Drugs
FDA has approved an expanded label for Merck’s Keytruda (pembrolizumab) as monotherapy for treating patients with locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation. Approval is based on data from the Phase 2 KEYNOTE-629 trial that showed an objective response rate of
Drugs
FDA has denied all but one of the requests in a 3/9/15 Celgene/Abraxis BioScience petition asking that the agency refrain from receiving for substantive review or approving any ANDA or NDA that references Abraxane for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) unless
Drugs
Vifor has petitioned FDA for reconsideration and a stay of certain actions the agency has taken with respect to Venofer (iron sucrose USP) injection that the company says will undermine the public health and are contrary to law. The 6/25 petition arises from FDA’s 5/26 response to
Drugs
FDA says Teva has recalled one lot of topotecan injection (4mg/4mL) due to the presence of particulate matter. An agency statement says the nationwide recall to the retail/institutional level was initiated based on a complaint from a pharmacy after a single glass particle was observed inside one vial.
Drugs
FDA has issued a guidance, Providing Regulatory Submissions in Alternate Electronic Format, with recommendations on an alternate electronic format for submissions covered under an exemption from or waiver of the requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act. The recommendations pertain to the format of
Drugs
ChemoCentryx has filed an amendment to its NDA for avacopan for treating anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. The submission is intended to address advisory committee concerns that led to a split vote during a 5/6 meeting (see earlier story). The submission triggers a three-month user fee
Drugs
A 9/10-11/5/20 FDA inspection at the Novel Laboratories drug manufacturing facility, doing business as Lupin, in Somerset, NJ, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 6/11 Warning Letter says specific violations were: * failing to establish and follow adequate
Drugs
FDA has issued a draft guidance, Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications, with recommendations for clinical trials designed to assess the adhesion performance of transdermal and topical delivery systems. The document says adhesion performance can affect both safety and effectiveness of transdermal and
Drugs
FDA has issued Provention Bio a complete response letter on its BLA for teplizumab and its use for delaying clinical Type 1 diabetes in at-risk individuals. The letter stated that a single, low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging study in healthy volunteers to compare planned commercial product with
Drugs
CDER director Patrizia Cavazzoni has named Jacqueline Corrigan-Curray to the newly-created position of principal deputy Center director. Since February, Corrigan-Curray has been CDER acting deputy Center director for operations and director of the Office of Medical Policy (OMP). Cavazzoni says she has worked on implementing medical policy
Drugs
FDA has told Soleno Therapeutics that an additional clinical trial is necessary before the company submits an NDA for once-daily DCCR (diazoxide choline) extended-release tablets for treating Prader-Willi Syndrome (PWS). CDER’s Division of Diabetes, Lipids and Obesity said that based on data it has seen to
Drugs
After 20 years at FDA, CDER Division of Therapeutic Proteins director Amy Rosenberg is leaving to join EpiVax as senior director of immunology and protein therapeutics. Rosenberg’s work at the agency was focused on immune tolerance induction and immunogenicity, and she oversaw the regulation and approval of numerous protein
Drugs
A report on FDA’s use of patient-focused drug development (PFDD) in regulatory decision-making calls on the agency to continue to develop and update PFDD guidance and to consider expanding its compendium of clinical outcome assessments (COAs) to delineate not-yet-accepted and accepted patient experience PFDD tools
Drugs
FDA has approved Jazz Pharmaceuticals’ Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who are allergic to the E. coli-derived asparaginase products used most commonly for treatment. An agency statement says
Drugs
FDA has posted a draft guidance on Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies. The document provides recommendations to help sponsors comply with the expedited safety reporting requirements under an IND or as part of a bioavailability or bioequivalence study that is exempt
Drugs
FDA has told AbbVie that it will not meet the user fee action dates for two supplemental NDAs for Rinvoq (upadacitinib), a JAK inhibitor for treating adults with active psoriatic arthritis and adults with active ankylosing spondylitis. The agency cited its ongoing review of Pfizer’s post-marketing study, ORAL
Drugs
FDA has published a draft guidance, Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings, with recommendations for including patients who have not received available therapy for their cancer in clinical trials of investigational drugs and biological products in a non-curative setting. The document says
Drugs
Members of the Oncologic Drugs Advisory Committee voted 13-4 on 6/24 to recommend that FDA defer regulatory action on Incyte’s retifanlimab, pending more research. The company is seeking an indication to treat patients with locally advanced or metastatic squamous carcinoma of the anal canal who have progressed
Drugs
FDA has granted breakthrough therapy designations for drugs from Lilly and Eisai/Biogen intended to treat Alzheimer’s disease. The designation was granted for Lilly’s donanemab, an investigational antibody therapy. The company says the designation is based on clinical evidence in the TRAILBLAZER-ALZ Phase 2 trial that studied
Drugs
A 7/22/19-8/14/19 FDA inspection at Roger Williams Medical Center Oncology Pharmacy Clinic, Providence, RI, found deficiencies in the clinic’s practices for producing compounded sterile drug products that put patients at risk. A just-released 3/18 Notice of Violation says the agency investigators found
Drugs
FDA is asking the Oncology Drugs Advisory Committee whether a regulatory decision on Incyte’s retifanlimab to treat advanced or metastatic squamous carcinoma of the anal canal (SCAC) should be delayed until further clinical trial data are available. An agency briefing document released in advance of a 6/24 committee
FDA Policy/General
FDA says its review of a Web site and Amazon storefront maintained by Fresh Nutrition, Inc., Yorba Linda, CA, determined that the company is taking orders for several products that are legally considered to be drugs for use in diagnosing, curing, mitigating, treating, or preventing disease in humans and animals.