Merck wins European approval for first-ever Ebola vaccine
FILE PHOTO: The Merck logo is seen at a gate to the Merck & Co campus in Linden, New Jersey, U.S., July 12, 2018. REUTERS/Brendan McDermid (Reuters) - Merck & Co Inc on Monday received approval from the European Commission to market (bit.ly/2NZ0QMB) its Ebola vaccine, less than a month after a European medicines panel backed the first-ever vaccine against the deadly virus. The vaccine, Ervebo, is approved for individuals aged 18 years and older and has already been used under emergency guidelines to try to protect against the spread o......
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(Reuters) - Privately held drug developer Enzyvant said on Thursday the U.S. Food and Drug Administration declined to approve its regenerative tissue therapy for a rare immunodeficiency disorder and raised concerns about its manufacturing. The company was hoping to win its first approval for the therapy, RVT-802, aimed at treating congenital athymia, a disorder affecting babies born without a small gland called thymus, which produces T-cells needed to regulate the immune system. The health regulator in a letter to Enzyvant raised question... ...
(Reuters) - Privately held drug developer Enzyvant said on Thursday the U.S. Food and Drug Administration declined to approve its regenerative tissue therapy for a rare immunodeficiency disorder and raised concerns about its manufacturing. The company was hoping to win its first approval for the therapy, RVT-802, aimed at treating congenital athymia, a disorder affecting babies born without a small gland called thymus, which produces T-cells needed to regulate the immune system. The health regulator in a letter to Enzyvant raised question... ...
LONDON, Dec 5 (Reuters) - - A stockpile of 500,000 doses of Ebola vaccine for emergency use in outbreaks of the deadly fever is being established by the global vaccine alliance GAVI. FILE PHOTO: A health worker fills a syringe with Ebola vaccine before injecting it to a patient, in Goma, Democratic Republic of Congo, August 5, 2019. REUTERS/Baz Ratner The plan is for poor and middle-income countries to access the $178 stockpile free of charge, GAVI said on Thursday, while other countries will need to refund the costs. The stockpilin... ...
FILE PHOTO: A health worker fills a syringe with Ebola vaccine before injecting it to a patient, in Goma, Democratic Republic of Congo, August 5, 2019. REUTERS/Baz Ratner LONDON (Reuters) - The global vaccine alliance GAVI said on Thursday it had agreed to fund and create a $178 million stockpile of Ebola vaccines for emergency use in outbreaks. The aim is for a global stock of 500,000 doses of vaccine against the deadly haemorrhagic fever, GAVI said in a statement. The stockpiling will start with Merck’s newly developed Ervebo vacci... ...
FILE PHOTO: A GSK logo is seen on a flag at a GlaxoSmithKline (GSK) research centre in Stevenage, Britain November 26, 2019. REUTERS/Peter Nicholls (Reuters) - GlaxoSmithKline Plc said on Thursday its HIV unit has submitted a new drug application to the U.S. Food and Drug Administration seeking approval for fostemsavir, an experimental treatment for HIV in adults. Fostemsavir is being developed for use in combination with other antiretroviral agents in adults who have been previously taken treatments for HIV and have developed resista... ...
FILE PHOTO: The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland February 1, 2018. REUTERS/Arnd Wiegmann/File Photo ZURICH (Reuters) - Roche’s Tecentriq immunotherapy mixed with chemotherapy won U.S. approval as an initial treatment for a form of lung cancer as the Swiss drugmaker seeks to establish its alternative to drugs from Merck and Bristol-Myers Squibb. The U.S. Food and Drug Administration approved Tecentriq mixed with Celgene’s Abraxane and carboplatin chemotherapy to treat metastatic non-sq... ...
(Reuters) - The U.S. Food and Drug Administration said on Monday it approved a drug from Global Blood Therapeutics Inc to treat sickle cell disease in adults and pediatric patients aged 12 years or older The treatment to be sold under the brand name Oxbryta is the second drug in recent days to win U.S. approval for sickle cell anemia, and the first to target the underlying cause of the disease rather than symptoms. The drug, known chemically as voxelotor, works by preventing red blood cells from sickling, a deformation that restricts flo... ...
FRANKFURT (Reuters) - AstraZeneca (AZN.L) shares rose 2.7% on Friday after the British drugmaker won earlier-than-expected U.S. regulatory approval for a leukemia drug, in a challenge to rival AbbVie (ABBV.N). FILE PHOTO: The company logo for pharmaceutical company AstraZeneca is displayed on a screen on the floor at the New York Stock Exchange, U.S., April 8, 2019. REUTERS/Brendan McDermid/File Photo AstraZeneca said late on Thursday that the U.S. Food and Drug Administration (FDA) had given its go ahead for the company’s Calquence... ...
FILE PHOTO: Novartis' logo is seen at the Swiss drugmaker's plant in the northern town of Stein, Switzerland on October 23, 2017. REUTERS/Arnd Wiegmann (Reuters) - Novartis on Friday won U.S. approval for its experimental sickle cell disease drug, making it the first of several proposed new therapies designed to offer lasting relief for patients with the debilitating blood disease to get U.S. regulatory clearance. The biologic drug, also known as crizanlizumab, was shown in trials in its high-dose formula to cut sickle cell pain cris... ...
(Reuters) - The U.S. Food and Drug Administration on Thursday approved BeiGene Ltd’s lymphoma treatment, validating the China-based drugmaker’s strategy of largely using data from trials held outside the United States to file for approval. The company tested the treatment, Brukinsa, in 118 patients with mantle cell lymphoma enrolled in two studies. About three-quarters were Asian, 21% Caucasian, and between 10% to 15% were from the United States, BeiGene said. The FDA granted accelerated approval to the capsules for treatment of adult... ...