The beleaguered PI3K-delta inhibitor space took another blow after MEI Pharma Inc. and partner Kyowa Kirin Co. Ltd. said the U.S. FDA won’t greenlight zandelisib without data from a randomized study. The firms had hoped to win accelerated approval in relapsed/refractory follicular lymphoma and marginal zone lymphoma based on a single-arm phase II study called Tidal.
Innovent Biologics Co. Ltd. and Eli Lilly and Co. are "assessing next steps" for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from the U.S. FDA. The pair sought approval of a BLA for sintilimab plus pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small-cell lung cancer (NSCLC) but found near-unanimous opposition from FDA advisers dissatisfied with China-only trial data submitted in support of the application. The medicine is already approved for multiple indications in China, where it’s marketed as Tyvyt.
The U.S. FDA has approved Novartis AG’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan, formerly referred to as 177Lu-PSMA-617) for treating adults with metastatic prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. The treatment is the indication’s first FDA-approved targeted radioligand therapy that contains a radioisotope.
Citing a court order for its haste, the U.S. FDA skipped the draft and went straight to issuing a final guidance that will change how certain ophthalmic drugs are regulated.
As congressional scrutiny of the U.S. FDA’s accelerated approval path continues, the agency is focusing research efforts into appropriate disclosure on direct-to-consumer websites about a drug’s accelerated approval and the status of confirmatory trials. Previous research by the FDA’s Office of Prescription Drug Promotion (OPDP) found that 27% of DTC websites providing information about a drug with accelerated approval don’t disclose that the products are on the market through accelerated approval.
Much of the question of FDA regulation of artificial intelligence (AI) and machine learning (ML) is seen as revolving around changes to the statute, but that does not mean the FDA and other agencies are in wait-and-see mode. Representatives of both the FDA and Health Canada said on a March 22 webinar that guidances related to these algorithms will be posted later this year, thus opening the door to a more predictable premarket path for these products.
Murrysville, Pa.-based Philips Respironics Inc. has had its share of troubles with its devices for respiratory use, including several CPAP machines. The FDA reported March 21 that the company’s V60 and V60 Plus respirators are now the subjects of a class I recall due to the use of an expired adhesive that could ultimately lead to a shut-down of the devices, including instances in which the shut-down would not be accompanied by an alarm.
Citing a court order for its haste, the U.S. FDA skipped the draft and went straight to issuing a final guidance that will change how certain ophthalmic drugs are regulated.
The U.S. biosimilar review process seems to be hitting its stride, with the FDA approving, in the first cycle, 67%, or 14, of the 21 biosimilar applications filed and acted upon in the first four years of BsUFA II.
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