All articles by Manish Kumar
EC approves Pfizer’s Durveqtix for adults with haemophilia B
The conditional marketing authorisation is based on the Phase 3 BENEGENE-2 study in which Durveqtix achieved the primary efficacy endpoint of non-inferiority
Mankind Pharma to acquire Bharat Serums & Vaccines for $1.6bn
Bharat Serums & Vaccines operates through six subsidiaries in India, the Philippines, Germany, the US, and Malaysia, and has business operations in over 50 countries
Summit Therapeutics and MD Anderson announce strategic collaboration to accelerate development of Ivonescimab
Five Year Collaboration Intended to Advance PD-1 / VEGF Bispecific in Several Solid Tumors across Multiple Clinical Trials
Pfizer’s giroctocogene fitelparvovec meets primary endpoint in Phase 3 trial
Giroctocogene fitelparvovec is being developed by Pfizer under a collaboration with Sangamo Therapeutics as a gene therapy for haemophilia A
UK’s MHRA approves JN.1 strain-targeting Comirnaty Covid-19 vaccine
The MHRA has approved four variants of the adapted Comirnaty JN.1 vaccine after reviewing their safety, quality, and effectiveness as per UK’s regulatory standards
Autobahn Therapeutics completes oversubscribed $100m Series C financing to advance pipeline of Novel Therapeutics for depression and other CNS disorders
Advancing ABX-002, a highly potent, selective and centrally active thyromimetic, into Phase 2 clinical trials for patients with major depressive disorder and bipolar disorder depression
Merck’s clesrovimab protects against infants RSV in Phase 2b/3 trial
Clesrovimab met its primary safety and efficacy endpoints and reduced MALRI caused by RSV through Day 150
BeiGene inaugurates new biologics facility in New Jersey, US
The site provides scalable production capacity to address both current and future demands for its cancer therapies, including BeiGene’s over 30 molecules in clinical or commercial stages
Pinetree Therapeutics announces exclusive option and global license agreement for preclinical EGFR degrader candidate with AstraZeneca
Pinetree to receive up to $45 million in upfront and near-term payments, with a total deal value of over $500 million including potential additional development and commercial milestone payments
Astellas and Osaka University to develop cell therapy for intervertebral disc degenerative disease
The agreement combines the cartilage tissue creation protocol established by Professor Tsumaki from Osaka University, Universal Cells’ UDC technology, and AIRM’s R&D expertise in cell therapy