Drugs
FDA has accepted for priority review a Merck supplemental BLA seeking accelerated approval for Keytruda for treating adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). The submission is based on data from the Phase 2 KEYNOTE-017 trial that evaluated the overall response rate
Drugs
Pfizer says it has publicly urged manufacturers of Biosimilar User Fee Act products not to be solely focused on similarity when meeting with FDA. It has said that sponsors should be discussing manufacturing, packaging, and filing questions with the agency as they would for any biological product. “This should be
Drugs
FDA has published a guidance, Physiologically Based Pharmacokinetic Analyses—Format and Content, to outline the recommended format and content for a sponsor or applicant to submit physiologically based pharmacokinetic (PBPK) analyses to FDA to support applications including NDAs, BLAs, or ANDAs. The document says the agency recommends including these six
Drugs
FDA says HelloLife is recalling certain lots of four drug products — Neuroveen, Respitrol, Thyroveev, and Compulsin. An agency notice says the products are labeled as homeopathic and are being recalled due to microbial contamination. The products were manufactured, FDA says, at the King Bio Inc., facility in Asheveille, NC.
Drugs
Janssen has submitted an NDA for esketamine nasal spray, indicated for treatment-resistant depression in adults. The company says the investigational, rapidly acting antidepressant works differently than currently available therapies for major depressive disorder. “Through glutamate receptor modulation, esketamine is thought to help restore connections between brain cells in people
Drugs
Federal Register notice: FDA has renewed for two years the charter of the Endocrinologic and Metabolic Drugs Advisory Committee. The new charter will now be in effect until 8/27/2020. To view the notice, click here.
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA efforts in a guidance to clarify when and how the agency will consider waiving the requirement that an ANDA applicant use a single shared system (SSS) of elements to assure safe use with its reference-listed drug. “PhRMA supports
Drugs
As part of a settlement approved by the Securities and Exchange Commission, Sanofi will pay $20.2 million to the U.S. government to resolve allegations the company violated the Foreign Corrupt Practices Act by making payments in several countries to officials and healthcare professionals to influence them and increase
Drugs
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Zimmer Biomet, Warsaw, IN (8/24): FDA re-inspected the firm in April as a follow-up to a 2016 inspection and
Drugs
Alcon has withdrawn from the market its CyPass Micro-Stent for surgical glaucoma due to safety concerns documented in a five-year study. The COMPASS-XT study showed that at five years, the CyPass Micro-Stent group experienced statistically significant endothelial cell loss compared to the group who underwent cataract
Drugs
Pfizer has petitioned FDA to tighten bioequivalence requirements for any ANDA submitter seeking to gain approval for generic copies of its Premarin (conjugated estrogens) tablets. The petition seeks to revise a 12/2014 draft guidance on methods for establishing active pharmaceutical ingredient sameness and bioequivalence for conjugated estrogens. Pfizer had
Drugs
FDA has issued a safety warning following a Camber Pharmaceuticals recall of one lot of montelukast sodium tablets. Sealed bottles labeled as montelukast were found to instead contain losartan potassium tablets, 50 mg. “This tablet mix-up may pose a safety risk as taking losartan tablets when not prescribed has
Drugs
FDA has issued Sunovion Pharmaceuticals a complete response letter rejecting its NDA for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor for treating attention-deficit hyperactivity disorder. The letter asked for additional clinical data to further evaluate the drug’s efficacy and tolerability, according to the company. Sunovion
Drugs
FDA has approved Bayer’s Jivi (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older. The agency also approved Jivi for on-demand treatment and perioperative management of bleeding in the same
Drugs
FDA has granted Insys Therapeutics a fast track designation for its epinephrine nasal spray as an investigational treatment for anaphylaxis. “In a previous clinical trial, the intranasal epinephrine product candidate from Insys showed promise as a potential needle-free, non-invasive and easy-to-use alternative to intramuscular injection for
Drugs
The National Association of Chain Drug Stores says it is concerned that FDA draft guidances on waivers of the single, shared system (SSS) risk evaluation and mitigation strategy (REMS) requirement and on development of a shared system risk evaluation and mitigation strategy would not stop brand drug manufacturers from manipulating
Drugs
CDER statistical researchers say they are promoting and developing innovative clinical trial designs to meet the challenges of precision medicine. In an online research post, the statisticians describe work they undertook a few years ago during the Ebola outbreak to evaluate new treatments for the deadly viral disease. They then
Drugs
FDA is modernizing its overall approach to regulation to effectively advance the kinds of medical innovations that are becoming available, according to FDA commissioner Scott Gottlieb. In a lengthy FDA Voice blog post, Gottlieb says the changes, including modernizing organization of the medical product review programs, are part of the
Drugs
The New Jersey federal court has entered an order of permanent injunction against several firms and their executives charged with selling unapproved and misbranded drugs to U.S. consumers through more than 100 Web sites. According to an FDA statement, the defendants’ products claimed, without FDA approval or clinical studies
Drugs
FDA has approved Auris Medical’s proposed choice of primary and secondary efficacy endpoints, the safety endpoints, as well as the planned sample size and statistical methodology for a pivotal Phase 3 trial of AM-111 (brimapitide), an investigational treatment for sudden sensorineural hearing loss. In a recent meeting with
Drugs
FDA has approved two Merck NDAs for human immunodeficiency virus (HIV)-1 drugs — Delstrigo, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (300 mg) and tenofovir disoproxil fumarate (300 mg); and Pifeltro (doravirine) 100 mg, a new non-nucleoside reverse transcriptase inhibitor to be administered in
Drugs
A bipartisan group of three House members have introduced H.R. 6688 to establish the Prescription Safety Alert System for covered drug products. The legislation, introduced by Reps. Tom Macarthur (R-NJ), Ann Kuster (D-NH), and Barbara Comstock (R-VA), is known as the Analyzing and Leveraging Existing Rx