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Over-the-counter drug major Perrigo said this week it is selling its generic prescription drug business to Altaris Capital Partners for $1.55 billion. The purchaser is paying $1.5 billion in cash and taking on more than $50 million in potential R&D milestone payments and contingent purchase obligations with third-party prescription partners. Read More
GlaxoSmithKline (GSK) should not be allowed to add an allergy indication to its European Medicines Agency (EMA) marketing authorization for Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol), the agency’s Committee for Medicinal Products for Human Use (CHMP) decided last week. Read More
New Mexico’s attorney general has filed a lawsuit against Gilead Sciences, Teva Pharmaceuticals and Bristol Myers Squibb (BMS) over alleged anticompetitive practices that caused the state to significantly overpay for HIV medications. Read More
The FDA has suddenly decided to call for an advisory committee meeting to discuss San Francisco biotech FibroGen’s investigational anemia pill, roxadustat, late in its review process, a development that was not anticipated. Read More
To speed the rollout of COVID-19 vaccine doses, the European Commission (EC) is considering an emergency approval mechanism in lieu of its more time-consuming and stringent conditional marketing authorization process. Read More
With Johnson & Johnson struggling to meet its COVID-19 vaccine supply commitments for the U.S., pharma titan Merck will provide its support to ramp up manufacturing of the one-shot vaccine, the Biden administration said Tuesday. Read More
Merck KGaA will pay Switzerland-based Debiopharm up to $1.08 billion (€900 million) for the global rights to Xevinapant, an investigational head and neck cancer treatment. Read More
CorMedix has received a Complete Response Letter (CRL) from the FDA regarding a New Drug Application (NDA) for its catheter-lock solution, DefenCath (taurolidine/heparin). Read More
Because of the way expensive, single-dose drugs are priced and paid for in the U.S., extra doses in discarded vials can’t be used to recoup costs, according to a congressionally mandated report from the National Academies of Sciences, Engineering, and Medicine. Read More