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Biogen Inc announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a marketing authorization under exceptional circumstances for QALSODY® (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.

AstraZeneca to acquire Icosavax, including potential first-in-class RSV and hMPV combination vaccine with positive Phase II data

AstraZeneca has entered into a definitive agreement to acquire Icosavax, Inc , a US-based clinical-stage biopharmaceutical company focused on developing differentiated, high-potential vaccines using an innovative, protein virus-like particle (VLP) platform.

Novavax, Inc a global company advancing protein-based vaccines with its novel Matrix-M adjuvant, has been granted full Marketing Authorization (MA) by the European Commission in the European Union (EU) for Nuvaxovid  (NVX-CoV2373). This decision follows positive opinion for a full MA from the Committee for Medicinal Products for Human Use of the European Medicines Agency. The vaccine is now fully authorized for use as a primary series in individuals aged 12 and older and as a booster dose in adults aged 18 and older for the prevention of COVID-19.

LEO Pharma, a global leader in medical dermatology, and ICON plc announced a strategic partnership that will enable LEO Pharma to scale clinical trial execution that is patient-centric and cost effective, and which will support the company’s overall ambition of building one of the most effective and efficient clinical portfolio execution organisations in the industry.

Moderna, Inc a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the finalization of a strategic partnership with the UK government to establish a state-of-the-art mRNA research, development, and manufacturing facility in the UK. This milestone follows the agreement in principle between Moderna and the UK government, announced in June 2022.

BioNTech SE announced the initiation of a first-in-human Phase 1 study with BNT165b1, the first candidate from the Company’s BNT165 program, to develop a multi-antigen malaria vaccine candidate. BioNTech will initially evaluate a set of mRNA-encoded antigens of the malaria-causing parasite Plasmodium falciparum (P. falciparum) to help select the multi-antigen vaccine candidate to proceed to planned later-stage trials. This first clinical trial (NCT05581641) will evaluate the safety, tolerability and exploratory immunogenicity of the vaccine candidate BNT165b1.

BioNTech SE announced its Singapore affiliate BioNTech Pharmaceuticals Asia Pacific Pte. Ltd. had entered into an agreement with Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. to acquire one of its GMP-certified manufacturing facilities. The acquisition is part of BioNTech’s expansion strategy to strengthen its global footprint in Asia. Supported by the Singapore Economic Development Board (“EDB”), the facility will serve as BioNTech’s Regional Headquarters and become its first mRNA manufacturing facility in Singapore.

scPharmaceuticals Inc a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that the U.S. Food and Drug Administration (FDA) has approved FUROSCIX® (furosemide injection), a proprietary formulation of furosemide delivered via an On-Body Infusor for the treatment of congestion due to fluid overload in adults with New York Heart Association Class II/III chronic heart failure.

Heron Therapeutics, Inc  a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs,  announced that the U.S. Food and Drug Administration (FDA) has approved APONVIE (aprepitant) injectable emulsion, for intravenous use for the prevention of postoperative nausea and vomiting (PONV) in adults.