The U.S. FDA issued Cytokinetics Inc. a complete response letter (CRL) for omecamtiv mecarbil, branding the clinical evidence behind it as not “persuasive” enough to establish its effectiveness for reducing the risk of heart failure events and cardiovascular death. The company is developing the drug as an add-on therapy for patients with worsening heart failure who remain at high risk for heart failure events and hospitalization.
After a long and bumpy road to approval, Reata Pharmaceuticals Inc. is to roll out the first treatment for Friedreich’s ataxia in the U.S. for patients ages 16 and older after the FDA gave its anti-inflammatory drug, Skyclarys (omaveloxolone), the green light.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Spectrawave, Theranica.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Cstone, Dynavax, Eisai, Incyclix, Jaguar, Laevoroc, Ocugen, Transcode, Verrica, Ymmunobio.
In light of the growing interest in the use of psilocybin, MDMA and other psychedelics in psychotherapy, Health Canada issued a notice spelling out how licensed providers can obtain the drugs through the agency’s special access program on a case-by-case basis.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Elekta, Hyperfine, Milestone Scientific.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amo, Asklepios, Biophytis, Glaukos, Orchard, PDS, Priothera, Replimune, Springworks.
The U.S. FDA announced Feb. 27 that it is aware of data that suggest that the Trifecta surgical aortic valve replacement (SAVR) devices are potentially prone to early structural deterioration that could compromise both valve performance and valve durability.
The European Health Data Space (EHDS) proposal is designed to standardize practices for transmission and other sharing of health information, but this proposal is far from the only significant development coming out of Brussels.
Shares of Reata Pharmaceuticals Inc. tanked unexpectedly Feb. 27, a day before the U.S. FDA is set to make a decision on the NDA seeking approval of once-daily Nrf2 activator omaveloxolone for Friedreich’s ataxia, on reports that Billy Dunn, the director of the FDA’s Office of Neuroscience, was stepping down from his position.
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