Opinion on Wall Street said the matter could have gone either way, but in the end Akebia Therapeutics Inc.’s vadadustat, a HIF prolyl-hydroxylase inhibitor for anemia caused by chronic kidney disease (CKD), garnered a complete response letter (CRL) instead of approval from the FDA. The news slammed Akebia shares (NASDAQ:AKBA), which closed at 82 cents, down $1.61, or 66%. Specifically, the agency said that the data in the NDA do not support a favorable benefit-risk assessment of vadadustat in dialysis-dependent (DD) and non-DDs patients.

Researchers at the University of Minnesota have identified a nonhormonal form of contraception for males, which left male mice temporarily sterile after a few weeks of administration.

Researchers at the University of Queensland have found a genetic link between endometriosis and ovarian cancer subtypes, enabling them to identify potential drug targets for therapy and increasing the understanding of both diseases.

A team of researchers at Tokyo Metropolitan University have discovered that osmolytes such as mannitol, which are used to treat increased intraocular or intracranial pressure, can cause kidney damage by inducing hyperosmotic stress that leads to epithelial-mesenchymal transition (EMT) of the tubular epithelial cells.

TORONTO – Hyivy Health Inc. has secured CA$1.1 million (US$888,000) in pre-seed funding to manufacture, test and obtain medical device approval for a women’s pelvic rehabilitation platform and to explore its use for relieving pelvic pain during clinical trials this summer.

A panel of leaders in women’s health at the 2022 edition of the J.P. Morgan Healthcare Conference addressed the challenges and benefits of digital health and new apps in enabling women to be the “chief medical officers” of their families’ health and to take the necessary steps to improve their own. The panel included moderator Lynne Chou O’Keefe, founder and managing partner of Define Ventures; Apple Inc.’s Vice President of Health Sumbul Ahmad Desai; Veronica Gillispie-Bell, assistant professor, Ochsner Health System; Found CEO Sarah Jones Simmer; Michelle Williams, dean of faculty at the Harvard T.H. Chan School of Public Health; and Tia Inc. CEO and co-founder Carolyn Witte.

The FDA has delivered on a final guidance for non-clinical and clinical investigations of devices used for treatment of benign prostatic hyperplasia (BPH), needing only a year and a half to convert the draft guidance into a final version. The final guidance retains the draft’s recommendation that pivotal studies follow patients for at least a year, a provision some in the med-tech industry saw as unnecessary in some instances. The scope of the July 2020 draft included non-clinical testing, a novelty compared to previous guidance on the topic. The scope of this latest guidance includes four product codes, including KNS for endoscopic electrosurgical instruments, and the FDA included several specific suggestions for the use of thermotherapy and permanent prostatic stents as treatments for BPH.

PERTH, Australia – In the second multi-billion-dollar pharma merger this week, CSL Ltd. has announced plans to buy Vifor Pharma Ltd. for an equity value of $11.7 billion. It’s also the second largest biopharma merger of 2021, a whisker above Merck & Co Inc.’s $11.5 billion acquisition of Acceleron Pharma Inc. in November, although way off Astrazeneca plc’s $39 billion buy of Alexion Pharmaceuticals Inc. in July.