The U.S. FDA recently cleared two new medical devices to treat benign prostatic hyperplasia, offering men with enlarged prostates additional treatment options which are minimally invasive. The approvals include Proverum Medical Ltd.’s Provee System and Zenflow Inc.’s Zenflow Spring Implant and Delivery System, both are first-line interventional therapeutic options which offer relief to the millions of men living with the condition.
Two new therapies are now FDA approved to treat the sexually transmitted infection gonorrhea, with Innoviva Inc.’s Nuzolvence (zoliflodacin) and GSK plc’s Blujepa (gepotidacin) offering additional antibiotic options comparable to standard of care. Both products had fast track, qualified infectious disease product and priority review designations.
Restricting the recommended use of COVID-19 vaccines in the U.S. wasn’t enough. Now the Children’s Health Defense (CHD) is trying to get the FDA to revoke the BLAs for all versions of the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 vaccines.
The U.S. FTC is taking a bow after Teva Pharmaceutical Industries Ltd. asked the FDA to remove more than 200 patent listings from the agency’s Orange Book.
Formation Bio Inc. acquired ex-China rights to Lynk Pharmaceuticals Co. Ltd.’s oral TYK2-inhibitor, LNK-01006, for up to $605 million. The phase I-ready central nervous system (CNS) candidate will be developed at Formation’s newly formed subsidiary, Bleecker Bio.
D3 Bio Inc. secured $108 million in a series B financing round Dec. 9 to support its planned phase III program of lead oral KRAS G12C inhibitor, elisrasib (D3S-001).
As the systematic dismantling of the U.S. vaccine schedule escalates, the demands to hold Health and Human Services Secretary Robert Kennedy accountable are growing. Claiming that Kennedy has turned his back on science and is endangering public health, Rep. Haley Stevens, D-Mich., formally introduced articles of impeachment against him Dec. 10 for “high crimes and misdemeanors.” Under the Constitution, federal officials can only be impeached for treason, bribery and “other high crimes and misdemeanors.”
Management is beaming with delight at Heartbeam Inc. as the company's appeal strategy paid off with U.S. FDA clearance for its synthetic 12-lead electrocardiogram software for the assessment of arrhythmias. In November, the Santa Clara, Calif.-based company received a Not Substantially Equivalent determination from the agency on its 510(k) application, which could have substantially delayed commercialization. Following a plan disclosed Nov. 28, the company resolved the agency's issues through an appeal process and active engagement and obtained clearance much more quickly than expected.
Ideaya Biosciences Inc. has submitted an IND application to the FDA for IDE-574, a KAT6/7 dual inhibitor with potential to treat hormone receptor-positive breast cancer and lung adenocarcinoma. A phase I trial of IDE-574 monotherapy is expected to begin in the first quarter of next year.
While the U.S. Congress has yet to address the artificial line it created between biosimilars and interchangeables when it passed the Biologics Price Competition and Innovation Act in 2010, the FDA is erasing that distinction for all practical purposes.
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