Legislation introduced by Utah Senator Mike Lee would eliminate testing to show a biosimilar can be substituted for a reference biologic product. Lee contends the current testing requirement adds costs and delays market access for these lower-cost biological medicines.
Grifols said the layoffs sparked by its restructuring represent just 8% of its workforce. But the cuts will happen mainly in the Barcelona-based company’s U.S. plasma operations, source of most of the plasma that is the basis for its biologic medicines.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Juvena Therapeutics is developing secreted protein drugs built on new knowledge gleaned from proprietary technology that maps these proteins and the tissues in the body where they offer a regenerative effect. The startup’s lead program is in development for the muscle disorder myotonic dystrophy type 1.
An experimental hemophilia A therapy from Sanofi and partner Sobi has met the goals of a pivotal study, and the pharmaceutical giant is now planning global regulatory submissions for later this year. The drug could compete against a blockbuster hemophilia A treatment marketed by Roche.
Biocon Biologics is acquiring the biosimilars business of its longtime partner, Viatris. The deal gives Biocon a biosimilars presence in both emerging and developed markets, while Viatris sheds non-core assets as part of a broader strategic review.
The FDA has rejected Pfizer’s somatrogon, a long-acting form of human growth hormone designed for once-weekly dosing. The setback delays Pfizer and partner Opko Health from competing against a newly approved human growth hormone drug from Ascendis Pharma that is also designed for once-weekly dosing.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
In acquiring Amunix, Sanofi becomes the latest big pharmaceutical company to strike a deal to gain access to technology that improves the safety and efficacy of T cell engager cancer therapies. Sanofi agreed to pay $1 billion up front to buy preclinical Amunix.
Evotec is an old player in the life sciences, but in offering new shares on the Nasdaq, the Germany-based company plans to bolster its new biologics manufacturing capabilities in the U.S and Europe. In other stock market debuts, IO Biotech’s IPO raised $100 million as it prepares a pivotal test of its lead cancer immunotherapy.
Harvard University spinout GRO Biosciences has technology offering the potential for protein therapies that are safer and more effective than currently available biologic drugs. The startup's research is now backed by $25 million, a Series A financing round whose investors include the venture arm of Bayer.
Biomanufacturing technologies company Resilience is partnering with Harvard in a deal that could see innovations from the university’s labs commercialized under new businesses. Resilience has committed $30 million in funding to support Harvard biomanufacturing research.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
Bioprocessing technologies company Repligen is acquiring Avitide, and its biologics purifying technology, in a $150 million cash and stock deal. Repligen said Avitide will help it meet growing demand for gene therapy solutions.