DOJ sues Regeneron over charity-funded cost sharing

Group urges FDA to add warning on diabetes drug label | FDA finalizes guidelines for bacterial pneumonia drugs | FDA clears late-stage trial for Fulcrum's losmapimod in COVID-19

Created for majed2aboshddad.majed@blogger.com | Web Version

June 25, 2020

News for the food and drug law community

Drugs & Biologics

DOJ sues Regeneron over charity-funded cost sharing

The Department of Justice filed a lawsuit against Renegeron Pharmaceuticals accusing the company of funneling kickbacks through a patient assistance foundation to cover cost sharing for Medicare patients taking its macular degeneration drug Eylea. According to the lawsuit, the scheme helped boost sales of Eylea, which normally costs more than $10,000 per year, and allowed Regeneron to receive $1.9 billion from Medicare.

Full Story: Reuters (6/24)

Group urges FDA to add warning on diabetes drug label

A citizen's petition was filed by a consumer advocacy group urging the FDA to include a black box warning on the labeling of SGLT-2 inhibitors noting the risk of a potentially fatal complication if used to treat people with type 1 diabetes. "The current dangerous off-label prescribing of these drugs to patients with type 1 diabetes, which has been well documented by the FDA, is enabled by the dangerous incompleteness and submerged prominence of the warnings about the risk of [ketoacidosis] in the current product labeling," according to Public Citizen.

Full Story: Becker's Hospital Review (6/24)

FDA finalizes guidelines for bacterial pneumonia drugs

The FDA released two final guidances on developing drugs for community-acquired bacterial pneumonia and hospital-acquired and ventilator-associated bacterial pneumonia. Both documents include updates to trial populations and statistical considerations for analysis populations.

Full Story: Regulatory Focus (6/24)

FDA clears late-stage trial for Fulcrum's losmapimod in COVID-19

Fulcrum Therapeutics said the FDA has signed off on its Phase III study to evaluate losmapimod's safety and efficacy to treat higher-risk adults hospitalized due to COVID-19. The trial aims to enroll about 400 patients, with topline data expected by the first quarter of next year.

Full Story: Seeking Alpha (free registration) (6/24)

CDC, industry brace for high flu vaccine demand

US health authorities and vaccine makers are working to boost supplies of flu vaccine doses amid fears that a spike in COVID-19 infections will coincide with the flu season. Manufacturers plan to produce 189 million doses this year, up 10% from last year's volume, while the CDC is purchasing 7 million doses to be used in state adult vaccination programs, 14 times the total the agency normally buys for adults.

Full Story: The Washington Post (tiered subscription model) (6/24)

Medical Devices

Astigmatism management tech from J&J Vision cleared

The FDA has given 510(k) clearance to Johnson & Johnson Vision for its CATALYS cOS 6.0, an astigmatism management software for its laser cataract surgery system that automatically compensates for cycloration and allows for a more accurate laser alignment.

Full Story: FDAnews (6/25)

COVID-19 tests from Laihe Biotech, Gencurix get EUA

The FDA has given emergency use authorization to Laihe Biotech for its Lyher Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit and to Gencurix for its GenePro SARS-CoV-2 Test.

Full Story: GenomeWeb Daily News (free registration) (6/24)

BARDA awards $629K to MBio for COVID-19 antibody test

The Biomedical Advanced Research and Development Authority has given $629,595 to MBio Diagnostics to aid in the development and commercialization of its COVID-19 Antibody Panel.

Full Story: 360Dx (tiered subscription model) (6/23)

Food and Drug Law Institute (FDLI) Highlights

Members: Submit a Law Over Lunch Topic

Member-Only Opportunity
Is there a timely, interesting topic that you would like to discuss with other FDLI members? Submit a proposal to facilitate a discussion at an upcoming virtual Law Over Lunch program! Submit a Topic

Access New Update Magazine Articles

FDLI has released three new Update magazine articles on our website from the Summer 2020 issue. If you're interested in writing for Update, view authorship opportunities on our site. Read Now