Drug Manufacturing

Calluna secures FDA orphan drug designation for CAL101 in IPF

Norway-based biotechnology company Calluna Pharma has received orphan drug designation from the US Food and Drug Administration (FDA) for its lead clinical candidate, CAL101.

J&J’s Tremfya gets FDA approval for SC induction in active UC

Johnson & Johnson (J&J) has secured approval from the US Food and Drug Administration (FDA) for a subcutaneous (SC) induction regimen of Tremfya (guselkumab) in adults with moderately to severely active ulcerative colitis (UC).

Biogen to acquire Alcyone Therapeutics for $85m

Biogen has signed a definitive agreement to acquire Alcyone Therapeutics for advancing the development and commercialisation of ThecaFlex DRx drug delivery system.

Deciphera’s Romvimza secures EC nod for TGCT treatment

The European Commission (EC) has sanctioned the use of Deciphera Pharmaceuticals’ Romvimza (vimseltinib) to treat tenosynovial giant cell tumour (TGCT) in adults.

Dualitas secures $65m for bispecific antibody pipeline

Dualitas Therapeutics has secured $65m in a series A funding round aimed at progressing its pipeline of bispecific antibodies (BsAbs) in immune and inflammatory diseases.

YolTech Therapeutics raises approximately $45m via Series B financing

YolTech Therapeutics has closed its approximately $45m Series B financing led by the AstraZeneca-CICC healthcare investment fund.

Takeda receives FDA approval for Vonvendi sBLA

Takeda Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for the supplemental Biologics License Application (sBLA) of an expanded indication for Vonvendi, for routine prophylaxis in adults with von Willebrand disease (VWD), including Types 1 and 2.

Polpharma Biologics signs biosimilars licensing deals with MS Pharma

Polpharma Biologics has entered into licensing agreements with MS Pharma to commercialise three proposed biosimilars in the Middle East and North Africa (MENA) region.

OMass signs deal with Genentech for IBD small molecules

OMass Therapeutics in the UK has signed an exclusive collaboration and licensing agreement with Roche Group member Genentech to develop and commercialise inflammatory bowel disease (IBD) therapies.