Royalties for licensed patents ordinarily need not be paid after the underlying patent has expired, but the case of Zimmer Biomet Holdings Inc. v. Insall would seem to throw out a cautionary flag regarding such agreements.
Exthera Medical Corp.’s Oncobind procedure hemoperfusion filter reduced circulating tumor cells in blood samples of patients with pancreatic cancer in a study published in Nature’s BJC Reports. "Researchers observed on average a 94% reduction in circulating tumor cells with a single use of our technology,” Exthera CEO Eric Borger said.
Denver-based Davita Inc. agreed to pay more than $34 million to settle allegations that the company violated the Anti-Kickback Statute (AKS) by not collecting management fees from physicians to induce referrals to the company’s dialysis clinics.
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.
Artiva Biotherapeutics Inc. raised $167 million through an upsized IPO, with funds aimed at the development of its lead AlloNK program for systemic lupus erythematosus and other autoimmune indications. Just a few days ago, the San Diego based company had aimed to sell 8.4 million shares between $14 and $16 each, but it raised the number of shares offered to 13.92 million and lowered the price to $12 each. The upsize brings Artiva’s shares outstanding following the IPO to about 22.8 million, giving the company a market cap of $273.6 million based on the IPO price.
New U.S. SEC rules designed to reel back the special purpose acquisition (SPAC) market went into effect on July 1, yet only a few weeks later two such companies completed IPOs and are now targeting mergers with health care and life sciences firms, including biopharma and medical technology.
The U.S. FDA’s Center for Devices and Radiological Health has rewired its organizational structure on several fronts, including a promotion of its communication function into a “super office,” which the agency said will help it be more agile and responsive to its strategic priorities.
Aussie biotech Alterity Therapeutics Ltd. released interim data of an open-label phase II trial for lead candidate ATH-434 for treating multiple system atrophy that showed 43% of participants improved, with 29% showing either stable or improved neurological symptoms.
The U.S. FDA advised Agenus Inc. to conduct a phase III trial for its immunotherapy combination, botensilimab (bot) and balstilimab (bal), instead of seeking accelerated approval based on phase II data, sending company shares plunging by 58.8% July 18.
The bill the U.S. Senate passed to prune biologic patent thickets could be among the first in a legislative thicket aimed at prescription drug prices to make it through the Senate before the year ends.