US FDA grants Breakthrough Therapy Designation for potential next-generation RSV medicine MEDI8897
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- Category: AstraZeneca
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for MEDI8897, an extended half-life respiratory syncytial virus (RSV) F monoclonal antibody (mAb) being developed for the prevention of lower respiratory tract infection (LRTI) caused by RSV. Forxiga receives positive EU CHMP opinion for the treatment of adults with type-1 diabetes
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- Category: AstraZeneca
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a new indication for the marketing authorisation of Forxiga (dapagliflozin), after adopting a positive opinion for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D). Pfizer receives positive CHMP opinion for Vizimpro® (dacomitinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR-activating mutations
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- Category: Pfizer
Pfizer today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Vizimpro® (dacomitinib) 45 mg, as monotherapy, be granted marketing authorization in the European Union (EU) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations. Merck Granted U.S. Patent for novel combination of Artificial Intelligence and Blockchain Technology
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- Category: Merck Group
Merck, a leading science and technology company, today announced that it has been granted Patent No. US 10,193,695 by the United States Patent and Trademark Office (USPTO). The patent relates to the formation of 'crypto-objects', a novel security procedure linking Artificial Intelligence (AI) and blockchain technology. Pfizer and Lilly announce top-line results from second Phase 3 study of tanezumab in osteoarthritis pain
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- Category: Pfizer
Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced positive top-line results from a Phase 3 study evaluating tanezumab 2.5 mg or 5 mg in patients with moderate-to-severe osteoarthritis (OA) pain. The tanezumab 5 mg treatment arm met all three co-primary endpoints at 24 weeks, demonstrating a statistically significant improvement in pain, physical function and the patients' overall assessment of their OA compared to those receiving placebo. Amgen receives NMPA approval for Repatha® (evolocumab) In China to reduce the risk of cardiovascular events
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- Category: Amgen
Amgen (NASDAQ:AMGN) announced that the National Medical Products Administration (NMPA) has approved a new indication for Repatha® (evolocumab) as the first PCSK9 inhibitor in China for adults with established atherosclerotic cardiovascular disease (ASCVD) to reduce the risk of myocardial infarction, stroke and coronary revascularization. Merck and Tencent announce collaboration on intelligent digital healthcare services in China
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- Category: Merck Group
Merck, a leading science and technology company, signed a strategic collaboration agreement with Tencent, a leading provider of Internet value added services. The collaboration will primarily focus on increasing public disease awareness and providing more accessible healthcare services via digital platforms in China, by leveraging the company's scientific leadership and expertise combined with Tencent's leading technology in the fields of internet and artificial intelligence. More Pharma News ...
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