Devices
FDA's recent Warning Letter to O.N. Diagnostics raises questions about whether the agency is applying an overly expansive interpretation of when software modifications require a new 510(k), according to a new legal analysis. In a 10/26 FDA Law Blog article, attorney Jennifer Newberger examines the
Biologics
FDA has approved AbbVie’s subcutaneous (SC) induction regimen for Skyrizi (risankizumab-rzaa) for adults with moderately to severely active Crohn's disease (CD). “Patients now have the option to start SKYRIZI treatment at home, with induction doses delivered by an on-body injector (OBI) induction pack and then
Drugs
BreakBio, a biotechnology company developing personalized cancer immunotherapies, has appointed former FDA Commissioner Stephen M. Hahn, who led the agency from 12/2019 to 1/2021 during the first Trump Administration, as an advisor. The company says Hahn will advise BreakBio on clinical development, regulatory strategy, oncology, platform development and
enforcement
FDA has accelerated the public release of Form FDA-483 inspection records as part of its expanded transparency initiative (see earlier story), increasing the volume of inspection documents available through the agency's FOIA Electronic Reading Room. On 10/23, the agency published 26 Form FDA-483 records covering
Drugs
A citizen petition filed by Foley & Lardner urges FDA to require mandatory monthly immunoglobulin monitoring and explicit treatment-interruption instructions in the prescribing information for Vertex Pharmaceuticals' investigational IgA nephropathy treatment povetacicept, ahead of an 11/30 user fee review action target date. The 10/21 petition contends
Biologics
Bristol Myers Squibb reported preliminary safety and efficacy data from a Phase 1 study of its investigational CAR T-cell therapy zolacabtagene autoleucel (zola-cel; BMS-986353) in patients with multiple sclerosis, but disclosed that one trial participant died of septic pneumonia 44 days after receiving treatment. The death reportedly
Biologics
If vaccine advocates gain substantial support in Congress following next month’s midterm elections, the Trump administration could still accelerate changes to federal vaccine policies in 2027, potentially limiting the effectiveness of congressional oversight, two former federal health policy officials warn. In a 10/20 MedPage Today commentary, Steven Grossman,
Drugs
An FDA analysis of digital health technology (DHT) use in drug development found that electronic diaries and patient-reported outcomes accounted for the largest share of qualifying regulatory submissions, while sensor-based technologies were concentrated in a relatively small number of therapeutic areas. The study, published in Clinical and Translational
enforcement
Texas has negotiated a $45 million settlement with Gilead Sciences to resolve claims that the company engaged in an illegal kickback scheme that improperly influenced prescriptions paid for by Texas Medicaid. The settlement follows a 10/2023 state lawsuit alleging that Gilead engaged in “unlawful marketing practices that were designed
Biologics
Merck and Moderna are reporting positive recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) results from a highly anticipated Phase 3 trial evaluating their personalized cancer vaccine, intismeran autogene, in combination with Keytruda (pembrolizumab). The Phase 3 INTerpath-001 trial is evaluating intismeran autogene, an investigational mRNA-based
FDA Policy/General
FDA's expanding transparency initiative could significantly change how pharmaceutical and biotechnology companies evaluate potential acquisitions, giving buyers greater access to regulatory information that could influence asset valuations, purchase agreements and the allocation of financial risk, according to attorneys at Arnall Golden Gregory (AGG). Earlier this month, FDA unveiled
Drugs
BDR Pharmaceuticals International has filed a lawsuit against FDA, alleging the agency unlawfully extended market exclusivity for Phathom Pharmaceuticals’ acid-suppressing drug Voquezna (vonoprazan), preventing BDR from submitting an ANDA for a generic version until 5/2032. In a 10/21 complaint filed in the U.S. District Court for
FDA Policy/General
The Partnership for Safe Medicines (PSM) has filed a citizen petition urging FDA to ban compounding of unapproved peptides and to disregard the advisory committee vote that recommended allowing them. The advocacy group contends the committee was constituted in violation of the Federal Advisory Committee Act and the Ethics in
enforcement
A new analysis by Hogan Lovells finds CDER enforcement activities are “substantially larger, broader in scope, and more centralized than they were two years ago. Moreover, the composition of enforcement activity has shifted in ways that should prompt pharmaceutical manufacturers to reassess their compliance risks.” Examining CDER Office of Compliance’
Devices
FDA is alerting health care providers about an import alert for certain Olympus Medical Systems medical devices manufactured in Japan. “Despite extensive and ongoing efforts to address compliance issues, the FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus,” the agency says. “Therefore, the FDA
Drugs
FDA granted traditional approval to Merck’s Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) for certain patients with unresectable or metastatic tumor mutational burden-high (TMB-H) solid tumors, while raising the biomarker threshold used to determine eligibility for treatment. The approval covers adult and pediatric patients
Drugs
Bipartisan legislation intended to accelerate the development of rare disease treatments by making clinical trials faster, cheaper, and more accessible to patients was to be introduced in the House on 10/22 by Reps. Jake Auchincloss (D-MA) and Morgan Griffith (R-VA). CNBC Cures reports that the Faster Clinical
enforcement
FDA has released the 27-page Form FDA-483 with six observations from a 5/4-5/15 inspection at the Mylan Laboratories drug manufacturing facility in Maharashtra, India. The inspection observations were: * failure to fully follow the responsibilities and procedures applicable to the quality control unit; * failure to exercise
Drugs
The Association for Accessible Medicines (AAM), which represents America’s generic and biosimilar drug sector, says it “strongly supports” the proposed GDUFA 4 commitment letter outlining the agreement negotiated between FDA and the industry. “GDUFA has played an essential role in strengthening the generic drug review process, helping to ensure
Drugs
The U.S. Justice Department says Jeffrey McIndoo (Phoenix, AZ) and his company, JeffMac Investments LLC doing business as SARMS Pharm LLC , were sentenced following prior guilty pleas over the alleged illicit sale of potentially dangerous chemical substances known as selective androgen receptor modulators (SARMs). SARMS mimic the effects of
Drugs
Three Democratic senators are turning up the heat on FDA to explain its response to widespread shortages of estradiol transdermal patches used to treat menopause symptoms, questioning why the agency has not formally declared a shortage and demanding details about plans to expand manufacturing capacity. Last month, FDA said it
FDA Policy/General
FDA has launched a new cross-center program to advance medical product development for neurological and psychiatric conditions, with an initial initiative focused on improving clinical trial approaches for preventing or delaying Alzheimer's disease. The Neuroscience Advancement and Innovation Nexus (NAIN) it intended to coordinate scientific and regulatory