Biologics
FDA says two physician researchers at Minneapolis’ Hennepin County Medical Center failed to submit INDs for the conduct of clinical investigations with investigational new drugs. The agency just released a 5/5 Warning Letter to Jon Cole and a 5/6 Warning Letter to Lauren Klein detailing issues with Cole’
Drugs
An FDA 5/3-5/14 inspection at Marcus Research Laboratory, a St. Louis, MO, drug manufacturing facility, identified significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 9/30 Warning Letter says specific deviations were: * failing to have the procedures and processes necessary
Drugs
FDA has issued Omeros a complete response letter on its BLA for narsoplimab as a treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). In the letter, according to the company, FDA said it had difficulty in estimating the treatment effect of narsoplimab in HSCT-TMA and requested
Drugs
FDA is reminding in vitro diagnostic manufacturers that the agency requires an institutional review board (IRB) review for all device clinical investigations that involve human subjects, including those that use leftover, deidentified human specimens in FDA-regulated studies. “This requirement pertains to data used to support an investigational device exemption,
Drugs
FDA has issued United Therapeutics a complete response letter on its NDA for Tyvaso DPI (treprostinil) for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease to improve exercise capacity. FDA’s letter, according to the company, cited a deficiency related to an open inspection issue
Drugs
Lupin Pharmaceuticals has recalled all irbesartan and irbesartan/hydrochlorothiazide tablets after an analysis revealed that certain active pharmaceutical ingredient batches were above the specification limit for the impurity N-nitrosoirbesartan. Irbesartan is an angiotensin II receptor blocker indicated for treating hypertension, and diabetic nephropathy in hypertensive patients with Type 2
Drugs
FDA has approved Genentech’s Tecentriq (atezolizumab) as an add-on treatment following surgery and platinum-based chemotherapy for adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L1 greater than or equal to 1%. Approval is based on data from an interim analysis
Drugs
Teligent Pharma has recalled five lots of lidocaine HCl Topical Solution 4%, 50ml in screw cap glass bottles because the firm’s testing has found it to be super potent based on an out-of-specification result obtained at its 18-month stability timepoint. “An increased lidocaine dose could lead
Drugs
FDA has accepted for priority review a Regeneron Pharmaceuticals BLA for Regen-Cov (casirivimab and imdevimab) for treating Covid-19 in non-hospitalized patients and as prophylaxis in certain individuals. Currently, the therapy is authorized under an emergency use authorization to treat people with mild to moderate Covid-19 who
Drugs
CDER’s Office of Compliance has been targeting three enforcement areas in drug advertising and promotion — fraudulent Covid-19 products, products containing hidden drug ingredients, and illegally marketed opioid products. Speaking at an enforcement update at the Food and Drug Law Institute’s annual advertising and promotion conference 10/13,
Drugs
FDA’s Vaccines and Related Biological Products Advisory Committee 10/14 voted unanimously to support Moderna’s request for an emergency use authorization (EUA) for a booster dose of its mRNA Covid-19 vaccine. Panel members agreed that the booster dose was appropriate for older and higher-risk adults who
Drugs
CDER director Patrizia Cavazzoni and Office of Pharmaceutical Quality director Michael Kopcha say the Center’s efforts to promote advanced manufacturing initiatives through its Emerging Technology Program (ETP) have increased to the point that ETP 2.0 is being created to meet workload challenges and enhance communication with companies that
Drugs
FDA has approved Lilly’s Verzenio (abemaciclib) to be used in combination with endocrine therapy for the adjuvant treatment of adult patients with HR+, HER2-, node-positive early breast cancer at high risk of recurrence with specified results on an FDA-approved diagnostic test. The company says Verzenio is the
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1. The agency also granted full approval to the therapy’s previous accelerated approval as a single agent for patients with recurrent
Drugs
FDA has released the FDA-483 with five inspection observations issued following a 6/21-7/2 inspection at Revance Therapeutics, a Newark, CA, drug substance and drug product manufacturer. The inspection observations were: * current release and stability cell bank testing methods are insufficient to monitor quality and shelf-life
Drugs
FDA has accepted for priority review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) for treating schizophrenia in adolescents. Currently, Rexulti is approved for treating schizophrenia in adults and as an add-on treatment in adults with major depressive disorder in adults. The submission is based on
Drugs
FDA has posted a draft guidance entitled Continuous Manufacturing of Drug Substances and Drug Products — Q13. The document describes scientific and regulatory considerations for developing and implementing continuous manufacturing (CM). It also provides clarification on CM concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances
Drugs
FDA has approved a modification to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin effective 12/13. An agency notice says that for healthcare providers, REMS patient risk categories will be reduced from three to two — patients who can get pregnant and patients who cannot get pregnant. There
Drugs
Federal Register notice: FDA has announced the withdrawal of three guidance documents entitled Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (Covid-19), Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, and Temporary Policy
Drugs
A 5/3-19 FDA inspection of contract testing laboratory Missouri Analytical Laboratories has led to a just-posted 9/30 Warning Letter that cited significant GMP violations for finished pharmaceuticals and active pharmaceutical ingredients. For example, FDA said the firm failed to thoroughly investigate unexplained discrepancies and out-of-
Drugs
FDA has lifted a Protagonist Therapeutics clinical hold on the company's rusfertide clinical studies. The hold followed notification to FDA about a recent non-clinical finding in a 26-week rasH2 transgenic mouse model study, according to the company. “The rasH2 model is designed to detect signals related
Drugs
FDA has approved an Ocular Therapeutix supplemental NDA to broaden Dextenza’s (dexamethasone ophthalmic insert) label to add an additional indication for treating ocular itching associated with allergic conjunctivitis. Previously the corticosteroid was approved for treating ocular pain and inflammation following ophthalmic surgery. The new approval was based on data