Research & Development

Alkermes’ alixorexton secures FDA and EC orphan designations

Alkermes has received orphan drug designations (ODD) from both the US Food and Drug Administration (FDA) and the European Commission (EC) for alixorexton, its investigational oral orexin 2 receptor (OX2R) agonist to treat idiopathic hypersomnia (IH) and narcolepsy.

Simcere and Stanford partner to develop IPF therapies

Simcere Pharmaceutical Group has entered a research collaboration agreement with Stanford Medicine to develop new therapies for idiopathic pulmonary fibrosis (IPF).

FDA clears MSD’s Keytruda combo plus Welireg for ccRCC treatment

Merck & Co (MSD) has received approval from the US Food and Drug Administration (FDA) for both Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), in combination with Welireg (belzutifan), as adjuvant treatment for adults with renal cell carcinoma with a clear cell component (ccRCC).

China’s NMPA approves Akeso’s gumokimab for plaque psoriasis

Akeso has received approval from China’s National Medical Products Administration (NMPA) for gumokimab (AK111), an anti-Interleukin-17 (IL-17) monoclonal antibody, to treat adults with moderate-to-severe plaque psoriasis.

XtalPi enters $400m partnership for small molecule therapy for GPCR target

XtalPi has entered a strategic partnership valued at more than $400m with an international biopharmaceutical company to develop oral small-molecule therapeutics targeting a G protein-coupled receptor (GPCR).

Aditxt and Ignite announce merger plans with strategic partner

Health innovation platform developer Aditxt and its fully owned subsidiary Ignite Proteomics have announced their plans for a business combination with a strategic partner that values the latter at an implied equity value of nearly $150m.

MHRA to roll out new AI sandbox for medicines development

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced plans to launch a new AI sandbox to expedite the development of medicines and improve safety.

J&J to acquire Firefly Bio for $1bn to enhance oncology pipeline

Johnson & Johnson (J&J) has agreed to purchase Firefly Bio for $1bn in cash, aiming to strengthen its oncology pipeline with Firefly Bio’s proprietary Firelink degrader-antibody conjugate (DAC) platform.

Sanofi and Owkin partner to develop next-generation biopharma AI agents

Sanofi has entered a multi-year agreement with France-based agentic AI company Owkin to co-develop next-generation AI-driven biopharma agents.