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The FDA has released two draft guidances with interim policies addressing the FDA’s efforts to finalize bulk drug lists for compounders subject to 503A regulations and for compounders using bulk substances under 503B regulations. Read More
AbbVie and Cerevel Therapeutics announced that AbbVie will buy Cerevel Therapeutics and its neuroscience pipeline of schizophrenia, Parkinson's disease, and mood disorder drugs that are in multiple clinical and preclinical stages for $8.7 billion. Read More
Roche has announced the $2.7 billion acquisition of Carmot Therapeutics, including that company’s three potential incretin obesity and diabetes drugs. Read More
AbbVie and ImmunoGen today announced an agreement under which AbbVie will acquire ImmunoGen, and its flagship cancer therapy Elahere (mirvetuximab soravtansine-gynx) an antibody-drug conjugate (ADC) approved for platinum-resistant ovarian cancer, accelerating AbbVie’s presence in the solid tumor space. Read More
Novo Nordisk has filed complaints against two Florida-based compounding pharmacies for marketing unapproved versions of its semaglutide products, claiming the products are weaker in strength than labeling indicates and may contain up to 33 percent impurities. Read More
This edition of Quick Notes highlights recalls for Excela sodium bicarbonate, sodium chloride and cysteine hydrochloride, Novartis cyclosporin, Bayer larotrectinib, Unomedical VariSoft infusion sets and SoClean CPAP cleaner. Read More
The troubled U.S. drug supply chain remains in the spotlight with President Biden announcing nearly 30 new actions to help bolster supply chain resilience, including convening a new White House council focused on the issue and deploying the Defense Production Act to bolster U.S. manufacturers’ ability to make more essential medicines. Read More