Drugs
FDA has accepted for review an Ortho Dermatologics NDA for tazarotene 0.045%) lotion for treating moderate to severe acne. The agency has set a 12/22 user fee review action target date. The submission includes data from two Phase 3 trials in 1,614 patients. The primary efficacy endpoints
Drugs
Amarin says it expects FDA will extend its review of a supplemental NDA seeking an expanded indication for Vascepa (icosapent ethyl) capsules based on data from the REDUCE-IT cardiovascular (CV) outcomes study. The current user fee review action target date is 9/28, but FDA told the company 8/
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Fabry Disease: Developing Drugs for Treatment.” The document describes the agency’s current recommendations regarding eligibility criteria, trial design considerations, and efficacy endpoints to be used in clinical development programs of investigational drugs to treat the disease. To view
Drugs
Following a 7/25 meeting with FDA, Evoke Pharma says it will resubmit its Gimota (metoclopramide) NDA to the agency in the fourth quarter of 2019. The company says the meeting was to obtain FDA feedback and agreement on the company’s plan to address deficiencies cited in a 4/
Drugs
FDA has granted Dynacure an orphan drug designation for DYN101, an investigational antisense medicine designed to modulate the expression of dynamin 2 (DNM2) for treating centronuclear myopathies (CNM). The company expects to initiate a Phase 1/2 study (Unite-CNM) in a few months. The therapy is being developed in
Drugs
The Federal Trade Commission (FTC) says Boston Scientific has agreed to divest certain assets to Varian Medical Systems to resolve FTC charges that the company’s proposed $4.2 billion acquisition of BTG would violate antitrust law. BTG is a medical equipment and pharmaceutical supplier. FTC says that as originally
Drugs
CDER director Janet Woodcock says that rather than develop individual products, the National Institutes of Health (NIH) could be of greatest use by filling the gaps in translational science generally to help understand how to evaluate health conditions. Speaking at a 7/25 workshop on the NIH role in drug
Drugs
FDA has authorized a Helix BioPharma IND to begin a Phase 1b/2 study of L-DOS47 and doxorubicin in patients with advanced metastatic pancreatic cancer who have progressed on at least two prior treatment regimens. The Phase 1b will involve a dose escalation safety run-in to determine the
Drugs
Sarepta Therapeutics says an adverse report that was erroneously submitted to the FDA adverse event reporting system on a case of rhabdomyolysis in a participant in a study of the company’s micro—dystrophin gene therapy candidate in patients with Duchenne muscular dystrophy did not result in any interruption in
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable” (OMB Control Number 0910-0582). The document outlines the circumstances in which the agency intends to exercise enforcement
Drugs
FDA has released the FDA-483 issued following a 7/24-8/2 inspection at AveXis, San Diego, CA, the control testing laboratory at the center of data manipulation concerns (see story) with recently approved Zlogensma, a gene therapy product intended to treat children less than two years old with
Biologics
A CBER FY 2018 annual summary of biological product and HCT/P (human cells, tissues, and cellular and tissue-based products) deviations reports gives an overview of the types of reports received during the fiscal year, with detailed information about the number and type of deviations reports received. “Each firm
Drugs
FDA’s Antimicrobial Drugs Advisory Committee has voted 16-2 to recommend approval for Gilead Sciences’ HIV drug Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) for pre-exposure prophylaxis (PrEP) in men and transgender women who have sex with men. Panel members were mixed in
Drugs
Senate Finance Committee chairman Chuck Grassley (R-IA) says FDA should reinstate unannounced inspections of prescription drug manufacturing facilities in foreign countries in light of the administration’s proposed Safe Importation Action Plan and the fact that the foreign facilities provide most of the ingredients for drug production in the
Drugs
FDA has issued a draft guidance, Fabry Disease: Developing Drugs for Treatment, to give sponsors recommendations regarding clinical trial design features that can support approval of drugs and biological products intended to treat Fabry Disease (FD). The document says FD is a rare, X-linked, slowly progressive, lysosomal storage disorder
Drugs
The CDER Office of Prescription Drug Promotion is proposing research to determine healthcare providers’ awareness, perceptions, and beliefs about the benefits and risks of an FDA-approved product that carries a Boxed Warning. A Federal Register notice says Boxed Warning information may be included as part of prescribing information at
FDA Policy/General
A CMI Media survey of 127 doctors across 25 specialties looked at what information providers find most engaging and how they most prefer to receive it. The online report says that over 99% of healthcare providers who responded say they find medical reprints useful. One of the most effective tools
FDA Policy/General
Federal Register notice: FDA has made available an annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.” FDA is required to report annually on the status of postmarketing requirements and postmarketing commitments agreed upon by application holders of approved drug and
FDA Policy/General
Federal Register notice: FDA has revoked an Emergency Use Authorization issued to InBios International for the ZIKV Detect 2.0 IgM Capture ELISA based on the company gaining de novo marketing clearance 5/23 for the Class 2 device under the generic name “Zika virus serological reagents.” To view the
FDA Policy/General
Federal Register notice: FDA has filed with the Library of Congress an annual report on agency advisory committees that held closed meetings during fiscal year 2018. The report is mandated by the Federal Advisory Committee Act. To view the notice, click here.
Devices
FDA says that because of ongoing concerns about a late mortality signal in patients treated for peripheral artery disease in the femoropopliteal artery with paclitaxel-coated balloons and paclitaxel-eluting stents, it is working with manufacturers working on updated device labeling and clinical trial informed consent documents. In an 8/
Drugs
FDA is funding a 9/17 meeting hosted by The Critical Path Institute and the National Organization for Rare Disorders (NORD) to formally launch development of a new rare disease data and analytics platform. The host organizations say the platform’s goal is to accelerate movement of therapies from bench