Roche's cobas SARS-CoV-2 Test to detect novel coronavirus receives FDA Emergency Use Authorization
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the cobas® SARS-CoV-2 Test. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing.
U.S. Food and Drug Administration approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) for patients with hepatocellular carcinoma (HCC) previously treated with sorafenib
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- Category: Bristol-Myers Squibb
Bristol Myers Squibb Company (NYSE: BMY) today announced that Opdivo (nivolumab) 1 mg/kg plus Yervoy (ipilimumab) 3 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) to treat hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.1,2 Approval for this indication has been granted under accelerated approval based on
Voluntis and Bristol-Myers Squibb to co-develop digital therapeutics for oncology
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- Category: Bristol-Myers Squibb
Voluntis (Euronext Paris, Ticker: VTX - ISIN: FR0004183960), a leader in digital therapeutics, and Bristol-Myers Squibb Company (NYSE:BMY) announced a collaboration agreement to create and investigate digital therapeutic solutions that will support cancer patients. Leveraging Theraxium Oncology, Voluntis' core platform for digital therapeutics in oncology,
International research partnership and EDCTP to invest €44m in next-generation antimalarials to combat drug-resistant malaria in Africa
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- Category: Novartis
The European & Developing Countries Clinical Trials Partnership (EDCTP) awarded a new grant to the new PAMAfrica research consortium led by Medicines for Malaria Venture (MMV). The consortium will support the development of new treatments for malaria in the most-at-risk populations, including babies, patients with severe malaria, and those with drug-resistant infections.
First-of-its-kind global collaboration launched to develop transformative treatment regimens for tuberculosis
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- Category: GlaxoSmithKline
The consortium of philanthropic, non-profit and private sector organisations launched a collaboration that aims to accelerate the development of novel "pan-TB" drug regimens for the treatment of tuberculosis (TB) that are ready for phase 3 development. The regimens will be designed to have little to no drug resistance and an acceptable safety profile, and be better-tolerated, shorter in duration and simpler to use than existing options.
AstraZeneca completes divestment agreement with Atnahs Pharma for established hypertension medicines
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- Category: AstraZeneca
AstraZeneca today announced that it has completed the previously communicated agreement with Atnahs Pharma (Atnahs) to divest its global commercial rights to Inderal (propranolol), Tenormin (atenolol), Tenoretic (atenolol, chlorthalidone fixed-dose combination), Zestril (lisinopril) and Zestoretic (lisinopril, hydrochlorothiazide fixed-dose combination).
FDA accepts Roche’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for the fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy,
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