The European Commission (EC) has granted conditional marketing authorisation (CMA) to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Talvey (talquetamab) for the treatment of relapsed and refractory multiple myeloma (RRMM) in adult patients who received a minimum of three prior lines of therapies.
Emergent BioSolutions has announced receipt of the US Food and Drug Administration’s (FDA) approval for CYFENDUS (Anthrax Vaccine Adsorbed, Adjuvanted), for post-exposure prophylaxis of disease after suspected or confirmed exposure to Bacillus anthracis in persons aged 18 through 65 years when administered along with recommended antibacterial drugs.
Eli Lilly and Company has signed a definitive agreement to acquire a biopharmaceutical company DICE Therapeutics.
Alvotech and global pharmaceutical company STADA Arzneimittel (STADA) announced that their Marketing Authorization Application for AVT04, the former’s proposed biosimilar to Stelara (ustekinumab), has been accepted by the European Medicines Agency (EMA).
GSK has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its B-cell inhibiting monoclonal antibody Benlysta (belimumab) to potentially treat systemic sclerosis (SSc).
Quoin Pharmaceuticals has signed a license and distribution agreement with Hong Kong WinHealth Pharma Group for its lead product candidate, QRX003 for Netherton Syndrome and a second pipeline product, QRX004 for Epidermolysis Bullosa.
Boehringer Ingelheim has announced acceptance of a biologics license application (BLA) and granting of priority review by the US Food and Drug Administration (FDA) for spesolimab in treating generalized pustular psoriasis (GPP) flares.
AstraZeneca subsidiary Alexion has concluded the takeover of all the outstanding shares of Caelum Biosciences in a deal worth up to $500m.
Swedish Orphan Biovitrum (Sobi) has agreed a $8bn (SEK69.4bn) takeover offer from Advent International and Singapore’s wealth fund GIC.
Johnson & Johnson (J&J) will resume Covid-19 vaccine roll-out in Europe following the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed the overall benefit-risk profile being positive.
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