U.S. to provide states with up to 442,000 Jynneos doses to combat monkeypox
The U.S. government said on Monday it will provide states with up to 442,000 doses of Bavarian Nordic’s Jynneos vaccine to combat the outbreak of monkeypox disease.
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U.S. approves over-the-counter hearing aids for sale
/in FDA/Regulatory, TherapeuticsThe U.S. Food and Drug Administration (FDA) adopted a final rule on Tuesday to create a new category of over-the-counter hearing aids that can be sold directly to millions of Americans.
FDA clock starts for AstraZeneca and Merck in prostate cancer, Roche in DLBCL
/in FDA/Regulatory, R&D, TherapeuticsTuesday morning saw the FDA acceptance of a supplemental New Drug Application (sNDA) and supplemental Biologics License Application (sBLA) for three industry powerhouses.
Bill Gates, South Korea expand global health partnership
/in TherapeuticsSouth Korea agreed on Tuesday to expand its global health partnership with the foundation set up by Microsoft Corp. (MSFT.O) co-founder and philanthropist Bill Gates.
Evoke Pharma and EVERSANA Expand Patient Access to GIMOTI With New Telehealth Solution
/in Marketing & AdvertisingPatients with symptoms of diabetic gastroparesis now have direct-to-patient treatment support powered by UpScriptHealth.
European Medicines Agency Grants Orphan Drug Designation to INBRX-109 for the Treatment of Chondrosarcoma
/in TherapeuticsInhibrx Inc. announced that the European Commission (“EC”), based on a positive opinion issued by the European Medicines Agency (“EMA”), has granted orphan medicinal product designation to INBRX-109 for the treatment of chondrosarcoma.
UK’s autumn COVID vaccination campaign buoyed by Omicron booster nod
/in R&D, TherapeuticsThe United Kingdom’s COVID booster campaign is set to kick off this September, after the country became the first in the world to approve an Omicron-adapted shot.
VMLY&R HEALTH announces Patrick Beers in new role as Executive Director and Market Access Strategy lead
/in Marketing & AdvertisingThis latest leadership hire further advances the agency’s expanding health offering under its connected brands positioning.
AstraZeneca says data confirms Enhertu benefit in breast cancer patients
/in R&D, TherapeuticsAstraZeneca said a late-stage trial had confirmed the benefit of breast cancer drug Enhertu in patients with an advanced form of the disease who had been previously treated with another therapy.
Seagen loses patent battle against Daiichi Sankyo as Merck waits in the wings
/in R&D, TherapeuticsAs the biotech world awaits the announcement of Merck’s anticipated buyout of Seagen, an arbitrator came down on the side of Daiichi Sankyo in a patent battle against the Seattle-based biotech.