FDA grants priority review to Boehringer Ingelheim's Afatinib* NDA for EGFR mutation-positive advanced NSCLC
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- Category: Boehringer Ingelheim
Boehringer Ingelheim today announced that the New Drug Application (NDA) for its investigational oncology compound afatinib* has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). The application for afatinib* is currently under review for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) mutation as detected by an FDA-approved test.
Sanofi updates its Research & Development pipeline
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- Category: Sanofi
Sanofi (EURONEXT: SAN and NYSE: SNY) has provided an update on its Research & Development (R&D) pipeline with Dr. Elias Zerhouni, President, Global Research and Development, presenting at the JP Morgan Healthcare Conference in San Francisco, California.
Phase III data show significant benefit of Novartis drug Afinitor® in patients with non-cancerous tumors associated with TSC
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- Category: Novartis
Data published in The Lancet showed that patients on Afinitor® (everolimus) tablets with non-cancerous kidney tumors known as renal angiomyolipomas associated with tuberous sclerosis complex (TSC) experienced a significant reduction in tumor size and the absence of tumor progression[1].
Bayer receives approval for new long-term contraceptive Skyla™ in the U.S.
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- Category: Bayer
Bayer HealthCare has received approval from the U.S. Food and Drug Administration (FDA) for its new low dose levonorgestrel-releasing intrauterine system (IUS) called Skyla™ in the U.S.. The new IUS is placed in the uterus for the prevention of pregnancy for up to three years.
Abbott initiates clinical trial of Absorb TM in the United States
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- Category: Abbott
Abbott (NYSE: ABT) announced today the initiation of the ABSORB III clinical trial in patients in the United States. This randomized, controlled trial is designed to enroll approximately 2,250 patients, the majority in the United States, and compare the performance of Abbott's drug eluting Absorb TM Bioresorbable Vascular Scaffold (BVS) device to the company's XIENCE TM family of drug eluting stents.
Boehringer Ingelheim and Eli Lilly and Company announce positive top-line pivotal Phase III data results for empagliflozin
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- Category: Boehringer Ingelheim
Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced top-line results for four completed Phase III clinical trials for empagliflozin, an investigational sodium glucose co-transporter-2 (SGLT2) inhibitor being studied for treatment of patients with Type 2 Diabetes (T2D).
Abbott completes separation of research-based pharmaceuticals business
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- Category: Abbott
Abbott (NYSE: ABT) has completed the separation of its research-based pharmaceuticals business, which became AbbVie, a new independent biopharmaceutical company. AbbVie will begin trading independently on the New York Stock Exchange today under the symbol "ABBV."
More Pharma News ...
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- Novartis drug Signifor® gains FDA approval as the first medication to treat Cushing's disease
- GSK forms partnership with Vodafone to help increase childhood vaccination in Mozambique
- Roche reports positive studies of MabThera given by subcutaneous injection
- Boehringer Ingelheim and Apexigen sign manufacturing agreement
- Roche and the Innovative Medicines Initiative join forces to promote use of Nobel Prize-winning stem cell technology
- Novo Nordisk to create the world's first all-diabetes professional cycling team