Drugs
FDA has granted EMD Serono a breakthrough therapy designation for its investigational targeted therapy tepotinib in patients with metastatic non-small cell lung cancer (NSCLC) that exhibit MET exon 14 skipping alterations and who have progressed following platinum-based cancer therapy. The designation was based on data showing that tepotinib
Devices
FDA has cleared a HeartFlow 510(k) for the HeartFlow Planner, a real-time virtual modeling tool for coronary artery disease (CAD) intervention. The device is intended to enable interventional cardiologists to virtually model clinical scenarios vessel-by-vessel, explore treatment strategies for patients with CAD before each procedure, review
Drugs
Federal Register notice: FDA has announced an 11/14 Endocrinologic and Metabolic Drugs Advisory Committee meeting. Panel members are scheduled to discuss an Amarin Pharma supplemental NDA for Vascepa (icosapent ethyl) capsules for oral administration for reducing the risk of cardiovascular events, as an adjunct to statin therapy in adult
Drugs
A lengthy Bloomberg Businessweek report looks at the ongoing issue of N- nitrosodimethylamine (NDMA) contamination in the widely-used hypertension medicine valsartan. The contamination led FDA in 7/2018 to oversee a recall of drugs from three companies. There have been 51 additional recalls since then, including two additional drugs,
Drugs
An opinion column posted online by CNN says that a key source of the problem of high drug costs is abuse of the U.S. patent system. “Healthcare costs could be brought down through greater availability of generic drugs and biosimilars — drugs that are identical to branded drugs but distributed
Drugs
The FDA Allergenic Products Advisory Committee meets 9/13 to consider Aimmune Therapeutics’ BLA for Palforzia (peanut allergen powder) with a proposed indication to reduce the incidence and severity of allergic reactions, including anaphylaxis after accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis
FDA Policy/General
Federal Register notice: FDA has determined that Sanofi Aventis’ Calcimar (calcitonin salmon) injection, 200 IU/mL was not withdrawn from sale due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference Calcimar if all other legal and regulatory requirements are met. To view the
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Tsunami MedTech’s Aegea Vapor System, indicated for ablation of the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes in whom childbearing is complete. The review period is 1,
Drugs
Bayer says an FDA draft guidance on the content and format of instructions for use (IFU) for drug, biologic, and combination products “provides an opportunity to align with the previous effort by FDA to consolidate the current formats of patient labeling into patient medication information (PMI). The finalization of this
FDA Policy/General
Federal Register notice: FDA is requesting comments on 21 drug substances concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use. The comments will be considered in preparing a response from the U.S. to the World Health Organization to use in
Drugs
Ultragenyx and Kyowa Kirin say they will submit a supplemental BLA to FDA for their Crysvita (burosumab) for treating FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors that can’t be curatively resected or localized. The companies say the decision to submit the sBLA follows a meeting with FDA and
Drugs
A Reuters investigative report, based on confidential federal court documents that were exposed due to filing errors, says New York federal judge Brian Cogan, who is hearing multi-district litigation against Merck’s Propecia, allowed the company to keep medical secrets contained in documents marked confidential by the company out
Drugs
Hospira has recalled one lot (# W20308) of its bacteriostatic water for injection, USP, 30 mL, multi-dose vial due to sterilization concerns. “In the event that impacted product is administered to a patient, there is an increased risk that severe adverse events such as invasive bacterial infection, including bacterial meningitis,
Drugs
After a 9/11 White House meeting between FDA acting commissioner Ned Sharpless, HHS secretary Alex Azar and President Donald Trump, the agency is moving forward to ban non-tobacco-flavored e-cigarettes, including mint and menthol. FDA is preparing an enforcement and compliance guidance in the coming weeks to
Drugs
FDA has accepted for review a Puma Biotechnology supplemental NDA for Nerlynx (neratinib) in combination with capecitabine for treating patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed therapy. FDA has set a late 4/2020 user fee review action date,
Devices
FDA has granted Checkpoint Surgical a breakthrough device designation for the company’s brief electrostimulation therapy (BEST) system. The device is designed to provide electrical stimulation of peripheral nerves to promote nerve regeneration as an adjunct to surgical intervention following nerve injury. The company says it is enrolling patients in
Drugs
CDER director Janet Woodcock told 150 researchers at the Breakthroughs in Medicine conference 9/6 that there is a need for major reforms in scientists’ relationships with regulators, doctors, and one another. And without a wide-ranging overhaul, she cautioned, lab successes won’t make it to the patients who
Drugs
A 3/19-3/21 FDA inspection at Hangzhou Badi Daily Use Chemical Company, Zhejiang Province, China, found significant violations of current good manufacturing practice (CGMP) regulations. An 8/29 Warning Letter says specific violations were: * failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Enprani Co., Seoul, South Korea (8/15): FDA inspected the firm in March and cited significant GMP violations for finished pharmaceuticals. For example, The company failed to have, for
Drugs
Public Citizen 9/10 has filed suit in Washington, DC federal court against FDA over its inaction to respond to the group’s 7/2018 citizen petition urging a ban on all dietary supplements containing cesium chloride or other cesium salts from the market. Because its year-old petition has
Biologics
FDA says agency scientists have developed a technique that enables them to determine whether immune system cells (dendritic cells) appear primed to trigger the production of antibodies against Factor VIII products used to treat hemophilia A. “The technique might enable scientists to use the presence of such primed dendritic cells
Drugs
FDA has released the FDA-483 issued following an 8/19-8/23 inspection at Ipca Laboratories, Silvasa, India. The four inspection observations were: * deviations from written test procedures and laboratory mechanisms are not recorded and justified; * failing to thoroughly review any unexplained discrepancy and the failure of a batch