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.
THE LATEST
Omisirge is approved for patients who receive cord blood transplantation following myeloablative therapy.
A unanimous FDA committee vote supported the favorable risk-benefit profile of Innoviva’s sulbactam-durlobactam for hospital-acquired A. baumannii infections.
Roche, AstraZeneca, Moderna, Merck and Affimed presented new data in liver cancer, lung cancer, melanoma and lymphoma.
Thursday, the FDA greenlit Ostuka and Lundbeck’s Rexulti as the first treatment in the U.S. for agitation associated with dementia due to Alzheimer’s disease.
Merck finalized the acquisition of immune-focused Prometheus Biosciences for approximately $10.8 billion, picking up mid-stage ulcerative colitis and Crohn’s asset.
The Supreme Court extended the stay deadline to Friday at midnight to keep mifepristone on the market in the interim without conditions.
Between new formulations of traditional drugs nearing the market and completely novel approaches in mid-stage trials, 2023 is poised to be a pivotal year in Parkinson’s disease treatment.
Clinical results for experimental treatments in Alzheimer’s, ALS and more are expected over the coming months. BioSpace highlights a few of the more highly anticipated datasets.
Aer’s inhaled formulation targets the mucus plugs obstructing COPD patients’ airways.
The regulator found no issues with mirikizumab’s clinical or safety data.