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The European Medicines Agency (EMA) is the first regulator to adopt the International Council for Harmonization (ICH) new guideline Q13 on continuous manufacturing (CM) of drug substances and drug products, effective July 10, 2023. Read More
In the wake of the FDA allowing the so-called abortion pill to be dispensed via pharmacies, removing the requirement that the drug only be given to patients in a healthcare setting, the Center for Drug Evaluation and Research (CDER) has rejected two related citizen petitions — one to restrict use and the other to expand the indication. Read More
Dutch biotech Synaffix has signed a $2 billion licensing agreement with Amgen to bring a new generation of antibody-drug conjugates (ADC) to market. Read More
Eisai’s antiamyloid antibody lecanemab has won FDA Accelerated Approval for treatment of Alzheimer’s disease (AD) and, under the trade name Leqembi, will be available the week of Jan. 23. Read More
Gilead Sciences is working to shore up its rheumatoid arthritis (RA) and lupus assets, teaming up with EVOQ Therapeutics to work on treatments for the two diseases. Read More
Novartis has agreed to pay $245 million in settlements to end antitrust cases that claimed the drugmaker delayed the launch of generic versions of its hypertension medicine Exforge (amlodipine and valsartan) in the U.S. market. Read More
With a decision from the FDA on Eisai’s Alzheimer’s drug candidate lecanemab expected as soon as today, an autopsy report published in the New England Journal of Medicine highlighted the potential for devastating consequences associated with concomitant treatment with the antiamyloid antibody and thrombolytic therapy for ischemic stroke. Read More
The FDA sent a warning letter to Global Pharmacy Plus, an internet pharmacy, concerning the company’s marketing of generic versions of the immunosuppressant drugs mycophenolate mofetil and tacrolimus, both of which carry Black Box warnings and must only be distributed under an approved Risk Evaluation and Mitigation Strategy (REMS). Read More