Drugs
FDA has accepted for priority review a Pfizer NDA for talazoparib for use in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer. The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in this patient population. The user
Drugs
FDA has granted Ironwood Pharmaceuticals an orphan drug designation for olinciguat (IW-1701) for treating patients with sickle cell disease. Olinciguat is an orally administered soluble guanylate cyclase stimulator. The company is currently enrolling patients in STRONG-SCD, a multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase 2 trial
Drugs
John Jenkins, the former head of CDER’s Office of New Drugs, who left the agency following a public dust-up with Center director Janet Woodcock over approval of Sarepta’s Duchenne muscular dystrophy drug Exondys 51 (eteplirsen), is joining the board of Corbus Pharmaceuticals. Endpoints News reports that Corbus
FDA Policy/General
Federal Register notice: FDA is correcting a 2/23 notice that announced the withdrawal of 24 ANDAs from multiple applicants. That notice wrongly stated that Sun Pharmaceutical Industries asked to withdraw ANDA 077483 for benazepril hydrochloride and hydrochlorothiazide tablets, 5 mg/6.25 mg, 10 mg/12.5 mg, 20
Drugs
FDA has issued a complete response letter to Mylan and its partner Biocon on their application for a biosimilar citing Sanofi’s Lantus (insulin glargine) injection. The Center for Biosimilars reports that Mylan informed it that the letter had been expected and that the company had agreed to give the
Drugs
FDA has filed a complaint seeking a permanent injunction against Innovative BioDefense (Lake Forest, CA) and president/CEO Colette Cozean to prohibit them from selling Zylast topical antiseptics with claims that they are effective against infection by pathogens such as norovirus, rotavirus, flu virus, methicillin-resistant staphylococcus aureus and Ebola.
Drugs
FDA has issued a guidance, Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief, to describe circumstances in which an applicant may be eligible for a barrier-to-innovation waiver under PDUFA for some NDAs for fixed-combination and
Devices
FDA has published a draft guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, with an overview of the mechanisms available to submitters to request feedback from or a meeting with FDA on potential or planned medical device IDEs, PMAs, HDEs, De Novo requests, 510(
FDA Policy/General
Federal Register notice: FDA has announced a 7/25 Pulmonary-Allergy Drugs Advisory Committee meeting. Panel members are scheduled to discuss a GlaxoSmithKline supplemental BLA for mepolizumab for injection and its use as as add-on treatment for inhaled corticosteroid-based maintenance treatment to reduce exacerbations in patients with chronic
Devices
The CBER Office of Compliance and Biologics Quality says a Tiger Medical Web site is selling and distributing the Alere Determine HIV-1/2 Ag/Ab combo test kit without imposing the restrictions that are part of the kit’s approval. A 5/29 untitled letter says the agency’s
Drugs
FDA has released the FDA-483 with five observations issued following a 5/14-5/24 inspection at Glenmark Pharmaceuticals, a Madhya Pradesh, India, finished oral solid dose manufacturer. The specific observations were: * failing to establish and document the accuracy, specificity, and reproducibility of test methods; * failing to have laboratory
Drugs
FDA has approved a Partner Therapeutics NDA for leukine for treating adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome). The company notes that efficacy studies of Leukine could not be conducted in humans with acute radiation syndrome for ethical and feasibility
Drugs
FDA has accepted an Amag Pharmaceuticals NDA for bremelanotide, a first-in-class melanocortin 4 receptor agonist for treating hypoactive sexual desire disorder (HSDD) in premenopausal women. The user fee review action target date is 3/23/2019. HSDD is the most common type of female sexual dysfunction, affecting about
Devices
FDA has cleared a Rodo Medical 510(k) for the Rodo Smilekey, an induction remover device for use with the Rodo Abutment System. The device uses Rodo’s proprietary induction technology to remove dental prostheses retained by the Rodo Smileloc in less than 10 seconds without occlusal holes or damaging
Drugs
The CDER Office of Generic Drugs says the 843 fully approved and 184 tentatively approved generic drug applications in 2017 had an estimated cost-savings of $8.8 billion through 12/2017 and $11.8 billion through 2/2018. A cost savings report says the agency approved the most generic
Drugs
A 9/25-9/28 FDA inspection at Kolmar Korea Co., Sejong-si, South Korea, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a 5/18 Warning Letter. Specific violations listed in the letter are: * failing to thoroughly investigate any unexplained discrepancy or failure
Drugs
FDA has warned nine online networks that operate a total of 53 Web sites to stop illegally marketing potentially dangerous unapproved and misbranded versions of opioid medications, including tramadol and oxycodone. An agency news release says that Warning Letters went to these networks: AnonShop. Eassybuyonline, Instabill ECS-Rx, Medstore.biz,
Drugs
A 12/4-12/8/17 FDA inspection at IDT Australia, Boronia, Victoria, Australia, found current good manufacturing practice (CGMP) regulations deviations in the firm’s manufacturing of active pharmaceutical ingredients (API) and violations in its manufacturing of finished pharmaceuticals. A 5/23 Warning Letter says the API deviations were:
Drugs
FDA has accepted for priority review a Genentech supplemental BLA for Hemlibra (emicizumab-kxwh) for adults and children with hemophilia A without factor VIII inhibitors. The submission is based on data from the Phase 3 HAVEN 3 study. In the study, adults and adolescents with hemophilia A without factor VIII
Drugs
FDA has approved Eli Lilly’s Alimta (pemetrexed for injection) in combination with carboplatin and Merck’s Keytruda (pembrolizumab) for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer, irrespective of PD-L1 expression status. Previously, the combination use was permitted under an accelerated approval. The
Drugs
FDA says it is committed to using a multi-component system of pharmacovigilance to be able to intervene proactively and effectively in anticipation of changes in drug abuse. Writing in a New England Journal of Medicine Perspective column, three agency senior executives describe pharmacovigilance steps taken involving gabapentinoids, the botanical
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Fertility Partnership St Peters, MO (5/24): FDA inspected the firm in March and cited deviations from the regulations governing human cells, tissues, and cellular and tissue-based products