list of authorized robotic surgery systems—no epic interplanetary battles needed. read more Resources Sponsored by: Triangle Insights Group, LLC The TrialCard/Triangle Insights Group platform is uniquely positioned to support you as your asset progresses through the value chain, by integrating strategic commercialization and market access insights with comprehensive patient and provider support services. Sponsored by: Thermo Fisher Scientific See how integration of innovative genetic analysis techniques into drug development is driving biopharma & biotech companies ahead. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Carla Vozone discusses the significant trends in the OINDP segment including large molecules and novel indications, changes within CDMOs and various challenges facing the industry. Sponsored by: Catalent Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Free Virtual Event Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ | 