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
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
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
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
Drugs
FDA commissioner Scott Gottlieb says the agency is taking steps to make the entire continuum of drug development more efficient as a way to lower costs and expand opportunities for innovation. Speaking 6/2 at the annual meeting of the American Society of Clinical Oncology, Gottlieb outlined steps being taken
FDA Policy/General
An FDA 5/23 Warning Letter to Creative Science Inc., Ballwin, MO, says the company’s P-Bloc product is a new animal drug that is not generally recognized among experts as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. Further, the letter
Drugs
FDA has approved Mylan’s Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Amgen’s Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with
Drugs
CDER director Janet Woodcock has proposed changes to her Center’s new drug regulatory program that are intended to free up resources so staff can “focus on drug development, particularly for unmet medical needs, and on the multiple collaborations needed to make sure candidate drugs are developed and assessed properly,
Drugs
FDA has made available a guidance on “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.” The document provides recommendations on formal meetings between the agency and sponsors or applicants relating to developing and the review of biosimilar or interchangeable biological products. Formal meetings under the guidance
Drugs
Hospira has recalled two lots of naloxone hydrochloride injection, 0.4 mg/mL, 1 mL in 2.5 mL in its Carpuject single-use cartridge syringe system due to the potential presence of embedded and loose particulate matter on the syringe plunger. “In the event that impacted product is administered
Drugs
FDA has approved an Eli Lilly and Incyte NDA for Olumiant (baricitinib 2mg), a once-daily oral drug for treating adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor inhibitor therapies. Approval is based on data from