Drugs
Washington attorney general Bob Ferguson and Oregon attorney general Ellen Rosenblum are leading a multistate lawsuit against FDA accusing it of singling out one (mifepristone) of the two drugs used for medication abortions through “excessively burdensome regulation, despite ample evidence that the drug is safer than Tylenol,” the officials announced
Drugs
FDA has released a draft guidance entitled “Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment.” The document provides recommendations to sponsors regarding eligibility criteria, trial design considerations, and efficacy endpoints to enhance clinical trial data quality and improve efficiencies in drug development programs. The guidance recommends a parallel-group,
Drugs
A letter from six House Democrats urges FDA to do more to help resolve the ongoing shortage of pediatric ibuprofen and acetaminophen. Over the past six months, an increase in demand has been attributed to recent surges in Covid-19, respiratory syncytial virus and influenza, any of which can cause
Drugs
CDER has named Office of Compliance deputy director Jill Furman as permanent director after serving as acting director since previous head Don Ashley retired in November. Furman joined CDER in 2020 and has provided “strategic direction for risk-based decision-making in a broad range of critical areas, such as
Drugs
Octapharma USA has submitted an sBLA to FDA to expand the approval of Wilate (von Willebrand factor/coagulation factor VIII complex [human] lyophilized powder for solution for intravenous injection) to reduce the frequency of bleeding episodes in children and adults with any type of von Willebrand disease (VWD). The company
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Pharmaceutical Research and Manufacturers of America (PhRMA) says it is generally supportive of the International Council for Harmonization/FDA M11 Clinical Electronic Structured Harmonized Protocol with the M11 template and technical specification. The association's comment letter says it believes the documents provide “important standards for the content, format,
Drugs
The Centers for Medicare & Medicaid Services (CMS) says it is not reconsidering its national coverage determination (NCD) that restricts Medicare coverage on Alzheimer’s monoclonal antibodies approved under FDA’s accelerated approval pathway. CMS reiterated its position in response to an Alzheimer’s Association request for reconsideration. Currently, FDA
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University of Pennsylvania Perelman School of Medicines and Flatiron Health researchers say that given an increasing withdrawal of accelerated approval (AA) cancer drugs due to negative confirmatory trials and emerging evidence on the high spending associated with AA drugs, it is “critical to balance early access against population-level exposure
Drugs
A new study in JAMA that looked at ivermectin as a therapy for treating adult outpatients with mild to moderate Covid-19 finds that the drug’s use is not supported. The study by researchers from Duke, Vanderbilt, and Johns Hopkins, among numerous other institutions, involved 1,200 patients and
Drugs
Sens. Elizabeth Warren (D-MA) and Bernie Sanders (I-VT) and Reps. Pramila Jayapal (D-WA) and Katie Porter (D-CA) are calling on the U.S. Patent and Trademark Office (USPTO) to closely scrutinize any Merck requests for new patents for its cancer treatment Keytruda (pembrolizumab). A statement (includes
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FDA has released the form FDA-483 issued following a 12/13-12/21/22 inspection at Amneal Pharmaceuticals Private Limited, an Ahmedabad, Gujarat, India pharmaceutical parenteral manufacturer. The nine-page document lists 16 narrative observations of objectionable conditions made by the agency investigator.
Drugs
The Association for Accessible Medicines (AAM) says it appreciates FDA efforts to promptly revise a 2020 guidance to implement new commitments regarding controlled correspondence in the commitment letter authorizing GDUFA renewal. The association’s letter says the revised draft guidance “continues to provide useful information about what FDA will and
Drugs
FDA has accepted for priority review a Pfizer BLA for elranatamab to treat patients with relapsed or refractory multiple myeloma. The company says FDA is expected to decide on the BLA this year. Elranatamab is described as an investigational off-the-shelf, humanized BCMA CD3-targeted BsAB. BsABs are described
Drugs
FDA has expanded its warning against using specific artificial tears products to now include Delsam Pharma’s Artificial Eye Ointment due to potential bacterial contamination. The over-the-counter product is also manufactured by Tamilnadu, India’s Global Pharma Healthcare, which was issued an import alert and a safety warning
Drugs
FDA has accepted for priority review a Regeneron BLA for pozelimab (C5 antibody) to treat children and adults with CHAPLE disease. A company statement says CHAPLE is an ultra-rare disease also known as CD55 deficiency with Hyperactivation of complement, Angiopathic thrombosis and Protein Losing Enteropathy or CD55-deficient protein-
Drugs
FDA has notified Akebia Therapeutics that due to agency resource constraints and staffing needs, the deciding authority for the company’s formal dispute resolution request about the complete response letter received on 3/2022 for its vadadustat will be CDER Office of New Drugs (OND) director Peter Stein. The company
Drugs
FDA has extended to 5/22 the PDUFA priority review action date for Astellas Pharma’s fezolinetant, an investigational drug to treat moderate to severe vasomotor symptoms due to menopause. The company says the agency said it needed more time to complete its review of the Astellas NDA.
Drugs
Intarcia Therapeutics has accepted a proposal (see earlier story) from FDA chief scientist Namandjé N. Bumpus to allow an advisory committee to review and address a 2021 CDER decision not to approve the company’s NDA for ITCA 650 (exenatide in DUROS device), a drug/device combination product intended to
Drugs
HHS has published its semiannual regulatory agenda that outlines numerous FDA rulemaking activities under development, such as a final rule entitled “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format” and proposed rules entitled “Medication
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FDA has granted priority review for a Merck sNDA for its Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk. A company statement says the PDUFA action date on the sNDA is 6/5. FDA also accepted for review a second sNDA to
Drugs
FDA has accepted an Iveric Bio NDA for avacincaptad pegol, described as a novel investigational complement CS inhibitor for treating geographic atrophy secondary to age-related macular degeneration. The company says the PDUFA action date on the NDA is 8/19. The agency granted priority review of the NDA. Iveric
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Eisai CEO Ivan Cheung says the company expects FDA to fully approve its Alzheimer’s drug Leqembi (lecanemab) this summer. In a 2/16 interview with CNBC, Cheung said approval could come as soon as July if the agency gives Leqembi priority review for demonstrating a significant improvement in how