U.S. Health and Human Services Secretary Xavier Becerra is getting more pressure to take the unprecedented step of marching in on the patent rights protecting Astellas Pharma Inc.’s prostate cancer drug, Xtandi (enzalutamide), because of its U.S. price. Referencing the provision under the Bayh-Dole Act that allows federal agencies to march in on licensed patents stemming from federally funded research when the products are not available to the public on “reasonable terms,” a dozen Democratic congressional members wrote to Becerra Feb. 8 urging him to move forward on the Xtandi patents.

The Cooper Companies Inc. plans to acquire the entirety of Cook Medical Inc.’s reproductive health business in this fiscal quarter for $675 million at closing plus $200 million paid in four $50 million annual installments. The acquisition will expand Cooper’s presence in the Asia-Pacific region. The Cook deal will also accelerate Cooper’s labor and delivery medical device efforts by adding 115 people sales, marketing, education and support staff globally.

While a number of U.S. cities and towns have been conducting wastewater testing for the SARS-CoV-2 virus for some time, the CDC has finally established a dashboard for reporting the results of this surveillance. While the resulting data may be useful in the current pandemic for allocation of resources, the establishment of a network of wastewater surveillance instruments can also be instrumental in future public health efforts, such as tracking foodborne infections and detecting the emergence of new antibiotic-resistant pathogens.

Witnesses at a Feb. 8 hearing in the U.S. Congress emphasized that the proposed Advanced Research Projects Agency – Health (ARPA-H) must be an independent agency to avoid a crippling case of bureaucratic torpor. However, several members of Congress and one of the witnesses made the case that ARPA-H would increase duplicative taxpayer spending without providing a commensurate increase in productive research in the life sciences, signaling that establishment of this new DARPA-like agency is anything but guaranteed.

Know Labs Inc. has received approval from an independent institutional review board for an internal clinical study of its noninvasive glucose monitoring technology. The aim is to further validate the Bio-RFID (radio frequency identification) platform’s ability to accurately measure and detect changes in blood glucose levels. The study will be conducted at the Seattle-based company’s new research and development laboratory and include 200 subjects.

Johnson & Johnson business Cerenovus Inc. is launching a balloon guide catheter for the U.S. and Canada stroke market. The Irvine, Calif.-based company’s Emboguard device is designed to remove blood clots by controlling blood flow during mechanical thrombectomy procedures. It is the latest addition to the Cerenovus stroke portfolio, which includes the Embotrap III revascularization device, the Prowler EX microcatheter, the Cerenovus large bore catheter and Cerebase guide sheath.

The U.S. House of Representatives passed the COMPETES Act of 2022 in a narrow Feb. 4 vote that may help restore U.S. manufacturing of pharmaceuticals and the semiconductors that are critical for medical devices. However, the House bill also includes unrelated provisions such as a section dealing with health insurance costs, just one of several elements that are not seen in a similar Senate bill and which foreshadow a drag-inducing showdown between the two bills.

The FDA’s device center reported the addition of four device types to the ranks of class II devices, including one each for de novo petitions by Apple Inc., of Cupertino, Calif., and Roche Molecular Systems Inc., of Pleasanton, Calif.