Category: Regions

Nektar and BMS End Clinical Development of Bempegaldesleukin in Combination with Opdivo
April 15, 2022 Off

Nektar and BMS End Clinical Development of Bempegaldesleukin in Combination with Opdivo

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Nektar Therapeutics (NASDAQ: NKTR) and Bristol Myers Squibb (NYSE: BMY) have announced that based on results from pre-planned analyses of two late-stage clinical studies of bempegaldesleukin (BEMPEG) in combination with Opdivo (nivolumab) in renal cell carcinoma (RCC) and bladder cancer, the companies have jointly decided to end the global clinical development program for bempegaldesleukin in combination with Opdivo.

Valneva’s Inactivated Covid-19 Vaccine Gets CMA in UK
April 14, 2022 Off

Valneva’s Inactivated Covid-19 Vaccine Gets CMA in UK

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The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional Marketing Authorization (CMA) for Valneva’s inactivated whole-virus COVID-19 vaccine candidate, VLA2001, for primary immunization in adults 18 to 50 years of age.

April 13, 2022 Off

FDA Doesn’t Give Myovant Sciences-Pfizer’s Pain Killer sNDA

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Myovant Sciences (NYSE: MYOV) and Pfizer (NYSE: PFE) have announced an update on the Supplemental New Drug Application (sNDA) for MYFEMBREE (relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg) for the management of moderate to severe pain associated with endometriosis.

EMA and the EUnetHTA 21 consortium set priorities for their collaboration
April 13, 2022 Off

EMA and the EUnetHTA 21 consortium set priorities for their collaboration

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The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published a  joint work plan until 2023. The focus of the plan is to prepare, from a methodological and operational perspective, for the coming into application of the Regulation on Health Technology Assessment (EU) 2021/228 in January 2025 after a 3-year implementation period.

GSK Buys Sierra Oncology for $1.9bn
April 13, 2022 Off

GSK Buys Sierra Oncology for $1.9bn

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GlaxoSmithKline plc (LSE/NYSE: GSK) and Sierra Oncology, Inc (Nasdaq: SRRA) have entered into an agreement under which GSK will acquire Sierra Oncology, a California-based, late-stage biopharmaceutical company focused on targeted therapies for the treatment of rare forms of cancer, for $55 per share of common stock in cash representing an approximate total equity value of $1.9 billion (£1.5 billion).

Bayer receives approval for precision oncology treatment Vitrakvi in China
April 13, 2022 Off

Bayer receives approval for precision oncology treatment Vitrakvi in China

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The Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) approved Bayer’s larotrectinib, under the brand name Vitrakvi, for the treatment of adult and pediatric patients with advanced solid tumors that harbor a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. NTRK gene fusions should be identified by a sufficiently validated test.