The U.S. FDA has given Pq Bypass Inc. the greenlight to conduct a pivotal trial aimed at assessing its Torus stent graft in the treatment of peripheral artery disease (PAD) in the superficial femoral artery. The TORUS-2 study is the Milpitas, Calif.-based startup's second IDE approval in less than two years and the first pivotal IDE for an SFA stent graft since W.L. Gore & Associates Inc.'s Viabahn device, which notched an initial PMA approval in 2005.

The U.S. FDA has posted a draft guidance that will overwrite a 2014 draft guidance dealing with MRI compatibility for medical devices, but at least one observer is concerned that the agency posted draft as standards-setting organizations are rewriting their own related device performance standards, a fact that could draw out the time to completion of the draft.

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.

HONG KONG – I-Mab Biopharma (Shanghai) Co. Ltd. has received IND approval from China's National Medical Products Administration (NMPA) for its CD73 antibody, getting the go-ahead for a phase I/II trial of TJD-5 in patients with advanced solid tumors.

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-1110) is world's first NESP biosimilar to treat anemia.

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.