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The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee struggled to find definitive answers when it met Monday to consider dosing and labeling for Regeneron Pharmaceuticals’ aflibercept as a treatment for retinopathy of prematurity (ROP), a leading cause of childhood blindness. Read More
Eli Lilly and South San Francisco, Calif.-headquartered TRexBio have inked a multi-year research collaboration and licensing deal potentially worth up to $1.1 billion to develop therapies for immune-mediated diseases. Read More
AstraZeneca announced a plan to purchase Waltham, Mass.-based CinCor Pharma in a deal worth up to $1.8 billion as it looks to expand its pipeline of heart and kidney drugs with CinCor’s hypertension candidate baxdrostat. Read More
On the heels of nabbing accelerated approval of its Alzheimer’s therapy Leqembi (lecanemab), Eisai has filed for full approval of the drug in patients with mild cognitive impairment (MCI) or mild dementia and confirmed presence of amyloid beta plaque in the brain. Read More
The vaccine demonstrated noninferiority in antibody response compared to Pfizer’s 20-valent pneumococcal conjugate vaccine Prevnar 20 in 20 serotypes, the company said. Read More
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