Policy
After a three-month delay, GSK expects an FDA verdict for its myelofibrosis candidate, while Alnylam gears up for an advisory committee meeting discussing patisiran in cardiomyopathy of ATTR amyloidosis.
FEATURED STORIES
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.
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Cases of monkeypox infections reported in the latest viral outbreak have surpassed 14,000 in the U.S., according to the CDC. Some scientists believe the outbreak was predictable.
HHS found nearly half of NIH clinical trials were reported incorrectly, in violation of federal standards, according to a new report issued Friday by the agency.
The regulatory path for companies developing drugs for rare diseases is often fraught with challenges. KemPharm CEO Travis Mickle discussed just some of these with BioSpace.
Curis announced that the FDA has allowed patient enrollment to resume in the monotherapy phase of its TakeAim Leukemia Phase I/II trial studying emavusertib.
A trial evaluating generic drugs against severe COVID-19 provided data showing their overall ineffectiveness, and COVID-19-related lawsuits continue to pile up.
CDC director Dr. Rochelle Walensky announced plans to launch a “reset” of the agency amid criticism over its handling of the COVID-19 pandemic and other public health threats.
Cases of monkeypox are growing at an alarming rate and Bavarian Nordic, the company that owns one of the two approved vaccines, may no longer be able to keep up.
The FDA expects to foster innovation and competition among manufacturers, which would lower the prices of hearing aids without compromising their quality.
Blueprint Medicines’ Ayvakit is headed to the FDA for a new indication after the drug hit the mark in Part 2 of the PIONEER trial for non-advanced systemic mastocytosis.
The Bill & Melinda Gates Foundation inked a memorandum of understanding with South Korea’s foreign and health ministries to expand their partnerships revolving around public health.