FDA grants Roche’s Polivy accelerated approval for people with previously treated aggressive lymphoma

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. Accelerated […]

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Full data from CAROLINA® outcome trial support long-term cardiovascular safety profile of Trajenta®

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. The trial […]

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Nucala (mepolizumab) gains FDA approval for two new self-administration options

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. This is the first anti-IL5 biologic to be licensed […]

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Long-term survival benefit shown for metastatic melanoma patients treated with Novartis Tafinlar® + Mekinist®

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. Researchers reported that 34% (95% CI: 30-38%) of all patients in the pooled analysis who were treated […]

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Bristol-Myers Squibb announces post-closing leadership team

Bristol-Myers Squibb Company (NYSE:BMY) today announced the future leadership team of the combined company effective upon completion of the company’s pending merger with Celgene Corporation (NASDAQ:CELG). The company is evolving key aspects of its R&D and Commercialization structure to drive the continued growth of a highly successful marketed portfolio, maximize the six near-term launch opportunities […]

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Novartis Kisqali significantly extends life in women with HR+/HER2- advanced breast cancer in MONALEESA-7 trial

Novartis announced statistically significant overall survival (OS) results for Kisqali in combination with endocrine therapy[1]. The Phase 3 MONALEESA-7 trial evaluated Kisqali plus endocrine therapy (goserelin plus either an aromatase inhibitor or tamoxifen) as initial treatment compared to endocrine therapy alone in pre- and perimenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 […]

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Merck pioneers new effort to see MS from the inside out

Merck, a leading science and technology company, joins the global multiple sclerosis (MS) community in recognition of World MS Day, an initiative created by the Multiple Sclerosis International Federation (MSIF) to raise awareness of the 2.3 million people worldwide living with this challenging disease. In support of this year’s World MS Day theme, #MyInvisibleMS, Merck […]

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Bayer receives U.S. FDA breakthrough therapy designation for copanlisib for the treatment of marginal zone lymphoma

Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for copanlisib (Aliqopa™) for the treatment of adult patients with relapsed marginal zone lymphoma (MZL) who have received at least two prior therapies. MZL is an indolent form of non-Hodgkin’s Lymphoma (iNHL) and accounts for about 10% of all non-Hodgkin’s […]

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