The U.S. Department of Health and Human Services (HHS) is 6-1 so far in blocking court challenges to the Medicare price negotiation program mandated by the Inflation Reduction Act (IRA). The department’s latest victory came July 31 when a federal district judge in New Jersey tossed a complaint filed by Novo Nordisk A/S, citing a lack of jurisdiction on the court’s part and the company’s lack of standing.
The U.S. Department of Health and Human Services has discovered viral maturation inhibitors and their prodrugs reported to be useful for the treatment of HIV infection.
With the COVID-19 pandemic still visible in the rearview mirror, the World Health Organization (WHO) is taking no chances as it preps for human avian influenza, or H5N1, a subtype of influenza A.
The U.S. Department of Health and Human Services’ Office of the Inspector General disclosed an advisory opinion finding Bluebird Bio Inc.’s fertility support program for a gene therapy treatment could run afoul of federal anti-kickback statutes. That follows a similar opinion against Vertex Pharmaceuticals Inc., and its fertility program associated with gene-editing therapy Casgevy (exagamglogene autotemcel). Vertex subsequently filed a lawsuit.
As the U.S. Congress continues to pass laws that require federal agencies to issue rules to implement new statutory provisions, a group of lawmakers is reminding the agencies that it will be looking over their shoulders to ensure they don’t stray beyond the scope of the law or overstep their authority.
In denying Medicaid patients with sickle cell disease or transfusion-dependent beta-thalassemia access to Vertex Pharmaceuticals Inc.’s fertility preservation program, which is intended to counteract a side effect of the company’s gene-editing therapy, Casgevy, “the federal government now stands as the barrier between thousands of predominantly Black Americans and the necessary medical care that would protect their basic right to have biological children,” Vertex said in a lawsuit filed July 15.
With all the criticism the U.S. NIH has been getting of late, it’s not surprising that yet another reform proposal for the research agency is brewing in Congress. In unveiling a proposed framework to reform the NIH, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) recognized the critical role the agency plays in life-saving medical research and innovation.
The Department of Health and Human Services (HHS) has no rulemaking authority over the 340B prescription drug discount program, the U.S. Court of Appeals for the District of Columbia Circuit said May 21 as it handed the government its second big loss in the ongoing debate over whether drug manufacturers have to give unlimited contract pharmacies the steep discounts the program provides to certain health care providers.
Kurome Therapeutics Inc. along with the Cincinnati Children’s Hospital Medical Center and U.S. Department of Health and Human Services have patented interleukin-1 receptor-associated kinase (IRAK) and/or FLT3 (FLK2/STK1) inhibitors reported to be useful for the treatment of cancer, autoimmune disease and inflammatory disorders.
The Pharmaceutical Research and Manufacturers of America (PhRMA) is not happy with the Biden administration or the new 340B rule, finalized on April 18 by the U.S. Department of Health and Human Services (HHS), concerning the dispute resolution process put in place in 2020.
