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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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Genmab announced Wednesday it is buying ProfoundBio and its pipeline of next-generation antibody-drug conjugates being developed for gynecologic cancers and other solid tumors.
With second-generation antibody-drug conjugates, Eli Lilly, Daiichi Sankyo and others look to reduce toxicity and improve the magnitude and duration of response.
The new Cambridge, Mass.–based facility is about 460,000 square feet. Labs occupy nearly 50% of the space.
Read the latest overview of people coming and going from executive positions at biopharma companies that BioSpace covers.
Plus, another big buy points to strength of CDMO market and a new treatment for pulmonary arterial hypertension
Under the agreement, Ipsen nabs exclusive global rights for development and commercialization of Sutro Biopharma’s STRO-003, an antibody-drug conjugate which is completing the final stages of preclinical development.
The biotech’s personalized neoantigen vaccine for colorectal cancer did not demonstrate a molecular response difference from the control arm. Gritstone blames trial protocol and plans for a Phase III study.
Roivant has chalked up a mid-stage victory for its Pfizer-partnered dual TYK2/JAK1 inhibitor, setting it up to start a Phase III trial in non-anterior non-infectious uveitis this year.
Verve Therapeutics is pausing enrollment in the Phase Ib Heart-1 study for its gene editor VERVE-101 after a patient developed grade 3 laboratory abnormalities, the company announced Tuesday.
Following promising Phase IIa data, Vertex Pharmaceuticals will now evaluate its oral drug candidate inaxaplin in a late-stage study of APOL-1 mediated kidney disease.