Drugs
Twenty-five bipartisan House representatives are urging FDA to create patient-centered policies on compounded hormones that maintain patients’ access to care and treatment options. In a 6/20 letter to FDA commissioner Robert Califf, the lawmakers said they were concerned that recommendations in a 2020 National Academies of Sciences,
Drugs
FDA has launched a voluntary pilot program to help cut risks in using laboratory-developed tests (LDTs) to identify cancer biomarkers. An online statement says the agency has become increasingly concerned that some tests made by laboratories and not authorized by FDA may not provide accurate and reliable test results
Drugs
FDA has issued F2G Ltd. a complete response letter on its NDA for olorofim, an antifungal for invasive fungal infections in patients who have limited or no treatment options. The letter requested additional data and analyses before it can approve the submission, according to the company. “The FDA encouraged the
Drugs
FDA has placed a clinical hold on Arcellx’s CART-ddBCMA, an investigational drug for treating patients with relapsed or refractory multiple myeloma, following a recent patient death. The company believes “limitations on bridging therapy are a contributing factor and is working with FDA to amend the protocol to expand
Drugs
University of Pennsylvania Perelman School of Medicine professor of medicine, medical ethics and health policy, and neurology Jason Karlawish says FDA should require a Risk Evaluation and Mitigation Strategy (REMS) for new Alzheimer’s disease drugs to mitigate the concern of Alzheimer’s clinicians that some patients will be needlessly
Drugs
FDA has granted in part and denied in part a 10/17/2012 Boehringer Ingelheim (BI) petition asking that the agency adopt certain requirements for proposed generic and follow-on versions of Boehringer’s Spiriva Handihaler or any other BI orally inhaled product containing the active ingredient tiotropium bromide. The
Drugs
The International Council for Harmonization (ICH) Assembly approved three new topics for harmonization at its 6/12-6/13 meeting in Vancouver, Canada. The topics are general considerations for patient preference studies, nonclinical safety studies for oligonucleotide-based therapeutics, and bioequivalence for modified-release products. An ICH statement says the
Drugs
FDA has extended by three months an ARS Pharmaceuticals NDA for neffy (intranasal epinephrine) for treating allergic reactions (Type 1), including anaphylaxis, for adults and children. The revised user fee review action target date is 9/19. Shortly after a favorable 5/11 vote (see story) by FDA’s Pulmonary-
Drugs
FDA says the number of surveillance inspections of human drug manufacturing sites tripled from FY 2021 to FY 2022. The agency’s FY 2022 Report on the State of Pharmaceutical Quality says CDER’s site catalog lists over 4,800 manufacturing sites, with over 40% in the U.S. While
Drugs
Senators Gary Peters (D-MI) and Joni Ernst (R-IA) have introduced bipartisan legislation to ensure the government is better prepared to address the national security threat posed by overreliance on foreign sources for critical medications. The legislation responds to two reports released by Peters in 2019 and2023 that identified
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FDA has approved a Pfizer NDA for Talzenna (talazoparib) with Astellas’ Xtandi (enzalutamide) for treating homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). Approval was based on data from the TALAPRO-2 (NCT03395197) 399-patient study whose major efficacy outcome measure was radiographic progression-free survival
Drugs
FDA has approved a Bristol Myers Squibb supplemental NDA to add positive data from its Phase 3 VALOR-HCM study to the U.S. prescribing information for Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules). Data added to the label showed that Camzyos significantly reduced the
Drugs
The Harvard Drug Group is recalling a single lot of dronabinol capsules (2.5 mg) and ziprasidone hydrochloride capsules (20 mg) after receiving a customer complaint from a distributor suggesting that some unit dose cartons labeled as ziprasidone were found to contain blister packages labeled as and containing dronabinol. Patients
Drugs
FDA has extended by three months its review of a GSK NDA for momelotinib, indicated for treating myelofibrosis patients with anemia, to allow more time to review recently submitted data. The revised user fee review action target date is 9/16. GSK says momelotinib has a novel mechanism of action,
Drugs
A just-posted, four-item Form FDA-483 provides more detail on medical device reporting (MDR) and other violations cited in a 2022 inspection of iRhythm’s Cypress, CA manufacturing facility that led to a recent Warning Letter on its ZIO AT arrhythmia monitoring system. The inspection form cited the
Drugs
Eli Lilly says a head-to-head clinical trial comparing its migraine drug Emgality (galcanezumab-gnlm) to Pfizer’s Nurtec ODT (Rimegepant) did not meet the primary endpoint — Emgality’s statistical superiority to Nurtec. Lilly says the drugs’ response rates were similar, but Emgality “performed numerically better on key secondary
Drugs
Reps. Adam Schiff (D-CA) and Ann McLane Kuster (D-NH) have introduced the Updated Drug Labeling for Patient Safety Act to ensure that patients are made aware of all potential risks and side effects of prescription drugs, including generics. In a statement (includes a link to the bill text)
Drugs
Researchers from FDA, PharmaLex, and Quinten Health say there remain challenges to address before artificial intelligence/machine learning (AI/ML) has an increased impact on precision medicine. Writing in Therapeutic Innovation & Regulatory Science, the researchers summarize the topics discussed at a 2022 panel of FDA and industry experts about
Drugs
Corvus Pharmaceuticals says it plans to meet with FDA officials in the third quarter to discuss a potential registration Phase 3 trial of its CPI-818 ITK inhibitor in T cell lymphoma. In a statement announcing updated CPI-818 Phase 1/1b results, the company says it is beginning to
Drugs
Harvard Medical School professor Jerry Avorn says the current FDA drug approval process under which a drug either gets full approval or is rejected should be changed. Writing in a Washington Post opinion piece, Avorn says that under the “pass-fail” system, a drug that FDA disapproves remains mostly unavailable,
Drugs
FDA has cleared the addition of a protocol amendment to the Phase 3 trial of GlycoMimetics’ uproleselan for relapsed/refractory acute myeloid leukemia. The company says the amendment will allow a time-based analysis of the overall survival primary endpoint to be conducted following a defined cutoff date if the
Drugs
FDA has issued a partial clinical hold against Mersana Therapeutics’ clinical trials of UpRi (upifitamab rilsodotin) in platinum-sensitive ovarian cancer after the company submitted a safety report that evaluated bleeding events. The hold affects the UP-NEXT and UPGRADE-A clinical trials, and patients who are already enrolled may