As more therapies are approved to treat severe atopic dermatitis, U.S. payers should make available at least one biologic and one JAK1 inhibitor, given how different the drug classes are in their onset of action and their risk profile, a panel of experts recommended at a recent Institute for Clinical and Economic Review (ICER) roundtable.
The HHS Advisory Committee on Immunization Practices that had mixed opinions in June on the necessity of boosters will have a chance to consider new data when it meets again Aug. 24. Since that June adcom, COVID-19 infection rates have risen steadily and the FDA allowed for a third dose of the mRNA vaccines in certain adults with compromised immune systems.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carrick, Edgewise, Eli Lilly, Enlivex, Galmed, Inxmed, Jupiter, Merck & Co., Oncolys, Pfizer, Sesen, Therapeutic Solutions.
The increasing use of artificial intelligence (AI) technologies across all stages of drug development is presenting challenges for regulators across the world.
Pfizer Inc.’s Ticovac has been approved by the FDA for immunizing those ages 1 year and older against tick-borne encephalitis, a disease that’s not endemic to the U.S. but increasingly is found in Europe and Asia. Ticovac, developed with a master seed virus, was first approved outside the U.S. 45 years ago. Before the FDA approval, the CDC had recommended that travelers on their way to high-risk areas be vaccinated in Europe though the process could take up to six months.
Clinical data in 2021 has risen by about 9.2% in comparison with the same timeframe in 2020. As of mid-August, BioWorld has tracked a total of 2,400 entries of clinical data, which is up from the 2,197 entries last year. The gap has decreased from about 26% in mid-April, suggesting a steady slowdown in activity.
PERTH, Australia – The Treasury Department is seeking feedback from industry stakeholders on its discussion paper on a patent box policy, which was first announced in the May 2021 federal budget.
The CDC’s Advisory Committee on Immunization Practices (ACIP) deliberated the matter of third COVID-19 shots, with panel members voting whether to recommend “additional doses of mRNA COVID-19 vaccines as part of a primary [two-shot] series” in certain immunocompromised patients. A work group set up by ACIP decided previously that the desirable consequences outweighed undesirable ones in such a population.
Merck & Co. Inc.'s $1.05 billion acquisition of Peloton Therapeutics Inc. in 2019, a big bet on the hypoxia inducible factor-2 alpha inhibitor belzutifan, has paid off with an earlier-than-anticipated FDA approval of the drug for cancers associated with von Hippel-Lindau disease. The therapy will be marketed as Welireg.
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