Adhering to the recommendation of a mixed advisory committee vote, the U.S. FDA cleared use of GSK plc’s daprodustat as the first oral hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor for treating anemia in patients with chronic kidney disease (CKD) who are on dialysis. For CKD patients not on dialysis, the agency determined the drug’s safety has not been established. Branded Jesduvroq, daprodustat is cleared specifically for CKD patients who have been receiving dialysis for at least four months.

Now COVA is over, Biophytis vies for a piece of the COVID-19 pie

Biophytis SA’s investigational treatment for hospitalized COVID-19 patients with severe disease, Sarconeos (BIO-101), reduced the risk of respiratory failure or early death by 44% compared to placebo, final data from a phase II/III COVA trial show, but with the disease not being quite the emergency it once was, the drug’s future could be on shaky ground.

Decision of expanding WTO COVID-19 waiver drags on

Any decision on whether to expand a World Trade Organization (WTO) waiver of intellectual property rights for COVID-19 vaccines to diagnostics and therapies likely will be delayed much longer than proponents had hoped. WTO members originally were scheduled to vote on expanding the waiver in December, but the deadline was extended indefinitely when key members, including the U.S., pushed for a delay. At the time, the U.S. Trade Representative asked the U.S. International Trade Commission (USITC) to investigate the market dynamics of COVID-19 diagnostics and drugs “to help inform the discussion.” The USITC said yesterday that it has launched the investigation, but it doesn’t expect to submit its report until Oct. 17.

Bcht Biotech gains China’s first approval for domestic zoster vaccine

Changchun Bcht Biotechnology Co. Ltd has obtained marketing approval for its live attenuated zoster vaccine in China, making it the first approved shingles vaccine developed by a Chinese company. An injectable of 0.5 ml per dose, it is designed for adults ages 40 and older. The company's herpes zoster vaccine covers people aged 40 to 50 years old, which is wider than GSK plc’s Shingrix, according to He Juying, analyst at CSC Financial Co. Ltd. “After the product is commercialized, it is expected to rapidly expand its market share along with imported vaccines.”

Kyocera pulls out of Regeneus deal for stem cell therapy Progenza for osteoarthritis

In a blow to Aussie regenerative medicine company Regeneus Ltd., Japan’s Kyocera Corp. has pulled out of a licensing deal for Regeneus’ lead mesenchymal stem cell (MSC) therapy, Progenza, for osteoarthritis of the knee for the Japan market. Under the terms of the deal, Regeneus, of Sydney, was to receive $19 million in up-front and milestone payments, consisting of $9 million up front and $10 million in regulatory and development milestones. Regeneus would have also received double-digit royalties on sales and retained rights to negotiate licenses with other partners for additional indications inside and outside of Japan. Osteoarthritis of the knee is the first indication for Progenza, an allogeneic off-the-shelf adipose-derived MSC therapy.

Trial data on Atrogi’s new diabetes drug imminent

By next June or July, Swedish firm Atrogi AB expects to have data from a first-in-human phase Ia/Ib trial of its novel beta-2 adrenergic receptor agonist, ATR-258, which is in development for type 2 diabetes. The study has completed single ascending and multiple ascending-dose arms in 52 healthy volunteers and recently started recruiting 24 patients onto the phase Ib portion. Safety is the primary endpoint, and the key secondary endpoint is its pharmacokinetic profile. The one-month treatment period will not be sufficient to show an effect on patients’ glycosylated hemoglobin levels, the gold standard measurement for long-term control of blood glucose. But the company will look at several glucose-related biomarkers and other parameters of glucose homeostasis.

The BioWorld Insider Podcast: Rethinking obesity – Fitness may be more directly linked to health than weight

After many years of research and development, drug-induced weight loss has matured into a viable therapeutic option. But do the drugs directly help people become healthier or is it the weight loss? There are longstanding concerns that the health effects of weight might be overrated. And new studies show fitness improves health outside of weight. So, can a person still be considered healthy despite being over a “normal” weight? How will future medical science consider what is called the obesity epidemic? In this edition of the BioWorld Insider podcast, BioWorld Science Managing Editor Anette Breindl, discusses her new analysis of multiple studies related to weight loss, metabolic health and fitness which in many ways goes against the mainstream health care state of mind about obesity.

Also in the news

Agile, Aqualung, Artiva, Beactica, Cardiff, Cybin, Dragonfly, Edesa, Ellipses, Evelo, Flag, Genoscience, Greenlight, GSK, Immunorizon, Ionis, Karuna, Medigene, Mersana, Mesoblast, Mineralys, ONL, Plus, Prothena, Purple, Ratio, Roche, Roivant, Sobi, Stemson, Taysha Gene Therapies, Tonix, Vera, Vistagen, Vtv, Xortx