Drugs
La Jolla Pharmaceutical Co. has reported positive top-line results from the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase 3 study of LJPC-501 (angiotensin II) in patients with catecholamine resistant hypotension. “The analysis of the primary efficacy endpoint, defined as the percentage of patients
Drugs
The 6th Circuit Court of Appeals has affirmed a lower court decision preempting a strict liability claim for failing to conform to representations of a prescription anti-seizure medication that the plaintiff said caused physical deformities and cognitive disabilities in her child who was born while she was taking the
Drugs
FDA already has the regulatory flexibility it needs to make drug decisions based on evidence from a variety of sources, according to former FDA commissioner Robert Califf and four other agency staffers, writing in an online Nature article that was submitted while Califf was still in office. The article says
FDA Policy/General
Federal Register notice: FDA has confirmed the effective date of 2/23 for a direct final rule that removes an “essential use” designation for certain ozone-depleting substances (ODSs) under the Clean Air Act. The action removes the essential-use exemption for sterile aerosol talc administered intrapleurally by thoracoscopy for
Drugs
A bipartisan group of senators led by Michael Bennet (D-CO) and Marco Rubio (R-FL) have reintroduced the RACE for Children Act (Research to Accelerate Cures and Equity for Children Act) to support the development of innovative and promising cancer drugs for children. The bill would amend the Pediatric
Drugs
FDA has accepted for priority review an EMD Serono and Pfizer BLA for avelumab as a treatment for patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-based therapy. The agency has set a user fee review target action date of 8/27. Avelumab
Devices
AdvaMed is telling the HHS Inspector General that existing federal anti-kickback law safe harbors retain beneficial value-based solutions but some changes are needed. In a 2/27 letter, the trade association lists problems that it says manufacturers and others currently face in seeking to engage in value-based
Drugs
Panelists at a Harvard School of Public Health forum on “The 21st Century Cures Act: Implications for Research and Drug Development,” expressed concerns about the faster FDA drug approvals envisioned under the law. American Cancer Society chief medical officer Otis Brawley said that mere ineffectiveness is not the worst thing
Drugs
CDER officials say the Center has two initiatives intended to improve its ability to conduct benefit/risk assessments of new drugs. Writing in the International Society for Pharmacoeconomics and Outcomes Research journal, CDER director Janet Woodcock and Office of the Commissioner staffer Kathleen Miller say the initiatives include patient-focused
Drugs
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Chongqing Pharma Research Institute Co. Chongqing (2/14): FDA inspected the firm 5/2016 and cited significant GMP deviations for active pharmaceutical ingredients. For example, the firm failed to
Drugs
An AcelRx Pharmaceuticals 505(b)(2) NDA has been submitted for Dsuvia (sufentanil sublingual tablet, 30 mcg) for treating patients with moderate-to-severe acute pain in a medically supervised setting. The agency has set a user fee target review date of 10/12. The submission includes data from four
Drugs
Genentech says it supports FDA’s consolidation and move to electronically coded manufacturing establishments information. Late last year, the agency published a draft guidance, Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information, discussing the requirements and implementation of the Federal Food, Drug, and Cosmetic Act on valid
Drugs
FDA has accepted for review an Antares Pharma for QuickShot Testosterone (QST), a drug-device combination product for the delivery of testosterone enanthate using a subcutaneous auto injector, indicated for treating adult men with low testosterone associated with hypogonadism. The agency has set a user fee review target date of
FDA Policy/General
Several clinical research organizations have written the National Institutes of Health and National Library of Medicine urging them to engage FDA and other stakeholders to obtain recommendations for improving ClinicalTrials.gov. Medical product sponsors are required to register their trials and submit results information at ClinicalTrials.gov. According to the
Drugs
CDER has posted a revised Manual of Policies And Procedures (MaPP) on the publication and use of good review practices (GRPs) within the Center. “Review staff are expected to become thoroughly familiar with pertinent GRPs and to adhere to these GRPs when conducting their reviews unless a particular part of
FDA Policy/General
Federal Register notice: FDA has announced a 3/1 public workshop in Silver Spring, MD on the current state and further development of animal models for serious infections caused by Acinetobacter baumannii and Pseudomonas aeruginosa. The agency is conducting the workshop in order to facilitate the development of narrow-spectrum
Drugs
Endo Pharmaceuticals has recalled one lot of Edex (alprostadil for injection) 10 mcg 2 Pack due to a potential for lack of sterility assurance. The recall is due to the detection by Endo of a defect in the crimp caps used in the product’s manufacturing, according to a recall
FDA Policy/General
Xynomic Pharmaceuticals has acquired from Pharmacyclics the exclusive worldwide rights to develop, manufacture and commercialize Abexinostat, a potentially best-in-class innovative Pan-Histone Deacetylase Inhibitor designed to target hematological and solid tumors. To date a total of 14 Phase 1 and 2 clinical trials of Abexinostat in U.S.
FDA Policy/General
Putney ANDA for Mupirocin Ointment Approval Withdrawn Federal Register notification of withdrawal: FDA has at the sponsor’s request withdrawn approval of a Putney, Inc. ANDA for mupirocin ointment 2% because the product is no longer manufactured or marketed. To view the notice, click here. 20 New Animal Drug Approvals
FDA Policy/General
President Trump 2/24 signed an executive order requiring FDA and other federal agencies to “establish a regulatory reform task force, which will ensure that every agency has a team of dedicated — and a real team of dedicated people — to research all regulations that are unnecessary, burdensome and harmful to
FDA Policy/General
Federal Register notification of withdrawal. FDA has withdrawn approval of 18 new animal drug applications and two abbreviated new animal drug applications. The withdrawals involve antimicrobial drugs of importance to human medicine that are administered to food-producing animals in medicated feed, and they are no longer manufactured or marketed.
Devices
FDA has approved an Intersect ENT PMA for its Propel Contour steroid releasing sinus implant. The device features an hourglass design for treating patients with chronic sinusitis in the frontal (behind the forehead) and maxillary (behind the cheeks) sinuses. It also has a low-profile flexible delivery system to make