Author: Author

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

EC Approves Astellas-Seagen’s Locally Advanced or Metastatic Urothelial Cancer Drug

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Astellas Pharma Inc. and Seagen Inc. (Nasdaq:SGEN) have announced that the European Commission (EC) has approved PADCEV (enfortumab vedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor. The EC approval is supported by data from the global phase 3 EV-301 trial that demonstrated an overall survival (OS) benefit compared with chemotherapy.

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.

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.