Drugs
The Department of Justice says an Ohio federal grand jury on 7/31 returned a 19-count indictment charging eight people with participating in a scheme to defraud eight drug companies and FDA through conducting fraudulent clinical trials. A department statement says the eight were charged with conspiracy to commit
Drugs
The White House says President Trump is signing 8/6 an Executive Order to increase American production of essential medical supplies and cut down U.S. reliance on foreign drug producers. Under the order, FDA is directed to create a list of drugs, medical countermeasures, and “critical inputs” that are
Drugs
The Justice Department is pursuing claims against Purdue Pharma worth nearly $13 billion in penalties, after finding evidence of criminal and civil misconduct in the company’s alleged role in fueling the opioid crisis in the U.S. Reuters reports in an exclusive story that the details of the government’
Drugs
The Biotechnology Innovation Organization (BIO) says it appreciates FDA efforts to address challenges associated with developing therapies for rare diseases that do not yet have treatments but, given the number of identified rare diseases, is concerned and has questions about the potential scope of a single rare disease clinical trial
Drugs
The Biotechnology Innovation Organization (BIO) says it supports FDA efforts to modernize its data strategy to ultimately transform the way data is shared, analyzed, and used for regulatory purposes. Commenting in advance of an agency public meeting on the topic, BIO says it will be important to remember that just
Drugs
FDA has released the FDA-483 issued following a 5/28-29 and 6/1-6/15 inspection at MasterPharm, a South Richmond Hill, NY, producer of sterile and non-sterile drug products. The report’s inspection observations were: * releasing drug product in which the strength differs from, or its
Drugs
FDA has published a guidance, Limited Population Pathway for Antibacterial and Antifungal Drugs, with information on how the agency is implementing a section of the 21st Century Cures Act that established the limited population pathway for antibacterial and antifungal drugs (LPAD pathway). The document is intended to assist sponsors in
Drugs
A 2/25-3/20/19 FDA inspection at Acrx Specialty Pharmacy, Las Vegas, NV, found multiple violations of drug compounding and other provisions of the Federal Food, Drug, and Cosmetic Act in the production of finished drugs. A 7/24 Warning Letter says Acrx failed to meet requirements for
Drugs
FDA says it discontinued the MedWatch to Manufacturers program as of 7/31. Under the program, participating drug and biologic manufacturers could receive information from the agency on serious adverse event reports submitted directly to FDA for new molecular entities and original biologics for the first three years after approval,
Drugs
Public Citizen says that taxpayers invested $70.5 million in the development of Gilead’s remdesivir, which is being used to treat some Covid-19 cases, and thus the company should price the treatment at no more than $1 per day. The advocacy group cited a letter signed by a
Biologics
FDA commissioner Stephen Hahn and deputy commissioner for medical and scientific affairs Anand Shah say the agency has sought to encourage and facilitate the adoption of “advanced manufacturing,” which they say refers to new and emerging approaches for producing medical technologies. Writing in an FDA Voices post, Hahn and Shah
Drugs
GlaxoSmithKline (GSK)and Sanofi have separately disclosed in financial reports that they are being investigated by the U.S. Justice Department over alleged False Claims Act violations in the companies’ marketing and subsequent recall of heartburn drug Zantac (ranitidine). Earlier this year, FDA asked manufacturers (see earlier story) to withdraw
Drugs
Four former FDA commissioners are urging U.S. regulators, researchers and Covid-19-recovered patients to join in an effort to collect blood plasma and begin clinical trials to determine whether the plasma from recovered patients can help those who become sick. Writing in a Washington Post opinion piece, Mark
Drugs
A citizen petition from two groups and three individuals is asking FDA to ban music in direct-to-consumer (DTC) television, radio and internet streamed advertisements because it distracts the audience’s attention from product side effects and contraindications. Filed by Knowledge Ecology International, the Center for Digital Democracy, and
Drugs
FDA has posted a final guidance entitled “Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans.” The guidance addresses applications for which a study plan is required and the timing and content of such plans. It also provides a template
Drugs
FDA has approved a Janssen Pharmaceutical supplemental NDA for Spravato (esketamine) nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. Approval was based on data from two identical Phase 3 clinical trials in which Spravato plus
Drugs
FDA has approved a Genentech supplemental BLA for its triple combination of Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) for treating BRAF V600 mutation-positive advanced melanoma patients. The agency’s review was conducted under Project Orbis, an FDA Oncology Center of Excellence program that provides a framework for
Drugs
Catalyst Pharmaceuticals says that a Florida magistrate judge has ruled in favor of FDA in the company’s lawsuit against the agency for approving competitor Jacobus Pharmaceutical’s Ruzurgi (amifampridine) for treating the rare disorder Lambert-Eaton Myasthenic Syndrome. Catalyst had argued that its orphan drug exclusivity on a competing
Drugs
Eton Pharmaceuticals has submitted an NDA for zonisamide (previously known as ET-104) oral suspension for treating partial seizures in patients with epilepsy. Zonisamide is widely used as a capsule to treat partial seizures, but the molecule is not FDA-approved in a liquid form. Eton says its patent-pending
Drugs
FDA says it is proposing to include four bulk drug substances on the list of bulk drug substances that outsourcing facilities may use in drug compounding consistent with Section 503B of the Federal Food, Drug, and Cosmetic Act. An agency notice says the four substances are diphenylcyclopropenone, glycolic acid, squaric
Drugs
FDA has granted Takeda Pharmaceutical a breakthrough therapy designation for its investigational drug pevonedistat for treating patients with higher-risk myelodysplastic syndromes. The company says the candidate therapy, a first-in-class NEDD8-activating enzyme (NAE) inhibitor, could be the first novel therapy for the indication in more than a
Drugs
FDA has approved the Roche Ventana HER2 Dual ISH DNA Probe Cocktail assay to detect the HER2 biomarker in breast cancer and as a companion diagnostic for the company’s Herceptin (trastuzumab). The company says the assay is designed to be completed within the same day, enabling clinicians to get