→ Cladribine is back. Once given up for dead by Merck KGaA, the multiple sclerosis drug has been endorsed by the CHMP in Europe, setting up a likely approval. Longtime Merck KGaA watchers will recall that Merck killed the program after the FDA and the EMA quashed inadequate applications 6 years ago — an embarrassing setback that triggered a major overhaul of the company’s R&D group. “The positive opinion from the CHMP is an extraordinary development for Merck, affirming our belief in Cladribine Tablets as a potential important treatment option for patients living with multiple sclerosis,” said Belén Garijo, CEO Healthcare and member of the executive board of Merck. “We now eagerly await the European Commission decision, and the opportunity to make a difference in the MS treatment paradigm.”
→ Cladribine wasn’t the only comeback story of the day. The CHMP also recommended approval of Aveo’s $AVEO drug tivozanib (Fotivda) for advanced renal cell carcinoma, sending the microcap’s shares up more than 70% Friday morning. The European Commission is expected to make its final decision within 67 days. Its approval would trigger a $4 million research and development reimbursement payment from EUSA, and the possibility of up to $12 million in additional milestones.
→ Executives are under fire for selling drugs that triggered serious adverse events for three infants. Paul Elmer, president and owner of Pharmakon, and Caprice Bearden, director of compliance, are facing federal charges of engaging in commerce with adulterated drugs in an indictment unsealed on Thursday. The indictment alleges that the company was notified 70 times that the potency of their drugs did not match the labels, but that they continued to send them out regardless, without notifying the FDA or care providers.
→ Bioprocessing company Repligen is merging with Spectrum, which specializes in filtration and purification, for $359 million in cash and stock.
→ GenSight Biologics (Euronext: SIGHT) raised €22.5 million in a stock offering. The gene therapy company says it will use the cash to prep for a market launch of GS010 in Europe and the US.
→ GSK is presenting results from its Phase III Zoster-048 study at the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meeting. The results are promising, showing that its candidate vaccine, Shingrix, for the prevention of herpes zoster (shingles) induces a strong immune response in older adults who have previously been vaccinated against shingles with the currently available live-attenuated zoster vaccine.
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