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.

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.

While the U.S. House and Senate push forward with controversial legislative packages aimed at making prescription drugs more affordable for Americans, other bills that would impact the biopharma sector are making their own way through Congress, being absorbed into the larger pricing packages or getting tacked on to unrelated legislation.

The Cushing's syndrome market is heating up with three second-generation drugs in late-stage development to join the two approved medications, Signifor (pasireotide, Recordati SpA) and Korlym (mifepristone, Corcept Therapeutics Inc.), as well as a couple of off-label options.

HONG KONG –South Korea's leading biopharmaceutical developer, Celltrion Inc., has launched its early/metastatic breast and gastric cancer biosimilar Herzuma (trastuzumab) in Iraq. It is Herzuma's first foray into the Middle Eastern region.

The recent FDA approval of Ibsrela (tenapanor), Ardelyx Inc.’s treatment for irritable bowel syndrome with constipation in adults, brings, according to the agency’s data, the number of new molecular entities (NMEs) to 27 this year. With just three months remaining, it appears that the biopharma sector is on pace with the five-year average of about 43 NMEs approved annually. 

Two recent deals signaled to the industry that efforts to target previously undruggable RNA with small-molecule therapies may be moving from academic endeavor to fruitful application.

Device makers have reporting responsibilities for devices used in combination products per an FDA final rule published in 2016, but the FDA said in the 2018 draft guidance that the applicant of a drug- or biologic-led combo product must evaluate whether a malfunction of the device component would suggest a hazard for similar combinations using that device. That provision appears in the final rule, and thus puts the onus on makers of drugs and biologics to do a job device makers say is theirs to handle.

Drugs for rare diseases now account for 31% of R&D pipelines, up from 18% in 2010 and just 11% in 2005, according to a report from the Tufts Center for the Study of Drug Development. That's currently nearly 3,500 drugs in development, more than double the 1,530 in 2010.