The U.S. FDA is now accepting requests from biopharma companies to participate in its new Precheck pilot program, which is intended to make it faster and easier for companies to relocate their prescription drug manufacturing to the U.S.
The days of the U.S. FDA considering as trade secrets country-of-origin info for drugs and their ingredients have to end, the Senate Aging Committee was told at a Jan. 29 hearing on truth in drug labeling.
The pressure on U.S. drug prices continues, with the CMS lining up the drugs for round 3 of negotiations, which will set maximum fair prices to go into effect in 2028. The slate includes 15 drugs and, for the first time, opens the negotiations to Part B drugs, as well as Part D. Consequently, seven of the 15 selected drugs are biologics.
Nader Pourhassan, the former president and CEO of Cytodyn Inc., was sentenced Jan. 23 to 30 months in prison for his role in a securities fraud scheme to deceive investors about the Vancouver, Wash.-based company’s development of leronlimab as a treatment for HIV and COVID-19.
Although the American Academy of Pediatrics has been releasing guidances on vaccines for decades, the 2026 immunization schedule it issued Jan. 26 is creating some buzz given the U.S. CDC’s newly abbreviated childhood schedule that removed several routine recommendations.
After the U.S. House passed a package of spending bills Jan. 22 to fund several agencies and departments, including Health and Human Services, through fiscal 2026, the Senate was expected to quickly follow suit to ensure that no part of the federal government would shut down when the current continuing resolution expires Jan. 30. That was before a confrontation with Immigration and Customs Enforcement in Minnesota turned deadly over the weekend.
In a lawsuit that’s been bouncing through the courts for years, the U.S. Court of Appeals for the District of Columbia once again cleared the way for several biopharma and medical device companies to potentially be held liable, under the Anti-Terrorism Act, for terrorist attacks against hundreds of Americans in Iraq.
The U.S. NIH may be weathering the budget storm thanks to bipartisan congressional support, but another squall line is forming on the horizon over politicization of the research agency.
Another day, another insider trading settlement involving a biopharma company employee. This time the U.S. SEC settlement is with Mohit Verma, who was a researcher and associate director of immunology at the San Diego-based Infinitybio Inc. at the time of the alleged violative trading activity.
The good news is that the U.S. Congress is on track to pass a slate of fiscal 2026 spending bills before the current continuing resolution expires Jan. 30. So, barring any last-minute disputes or legislative hostage-taking, there should be no repeat of last year’s 43-day shutdown that impacted NIH grants and activities.
