Drugs
Vanda Pharmaceuticals 4/6 filed a lawsuit in the DC District Court that seeks to compel FDA to produce drug review records under the Freedom of Information Act (FOIA) associated with the company’s supplemental NDA for Hetlioz (tasimelteon) for treating Jet Lag Disorder (JLD) that was given a complete
Drugs
FDA has lifted a Gilead Sciences partial clinical hold earlier placed on studies evaluating its investigational agent magrolimab in combination with azacytidine in myelodysplastic syndrome and acute myeloid leukemia patients. The agency removed the hold after reviewing the comprehensive safety data from each trial, according to the company. Gilead says
Drugs
Bausch Health Companies has received only the second untitled letter from CDER’s Office of Prescription Drug Promotion (OPDP) this year, citing the firm over its promotional communications, a direct-to-consumer video, and an efficacy Web page on its healthcare professional Web site for Duobrii (halobetasol propionate and tazarotene)
Drugs
CMS has issued its long-awaited National Coverage Determination (NCD) on Medicare coverage of only FDA traditionally approved monoclonal antibodies that target amyloid (or plaque) for treating Alzheimer’s disease, which is a significant blow to Biogen’s controversial accelerated approval of Aduhelm (aducanumab). Additionally, CMS says that as part
Drugs
The Department of Justice says that Raidel Figueroa, the former CEO and co-founder of Pharmatech, a drug and dietary supplement manufacturer that operated in Broward County, FL, has been charged with conspiring to manufacture and distribute drugs outside FDA regulatory oversight and to interfere with and obstruct FDA. A
Drugs
Federal Register notice: FDA is making available a draft ICH guidance entitled “M7(R2)Addendum: Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes.” The document adds monographs for seven new compounds to the M7 Guideline which outlines considerations for assessment and control
Drugs
Bayer is petitioning FDA to confirm that it will stay final approval of an Apotex ANDA citing Bayer’s Astelin (azelastine HCl) nasal spray as the reference-listed drug until the expiration of the 30-month period beginning on the date Bayer received the Apotex Paragraph IV certification. The Bayer
Drugs
Minerva Neurosciences says the minutes of its 3/2 Type C meeting with FDA on the development of roluperidone to treat negative symptoms of schizophrenia show the agency continues to have significant concerns about a proposed NDA while acknowledging an unmet need for negative symptom treatments and urging Minerva to
Drugs
FDA’s reliance on its mutual recognition agreement (MRA) with the EU significantly helped the agency assess drug manufacturing quality during the pandemic and it is expected to be used even more after the public health emergency is over, according to FDA associate commissioner for regulatory affairs Judith McMeekin. Speaking
Drugs
FDA has published a guidance, Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment, to assist sponsors in the clinical development of drugs and biologics to treat chronic hepatitis B infection from the initial IND through the NDA or BLA and postmarketing phases. The document does not address the development
Drugs
FDA has published for comment a draft of the International Council for Harmonization (ICH) Addendum to M7(R2) containing revisions to the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes. The document contains the list of revisions to the M7 guideline and the new monographs for the seven
Drugs
GlaxoSmithKline says an FDA draft guidance on immunogenicity information in human prescription therapeutic protein and select drug product labeling content and format does not address where to place the information for labels subject to regulation at 21 CFR 201.80 rather than the 21 CFR 201.56 and 201.57
Drugs
FDA has published the October-December 2021 listing of potential signals of serious risk/new safety information identified by the FDA Adverse Event Reporting System. For each of the listings, FDA says it is evaluating the need for regulatory action.
Drugs
FDA has approved a BioXcel Therapeutics NDA for Igalmi (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or Bipolar I or II disorder in adults. This is the first new acute treatment for schizophrenia or bipolar disorder-associated agitation in nearly a decade and “represents a
Drugs
Amgen says that while it appreciates FDA’s issuance of a draft guidance on the assessment of presser effects of drugs, it has concerns about the agency’s recommendations to use ambulatory blood pressure monitoring for any drug intended for chronic use. The company comment says it is skeptical that
Drugs
Federal Register notice: FDA is announcing the following information collections that have been approved by OMB: * Reclassification Petitions for Medical Devices (OMB control # 0910-0138) * Pharmaceutical Distribution Supply Chain (0910-0806) * Environmental Impact Considerations (0910-0322) * Reporting Associated with Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration of
Drugs
FDA has granted commercial licensure approval for a Novartis Durham, NC, multi-product gene therapy manufacturing facility. The company says the approval allows the state-of-the-art 170,000 square-foot Zolgensma facility to make, test, and release commercial Zolgensma (onasemnogene abeparvovec-xioi), a gene therapy indicated for treating
Drugs
FDA is participating with the University of California San Francisco and Quantum Leap Healthcare Collaborative in an electronic health record (EHR) integration project that aims to streamline health data for clinical research trials. An EHR Intelligence story says that OneSource is an electronic data capture system based on open-source
Drugs
FDA says GlaxoSmithKline’s sotrovimab is no longer authorized to treat Covid-19 in any U.S. HHS region due to increases in the proportion of Covid-19 cases caused by the omicron BA.2 sub-variant. An agency update says Centers for Disease Control and Prevention data indicate that
Drugs
CDER director Patrizia Cavazzoni says FDA’s recent increased funding request for fiscal year 2023 would, if enacted, help address a Center priority to improve drug postmarket surveillance and oversight of marketed products. The budget request calls for an almost 10% increase — a $356 million boost over current authorized spending
Drugs
FDA says it is advancing a framework to objectively rate pharmaceutical manufacturing sites’ Quality Management Maturity (QMM). The program is part of a Biden Administration 2021 plan to address the vulnerabilities and drug shortages in the nation’s pharmaceutical supply chains (see earlier story). The agency has defined QMM as
Drugs
FDA has granted priority review for Sanofi and Regeneron’s sBLA for Dupixent (dupilumab) 300 mg weekly to treat adult and pediatric patients age 12 and older with eosinophilic esophagitis. The companies say the PDUFA target action date for the application is 8/3. Dupixent has already been granted breakthrough