Novartis receives European Commission approval for self-administration of Xolair® across all indications
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- Category: Novartis
Novartis today announced that the European Commission (EC) has approved Xolair® (omalizumab) prefilled syringe (PFS) for self-administration, allowing patients with severe allergic asthma (SAA) and chronic spontaneous urticaria (CSU) to administer their own treatment. With this approval, Xolair is the first and only biologic to offer the option of self-administration for SAA and CSU.
Amgen contributes $2 million to groundbreaking program providing cancer patients of all backgrounds access to U.S. clinical trials
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- Category: Amgen
Amgen (NASDAQ:AMGN) and the Lazarex Cancer Foundation, a non-profit organization focused on improving patient access to cancer clinical trials, have teamed up to support more equitable access to clinical trials for cancer patients in the U.S. Through a corporate donation, Amgen has contributed $2 million to Lazarex's IMPACT (IMproving Patient Access to Cancer Clinical Trials) program,
AstraZeneca and Cancer Research UK launch Functional Genomics Centre to accelerate the discovery of new medicines
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- Category: AstraZeneca
AstraZeneca today announced a new collaboration with Cancer Research UK to launch a centre of excellence in genetic screening, cancer modelling and big data processing aimed at accelerating the discovery of new cancer medicines. The Functional Genomics Centre will further develop CRISPR technology to better understand the biology of cancer,
FDA grants priority review to Roche's Tecentriq in combination with chemotherapy for the initial treatment of extensive-stage small cell lung 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 supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) treatment of people with extensive-stage small cell lung cancer (ES - SCLC).
GSK reaches agreement to acquire TESARO, an oncology focused biopharmaceutical company
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- Category: GlaxoSmithKline
GlaxoSmithKline plc (LSE/NYSE: GSK) and TESARO Inc (NASDAQ: TSRO) announced that the Companies have entered into a definitive agreement pursuant to which GSK will acquire TESARO, an oncology-focused company based in Waltham, Massachusetts, for an aggregate cash consideration of approximately $5.1 billion (£4.0 billion).
Pfizer reaches a global agreement with AbbVie
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- Category: Pfizer
Pfizer Inc. (NYSE:PFE) has signed licensing agreements with AbbVie, resolving all global intellectual property matters for Pfizer's proposed adalimumab biosimilar. Under the terms of the agreements, AbbVie grants Pfizer a non-exclusive patent license for the use and sale of Pfizer's proposed adalimumab biosimilar for many countries around the world.
FDA grants breakthrough device designation to artificial intelligence software for CTEPH pattern recognition from Bayer and MSD
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- Category: Bayer
Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to the Artificial Intelligence Software for Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Pattern Recognition, which Bayer is currently developing jointly with MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA).
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