Drugs
FDA has granted Dare Bioscience a qualified infectious disease product designation for its novel thermosetting hydrogel-containing clindamycin phosphate 2% and its use for treating bacterial vaginosis in women. The company says its thermosetting hydrogel formulation can result in better antibiotic delivery to the vaginal infection, which can lead to
Devices
Fresenius Kabi has recalled its Volumat MC Agilia Infusion Pumps and Vigilant Agilia Drug Library due to a “low priority — keep vein open, end of infusion” alarm and multiple software errors. “When enabled, the ‘keep vein open, end of infusion’ alarm triggers when the infusion is complete,” a recall notice
FDA Policy/General
Draft Guide on Fabry Disease Drug Development Federal Register notice: FDA makes available a draft guidance on Fabry Disease drug development. 08/08/2019 Info Collection on IVD Study Informed Consent Federal Register notice: FDA sends to OMB an information collection extension for its guidance on informed consent for in
FDA Policy/General
India’s Natco Pharma has signed a licensing agreement with Gilead Sciences, which allows Natco to sell generic versions in 91 developing countries of its hepatitis C treatment Sovaldi (sofosbuvir) and combination therapies using the active ingredient. Pfizer is closing a manufacturing plant in Foothill Ranch, CA that makes vitamins
FDA Policy/General
DEVICES AliveCor has received FDA approval for its AliveECG app, which can run an algorithm that detects atrial fibrillation. The company says the app runs on a smartphone and the patient places their hand over an AliveCor nodule device that fits over the back of the phone. It says the
Devices
FDA has given Endologix the green light to begin a pivotal study to evaluate the safety and effectiveness of its Nellix Chimney EndoVascular Aneurysm Sealing System and its use for the endovascular treatment of complex abdominal aortic aneurysms (AAA). The device combines the company’s Nellix 3.5 endograft with
Drugs
Is biotech G1 Therapeutics, which was cofounded by FDA acting commissioner Ned Sharpless, getting preferential treatment for its cancer drug trilaciclib? Progressive watchdog group Restore Public Trust says something smells fishy after the drug was recently given “breakthrough status” and company officials have reportedly been told by FDA to prepare
Drugs
FDA says it is planning an 11/7 public meeting on “Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA’s Office of New Drugs” to obtain “actionable policy suggestions“ for CDER review staff “regarding opportunities to promote effective drug development while maintaining the FDA’s regulatory standards for
Drugs
FDA has sent Kala Pharmaceuticals a complete response letter (CRL) on its NDA for KPI-121 (loteprednol etabonate) 0.25% for the temporary relief of dry eye disease signs and symptoms. The agency letter recommended efficacy data from an additional clinical trial before resubmission, the company says. Kala says it
Drugs
A new FDA Impact Story discusses new research the agency has undertaken to help would-be generic topical dermatological drug product developers demonstrate bioequivalence. “FDA collaborated with international researchers to evaluate a new method for monitoring the amount of a topical drug in the dermis,” it says. “In a procedure
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