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  • Merck wins European approval for first-ever Ebola vaccine
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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......

Lire la suite de l'article sur Reuters Source : Reuters - 11/11/2019 19:05 - trending_up116
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    FDA declines to approve Enzyvant regenerative therapy on manufacturing concerns

    (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... ...



    FDA declines to approve Enzyvant regenerative therapy on manufacturing concerns

    Source : Reuters - 05/12/2019 17:55 - trending_up 9

    • FDA declines to approve Enzyvant's regenerative tissue therapy - Reuters
    • FDA declines to approve Adamis Pharma's Zimhi to treat opioid overdose - Reuters
    • Adamis shares slump as FDA declines to approve opioid overdose treatment - Reuters
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    FDA declines to approve Enzyvant's regenerative tissue therapy

    (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... ...



    FDA declines to approve Enzyvant's regenerative tissue therapy

    Source : Reuters - 05/12/2019 17:16 - trending_up 10

    • FDA declines to approve Enzyvant regenerative therapy on manufacturing concerns - Reuters
    • FDA declines to approve Lipocine's testosterone drug for third time - Reuters
    • FDA declines to approve Adamis Pharma's Zimhi to treat opioid overdose - Reuters
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    Half a million Ebola vaccine doses to be stockpiled for emergency use

    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... ...





    Source : Reuters - 05/12/2019 15:55 - trending_up 17

    • Ebola vaccine doses to be stockpiled for emergency outbreak use - Reuters
    • Canberra becomes first Australian city to legalize marijuana for personal use - Reuters
    • Deployment of second Ebola vaccine would not be quick fix, experts warn - Reuters
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    Ebola vaccine doses to be stockpiled for emergency outbreak use

    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... ...





    Source : Reuters - 05/12/2019 14:35 - trending_up 37

    • Half a million Ebola vaccine doses to be stockpiled for emergency use - Reuters
    • Deployment of second Ebola vaccine would not be quick fix, experts warn - Reuters
    • No payment will be accepted for Fetal Tissue research, says Planned Parenthood - northerncalifornian
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    GSK seeks FDA approval for investigational HIV treatment

    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... ...





    Source : Reuters - 05/12/2019 14:35 - trending_up 0

    • German drugmaker Merck won't seek regulatory approval for its experimental cancer medicine evofosfamide - northerncalifornian
    • DigniCap, Chemotherapy Cooling Cap to Reduce Hair Loss gets FDA Approval in US - northerncalifornian
    • GSK gets FDA nod for wider use of ovarian cancer drug Zejula - Reuters
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    Roche wins FDA approval for immunotherapy cocktail against lung cancer

    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... ...





    Source : Reuters - 04/12/2019 08:05 - trending_up 42

    • Edwards Lifesciences, Medtronic heart valves win FDA approval for expanded use - Reuters
    • AstraZeneca wins FDA approval for key new lung cancer pill - Reuters
    • U.S. FDA approves Mylan generic of Lilly lung cancer drug Alimta - Reuters
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    FDA approves Global Blood Therapeutics sickle cell disease drug

    (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... ...



    FDA approves Global Blood Therapeutics sickle cell disease drug

    Source : Reuters - 25/11/2019 23:20 - trending_up 12

    • FDA approves Global Blood Therapeutics's sickle cell disease drug - Reuters
    • Novartis sickle-cell drug gets U.S. FDA approval - Reuters
    • FDA approves Novo Nordisk's long-awaited diabetes drug - Reuters
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    AstraZeneca shares rise on early U.S. approval for leukemia drug

    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... ...





    Source : Reuters - 22/11/2019 17:20 - trending_up 6

    • Biogen to seek U.S. approval for Alzheimer's drug; shares jump 21% - Reuters
    • Alnylam's rare genetic disorder drug gets early U.S. approval - Reuters
    • AstraZeneca's potential $3 billion cancer pill wins early approval - Reuters
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    Novartis sickle-cell drug gets U.S. FDA approval

    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... ...





    Source : Reuters - 15/11/2019 21:35 - trending_up 11

    • Orion, Bayer prostate cancer drug gets FDA approval - Reuters
    • DigniCap, Chemotherapy Cooling Cap to Reduce Hair Loss gets FDA Approval in US - northerncalifornian
    • Novartis gets FDA approval for skin cancer drug combination - Reuters
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    China's BeiGene gets FDA approval for drug to treat rare form of lymphoma

    (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... ...



    China's BeiGene gets FDA approval for drug to treat rare form of lymphoma

    Source : Reuters - 14/11/2019 23:35 - trending_up 21

    • Researchers in favor of new drug to treat progressive form of multiple sclerosis - northerncalifornian
    • FDA approves Relypsa's drug to treat high potassium levels - Reuters
    • Novartis gets FDA approval for skin cancer drug combination - Reuters

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