Morning Briefing
Summaries of health policy coverage from major news organizations
US Will Allow Telehealth Use For Drugs Like Adderall, Xanax Through Nov. 11
Bloomberg: US Extends Use Of Telehealth For Drugs Like Adderall, Xanax
Health-care providers can prescribe controlled substances online through Nov. 11, according an advance copy of a rule posted online Tuesday. In addition, practitioners who establish relationships with patients on or prior to that date can continue to prescribe controlled substances for an additional year. (Swetlitz and Belloni, 5/9)
Stat: Gilead Defeats CDC In Battle Over Patents For HIV Prevention Pills
A federal jury handed a major win to Gilead Sciences on Tuesday in a closely watched battle with the U.S. government over the rights to groundbreaking HIV prevention pills. The jury decided Gilead did not infringe on patents held by the Centers for Disease Control and Prevention and, in fact, that the agency’s patents were invalid. The CDC helped fund academic research into HIV prevention that later formed the basis for the pills. The Department of Health and Human Services contended that Gilead refused to reach a licensing agreement despite several attempts to reach a deal. (Silverman, 5/9)
Reuters: US FDA Approves Eyenovia's Pupil-Dilating Spray
The U.S. Food and Drug Administration (FDA) on Monday approved Eyenovia Inc's pupil-dilating spray for use with the company's proprietary drug delivery device during eye examinations. The spray is indicated for mydriasis, or pupil dilation, for eye examinations carried out before cataract surgery or corrective prescriptions and can only be used in combination with the company's experimental drug delivery device, Optejet. (5/8)
Stat: What To Know About The FDA Hearing On Sarepta's Gene Therapy
On Friday, a committee of advisers to the Food and Drug Administration will meet to discuss Sarepta Therapeutics’ closely watched experimental gene therapy for Duchenne muscular dystrophy. It will be the first FDA advisory panel hearing for a Duchenne drug from Sarepta since 2016, when hundreds of patients and family members traveled to the FDA campus in Maryland to plead with experts to authorize an earlier therapy from the company despite limited evidence. (Mast, 5/9)
FiercePharma: Amid High Demand, Novo Temporarily Throttles US Supply Of Low-Dose Wegovy
Just last week, GLP-1 giant Novo Nordisk promised a supply boost of its in-demand obesity med Wegovy after lining up a second contract manufacturer. Now, though, the company is “temporarily" reducing U.S. supply of lower dosage strengths to “safeguard continuity of care,” the company said in a statement. (Becker, 5/4)
Stat: Sun Pharma Halts Shipments From A Plant With A Troubled History
In a fresh sign of quality-control problems in the Indian pharmaceutical industry, the Food and Drug Administration decided that a Sun Pharmaceuticals facility failed to comply with a legal mandate to correct serious shortcomings. As a result, the company has halted exports from the plant to the United States. (Silverman, 5/9)
Reuters: Philips Will Continue To Deliver Hospital Equipment To Russia, CEO Says
Dutch health technology company Philips will continue to deliver hospital equipment to Russia, despite its war on Ukraine, Chief Executive Officer Roy Jakobs said on Tuesday. "The right to healthcare is universal, and we are part of the system delivering healthcare," Jakobs said at the company's annual shareholders meeting in Amsterdam. "We do this in Russia, as we do in Ukraine." (5/9)
Also —
CIDRAP: New Guidance Calls For Stopping Antibiotic Prophylaxis Immediately After Surgery
New expert guidance for the prevention of surgical-site infections (SSIs) recommends that antibiotic prophylaxis (prevention) be discontinued when a patient's incision is closed. (Dall, 5/5)
