Immunology

EMA accepts application for Alvotech’s monoclonal antibody AVT04

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 receives orphan drug designation for Benlysta to treat systemic sclerosis

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 signs license, distribution agreement with WinHealth Pharma

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 announces FDA acceptance of BLA for spesolimab

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’s Alexion concludes Caelum acquisition for $500m

AstraZeneca subsidiary Alexion has concluded the takeover of all the outstanding shares of Caelum Biosciences in a deal worth up to $500m.

Sobi agrees $8bn takeover offer from Advent and GIC

Swedish Orphan Biovitrum (Sobi) has agreed a $8bn (SEK69.4bn) takeover offer from Advent International and Singapore’s wealth fund GIC.

Johnson & Johnson to resume Covid-19 vaccine roll-out in Europe after EMA review

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.

GSK and Vir announce EMA review of VIR-7831 for early treatment of Covid-19

GlaxoSmithKline and Vir Biotechnology have announced the European Medicines Agency (EMA) review of VIR-7831 (GSK4182136) for the early treatment of Covid-19.

Dyadic and Medytox to co-develop Covid-19 variant fighting vaccines

US-based global biotechnology company Dyadic International has announced the expansion of its partnership with South Korea-based global research biopharmaceutical company Medytox to co-develop C1 manufactured Covid-19 vaccines.