FREIBURG, Germany, Sept. 14, 2021 /PRNewswire/ -- Eleva, a manufacturer of superior biologics, is scaling up its production capacity to 2500 l in state-of-the-art single-use reactors. This will produce enough factor H to cover all three clinical phases.
For Sanofi, snapping up Biogen spinout Bioverativ for $11.6 billion bolstered its rare disease franchise by adding hemophilia drugs Eloctate and Alprolix. But for a Swiss man, catching an early whiff of the deal has allegedly brought some illegal gains—and now, a civil and a criminal case in the U.S.
List of centrally authorised products requiring a notification of a change for update of annexes
Advate & Adynovate (Antihemophilic Factor)Nektar Therapeutics v. Bayer HealthCare LLC
After an unusually slow 2017, deal-making in Big Pharma roared back to life in the first half of this year, with $100 billion spent on mergers and acquisitions so far. And with such names as Johnson & Johnson and Allergan mulling both acquisitions and selloffs of some of their core assets, it’s likely the M&A boom will continue through 2018.
For many biotech companies, mergers and acquisitions have become a cornerstone in building a robust pipeline that can ensure positive growth for years to come. Although 2017 was slow for M&A activity, analysts have predicted 2018 could be a return to a spending frenzy.
Adynovate® (Antihemophilic factor) : Bayer HealthCare LLC v. Nektar Therapeutics
Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, today announced the U.S. availability of myPKFiT for ADVATE [Antihemophilic Factor (Recombinant)], a free web-based, Rx software that is the first and only pharmacokinetic (PK) dosing software cleared by the U.S. Food and Drug Administration (FDA) for use with hemophilia A patients 16 and older weighing at least 45 kilograms and treated with ADVATE.1 The software generates a patient’s estimated individual PK profile, which aids healthcare professionals in personalizing a patient’s prophylaxis ADVATE dose and schedule.1
Adynovate®. (Antihemophilic ): BAYER HEALTHCARE LLC v.NEKTAR THERAPEUTICS,nBAXALTA INCORPORATED, andnBAXALTA US INC
Afstyla is the first and only single-chain product for hemophilia A that is specifically designed for long-lasting protection from bleeds with two to three times weekly dosing. In clinical trials, patients undergoing prophylaxis with Afstyla experienced a median annualized spontaneous bleeding rate (AsBR) of zero. Once activated, Afstyla is identical to natural factor VIII. Afstyla also demonstrated a strong safety profile with no inhibitors observed in previously treated patients undergoing prophylaxis.