Author: Author

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.

April 13, 2022 Off

Avacta Announces AffyXell Joint Venture Milestone and Increased Equity Stake

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Avacta Group plc (AIM: AVCT), a clinical stage oncology drug company and developer of powerful diagnostics based on its innovative Affimer® and pre|CISION™ platforms, is pleased to announce that a milestone equity payment has been triggered resulting in an increase in Avacta’s shareholding in AffyXell Therapeutics (“AffyXell”), a joint venture between Avacta and Daewoong Pharmaceutical (“Daewoong”) in South Korea.

April 13, 2022 Off

ITM and MTTI Sign Clinical Supply Agreement for n.c.a. Lutetium-177

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ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Molecular Targeting Technologies Inc. (MTTI), a clinical stage biotech company focused on developing innovative therapies for rare cancers, today announced the signing of a global clinical supply agreement that provides MTTI with ITM’s medical radioisotope no-carrier-added lutetium-177 (n.c.a. Lu / EndolucinBeta) for the preclinical and clinical development as well as potential commercial production of MTTI’s radiopharmaceutical candidate n.c.a. Lu-EBTATE to treat a range of cancers.