Drugs
FDA has approved an Audentes Therapeutics IND for AT132, the company’s gene therapy product candidate to treat X-Linked Myotubular Myopathy (XLMTM). The IND covers the company’s plans to begin ASPIRO, a multicenter, multinational, open-label, ascending dose Phase 1/2 clinical study of AT132. Preliminary data from
Devices
FDA has granted an extension for soft contact lens labelers to comply with the requirements of the Unique Device Identification system. This is the third extension granted to the soft contact lens industry. The extension is effective until one year after FDA: 1) develops and fully integrates a technical solution
Biologics
FDA has told Dynavax Technologies that the Vaccines and Related Biological Products Advisory Committee will review 7/28 the company’s BLA for Heplisav-B [hepatitis Bb vaccine, recombinant (adjuvanted)], a vaccine candidate for immunization against hepatitis B infection in adults 18 years of age and older. The agency has
Devices
FDA has cleared an ETS Wound Care 510(k) for the Mirragen Advanced Wound Matrix for use in treating acute and chronic wounds. The resorbable borate glass matrix device comprises fibers and beads proven to be effective in wound care management, according to the company. It is designed to be
Drugs
FDA has approved a Teva Pharmaceutical Industries NDA for Austedo (deutetrabenazine) tablets for treating chorea (uncontrollable muscular tremors) associated with Huntington’s disease. Approval was based on data from a Phase 3 multi-center trial conducted in 90 ambulatory patients with manifest chorea associated with Huntington’s. “Total Maximal Chorea
Drugs
Public Workshop on Engaging With CDER 03/31/2017 Federal Register notice. CDER announces a 5/12 public workshop on a “Roadmap for Engaging with FDA’s Center for Drug Evaluation and Research (CDER).” Comments Sought on Cell Tissue Product Info. Collection 03/31/2017 Federal Register notice: FDA seeks
FDA Policy/General
FDA could win or lose $40 million in the current fiscal year (FY) 2017 continuing resolution depending on whether Congress allows the omnibus measure to proceed with spending recommendations adopted last year or allow new Trump Administration projections that would cut many government-wide programs to make way for defense
Drugs
FDA has granted full approved to an AstraZeneca NDA for Tagrisso (osimertinib) 80mg once-daily tablets for treating patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer. In 2015, FDA gave accelerated approval to the therapy for those whose disease has progressed on
Drugs
FDA has approved a Pfizer supplemental NDA for Ibrance (palbociclib) that converts the previous accelerated approval to a regular approval based on the results from the confirmatory Phase 3 trial PALOMA-2. The approval also broadens the range of anti-hormonal therapy that may be administered with the therapy. IBRANCE
Drugs
FDA has accepted for priority review a Novartis BLA for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for use in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia. CAR-T therapies are manufactured for each individual
Devices
FDA has cleared a Providence Medical Technology 510(k) for the standalone use of the Cavux Cervical Cage-L System. The device is manufactured from medical grade titanium and available in a variety of sizes. It offers proprietary “grit-blasted and acid-etched surfaces,” a large space for allogenic and
FDA Policy/General
Federal Register notice. CDER has announced a 5/12 public workshop on a “Roadmap for Engaging with FDA’s Center for Drug Evaluation and Research (CDER).” The workshop will have presentations on the drug approval process, as well as the opportunity for questions and answers following each presentation. To view
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension on “Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) : Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice.” The agency’s regulations (21 CFR part 1271) require domestic and foreign establishments
Devices
FDA has cleared a Qiagen 510(k) for its Ipsogen JAK2 RGQ PCR Kit (ipsogen JAK2 assay) for use as a qualitative in vitro diagnostic test for detecting JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood, which is found in nearly all patients with Polycythemia Vera
Drugs
FDA has granted Akari Therapeutics a fast track designation for Coversin for treating paroxysmal nocturnal hemoglobinuria (PNH) in patients who have polymorphisms conferring eculizumab resistance. Coversin is described by the company as a “second-generation complement inhibitor that acts on complement component-C5, preventing the release of C5a and the
Devices
A key component of having a successful de novo submission to CDRH for neurological devices is requesting a pre-submission meeting (see guidance), according to a transcript of a 3/22 webinar for developers and sponsors of such devices automatically placed in Class 3 after (XXX DELETE XXX)a “not
Drugs
A group of Senate Democrats have introduced the Improving Access to Affordable Prescription Drugs Act that is intended to ensure drug companies put patients before profits and bring some much-needed relief to families and seniors on high drug costs. The lawmakers acted in the wake of Congressional Republicans’ failed
Devices
Merit Medical has begun a Class 1 recall of its Prelude Short Sheath Introducer, which is used to guide the placement of catheters, grafts, and other medical devices into the veins and arteries. The recall is related to a manufacturing defect which may cause the tip to separate from the
Devices
An Emergo Group online post says that proposed Trump administration user fee increases “would disproportionately impact smaller medical device companies, as these firms make up the majority of the U.S. medical device industry.” The post notes that Congress must approve fees and thus companies may not have to face
Drugs
FDA has released the FDA-483 issued following a 2/21-3/1 agency inspection at Cadila Healthcare, Himachal, Pradesh, India. Inspection observations made at the drug manufacturing facility included: * equipment used is the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations
Drugs
FDA researchers say that although drugs approved with a Boxed Warning or priority review are more likely to experience post-marketing safety events, other information provided during the FDA drug review that is easy to quantify is generally not associated with such post-marketing events. “It appears that these post-
FDA Policy/General
The FDA 2016-16 Regulatory Science Progress Report, required under the FDA Safety and Innovation Act, cites gains it says it has made in a number of areas: * Advancing the Science of Medical Product Development and Evaluation through development of computational tools supporting nonclinical evaluation of medical products; * Improving Clinical