trending Market Intelligence /marketintelligence/en/news-insights/trending/pRZft0iv5Jw-hZ12Suqbdg2 content esgSubNav
In This List

Teva's prophylaxis generic gets sole EMA recommendation in October

Blog

Insight Weekly: Bank boards lag on gender parity; future of office in doubt; US LNG exports leap

Blog

Insight Weekly: Job growth faces hurdles; shale firms sit on cash pile; Africa's lithium future

Blog

Insight Weekly: Loan growth picks up; US-China PE deals fall; France faces winter energy crunch

Blog

Perspectives from China: Chinese M&A in 2022


Teva's prophylaxis generic gets sole EMA recommendation in October

The European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of one generic medicine in October: Teva Pharmaceutical Industries Ltd.'s Tacforius, intended for prophylaxis and treatment of transplant rejection.

Separately, the EU panel recommended Roche Holding AG's Alecensa as a first-line treatment of anaplastic lymphoma kinase-positive advanced non-small cell lung cancer. The drug was previously recommended as monotherapy for patients that had already been treated with Pfizer Inc.'s Xalkori, or crizotinib.

Santhera Pharmaceuticals Holding AG requested a reexamination of the CHMP's negative opinion for Raxone, or idebenone, intended to treat Duchenne muscular dystrophy, a rare genetic condition characterized by progressive muscle weakness and degeneration. The EMA panel will re-examine the opinion and issue a final recommendation.

The CHMP did not adopt a negative opinion in its October meeting. Also, no company withdrew its application during the month.