Pharmaceuticals, Biotechnology and Life Sciences
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.
Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) have announced topline results from the first cohort of the EPCORE NHL-1 phase 1/2, clinical trial evaluating epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody.
Sanofi has announced the positive results from the Phase 1/2 dose-finding study evaluating the safety, pharmacokinetics and clinical activity of rilzabrutinib, an investigational oral Bruton’s tyrosine kinase (BTK) inhibitor, in adults with heavily pre-treated immune thrombocytopenia (ITP) were published in the New England Journal of Medicine.
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.
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.
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.
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.
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).
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.
Oxford Biomedica plc has appointed Ms. Namrata P Patel to the Board as an Independent Non-Executive Director with immediate effect.