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After a sluggish 2025, biotech IPOs have roared back to life. Fueled by resilient stock performances and improving market sentiment, the total number of public debuts so far this year has already eclipsed 2025’s total.
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As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
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Read our takes on the biggest stories happening in the industry.
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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Eli Lilly has filed lawsuits in several states seeking to prevent unauthorized selling of products that claim to contain tirzepatide, the active ingredient in its blockbuster type 2 diabetes drug Mounjaro.
The Japanese biopharma will receive $40 million upfront from Genetech for R&D of its macrocyclic peptide-radioisotope drug conjugates, with another $1 billion on the line in milestone payments.
Though it received backing from the Pulmonary-Allergy Drugs Advisory Committee in May, the FDA on Tuesday rejected ARS Pharmaceuticals’ neffy as a nasal spray for allergic reactions.
The companies have announced the impending closures of their respective businesses. Histogen will lay off most of its employees by the end of September. Fresh Tracks will do so by early October.
After facing regulatory roadblocks, Novartis is returning the anti-PD-1 antibody to the cancer-focused biotech, which regains global rights to develop, manufacture and commercialize tislelizumab.
The latest data show Izervay is safe and effective in a two-year trial. Just six weeks after securing FDA approval, Astellas plans to submit it to the regulator to expand its label for a longer treatment timeframe.
After a sluggish start to the year, experts expect an uptick in IPO offerings moving into fall, although it’s unlikely 2023 will fully shrug off its slump.
The consent agreement struck between the FTC and Amgen and Horizon Therapeutics could have significant implications for ongoing and future M&A challenges, experts told BioSpace.
Nearly three years after European approval, the U.S. regulator has accepted Orchard Therapeutics’ BLA for its gene therapy OTL-200, being proposed for metachromatic leukodystrophy.
The French pharma company continues to pare down its central nervous system business by divesting 11 brands to U.K.-based Pharmanovia, which is expanding its neurology portfolio.