Drugs
Sanofi-Aventis has agreed to pay almost $12 million to resolve allegations that it violated the False Claims Act by paying kickbacks to Medicare patients taking its multiple sclerosis drug Lemtrada through a purportedly independent charitable foundation, The Assistance Fund. The Anti-Kickback Statute prohibits drug companies from offering or
Drugs
FDA has accepted for review a Pfizer and Eli Lilly BLA for tanezumab 2.5 mg administered subcutaneously for patients with chronic pain due to moderate-to-severe osteoarthritis who have experienced inadequate pain relief with other analgesics. The monoclonal antibody is part of an investigational class of non-opioid
Drugs
FDA says an unidentified drug manufacturer has alerted the agency about a drug shortage related to a manufacturing site affected by the coronavirus. “The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug,” FDA commissioner Stephen Hahn says. “It is important to
Drugs
The Association for Accessible Medications (AAM) is stepping up pressure on Congress to reject legislation to change FDA’s 180-day marketing exclusivity award for “first generics” that are the first to challenge brand-drug patents. The bill, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics
Drugs
FDA has approved an Esperion NDA for Nexlizet (bempedoic acid and ezetimibe) as an adjunct to diet and maximally tolerated statin therapy for treating adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease, who require additional lowering of LDL-C. Nexlizet is the first non-statin, LDL-C lowering
Drugs
FDA has launched a new pilot program to simplify public awareness about guidance documents that seek to modernize drug clinical trials and accelerate drug development. FDA says the Guidance Snapshot Pilot is a “communication tool that provide highlights from guidance documents using visuals and plain language.” During the Pilot, the
Drugs
FDA has approved a Cerovene ANDA for the first generic copy of Vyera Pharmaceuticals’ Daraprim (pyrimethamine) tablets for treating toxoplasmosis (an infection caused by the parasite Toxoplasma gondii) when used with a sulfonamide. Severe toxoplasmosis is more likely in pregnant women and individuals who have weak immune systems, such as
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA efforts to clarify through draft guidance the appropriate mechanisms and pathways for combination product sponsors to obtain agency feedback, including the inclusion of best practices regarding interactions between FDA and combination product sponsors. “While PhRMA appreciates the inclusion of
Drugs
FDA has extended by three months its review of a Zogenix NDA for Fintepla (fenfluramine oral solution) for treating seizures associated with Dravet syndrome. The new user fee review action target date is 6/25. The extension allows the agency time to review additional data submitted by Zogenix in response
Drugs
FDA says American Health Packaging recalled 2/27 11 lots of ranitidine tablets, 150 mg, 100-count unit dose blisters due to the potential for N-Nitrosodimethylamine amounts above levels established by FDA. An agency notice says the recall was initiated in response to a recall by the manufacturer, Amneal
Drugs
FDA’s Oncologic Drugs Advisory Committee has delivered a mixed vote (six to five) to support approval of Eli Lilly’s supplemental BLA for Cyramza (ramucirumab) and its use in combination with Roche’s erlotinib for patients with untreated metastatic EGFR-positive non-small cell lung cancer. The panel based
Drugs
FDA says it has received reports of “spot shortages” of some medical devices due to the global coronavirus outbreak. An FDA spokeswoman tells FDA Webview 2/27 that the agency is “currently not aware of specific widespread shortages of medical devices, but we are aware of reports from CDC and
Drugs
A New York federal judge has ruled that data from clinical trials conducted for not-yet-approved drugs and medical devices over a 10-year period between 2007 and 2017 must be published online at ClinicalTrials.gov. The ruling comes in a 2018 suit against HHS, FDA, and the National
Drugs
FDA has approved an Acacia Pharma Group NDA for Barhemsys (amisulpride injection) for preventing and treating postoperative nausea and vomiting (PONV) in adult patients. Approval of the selective dopamine D2 and D3 antagonist was based on data from four positive Phase 3 studies involving more than 3,300 surgical patients
Drugs
HHS deputy inspector general for evaluation and inspections Suzanne Murrin says the Office of Inspector General has identified risks associated with medical device safety and security and safety concerns with FDA-regulated drugs. In testimony before the House Appropriations Committee, Murrin says FDA: * needs to further mitigate the risk of
Drugs
FDA commissioner Stephen Hahn says media reports (see earlier story) are wrong about the agency monitoring 150 prescription drugs that could be in short supply if plants in China that make their active pharmaceutical ingredients are restricted from manufacturing or distributing products due to the recent coronavirus outbreak. “We are
Drugs
An FDA 2/18 Warning Letter says that LeeSar, Inc., Fort Myers, FL, which registered as an outsourcing facility 4/30/14, was inspected from 7/3-7/12/17 and it was determined that the firm’s drug products failed to meet the conditions under section 503B of the
Drugs
FDA has released the FDA-483 issued following a 9/9-9/26/19 inspection at Dynalabs, a St. Louis, Mo., control testing laboratory. The four inspection observations were: * failing to establish and document the accuracy, specificity, and reproducibility of test methods; * failing to have the written stability program for
Drugs
Two months ahead of its user fee review goal, FDA has approved Puma Biotechnology’s Nerlynx (neratinib) in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. An FDA release
Drugs
FDA commissioner Stephen Hahn says the agency is evaluating potential regulatory pathways outside of the existing drug pathway that would allow various types of CBD products to be lawfully marketed. In a 2/26 presentation to the National Association of State Departments of Agriculture, Hahn said the agency wants to
Drugs
Healthcare performance improvement consultants Vizient says the FDA Unapproved Drugs Initiative (UDI) will increase healthcare spending by $20.25 billion. In its analysis, Vizient says UDI is an FDA mandate that unapproved drugs that have been in use prior to agency review of safety and efficacy must be approved or
Drugs
Y-mAbs Therapeutics says it will complete in 10 weeks a rolling BLA for omburtamab for treating patients with central nervous system(CNS)/leptomeningeal metastases from neuroblastoma. At a recent pre-BLA meeting, the company says it reached “alignment” with FDA on an accelerated approval pathway for omburtamab. The company