Drugs
House Energy and Commerce Committee chair Frank Pallone (D-NJ) and Oversight and Reform Committee chair Carolyn Maloney (D-NY) have written to FDA acting commissioner Janet Woodcock seeking answers to 15 detailed questions on the agency’s review process and accelerated approval of Biogen’s Alzheimer’s drug Aduhelm
Drugs
Takeda Pharmaceutical is reporting disappointing data from its Phase 3 PANTHER (Pevonedistat-3001) study, which did not achieve pre-defined statistical significance for the primary endpoint of event-free survival (EFS). The trial evaluated whether the combination of pevonedistat plus azacitidine as first-line treatment for patients with higher-risk
Drugs
FDA has accepted for review an Orphalan NDA for trientine tetrahydrochloride (TETA 4HCl) for the first-line treatment of Wilson’s Disease. The rare inherited disorder of copper transport primarily affects the liver and brain, according to the company. If approved, trientine tetrahydrochloride would be an alternative copper chelating agent
Drugs
CDER Office of Generic Drugs (OGD) has reached the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy designation. The Competitive Generic Therapy program encourages the development and marketing of generic drugs for products with little to no competition. “Additionally, more than 80% of the
Biologics
FDA has announced a 9/17 Vaccines and Related Biological Products Advisory Committee meeting to discuss Pfizer-BioNTech’s supplemental BLA seeking approval for a booster dose of Comirnaty (Covid-19 vaccine, mRNA) in individuals 16 years of age and older. “The process for authorizing or approving the use of
Drugs
FDA has approved Janssen’s Invega Hafyera (paliperidone palmitate) extended-release injectable suspension to treat schizophrenia in some adults. An agency statement says the atypical antipsychotic is the first long-acting schizophrenia medication to be injected once every six months. Other long-acting injectable antipsychotics are administered every few weeks
Drugs
An 8/18 petition submitted to FDA by attorney Jordan Thomas (Labaton Sucharow) asks FDA to halt two ongoing Cassava Sciences trials of its novel Alzheimer’s drug simufilam pending an agency audit of concerns raised in the petition. The document says Cassava has publicly announced the completion of a
FDA Policy/General
Federal Register notice: FDA has announced an 11/4 Psychopharmacologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Levo Therapeutics NDA for carbetocin nasal spray, for the proposed treatment of hyperphagia, anxiety, and distress behaviors associated with Prader-Willi syndrome. To view the notice, click here.
Drugs
FDA has ordered a drug class warning for Janus kinase (JAK) inhibitors after reviewing a recent clinical trial that showed an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with Pfizer’s arthritis and ulcerative colitis medicines Xeljanz and Xeljanz
Drugs
FDA says new analytical methods for detecting the carcinogen NDMA (N-nitrosodimethylamine) developed by CDER scientists have shown that actual levels of NDMA in ranitidine drug products were much lower than previously reported. In the “What is New in Regulatory Science” online summer issue, CDER says that to further address
Drugs
A 9/9-9/19/19 FDA inspection at AnazaoHealth, Las Vegas, NV, found that drug products compounded at the facility don’t meet legal requirements for exemptions from the Federal Food, Drug, and Cosmetic Act for drugs produced by an outsourcing facility. An 8/18 Warning Letter says the
Drugs
Astellas Pharma says it has paused screening and dosing of additional participants in its ASPIRO clinical trial evaluating AT132 in patients with X-linked myotubular myopathy. A company statement says the pause follows reporting of a serious adverse event in a study participant due to abnormal liver function tests observed
Biologics
In the wake of the departures of two senior CBER vaccine officials (see earlier story), FDA acting commissioner Janet Woodcock has weighed in, pledging support and asserting confidence that she and the agency have in the Center’s ability to deliver safe and effective vaccines during the pandemic. CBER Office
Devices
FDA has cleared an Asensus Surgical 510(k) to expand the machine vision capabilities on its previously cleared Intelligent Surgical Unit (ISU), which is used with the company’s Senhance Surgical System to enable digital laparoscopy. “The current features of the ISU enable machine vision-driven control of the camera
Drugs
FDA has converted Merck’s accelerated approval to full approval for its anti-PD-1 Keytruda (pembrolizumab) and its use in first-line treatment of advanced urothelial carcinoma (bladder cancer). In addition, the indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial
FDA Policy/General
Attorneys Anne Walsh and JP Ellison (Hyman, Phelps & McNamara) say the Department of Justice (DoJ) “quietly” changed the role of guidance documents by reversing two Trump administration policies on such documents. Writing in their firm’s FDA Law Blog, Walsh and Ellison say the first policy, from 2017, prohibited
Drugs
FDA says its review of requested records supplied by Gulsah Uretim Kozmetik Sanayi Anonim Sirketi, Istanbul, Turkey, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 5/13 Warning Letter says specific violations were: * failing to have for each batch of drug product
FDA Policy/General
Federal Register notice: FDA has revoked 15 Emergency Use Authorizations (EUAs) — 12 decontamination systems for personal protective equipment, one bioburden reduction system for personal protective equipment, and two umbrella EUAs for certain imported, non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators. The revocations for the decontamination
Biologics
Two senior CBER vaccine officials are leaving FDA over the next couple of months — untimely departures that signal trouble with how the agency and Biden Administration are handling Covid-19 vaccine reviews and approvals. CBER Office of Vaccines Research and Review (OVRR) director Marion Gruber plans to retire 10/31,
Drugs
A 5/18-5/19 public meeting on potential medication error risks with IND drug container labels gathered information from national and international stakeholders for FDA to consider and determine if regulations are needed. The meeting was sponsored by FDA and the Reagan-Udall Foundation for FDA. CDER Office of
Drugs
FDA has released a guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH). The document provides detailed information and specifications for the content of the tabulated domains and analysis data sets submitted to FDA as part of a sponsor’s application for
Drugs
Former FDA commissioner Scott Gottlieb says the U.S. needs a “coordinated national clinical trial infrastructure in the setting of a public health crisis.” Writing online in JAMA Health Forum, Gottlieb says the need for a coordinated infrastructure was demonstrated during the Covid-19 pandemic when U.S. investigators conducted