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Eli Lilly announced Thursday that it will acquire the privately held biopharmaceutical company Sigilon Therapeutics with the goal of developing encapsulated cell therapies for the potential treatment of type 1 diabetes. Read More
The FTC and the DOJ are pushing for rules that would require companies planning a merger or acquisition to forestall consummation until federal agencies have had enough time to more deeply investigate whether the transaction would violate antitrust laws and “harm the American public.” Read More
The FDA’s June 22 Accelerated Approval of Sarepta’s gene therapy Elevidys for Duchenne muscular dystrophy (DMD) is appropriate, despite an apparent disagreement within the department, according to CBER Director Peter Marks. Read More
Citing potential for supply disruptions to patient care, the Healthcare Distribution Alliance (HDA) has recommended a phased approach to the FDA's final implementation of the Drug Supply Chain Security Act (DSCSA) instead of meeting the hard deadline of Nov. 27. Read More
Coherus BioSciences has resolved a key piece of its dispute with AbbVie over plans to market Yusimry (adalimumab-aqvh), a biosimilar for AbbVie’s blockbuster immunotherapy Humira, enabling it to begin selling the product July 1 at an 85 percent discount from AbbVie’s price. Read More
The current system of opaque prices due to confidential rebates poses a barrier to a well-functioning pharmaceutical marketplace, a JAMA Network Open editorial states. Read More
The industry association representing pharmacy benefit managers (PBM) has fired back at the introduction of a Senate bill that would curtail their revenue based on the price of the drugs they manage, pointing the finger instead at drug companies that set high prices. Read More
This monthly feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Read More
The discounts drug manufacturers are forced to offer pharmacy benefit managers (PBM) and insurance companies on their products are driving the sharp rise in drug prices, according to a study published Wednesday in JAMA Network Open. Read More
Pfizer has become the latest pharma company to unveil serious drug shortages in the ongoing U.S. drug supply crisis, announcing the discontinuation of two penicillin products and the limited supply of several penicillin syringes. Read More
Futura Medical has been granted the first FDA OTC marketing authorization for its MED3000, a topical gel for the treatment of erectile dysfunction (ED). Read More