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IPO
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.
FDA
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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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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Today, scientist-founders are likely to remain in charge, shepherding the companies they founded to the next iteration. BioSpace spoke with one such founder, Mammoth Biosciences’ Trevor Martin.
Tyvaso DPI marks the first approval of a dry powder inhaler for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
Johnson & Johnson and Momenta Pharmaceuticals have filed a patent infringement lawsuit over a generic multiple sclerosis drug developed by India-based Natco, Gland Pharma and Mylan.
Most of Samsung’s investment will be in South Korea, and it expects to create 80,000 new jobs through 2026, or about 16,000 positions annually.
Concerns are mounting for people that have been given Pfizer’s Paxlovid treatment regimen after contracting COVID-19, only to become positive for the infection once again.
Monday, Moderna told a Delaware federal court that it was immune from patent-infringement charges over the COVID-19 vaccine because it supplied the vaccine for a U.S. government effort.
There are many reasons why you might want to negotiate your stock options. Read on to discover what stock options are and how to negotiate your stock options with your employer.
Private investors, governmental institutions and longtime life sciences investors provided funding to develop therapies for cancers, dermatological problems and acute ischemic strokes.
Janssen shared positive updates from ongoing trials on candidate therapies for Crohn’s disease and ulcerative colitis at Digestive Disease Week in San Diego, California.
Vanda has again taken legal action against the FDA over its supposed failure to grant tradipant Fast Track designation. In its complaint, Vanda is challenging the FDA’s decision to deny the designation.