Citing what it called poor study design and execution coupled with a lack of follow-up data, the FDA’s Oncologic Drugs Advisory Committee voted 13-2 against recommending approval of Steba Biotech SA’s NDA for Tookad (padeliporfin dipotassium) for injection in men with localized early stage prostate cancer.

While the staff at the U.S. Department of Health and Human Services (HHS) is currently all hands-on-deck in responding to the COVID-19 outbreak, some of the agencies in the department may have to divert resources to get sponsors of drug and device clinical trials to fill in nearly a decade-long data gap on Clinicaltrials.gov. That’s if a judge’s decision handed down this week stands.

The U.S. FDA has given its nod to Novalung, a heart and lung support system from Fresenius Medical Care North America (FMCNA) for the treatment of acute respiratory or cardiopulmonary failure. The Waltham, Mass.-based company noted that Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use.

U.S.-based device makers have been grappling with FDA cybersecurity requirements for some time, but now the European Union (EU) is working on cybersecurity regulations as well. Throw in privacy requirements by the state of California and the EU’s General Data Protection Regulation (GDPR), and device makers are facing an increasingly complicated world of enforcement and litigation.

NATIONAL HARBOR, Md. – Cardiovalve Ltd., of Or Yehuda, Israel, scored a double hit with the U.S. FDA, winning a breakthrough device designation for its transcatheter tricuspid valve replacement system, as well as approval to conduct an early feasibility study in tricuspid regurgitation (TR).

Asuragen Inc., an Austin, Texas-based molecular diagnostics company, has received good news from the U.S. FDA. The agency gave the green light for the company’s Amplidex Fragile X Dx and Carrier Screen Kit, which aims to detect a genetic condition known as Fragile X syndrome. The diagnostic kit determines the number of cytosine-guanine-guanine (CGG) repeats in the FMR1 gene to aid in the diagnosis of Fragile X syndrome and associated disorders, including Fragile X-associated tremor/ataxia syndrome and Fragile X-associated primary ovarian insufficiency.

H. Lundbeck A/S’ antibody-based migraine therapy, Vyepti (eptinezumab-jjmr), which just received FDA approval as the first and only intravenous preventive treatment for adults, enters a market forecast to grow to $7 billion by 2027. While some analysts placed Vyepti’s earnings potential at about $800 million annually, the drug itself is positioned to become a possible blockbuster, earning $1 billion annually.

Valrox (valoctocogene roxaparvovec) from San Rafael Calif-based Biomarin Pharmaceutical Inc. moved one step closer to entering the U.S. market, with the company reporting that that the FDA had accepted for priority review the BLA for its investigational AAV5 gene therapy for adults with hemophilia A.