News
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
FEATURED STORIES
Dual and even triple or quadruple track processes have come roaring back in 2026 thanks to a glut of M&A that has refilled investors’ wallets. Big Pharma is being put on notice that time is critical if they want to acquire.
Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agency’s new investigational new drug pilot program as a sign of normalcy.
The FDA’s recently altered outlook on the evidence required for approval of rare disease drugs could have immediate benefits for companies including Skyhawk Therapeutics, Capricor Therapeutics and Biohaven.
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THE LATEST
For closing its $8 billion acquisition of Grail without regulatory approval, the European Union has slapped Illumina with a record $476 million fine—the maximum sanction allowed under the EU’s rules.
Following the regulator’s request for more data beyond the scope of its Phase III TIDES trial, Takeda decided to voluntarily withdraw the Biologics License Application for its TAK-003 dengue vaccine.
The company’s ruxolitinib cream Opzelura led to higher rates of treatment success in children with atopic dermatitis than with a control cream.
Severe respiratory problems killed seven patients and affected five others, though the company said that most of these were likely unrelated to the drug.
After paying $300 million upfront to BeiGene for option rights to ociperlimab in December 2021, Novartis has dropped the agreement and given the rights back to the Chinese biotech.
A handful of biotechs and pharma companies have posted sizable IPOs in 2023, despite a tight economy. Still, the numbers are way down from last year.
Burjeel Holdings and BridgeBio Pharma ink partnership deal in rare genetic diseases with a plan to set up headquarters in Abu Dhabi.
Bristol Myers Squibb is paying a total of $95 million to the two companies for exclusive global rights to programs developed within long-term partnerships designed to further BMS’ neuro pipeline.
Following its $5.9 billion Iveric Bio buy, Astellas is leaning into the eye disease space with a licensing agreement for 4D Molecular Therapeutics’ proprietary intravitreal AAV delivery system.
Despite a government report showing that hiring slowed over the month of June, job postings on BioSpace’s life sciences-focused job board saw a marked increase.