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Disc Medicine’s leadership tried to express optimism that its rare disease therapy bitopertin can be approved based on a Phase 3 trial set to begin shortly. However, analysts are worried that the protocol was developed with former FDA leaders.
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The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
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The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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Genentech’s latest layoffs are the second round of workforce reductions this year, following the company’s announcement in April that it was letting go around 3% of employees.
Quotient Therapeutics’ platform targets somatic mutations, which the startup contends can help identify a broader scope of genes potentially associated with disease phenotypes. Wednesday’s agreement is part of an existing partnership between Pfizer and Flagship Pioneering.
Navigator Medicine is looking to push its lead asset NAV-240 targeting immune-mediated diseases through to clinical studies “in the coming months,” which the startup in-licensed from a South Korean biotech for $20 million upfront.
For reasons including downsizing, avoiding retirement and a tight labor market, senior-level biopharma professionals are increasingly turning to fractional roles, according to two recruitment experts.
The regulator’s restrictions come as the U.S. is experiencing a surge in cases. Invivyd also announced updated Phase III data for Pemgarda, touting an 84% relative reduction in symptomatic COVID-19.
The company joins Eli Lilly in offering its own digital platform to more directly connect to patients, allowing them easier access to healthcare providers and prescription drugs.
Well-financed startup Tome is winding down operations just as two new companies, Borealis Biosciences and GondolaBio, are launching. Meanwhile, in the midst of already tense relations with China, House lawmakers raise the alarm about U.S. companies working with the country’s military on trials.
The vaccine maker is competing with well-established rivals in markets that have a mix of demand issues as well as commercial and structural headwinds, as the biotech looks to establish new growth drivers.
The company announced Tuesday that despite the error preventing the analysis of late-stage results, the FDA confirmed that data from other completed trials are sufficient to support an NDA submission in the first quarter of 2025.
Not all licensing deals are successful. Here, BioSpace examines a few noteworthy assets that Big Pharma returned in the last 12 months.