Mari Serebrov

Of all the U.S. SEC's recent proposed rules to make going, and staying, public more attractive, perhaps the most beneficial for biopharma and med-tech startups is the amendment that would give public companies the flexibility to file semi-annual rather than quarterly reports, Ben Bradford, head of external affairs at Massbio, told

What appears to be a routine item on a routine list of the U.S. Department of Health and Human Services' (HHS) proposed rulemakings for the next fiscal year is being seen as anything but routine, given HHS Secretary Robert Kennedy's stance on vaccines and several commonly used drugs.

A federal jury was wrong when it determined that Astrazeneca plc should pay Wyeth, a Pfizer Inc. unit, $107.5 million in damages for infringing two cancer patents, the U.S. Court of Appeals for the Federal Circuit said in a recent precedential decision.

Edwards Lifesciences Corp. and Genesis Medtech Group Ltd. will pay a total of $12 million in penalties as part of a U.S. FTC settlement resolving allegations that they intentionally structured a deal in which Edwards acquired Genesis' JC Medical to avoid complying with the notification and waiting period requirements of the Hart-Scott-Rodino Act.

The U.S. Court of Appeals for the Seventh Circuit revived Teva Pharmaceuticals USA Inc.'s breach-of-contract suit against Eli Lilly and Co. July 13, as it chided the lower court for dismissing the complaint at the pleadings stage.

More than 52,000 individuals, lawmakers, institutions and other organizations have submitted comments on the White House Office of Management and Budget's (OMB) proposal to revise its Guidance for Federal Financial Assistance, which serves as a government-wide framework for administering grants, cooperative agreements and other forms of assistance.

U.S. Health and Human Services Secretary Robert Kennedy was the 800-pound gorilla that couldn't be ignored as the Senate Health, Education, Labor and Pensions Committee held a joint confirmation hearing July 15 for President Donald Trump's nominees for CDC director and the head of the Administration for Strategic Preparedness and Response.

There have been plenty of complaints about U.S. Health and Human Services Secretary Robert Kennedy interfering with science. Now he's facing allegations of a different kind of interference. Sen. Ron Wyden, D-Ore., the ranking member of the Senate Finance Committee, asked the U.S. Office of Special Counsel to immediately open an investigation into election interference claims against the secretary.

Two med-tech companies agreed to settlements with the U.S. government to resolve False Claims Act (FCA) allegations that they submitted Medicare claims for medically unnecessary testing and devices.

Citing the significant advancements made in lab testing technologies since the Clinical Laboratory Improvement Amendments (CLIA) were enacted nearly 40 years ago, the U.S. CDC and Center for Medicare and Medicaid Services are considering updating the regulations to reflect today's technology.