Drugs
The House Appropriations Committee 6/4 released FDA’s budget bill for FY 2026 that mirrors the Trump Administration’s budget proposal posted earlier this week (see story). The budget proposal shows that beginning 10/1 the agency’s overall budget would decrease by 4% ($271 million) to $6.8
Drugs
FDA has granted platform technology designation for Sarepta Therapeutics’ rAAVrh74 viral vector used in its investigational SRP-9003 (bidridistrogene xeboparvovec) to treat limb-girdle muscular dystrophy type 2E/R4. A company statement says it is one of the first programs to receive the FDA designation. To be eligible for the
Drugs
FDA has released a draft guidance entitled “Hernia Mesh — Package Labeling Recommendations.” The recommendations are being issued to address “suboptimal device selection associated with these devices has resulted in serious adverse events, including deaths,” the guidance says. They are intended to supplement labeling recommendations in Section XI of the agency’
Drugs
All drug labeling has been updated to be more useful for pregnant women, according to CDER acting director Jacqueline Corrigan-Curay. The changes had been sought by Sens. Maggie Hassan (D-NH) and Ted Budd (R-NC). A statement issued by Hassan says that although the labeling system was replaced
Drugs
In a 6/5 petition, California, Massachusetts, New Jersey, and New York are asking FDA to remove the current shared risk evaluation and mitigation strategy (REMS) program for the abortion drug mifepristone (Mifeprex and its generics) in their states. The petition says it was submitted in response to HHS secretary
Drugs
An 8/26-8/30/2024 FDA inspection at the Huangshi Hygienic Material Medicine Co. in Huangshi Shi Hubei Sheng, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 3/24 Warning Letter says the specific violations were: * failure to have for
Drugs
Vigil Neuroscience says it is discontinuing its Phase 2 long-term extension study of investigational therapy iluzanebart based on disappointing results in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), a rare and fatal neurodegenerative disease. The company’s IGNITE trial, an open-label study evaluating
Drugs
FDA has released a draft guidance entitled “Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter (OTC) Monograph Drugs.” The document provides recommendations for how requestors can comply with the requirements described in a
Drugs
A 1/9-1/15 FDA inspection at Evi Labs in Medley, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 5/14 Warning Letter says the specific violations were: * failure to have for each batch of drug product appropriate laboratory determination of satisfactory
Drugs
Two former FDA officials are part of a group of seven former HHS employees who have filed a class-action wrongful termination lawsuit alleging the federal government knowingly used flawed and inaccurate personnel records during a controversial reduction-in-force (RIF) mass termination effort back in April. Former FDA chief
Drugs
FDA commissioner Martin Makary says the agency will conduct a review of the abortion drug mifepristone. Makary included the pledge in a 6/2 letter to Sen. Josh Hawley (R-MO), according to an online National Review story. Makary declined to comment further to the newsletter due to ongoing litigation
Drugs
An 8/26-9/6/2024 FDA inspection at the Rechon Life Sciences drug manufacturing facility in Skane Lan, Sweden, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/30 Warning Letter says the specific violations were: * failure to establish and follow
Drugs
An FDA review of records submitted by Zhejiang Easyclean Daily Chemical Co., Ltd. in Hangzhou, China, in response to a 3/11/2024 agency request, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 5/14 Warning Letter says the specific violations were: * failure to
Drugs
FDA has approved a Bayer Healthcare Pharmaceuticals supplemental NDA for Nubega (darolutamide) for metastatic castration-sensitive prostate cancer (mCSPC). The drug was previously approved in combination with docetaxel for mCSPC. Approval was based on data from the ARANOTE (NCT02799602) trial in 669 patients with mCSPC. Patients received either darolutamide or
Drugs
FDA has accepted for priority review a Kura Oncology NDA for ziftomenib, a potential new treatment for adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring nucleophosmin 1 (NPM1) mutations. Ziftomenib is described as an investigational oral menin inhibitor, and it is the only therapy of its kind
Drugs
FDA deputy commissioner for strategic initiatives Lowell M. Zeta, who joined the agency’s leadership team in April, has now been given a second role — Special Counsel for FDA in the Office of the Chief Counsel (OCC). “In this dual role, Mr. Zeta provides legal and strategic counsel to the
Drugs
Congressman Jason Crow (D-CO) is leading a bipartisan group of lawmakers in a push to significantly expand federal funding for Amyotrophic Lateral Sclerosis (ALS) research in the upcoming 2026 fiscal year budget. The move aims to accelerate efforts on effective treatments and a cure for the neurodegenerative disease. In
Drugs
A new combination therapy involving AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) and pertuzumab (Genentech’s Perjeta) has significantly extended progression-free survival for patients with HER2-positive metastatic breast cancer, according to results from the Phase 3 DESTINY-Breast09 trial presented 5/31 at the American Society of
Drugs
A federal appeals court has upheld a freeze on layoffs across FDA and other major federal agencies, rejecting an effort by the Trump administration to lift the ban and likely setting the stage for a Supreme Court review. The court sided with a coalition of unions, advocacy groups, and municipalities
Drugs
FDA is making available a draft guidance entitled “M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver.” The International Council for Harmonization (ICH) document is the second in the ICH M13 series and describes the scientific and technical aspects of study design and data analysis to support
Drugs
FDA has issued Aurolife an 11-item Form FDA-483 following a 3/24-4/10 inspection at its Durham, NC manufacturing facility that cited significant GMP deficiencies. For example, FDA took issue with the responsibilities and procedures applicable to the quality control unit, which are not in writing or
Drugs
Advocacy group Public Citizen has petitioned FDA to take immediate action to protect unborn children from potential harm caused by the popular wakefulness-promoting drugs Provigil (modafinil) and Nuvigil (armodafinil). The petition urges FDA to contraindicate the use of these drugs, which are made by Apotex, and any approved generics