FDA Policy/General
Protagonist Therapeutics and Takeda are announcing “positive topline results” for the Phase 3 VERIFY study, in which phlebotomy-dependent patients with polycythemia vera (PV) received rusfertide or placebo as an add-on to standard of care treatment. The study met its primary endpoint and all four key secondary endpoints, according
Drugs
Lexicon Pharmaceuticals says it will advance pain drug pilavapadin 10mg into a planned Phase 3 trial based on just-announced Phase 2 PROGRESS study results. The oral, non-opioid investigational adaptor-associated kinase 1 inhibitor is being evaluated in adult patients with moderate to severe diabetic peripheral neuropathic pain. “In
EIRs/483s
PharmaTher Holdings says it has resubmitted its NDA for Ketarx (ketamine) to address “minor” deficiencies cited in a 10/22/2024 complete response letter (see earlier story). The submission is seeking the drug’s use in anesthesia, sedation, pain, mental health, neurological, and medical countermeasures indications. The company says it
Devices
Boston Scientific is recalling (Class 1) its Accolade pacemakers and Visionist and Valitude cardiac resynchronization therapy pacemakers because of the possibility for them to enter “Safety Mode” during remote data collection (telemetry). “If the device enters Safety Mode, early device replacement is needed,” a recall notice says. “Once a device
Devices
Philips is recalling (Class 1) its Tack Endovascular Systems due to customer complaints, including events where additional interventions were required to retrieve or remove the implant. A recall notice recommends that customers should stop using the device immediately. Philips says it will no longer distribute the system for use. “The
Biologics
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should make sure its recent draft guidance entitled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices” aligns with other relevant guidances developed by the Internation Conference on Harmonization. Specifically, PhRMA says the protocol deviations guidance should align with
Devices
Olympus is recalling certain models of its endoscope single use guide sheath kits after receiving complaints about the radiopaque tip falling off into patients. “Olympus’s preliminary findings show that the tip detaches from the guide sheath when excessive force is applied as instruments are inserted into the guide sheath,
Drugs
FDA says it has ordered testosterone product makers to change their drug labeling to remove a warning about risk of adverse cardiovascular outcomes in men using them for hypogonadism. An agency notice says the warning can be removed based on findings from the Testosterone Replacement Therapy for Assessment of Long-
FDA Policy/General
With a potential government shutdown looming in two weeks, FDA’s ability to use its user fee carryover balances to fund product review operations during a shutdown may be unlikely because the agency is further along in the fiscal year and those balances are likely depleted, according to BrownStein lawyers
Biologics
FDA has approved an ALK supplemental BLA for Odactra (house dust mite allergen tablet) to expand its use for treating house dust mite-induced allergic rhinitis, with or without conjunctivitis, to now include children ages five through 11 years. Previously, the product was approved for use in patients aged 12
Drugs
Zevra Therapeutics says it has signed an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million. The proceeds are intended to support the commercial launches of Miplyffa And Olpruva, and “advancing our pipeline of product candidates to address unmet needs within the rare disease community,
Devices
ROi CPS is recalling (Class 1) its newborn kits after receiving an Urgent Field Safety Notice for a kit component from supplier Mercury Medical. The component is Mercury’s Neo-Tee T-Piece resuscitator, which is being removed due to an undersized spring in the controller that may prevent the
Drugs
Praxis Precision Medicines says it will continue a clinical trial despite an interim analysis that recommended Study 1 of the Essential3 program evaluating ulixacaltamide in essential tremor be stopped for futility because it is unlikely to meet the primary efficacy endpoint under the parameters set by its statistical model. An
Devices
Reps. Brad Finstad (R-MN) and Dan Crenshaw (R-TX) have introduced the Freedom for Laboratory Innovation and Testing Act to block FDA from regulating laboratory-developed tests (LDTs). The representatives also wrote to HHS secretary Robert Kennedy asking that he revoke the FDA rule that was adopted during the
Drugs
FDA has sent a Warning Letter to Granules about its finished dosages and pharmaceutical formulation intermediates manufacturing facility in Gagillapur, near Hyderabad, India. The Hindu reports that the Warning Letter follows an 8/29-9/6/2024 agency inspection that resulted in six observations on a form FDA-483. The
Devices
Ventec Life Systems has recalled (Class 1) its VOCSN Multi-Function Ventilators because the devices were serviced using incorrect parts which have the potential to cause unexpected shutdown. A recall notice says that using an active circuit with the device could result in inaccurate tidal volume monitor, less inspiratory volume,
Drugs
The Senate Health Education Labor & Pensions committee has announced a 3/6 confirmation hearing to review the nomination of Johns Hopkins surgeon and public policy researcher Marty Makary (see earlier story) as the next FDA commissioner. Makary was selected to correct FDA’s course, according to president Trump, who
Drugs
FDA has released the form FDA-483 issued following an 11/12-11/20/2024 inspection at the Zhejiang Huahai Pharmaceutical Co. active pharmaceutical ingredient (API) manufacturing facility in Linhai, Taizhou Zhejiang, China. The seven inspection observations were: * failure of laboratory records to include complete test data derived from all
Biologics
In a move suggestive of HHS secretary and vaccine skeptic Robert F. Kennedy Jr.’s interference in FDA regulatory activities involving vaccines, the agency 2/26 abruptly canceled a 3/13-planned Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting that would otherwise select the strains and the composition
Drugs
FDA has granted fast-track designation for Adicet Bio’s ADI-001 for the potential treatment of adults with systemic sclerosis. ADT-001 is described as an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T-cell therapy targeting CD20 to treat autoimmune diseases. FDA has granted it fast-track
Drugs
FDA has released the 19-page form FDA-483 issued following an 11/4-11/15/2024 inspection at Exela Pharma Sciences, a Lenoir, NC, outsourcing and sterile drug manufacturing facility. The form’s 15 inspection observations were: * failure of written records of investigations into unexplained discrepancies to always include
Drugs
FDA has cleared a Visby Medical 510(k) for its point-of-care respiratory health test. The Visby Medical Respiratory Health Test is described as a rapid polymerase chain reaction test that detects and differentiates between upper respiratory infections caused by influenza A & B, and SARS-CoV-2 (Covid-