United States-based Gilead Sciences has received a recommendation of marketing authorisation for its fixed-dose HIV combination pill Odefsey featuring emtricitabine 200mg, rilpivirine 25mg, and tenofovir alafenamide (TAF) 25mg from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP
), it was reported yesterday.
"The positive opinion by the CHMP
further validates the potential of this Empliciti-based combination to help patients with multiple myeloma who have relapsed or are refractory to prior therapies, a setting particularly in need of additional treatment options given the majority of patients with multiple myeloma will relapse," said Fouad Namouni, M.D., head, Oncology Development, Bristol-Myers Squibb.
granted a positive opinion for Epidyolex (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome, two forms of epilepsy.
Biotechnology company Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi Monday jointly announced the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP
) positive opinion for Praluent (alirocumab) Injection to reduce cardiovascular risk in adults with atherosclerotic cardiovascular disease (ASCVD), a build-up of plaque in the arteries that can lead to reduced blood flow,stroke, peripheral artery disease and acute coronary syndrome.
In an opinion, the CHMP
said Dengvaxia has been proven to be effective in preventing dengue caused by virus serotypes 1, 2, 3 and 4 in people between nine and 45 years old, living in an endemic area and with prior dengue virus infection.
Oasmia Pharmaceutical AB (STO:OASM) announced on Friday that the Committee for Medicinal Products for Human Use (CHMP
) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Apealea in combination with carboplatin, to treat adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.
GOLF: Alfred Dunhill Chmp
, SS2, (8.30am and 1.30pm).
advices everyone who received already one or two doses from this particular batch of Ixiaro and plans to travel soon to regions affected by Japanese encephalitis to be vaccinated again but with a different batch.
Soliris, a designated orphan medicinal product, is intended to reduce hemolysis (destruction of red blood cells) in patients with paroxysmal nocturnal hemoglobinuria (PNH), The CHMP
recommended a broad label for Soliris covering all patients with PNH.