Drugs
FDA has issued Athenex a complete response letter on an NDA for oral paclitaxel plus encequidar for treating metastatic breast cancer. The letter indicated concern about a safety risk due to an increase in neutropenia-related sequelae in patients on the oral paclitaxel arm compared with the intravenous paclitaxel arm
Devices
Empirical Spine says it will submit a rolling PMA for its LimiFlex Paraspinous Tension Band for treating patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The submission will be based on data from a pivotal trial comparing outcomes from patients who receive either LimiFlex or transforaminal lumbar interbody fusion
Devices
Medtronic has recalled all unused Valiant Navion thoracic stent grafts and informed physicians to immediately stop using the device until further notice due to reports from the Valiant Evo Global Clinical Trial indicating that three were observed to have stent fractures, two of which have confirmed Type IIIb endoleaks, and
Devices
FDA has granted a de novo marketing authorization to Q30 Sports Science for its Q-Collar, a device intended to be worn around the neck of athletes aged 13 years and older during sports activities to aid in protecting the brain from the effects associated with repetitive sub-concussive head
Drugs
FDA has approved an Amneal Pharmaceuticals ANDA for 150 mcg/day norelgestromin and 35 mcg/day ethinyl estradiol transdermal system, a generic copy of now-discontinued contraceptive Ortho Evra (Janssen Pharmaceuticals). As part of the approval, Amneal was granted 180 days marketing exclusivity. The product will be marketed under the
Drugs
FDA has approved B. Braun Medical’s acetaminophen injection in IV bags in 1,000 mg in 100 mL and 500 mg in 50 mL doses. The products are being manufactured using dual-sourced active pharmaceutical ingredients to reduce potential supply risks, the company says. Acetaminophen is indicated for managing
Drugs
FDA has asked Merck for additional data beyond a recently completed Phase 3 study of investigational Covid-19 drug MK-7110, an immune modulator. Previously, the company and the U.S. government penned a $356 million deal to supply the U.S. with 60,000 to 100,000 doses of
Biologics
An FDA advisory committee has voted 22-0 to support an emergency use authorization (EUA) for Janssen Biotech’s single intramuscular Covid-19 vaccine injection. In briefing materials released in advance of the meeting, agency reviewers determined that the vaccine “met the prespecified success criteria” in the pivotal trial. The
Biologics
GC Pharma has submitted a BLA for GC5107 (immune globulin intravenous (human),10% liquid) for treating patients with primary humoral immunodeficiency disease. The submission is based on data from a Phase 3 North America study that met its primary efficacy endpoint on the incidence rate of acute serious bacterial infections,
FDA Policy/General
Federal Register notice: FDA is amending its animal drug regulations to reflect the withdrawal of approval of seven new animal drug applications for lack of compliance with regulation-reporting requirements. They are: * Walco International’s Cuprate (cupric glycinate) * Oxis International’s Palosein (orgotein) * ConAgra Pet Products’ Sergeants Sure Shot (n-
Drugs
FDA has approved an AbbVie supplemental BLA for Humira (adalimumab) for treating moderately to severely active ulcerative colitis in pediatric patients five years of age and older. Approval was based on clinical trial (ENVISION I study) data showing that Humira induced clinical remission at week eight and maintained remission at
Devices
CDRH Office of In Vitro Diagnostics and Radiologic Health director Timothy Stenzel says that as of 2/17 FDA had authorized 331 tests and sample collection devices, including 247 molecular tests and sample collection devices, 70 antibody tests, and 14 antigen tests. Speaking at the 43rd CDRH virtual town hall
Drugs
A Consumer Reports (CR) investigation shows that FDA waited nine months in 2018 before warning the U.S. public about tianeptine, a dietary supplement that has opioid-like effects. The report says the magazine obtained FDA e-mails that “underscore concerns about FDA’s ability to police the $46 billion
Biologics
Former FDA chief of staff Lauren Silvis has been added to President Joe Biden’s Covid-19 response team. Silvis was agency chief of staff under former commissioner Scott Gottlieb. Before serving as chief of staff from 5/2017 to 6/2019, she was CDRH deputy director for policy. Silvis
Drugs
Aquestive Therapeutics says that feedback from FDA has put it on a “clear path” to resubmit its NDA for Libervant (diazepam) Buccal Film for managing seizure clusters. The further guidance from the agency addressed a revised weight-based dosing regimen, modeling and simulations data that Aquestive provided 12/2020, the
Drugs
FDA has granted accelerated approval to Sarepta Therapeutics NDA for Amondys 45 (casimersen) injection for treating Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping. Exons are DNA pieces that provide information for making proteins in a
Drugs
Three Hogan Lovells attorneys write that a 2/19 FDA announcement of Warning Letters sent to 10 companies for selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health disorders “signals that FDA labeling enforcement on health-related claims is on the rise under
Devices
Participants in a 2/24 DTx West virtual panel said a growing number of digital health companies “are finding themselves in a gray area of enforcement discretion, a term FDA uses for lower-risk products that meet the definition of a medical device but do not require regulatory submission, review,
FDA Policy/General
It's five weeks into the Biden presidency and the administration has not yet settled on a pick for FDA commissioner, which apparently does not bode well for the two frontrunners — acting commissioner Janet Woodcock and former FDA principal deputy commissioner Joshua Sharfstein. The commissioner nomination would seem important,
Biologics
FDA says it is allowing undiluted frozen vials of the Pfizer-BioNTech Covid-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. Previously, the vaccine’s preferred storage was in an ultra-low temperature freezer between
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Devices; Humanitarian Use Devices (HUD) — 21 CFR Part 814” (OMB Control Number 0910-0332). The collection is intended to assist FDA in making determinations on the following: (1) Whether to grant HUD designation of a medical
Drugs
The FDA Office of Clinical Pharmacology (OCP) met or exceeded its 2020 organizational, scientific, and regulatory goals, according to the OCP annual report, while also being very involved in FDA’s pandemic response. OCP expanded its policy fellowship program and published six new guidances, with a major focus on the