Novo Nordisk’s new Denmark site will produce drugs for rare diseases, such as hemophilias. Separately, the pharma giant said all regulatory conditions have been met for Novo Holdings’ acquisition of Catalent, which will bring to Novo Nordisk three manufacturing sites for GLP-1 medications.
Marstacimab, a Pfizer drug for both hemophilia A and B, met the main goal of a Phase 3 study and the company now plans to discuss the data with regulators. The Pfizer drug could beat to the market a Novo Nordisk drug that addresses the same novel target.
In an interview, Kyan Health Co-Founder and Chief Commercial Officer Konstantin Struck discussed how Kyan gives mid-market and enterprise employers access to premium workforce mental healthcare, at a price point that is affordable.
The companies will use a combination of more than seven years of medical record data with five years of prospective data on 5,000 MS patients, including real-world outcomes data and MRI images. Other disease areas to be explored include hematology and rare diseases.
The biotech company said the FDA had given priority review to valoctocogene roxaparvovec for hemophilia A in adults, with the PDUFA date set at Aug. 21.
An analyst wrote that while the data are encouraging, a longer follow-up is needed, and prior experience with gene therapy in the hemophilia A space means some roll-off of effect is likely.
An expert pointed to the draft guidance's lack of distinction between immune-activating bispecifics and those that do not activate the immune system, as well as potentially burdensome trials industry may have to conduct. The comment period ended Tuesday.
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An analyst wrote that while the Phase III data - released alongside Phase I/II data - for valrox could be enough for accelerated FDA approval and appeared to allay concerns about declining Factor VIII levels, it could face commercial challenges.
An analyst called the beta-thalassemia data - for a cell therapy gene-edited using zinc finger nuclease technology - early but a solid proof of concept for the technology's capability.
Patient engagement and education seem to be the largest drivers for building games for healthcare organizations.
Qiming U.S. Healthcare Fund, part of China-based Qiming Venture Partners, led the Series C round. Other investors in the business include Adams Street Partners, CVS Health, The Westly Group, HealthTech Capital and 500 Startups.
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Pfizer has doubled-down on a gene therapy approach to treating hemophilia, announcing a new deal with Sangamo Therapeutics that could be worth up to $545 million.
After its shares plunged nearly 50 percent in October, Alnylam, the double-stranded RNAi company, is trying to resurrect itself with new data at the annual meeting of the American Society of Hematology (ASH).
Also, AstraZeneca and Eli Lilly got a greenlight from the FDA for the second part of a Phase 2/3 trial for a treatment to slow the advance of Alzheimer's disease and sales of short term health insurance are continuing, despite ACA restrictions.
Fledgling startup LogicBio Therapeutics has raised $4 million from OrbiMed Advisors for its hemophilia gene therapy therapeutic candidate.