Drugs
Genentech says it commends FDA for leveraging scientific and regulatory experience to develop guidance for sponsors on how PK-based criteria can be used to support registration of alternative dosing regimens beyond those studied in dedicated clinical trials. Responding to an agency draft guidance, Pharmacokinetic-Based Criteria for Supporting Alternative
Drugs
Novartis says the CANOPY-1 Phase 3 study of canakinumab in lung cancer did not meet its primary endpoints of overall survival and progression-free survival in patients with previously untreated locally advanced or metastatic non-small cell lung cancer. The company says patients in the treatment arm received canakinumab
Drugs
[Report by David McFarland] FDA’s need to conduct preapproval inspections was reduced by 55% during the Covid-19 pandemic by the agency’s use of alternative tools, CDER Office of Pharmaceutical Manufacturing Assessment director Stelios C. Tsinontides told an online Pharmaceutical Quality Symposium 10/26. Historically, about 20% of
FDA Policy/General
Federal Register proposed order: FDA is proposing to exempt certain categories of biological products from certain reporting requirements under the Federal Food, Drug, and Cosmetic Act as amended by the Coronavirus Aid, Relief, and Economic Security Act. Under the proposal, the following two categories of biological products would be exempt
Drugs
Washington Legal Foundation (WLF) has asked the 9th Circuit Court of Appeals to affirm a lower court ruling that federal law preempts the plaintiffs’ state law failure-to-warn claim because it was impossible for the drug’s manufacturer to change the drug’s label under federal law. Adams v.
Drugs
Three Sidley attorneys say a new FDA final rule amending the agency’s regulations defining intended use opens many consumer products without therapeutic claims to regulatory oversight as drugs or medical devices. In their analysis, the attorneys say the rule provides that the agency can find a product subject to
Drugs
The Association for Accessible Medicines (AAM) says FDA should expand the scope of the draft guidance Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA to include complex formulations like inhalation products, liposomal products, and vaginal cream. “Additional clarity around FDA’s expectations related to locally acting oral
Devices
The Pew Charitable Trusts says Congress should pass legislation to increase the transparency of the market for laboratory-developed tests (LDTs) and authorize FDA to review the tests based on their risk to patients. In an online report, Pew says that because LDTs are not centrally registered or tracked, no
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee voted 17 to 0 to recommend the agency authorize the use of Pfizer’s Covid-19 lower-dose vaccine in children ages 5 to 11 years. Panel members agreed that the vaccine’s benefits outweighed the risks, but some seemed concerned
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution — 21 CFR Part 207” (OMB Control Number 0910-0045). The collection was revised to include the collection of certain information required by the Coronavirus Aid,
Devices
Eyenovia has received a complete response letter on its NDA for MydCombi (tropicamide and phenylephrine), indicated for in-office pupil dilation, because the agency had reclassified the drug as a drug-device combination product. The reclassification was prompted by FDA’s recent court loss (see earlier story) in Genus Medical
Drugs
FDA has granted Alkermes a fast track designation for nemvaleukin alfa, an engineered interleukin-2 (IL-2) variant immunotherapy for use in combination with Merck’s Keytruda (pembrolizumab) in treating platinum-resistant ovarian cancer. Alkermes says nemvaleukin is designed to “preferentially expand tumor-killing immune cells while avoiding the activation
Drugs
Responding to a dispute resolution request, CDER’s Office of New Drugs has told Avenue Therapeutics that additional input is needed and an advisory committee meeting will be convened to review issues on its twice-rejected intravenous tramadol NDA, indicated for treating pain. After the joint Anesthetic and Analgesic Drug
FDA Policy/General
Federal Register notice: FDA has announced a 12/10 meeting of the Medical Devices Advisory Committee’s Neurological Devices Panel. Members are scheduled to vote on a BrainsGate PMA for its Ischemic Stroke System, indicated for increasing cerebral blood flow and to reduce disability in adult patients with acute ischemic
Drugs
FDA has posted a six-observation Form FDA-483 after inspecting a Biocon drug substance manufacturing facility in Malaysia last month. For example, the heavily redacted form cited the firm for inadequate aseptic behavior and monitoring. It also said its facilities and equipment are not adequately validated and maintained. Additionally,
Devices
CDRH has created a patient resource Web page to provide information about endometrial ablation for heavy menstrual bleeding, including the procedure's benefits and risks. The page covers approved endometrial ablation devices for premenopausal patients with heavy menstrual bleeding due to benign causes. The devices use various methods, such
FDA Policy/General
FDA Withdraws Approval for 216 ANDAs 10/22/2021 Federal Register notice: FDA has withdrawn the approval of 216 ANDAs from multiple holders because they repeatedly failed to submit required annual reports to the agency. Previousy, FDA published a notice offering an opportunity for a hearing on proposal to withdraw
FDA Policy/General
Alexion Pharmaceuticals has agreed to acquire Wilson Therapeutics and investigational drug WTX101 (bis-choline tetrathiomolybdate) for treating Wilson disease. The first-in-class copper-binding agent with a unique mechanism of action is designed to detoxify excess copper in both liver and blood, and promotes copper clearance through biliary excretion.
FDA Policy/General
BIOLOGICS FDA has approved Hospira’s Inflectra (infliximab-dyyb), a biosimilar product referencing Janssen Biotech’s Remicade. The approval covers indications such as: adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy;
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Data Standards for Drug and Biological Product Submissions Containing Real-World Data. The document provides recommendations to sponsors when submitting study data derived from real-world data sources in applicable regulatory submissions using standards specified in the Data Standards
FDA Policy/General
Federal Register notice: FDA has determined that 20 listed drug products were not withdrawn from sale due to safety or effectiveness issues. The determination means that FDA will continue to approve ANDAs that reference the products as long as they meet relevant legal and regulatory requirements. To view the notice,
Drugs
FDA has placed a clinical hold against Tryp Therapeutics and a Phase 2a study evaluating its psilocybin for eating disorders (binge eating disorder and hypothalamic obesity). The company says the agency notification did not provide a reason for the clinical hold and advised that additional details on any deficiencies will