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After reporting promising interim findings from the Phase IIa INTEGRIS-IPF trial, Pliant Therapeutics commenced a public stock offering of $175 million.
The FDA’s Peripheral and Central Nervous System Drugs advisory committee will discuss the merits of Biogen and Ionis’s ALS candidate tofersen on March 22nd.
Rhythm Pharmaceuticals published data Monday showing Imcivree (setmelanotide) improved quality of life for patients with obesity related to Bardet-Biedl Syndrome.
J&J’s Janssen terminated its integrin research collaboration with Morphic Therapeutics. This follows the June 2022 termination of a partnership with AbbVie.
Phase III data showed Ipsen’s Onivyde boosted overall survival in metastatic pancreatic ductal adenocarcinoma.
Takeda entered into an exclusive licensing agreement with Hutchmed Limited to develop its colorectal cancer candidate, fruquintinib, beyond mainland China, Hong Kong and Macau.
Sanofi licensed CytoReason’s inflammatory bowel disease model in a multi-million dollar bid to identify new therapies for IBD and Crohn’s and colitis.
FDA
The FDA granted Seagen’s tyrosine kinase inhibitor Tukysa accelerated approval for an aggressive form of colorectal cancer Thursday.
FDA
Thursday, Astellas announced that the FDA had lifted its clinical hold for the company’s experimental gene therapy trial for late-onset Pompe disease.
The FDA issued a complete response letter Thursday refusing accelerated approval for Eli Lilly’s Alzheimer’s disease candidate donanemab.
Disc Medicine inked an exclusive license agreement with Mabwell Therapeutics for the latter’s portfolio of monoclonal antibodies against the TMPRSS6 protein.
bluebird bio, Inc. is expecting gross proceeds of $120 million with its newly announced public offering of 20,000,000 shares.
Jazz Pharmaceuticals and Zymeworks announced results from a Phase II trial of the latter’s HER2-targeted antibody for metastatic gastroesophageal adenocarcinoma.
Roche’s Tecentriq (atezolizumab) combined with Avastin (bevacizumab) met the primary efficacy endpoint in early-stage hepatocellular carcinoma in the Phase III IMbrave050 study.
Editas announced the sale of its iPSC-derived iNK programs to Shoreline Biosciences. Shoreline also licensed Editas’ SLEEK technology.
Johnson & Johnson discontinued the Phase III trial of an investigational HIV vaccine regimen Wednesday after an independent review showed it was ineffective at preventing disease.
The neurodegenerative drug development space saw incremental victories in 2022. Leaders from Eisai, Voyager and QurAlis discuss upcoming milestones.
Breast cancer came in as the most studied disease in 2022, according to the patient data analytics firm Phesi.
The FTC issued a Notice of Proposed Rulemaking (NPRM) that could change the landscape for employer-employee relationships nationwide, specifically in the biopharma industry.
Horizon Therapeutics’ dazodalibep met the primary endpoint in a second straight Phase II trial for Sjögren’s syndrome.