AllSci News
Kairos Pharma agrees terms to take on EGFRi CL-273 from Celyn Therapeutics
Los Angeles-based Kairos Pharma, Ltd. (NYSE American: KAPA) revealed the signing of a binding terms sheet to acquire exclusive worldwide rights to…
US FDA grants Novo Nordisk three new pediatric indications for growth hormone Sogroya
The US FDA has approved three new pediatric indications for Sogroya (somapacitan-beco), Novo Nordisk’s once-weekly growth hormone, making it the first long-acting…
Celldex’s barzolvolimab restores efficacy in cold urticaria, dermographism in Phase II
Celldex Therapeutics reported Phase II open-label extension data showing that retreatment with barzolvolimab restores efficacy in patients with cold urticaria (ColdU) and…
Rhythm Pharma posts Phase III data for setmelanotide in hypothalamic obesity before FDA decision
Boston-based Rhythm Pharmaceuticals announced additional data from the Phase III TRANSCEND trial evaluating setmelanotide in patients with acquired hypothalamic obesity, reporting a…
Sanofi’s rilzabrutinib takes Orphan Drug Designation in Japan for IgG4-related disease
Sanofi (EURONEXT: SAN; NASDAQ: SNY), the Paris-headquartered biopharma company, announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted orphan…
Pfizer withdraws EMA filing for sc PD-1 Zumrad in high-risk bladder cancer
Pfizer Europe MA EEIG withdrew its EU marketing authorization application for Zumrad (sasanlimab), a subcutaneous PD-1–blocking monoclonal antibody being developed with bacillus…
Henlius restructures PD-1 antibody license as Abbott gains rights across 42 additional markets
Shanghai Henlius Biotech, Inc. (SEHK: 2696), headquartered in Shanghai, China, has restructured the commercialization arrangements for its anti-PD-1 monoclonal antibody HANSIZHUANG (serplulimab…
CHMP gives approval recommendations for 12 drugs, including Moderna’s mRNA flu-COVID combo vaccine
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended 12 medicines for approval at its February…
Pfizer terminates Phase Ib trial for CCR6 antagonist PF-07054894 in ulcerative colitis
Pfizer has terminated its Phase Ib clinical trial evaluating PF-07054894, an oral CCR6 antagonist, in adults with ulcerative colitis, according to an…
Boehringer’s Hernexeos becomes first oral therapy for 1st-line HER2+ NSCLC in US
The US FDA has approved Hernexeos (zongertinib) from Boehringer Ingelheim for the treatment of adult patients with advanced non-small cell lung cancer…
Asieris files Photocure’s Cevira with the EMA seeking approval for cervical lesions
The European Medicines Agency has accepted a marketing authorization application for Cevira (APL-1702), a photodynamic drug-device combination product developed for the non-surgical…
Soligenix’s SGX945 recommended for EMA Orphan Drug Designation for Behçet’s disease
Soligenix, Inc., a Princeton, New Jersey–based late-stage biopharmaceutical company, revealed that the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) has…
WuXi XDC, Earendil Labs form ADC collaboration worth up to USD 885m
WuXi XDC Cayman Inc. (2268.HK), a Shanghai-based CRDMO specializing in bioconjugates, and US-based Earendil Labs, an AI-driven biotechnology company, have entered a…
Generate Biomedicines prices IPO at USD 400m, begins trading on Nasdaq
Generate Biomedicines, Inc. (Nasdaq: GENB), a clinical-stage generative biology company based in Somerville, Massachusetts, announced the pricing of its initial public offering.…
AtaiBeckley’s MDMA drug shows positive Phase IIa results in social anxiety disorder
New York-based AtaiBeckley (NASDAQ: ATAI) announced topline results from its exploratory Phase IIa trial evaluating EMP-01, an oral R-MDMA candidate, in adults…
The AllSci Brief
Systematic R&D and deal news. Daily.