Featured Story | By Max Bayer After selling its potential blockbuster migraine program to Pfizer, Biohaven is hoping to strike gold twice. Its immediate future rests with two looming phase 3 readouts, the first of which is due in a few weeks. read more |
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Top Stories By Nick Paul Taylor Uh-oh. It was easy for Roche to brush off the failure of a high-risk bet on its anti-TIGIT drug tiragolumab in March. The indication was always a long shot. Now, though, tiragolumab has flunked a second phase 3 test, failing to improve on the progression-free survival achieved by Tecentriq alone in patients with non-small cell lung cancer. read more By Annalee Armstrong Inovio’s founding CEO is throwing in the towel after a bumpy couple of years trying to join the COVID vaccine market. He will be replaced by Jacqueline Shea, Ph.D., who will pick up where he left off during this “particularly challenging period in Inovio's history.” read more By Max Bayer Peter Marks, M.D., Ph.D., head of the FDA's Center for Biologics Research and Evaluation, says the agency needs more staff if it's to replicate the efficiency of the famed federal response to the COVID-19 pandemic for rare diseases. His comments came in a discussion of his center's budget priorities that are up for debate in Congress. read more By Nick Paul Taylor Takeda has finally given up on its treatment for the rare genetic disorder Hunter syndrome. After years of talks with regulators, the Japanese drugmaker has decided to cut its losses, further weakening the wave of new products it expects to fuel growth in the years to come. read more By Gabrielle Masson Novo Nordisk has struck up a new—and unconventional—partnership with Flagship Pioneering, aiming to quickly create a portfolio of breakthrough medicines for cardiometabolic and rare diseases by leveraging Novo’s disease expertise and the technology from Flagship’s bioplatform companies. read more By Annalee Armstrong Bioasis and Neuramedy are hoping to cross the blood-brain barrier together in a new $72 million biobucks collaboration for a Parkinson’s disease therapy. read more By James Waldron With Big Pharma backing and helmed by a research veteran, Nuvig has exited stealth mode with the bold aim of fundamentally transforming autoimmune disease treatment. The company is based on a “new understanding of how the immune system naturally equilibrates itself,” Nuvig said in a May 11 announcement. read more By Annalee Armstrong Rallybio is making room for a rare disease candidate from Sanofi’s stockroom with a small $3 million upfront cash payment. The biotech will take over development of KY1066, which will be renamed RLYB331, for severe anemia and iron overload in patients who have diseases such as beta thalassemia and a certain type of myelodysplastic syndrome. read more By James Waldron As if a SPAC merger crashing and burning alongside a phase 3 failure wasn’t enough for Amicus Therapeutics this year, the company’s late-phase gene therapy has faced another setback in the form of a delayed FDA review. read more By Gareth Macdonald The cancellation of two COVID-19 studies had a negative impact on Science 37’s first quarter, but the trial tech firm sees an opportunity in the push for more diverse study populations. read more By Eric Sagonowsky Only a month after mRNA giant Moderna unveiled a CFO switch, its new finance chief is out the door because his former employer disclosed an internal accounting probe. As a result, Moderna is bringing back its former finance chief David Meline to run its books. read more By Paige Minemyer Centene is in the midst of a companywide value creation initiative. Here's how that work has changed its perspective on mergers and acquisitions. read more Resources Sponsored by: Catalent In this executive summary, we describe the benefits of controlled release, look at how to determine whether a drug is suitable for controlled release, review the application of PBPK modelling in controlled release formulation development and discuss how modified release products can be developed to deliver optimal patient outcomes. Sponsored by: Merit Solutions Quality operations guide your organization through regulatory compliance processes and safeguard your products, processes, and reputation. But your team is capable of so much more. Quality incident data and processes can be a driver of significant business value if shared with other stakeholders. 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