Drugs
Citing information from industry sources, multiple media outlets are reporting that the Trump administration is looking at ways to lower prices for almost all prescription drugs sold to Medicare and other government programs by tying prices the programs would pay to lower prices in other countries. Reuters says White House
Drugs
FDA has approved an Eli Lilly NDA for Baqsimi (glucagon) nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection. “This new way to administer glucagon may simplify the process, which can be critical during an episode, especially since
Drugs
FDA has accepted for review a resubmitted Correvio Pharma NDA for Brinavess (vernakalant HCl, IV), an antiarrhythmic drug for rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults. The agency assigned a target PDUFA action date of 12/24. Correvio says the Brinavess NDA is supported
Drugs
FDA has established a docket to receive comments for 60 days on its publication of a glossary of terms that is part of the BEST (Biomarkers, Endpoints, and Other Tools) Resource Taxonomy. A Federal Register notice says FDA developed a Web page describing the BEST resource taxonomy and links to
Drugs
FDA has canceled a 7/31 meeting of its Psychopharmacologic Drugs Advisory Committee meeting that was scheduled to review an Intra-Cellular Therapies NDA for lumateperone tosylate capsules for treating schizophrenia. The company says the panel meeting was canceled to give FDA reviewers time to review FDA-requested additional information
Drugs
Loyola Law School professor Adam Zimmerman says the Supreme Court decision in Merck v. Albrecht demonstrates how the issue of federal preemption transcends the typical conservative and liberal positions. Writing online in The Regulatory Review, Zimmerman says Albrecht was a case of “impossibility preemption” in which the company said it
Drugs
Federal Register notice: FDA has submitted to OMB an information collection extension for “Clinical Laboratory Improvement Amendments (CLIA) Waiver Applications” (OMB Control Number 0910-0598). CLIA establishes quality standards for all laboratory testing, and it requires that clinical laboratories obtain a certificate before accepting materials derived from the human body
Drugs
Jubilant Cadista Pharmaceuticals (Salisbury, MD) has recalled one lot of drospirenone and ethinyl estradiol tablets due to out-of-specification dissolution results at the three-month stability time point. The affected product is made by contract manufacturer Cyndea Pharma in Soria, Spain. As a result of the dissolution results, product
Drugs
The World Health Organization (WHO) has published its draft working document QAS/19.81, Quality Management System Requirements for National Inspectorates, describing the quality management system requirements for operation of inspection services within national regulatory authorities or other state structures. WHO says it is intended that each inspection service will
Drugs
Pfizer says it appreciates the information in an FDA draft guidance on comparative analytical assessment and other quality-related considerations for developing therapeutic protein biosimilars. The company’s comment letter says it believes that combining the comparative analytical assessment within the previously issued quality considerations guidance is a very positive
Drugs
The Senate Finance Committee meets 7/25 to mark up the Prescription Drug Pricing Reduction Act of 2019, introduced by committee chairman Chuck Grassley (R-IA) and ranking member Ron Wyden (D-OR). Grassley and Wyden say the bill as drafted would result in Medicare savings of $85 billion over
Drugs
A 1/17-1/25 FDA inspection at the Indoco Remedies Limited drug manufacturing facility in Goa, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/9 Warning Letter says specific violations were: * failing to prepare batch production and control records with complete
Drugs
The DC federal court has vacated an FDA 12/2018 exclusivity determination that blocked Braeburn’s Brixadi (buprenorphine) extended-release injection for treating opioid use disorder from final approval through 11/30/20 due to exclusivity granted to Indivior’s Sublocade. The court told FDA to reconsider its decision “with
Drugs
A 12/17/18-2/8/19 FDA inspection at High Chemical Company, Levittown, PA, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A 7/2 Warning Letter says specific deviations were: * failing to ensure that, for each batch of API, appropriate laboratory
Drugs
FDA has issued a Warning Letter to Curaleaf (Wakefield, MA) for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases. “As we examine potential regulatory pathways for the lawful
Drugs
Restore Public Trust, a self-described non-partisan public interest group, says lobbying spending disclosures for the first half of 2019 show that the drug industry is doubling down to leverage its influence over policymakers. Restore Public Trust director Lizzy Price says that “HHS secretary Alex Azar and President Trump
Drugs
Bayer says it is recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials in the U.S. to the patient level. A company statement posted by FDA says that certain vials from the two lots that were labeled as Kogenate FS actually contain the FVIII hemophilia A
Drugs
FDA has approved nine ANDAs for first generics of Pfizer’s Lyrica (pregabalin) for managing neuropathic pain associated with diabetic peripheral neuropathy, and for managing postherpetic neuralgia. The generics are also indicated as adjunctive therapy for treating partial onset seizures in patients 17 years of age and older, for managing
Drugs
FDA has issued Biohaven Pharmaceutical Holding Co. a complete response letter on a 505(b)2 application seeking approval for Nurtec (riluzole) for treating amyotrophic lateral sclerosis (ALS). The letter raised concerns with the use of an active pharmaceutical ingredient (API) that was manufactured by Apotex Pharmachem India Private Ltd.
Drugs
Vanda Pharmaceuticals says it has received FDA notification about undisclosed deficiencies that “preclude discussion of labeling and postmarketing requirements/commitments” involving a supplemental NDA for Hetlioz (tasimelteon) for treating jet lag disorder. FDA stated that the notification does not reflect a final decision on the information under review. The user
Drugs
A new study in BMJ criticizes the strength of the data on which FDA based its 2017 approval of an Otsuka Pharmaceutical NDA for mental disorder-treating Abilify MyCite (aripiprazole tablets with sensor) — the first drug-device combination in the U.S. with a digital ingestion tracking system. Study researchers
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) is proposing to conduct research to determine how physician perceptions are influenced by drug marketing, specifically with variations in information context (presence of graphical elements and information delivery vehicle— medical journal abstract or sales aid), methodologic rigor of the underlying clinical study