News
After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
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Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Read our takes on the biggest stories happening in the industry.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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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.
The FDA granted Moderna’s RSV vaccine candidate Breakthrough Therapy Designation Monday.