FDA Policy/General
Former FDA senior regulatory counsel Joy Sharp has joined the law firm Faegre Drinker as counsel in Washington, DC. Sharp recently left the agency after 15 years of service. The law firm said in a release that she “brings a wealth of specialized legal and regulatory knowledge to the table
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for use with platinum-containing chemotherapy as neoadjuvant treatment and continuing as a single-agent post-surgical adjuvant treatment for resectable non-small cell lung cancer (NSCLC). Approval was based on data from the KEYNOTE-671 trial in 797 patients with previously untreated
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol.” The document is intended to alert pharmaceutical manufacturers and compounding pharmacists to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated with
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Diabetic Foot Infections: Developing Drugs for Treatment.” The document is intended to assist sponsors in their clinical development of drugs for treating diabetic foot infections without concomitant bone and joint involvement. To view the notice, click here.
FDA Policy/General
Center for Medicine in the Public Interest president Peter Pitts, a former FDA associate commissioner for external affairs, questions whether the “Chevron deference” that favors government agencies in court cases is dead. Writing online at IP Watchdog, Pitts says the Chevron deference is from a 1984 case in which the
Devices
Former Dolor Technologies CEO Mark Wright pleaded guilty in federal court on 10/11 to misdemeanor charges of causing the introduction of misbranded and adulterated medical devices into interstate commerce. The Justice Department says Dolor sold the SphenoCath, which was intended to treat migraine headaches by administering nerve blocks to
Drugs
FDA says CDER is soliciting comments on the barriers and facilitators to incorporating successful or promising innovative clinical trial approaches in drug development programs. An online notice lists questions the agency says could be considered in responses. “Comments submitted to this public docket will inform CDER’s future work related
Drugs
Verrica Pharmaceuticals is asking FDA to take specific actions on the compounding of its Ycanth (cantharidin) by pharmacies and outsourcing facilities. Ycanth is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients two years of age and older. The petition asks the agency to: * remove cantharidin
Drugs
FDA has released the form FDA-483 issued following an 8/21-9/1 inspection at the Samsung Biologics drug manufacturing facility in Incheon, Korea. The six inspection observations are: * the Manufacturing Scientific Analytical Technology laboratory used to support application submission testing has inadequate controls over data integrity; * written production
Biologics
FDA has granted Diakonos Oncology a fast-track designation for the company’s dendritic cell vaccine, DOC1021, for use in patients with glioblastoma multiforme (GBM). The designation was based on “positive preliminary safety and efficacy data” from a Phase 1 clinical trial in GBM patients, the company says. “Because Phase
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says the Supreme Court should hear an appeal filed by Danco Laboratories and FDA challenging a 5th Circuit Court of Appeals decision that would restrict how the abortifacient Mifeprex (mifepristone) is distributed to and used by patients. In its petition, Danco asked the
Drugs
FDA has denied without comment a UCB 5/16 petition asking the agency not to approve an Apotex ANDA for fenfluramine oral solution that cites UCB’s Fintepla (fenfluramine) oral solution as the reference-listed drug, unless specified conditions are met. The denial letter says UCB specifically said the Apotex
FDA Policy/General
Federal Register notice: FDA has determined that Sandoz’s Zofran ODT (ondansetron) orally disintegrating tablets (4mg and 8mg) were not withdrawn due to safety or effectiveness reasons. The determination means that the agency will continue to approve ANDAs that reference the products as long as they meet relevant legal and
Drugs
Aldeyra Therapeutics says it is addressing “substantive” late review-cycle concerns raised by FDA on the company’s NDA for reproxalap for treating the signs and symptoms of dry eye disease. During a recent meeting with Aldeyra, FDA stated that “[i]t does not appear that you have data to
Devices
An FDA update says GE HealthCare preliminary testing on its newly manufactured neonatal incubators suggests they may have higher levels of formaldehyde that rapidly decrease over one week. The update is part of the agency’s ongoing evaluation of published literature that found elevated levels of formaldehyde, cyclohexanone, and other
Drugs
FDA has accepted for priority review an AstraZeneca supplemental NDA for Tagrisso (osimertinib) in combination with chemotherapy for treating adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The agency has set a user fee review action target date of
Devices
FDA has cleared a SentiAR 510(k) for its CommandEP, which the company says integrates existing 3D cardiac mapping systems to create a real-time 3D holographic interface that provides physicians with an interactive, 360-degree view of the patient’s specific anatomy to allow them to deliver cardiac ablation
Drugs
Omeros says it is discontinuing its development of narsoplimab for treating immunoglobulin A (IgA) nephropathy based on Phase 3 clinical trial (ARTEMIS-IGAN) data that did not show statistical significance. An interim analysis of the ARTEMIS-IGAN trial failed to show a “statistically significant improvement over placebo,” the company says.
Drugs
AbbVie is reporting “positive results” from the head-to-head Phase 3 SEQUENCE study that evaluated the efficacy and safety of its Skyrizi (risankizumab) 600 mg intravenous [IV] drug compared to Janssen’s Stelara (ustekinumab) 600 mg IV in patients with moderately to severely active Crohn’s disease who have
Drugs
FDA has posted a final guidance entitled “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol.” The document is intended to alert pharmaceutical makers and state-licensed pharmacies who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol
Drugs
FDA has released a draft guidance entitled “Diabetic Foot Infections: Developing Drugs for Treatment.” The document is intended to assist developers that are developing such drugs where concomitant bone and joint issues are not involved. It provides FDA’s current thinking regarding the overall development program and clinical trial designs
Devices
FDA has updated its Compliance Program Guidance Manual for the Inspection of Medical Device Manufacturers, Compliance Program 7382.845 to “clarify current processes, incorporate new authorities, and update references and program contacts.” For example, the revised manual addresses Section 704(a)(4) of the FD&C Act, which was