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
Mirati Therapeutics’ adagrasib is going up against Amgen’s Lumakras in the KRAS race, and according to Friday pre-market trading, the results shared Thursday don’t seem to be enough for investors.
Two therapies for different cancers are moving forward in development following positive outcomes in their clinical trials ahead of the ASCO’s annual meeting in early June 2022.
Biopharma and life sciences companies strengthen their leadership teams and boards with these Movers & Shakers.
On June 5, the FDA is expected to decide the fate of Acer Therapeutics’ experimental treatment for Urea Cycle Disorders (UCDs), ACER-001. CEO Chris Schelling spoke with BioSpace.
Two researchers affiliated with Northwestern University have discovered a new drug that may outperform existing treatments for amyotrophic lateral sclerosis (ALS).
ZYESAMI, (aviptadil), being assessed by NRx Pharmaceuticals, failed a review conducted by the Data Safety and Monitoring Board (DSMB), with the board recommending that arm of the trial cease.
Pfizer announced the FDA has granted its combinatorial therapeutic ervogastat/clesacostat Fast Track Designation that is intended for the treatment of NASH with liver fibrosis.
Research is emerging showing a causal link between COVID-19 and diabetes. Dr. Brian Fertig, M.D., founder and president of the Diabetes & Osteoporosis Center in New Jersey, spoke with BioSpace.
Four biotech companies are holding Research-and-Development Day events to present and discuss their pipelines. Here’s a look.
The new R&D facility is a product of its new licensing deal with BridgeBio Pharma and will operate under Helsinn Therapeutics.