Supporting their conclusions with data from the same phase III study, the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for extending the use of Oncopeptides AB’s Pepaxti (melflufen) to earlier lines of treating relapsed, refractory multiple myeloma even as the FDA dug in its heels about withdrawing the drug from the U.S. market.

Mirati Therapeutics Inc.’s cancer treatment Krazati (adagrasib) is having a tough time outside the U.S. The EMA’s Committee for Medicinal Products for Human Use (CHMP) came out with a negative opinion on an MAA for treating KRAS G12C-mutated advanced non-small-cell lung cancer (NSCLC). The ruling came with a flurry of positive CHMP opinions for companies, including Abbvie Inc., Beigene Ltd. and the Janssen Pharmaceutical Cos., plus a mixed result for Ipsen SA after a stumble earlier this week.

Otsuka Pharmaceutical Co. Ltd. has gone back on efforts to get its medicine, Asimtufii (aripiprazole), a long-acting maintenance treatment for schizophrenia, approved in Europe, after the EMA gave a provisional negative opinion.

Otsuka Pharmaceutical Co. Ltd. has gone back on efforts to get its medicine, Asimtufii (aripiprazole), a long-acting maintenance treatment for schizophrenia, approved in Europe, after the EMA gave a provisional negative opinion.

A heart-protective cardiac myosin inhibitor and two biologics – one for a type of non-Hodgkin lymphoma and another for an inflammatory skin condition – were among the therapies recommended for approval by the EMA’s Committee for Medicinal Products for Human Use this week.

Where European regulatory decisions were concerned, there was good news and bad news for pharma today as Sanofi SA and Regeneron Pharmaceuticals Inc. got the go-ahead for expanded approval of Dupixent (dupilumab) in pediatric atopic dermatitis patients whilst Ipsen SA’s ultra-rare bone disease drug palovarotene was left off the shelf as efficacy data failed to impress.

A vaccine for dengue fever, an advanced therapy for a complication after transplants, and a potential first-in-class drug for a form of psoriasis were among medicines recommended for approval by European regulators on Oct. 14. 

An antibody that protects babies against respiratory syncytial virus (RSV) from Astrazeneca Ltd. and Sanofi SA was among a string of recommendations from the EMA’s Committee for Medicinal Products for Human Use, paving the way for approval within the next few months and a potential launch in 2023.

An antibody that protects babies against respiratory syncytial virus (RSV) from Astrazeneca Ltd. and Sanofi SA was among a string of recommendations from the EMA’s Committee for Medicinal Products for Human Use, paving the way for approval within the next few months and a potential launch in 2023.