Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Alvotech, Ascendis, Astrazeneca, Avstera, Eagle, Ensysce, Gmax, Immune Bio, Merck & Co., Nuance, Oncopeptides, Protalix, UCB.
Patients with ophthalmic disease use eyedrop containers and eyecups millions of times a year, but these two devices have been treated as one device type and informally regulated as class II devices up to now. A U.S. FDA advisory committee recommended a class I designation for these products, which will relieve some of the burden on manufacturers, but the panel also endorsed that these two types of products be split into two separate product codes, which would greatly facilitate adverse event reporting.
Ardelyx Inc. could have a rocky row to hoe when it makes its case for tenapanor, as a hyperphosphatemia therapy in adults with chronic kidney disease, before the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee Nov. 16. The big question facing the adcom is whether the change in baseline serum phosphorous levels achieved by the drug is clinically meaningful. Clearly, FDA reviewers don’t think so, as that question already has resulted in delayed PDUFA dates, a complete response letter and two formal dispute resolution requests.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Perkinelmer, Xironetic.
The U.S. FDA has wrapped up its guidance effort to deal with counterfeit devices, an effort that consumed roughly 11 months. That span of time had little discernible effect on the draft, however, as the final guidance seems to leave the draft’s explanation that future FDA guidances may refer to more than one section of the statute in references to the definition of a device.
GSK plc said it will restrict the second-line maintenance indication for ovarian cancer drug Zejula (niraparib) to only patients with deleterious or suspected germline BRCA mutations, at the request of the FDA, in a sign that U.S. regulators aren’t going to relax scrutiny on PARP inhibitors any time soon.
With labeling discussions begun for TG Therapeutics Inc.’s ublituximab to treat relapsing multiple sclerosis, Wall Street was optimistic about the PDUFA date of Dec. 28 assigned to the glycoengineered CD20 monoclonal antibody. Shares of New York-based TG (NASDAQ:TGTX) closed Nov. 11 at $9.34, up 91 cents, or 10.8%, having risen more than 52% over the previous five days. With late-cycle review talks with the U.S. FDA done, ublituximab seemed well on its way.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogx, Novocure, Trireme Medical.
Acting on its new promise to restore “rigorous enforcement” of the U.S. ban on unfair methods of competition, the FTC filed an amicus brief Nov. 10 supporting Avadel CNS Pharmaceuticals LLC’s motion to delist a Jazz Pharmaceuticals Inc. patent from the FDA’s Orange Book.
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