Japan becomes the first country to approve Roche's personalised medicine Rozlytrek
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Rozlytrek® (entrectinib) for the treatment of adult and paediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours.
FDA approves Amgen and Allergan's KANJINTITM (trastuzumab-anns), a biosimilar to Herceptin® (trastuzumab)
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- Category: Amgen
Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTITM (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab): for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
FDA grants Roche's Polivy accelerated approval for people with previously treated aggressive lymphoma
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Polivy™ (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies.
Full data from CAROLINA® outcome trial support long-term cardiovascular safety profile of Trajenta®
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- Category: Boehringer Ingelheim
Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced full data from the CAROLINA® trial demonstrating that Trajenta® (linagliptin) did not increase cardiovascular risk compared to glimepiride in adults with type 2 diabetes and cardiovascular risk.(1) The findings were reported today at the American Diabetes Association's 79th Scientific Sessions in San Francisco.
Nucala (mepolizumab) gains FDA approval for two new self-administration options
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- Category: GlaxoSmithKline
GlaxoSmithKline (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved two new methods for administering Nucala (mepolizumab), an autoinjector and a pre-filled safety syringe, for patients or caregivers to administer once every four weeks, after a healthcare professional decides it is appropriate.
Jeff Settleman, Ph.D., joins Pfizer to lead Oncology Research & Development
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced that Jeff Settleman, Ph.D., will join the company as Senior Vice President and Group Head of Oncology Research & Development, leading all early oncology research, from discovery to proof of concept clinical studies. Dr. Settleman, a leader in molecularly targeted cancer therapeutics, the epigenetics of cancer drug resistance, and personalized cancer medicine, will report directly to
Long-term survival benefit shown for metastatic melanoma patients treated with Novartis Tafinlar® + Mekinist®
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- Category: Novartis
Novartis announced results from the landmark COMBI-d and COMBI-v clinical trials, concluding that first-line treatment with Tafinlar (dabrafenib) and Mekinist (trametinib) offers both overall and progression-free long-term survival benefits to patients with unresectable or metastatic BRAF-mutation positive melanoma.
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