The FDA’s Office of Pediatric Therapeutics will hold a public workshop at the agency’s Silver Springs, Md., campus Nov. 12 to discuss pediatric patient-specific engagement in the development of clinical trial endpoints for rare diseases.

Unexplained price increases are a recurring theme whenever a congressional committee discusses U.S. prescription drug prices, and both state and federal lawmakers have proposed measures to force drug manufacturers to justify those increases.

HONG KONG – Taiwan's National Health Insurance Administration has added Gilead Sciences Inc.'s Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide), a once-daily single tablet for the treatment of adults with HIV-1, to its list of reimbursed medicines.

DUBLIN – Novartis AG gained FDA approval for its VEGF-A inhibitor Beovu (brolucizumab) in wet age-related macular degeneration (AMD) a week ahead of its presumed PDUFA date. The Basel, Switzerland-based pharma used a priority review voucher to speed up the review process, which kicked off on April 15. The stage is now set for what could be an eye-catching – pun intended – contest between Beovu, a single-chain antibody fragment that binds all VEGF-A isoforms, and Eylea (aflibercept), the VEGF trap that has developed into a multibillion-dollar behemoth straddling several ophthalmic indications since its original approval for treating wet AMD in November 2011.

HONG KONG – South Korea's Chong Kun Dang (CKD) Pharmaceutical Corp. received approval for its novel erythropoiesis stimulating protein (NESP) biosimilar from Japan's Ministry of Health, Labour and Welfare (MHLW). The drug (CKD-11101) is world's first NESP biosimilar to treat anemia.

WASHINGTON – Since 2012, Americans at risk of HIV-1 infection from sex have had just a single option for reducing their odds of acquiring it: a daily dose of Gilead Sciences Inc.'s Truvada (emtricitabine and tenofovir disoproxil fumarate). Now, about a year before Truvada goes generic, at least some of them have a second option in Gilead's Descovy (emtricitabine and tenofovir alafenamide). On Thursday, the FDA approved Descovy for HIV-1 pre-exposure prophylaxis, or PrEP, to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex.

Rough times continued Friday at Arbutus Biopharma Corp. as it discontinued clinical development of AB-506, an oral capsid inhibitor, which is in a clinical trial for treating chronic hepatitis B. The decision was made when two healthy volunteers were found to have acute hepatitis.

LONDON – The U.K. government has placed an immediate ban on the export of certain drugs in a bid to prevent wholesalers taking advantage of the fall in the value of the pound against the euro by selling off U.K. stockpiles that have been built up to protect against an interruption in supplies in event of a no-deal Brexit.

Following a speech that seemed more campaign rhetoric than policy, President Donald Trump signed an executive order Thursday that's his answer to the Democrats' proposed Medicare for All Act.