Drugs
FDA has granted MyoKardia a breakthrough therapy designation for mavacamten, an oral, allosteric modulator of cardiac myosin for treating symptomatic, obstructive hypertrophic cardiomyopathy. In May, MyoKardia announced topline results from the pivotal Phase 3 EXPLORER clinical trial that showed mavacamten was well tolerated and has a safety profile comparable to
FDA Policy/General
Federal Register notice: FDA is proposing to establish requirements for the deadline and annual summary contents for sponsors and manufacturers who provide an eligible investigational drug for use by an eligible patient under the Right to Try Act. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies — 21 CFR part 58” (OMB Control Number 0910-0119). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has revoked the Emergency Use Authorization issued to Chembio Diagnostic Systems for the DPP Zika IgM Assay System because the company obtained premarket notification clearance for the device and related accessories. To view the notice, click here.
Drugs
FDA has granted Kite accelerated approval for Tecartus (brexucabtagene autoleucel), a chimeric antigen receptor T cell therapy for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL). Approval is based on results from ZUMA-2, a single-arm, open-label study in which 87% of patients responded to
Drugs
FDA has cleared a Palliare 510(k) for its EVA15 insufflator and smoke evacuation system. The device was designed to meet the “demanding insufflation requirements of endoscopic and robotic surgery, while offering integrated surgical smoke evacuation capability, filtering the hazardous smoke particles produced during laparoscopic surgery and removing them from
Drugs
Taro Pharmaceuticals has agreed to pay $205 million in criminal fines to resolve charges of conspiring to fix prices for generic drugs, according to the U.S. Justice Department. A two-count felony charge was filed in eastern Pennsylvania federal court that charged the company with participating in two criminal
Devices
Internet of Things (IoT) security firm Ordr says 86% of healthcare deployments had more than 10 FDA recalls against their medical IoT devices, meaning that the medical device was defective, posed a health risk, or both. The analysis was included in Ordr’s research into connected device adoption and risks,
Devices
U.S. senators Mike Enzi (R-WY) and Maggie Hassan (D-NH) have introduced legislation that would help protect patients from counterfeit medical products that could cause serious harm. Their Safeguarding Therapeutics Act would give FDA authority to seize and destroy counterfeit medical devices and products, including vaccines and combination
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Guidance for Industry on E6 (R2) Good Clinical Practice; International Council for Harmonization; Integrated Addendum to ICH E6 (R1)” (OMB Control Number 0910-0843). The guidance is intended to help implement improved and more efficient approaches to
FDA Policy/General
Federal Register notice: FDA has announced a 9/15 Pediatric Advisory Committee meeting. Panel members are scheduled to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003. They will also discuss acute dystonia associated with the use
Drugs
FDA is proposing a rule to establish requirements for the deadline and contents of an annual summary required from sponsors and manufacturers who provide an eligible investigational drug for use by an eligible patient under the Right to Try Act of 2017. The proposed rule says that under the law
Drugs
FDA has lifted its clinical holds on CymaBay Therapeutics’ seladelpar for its three IND applications for nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC), and primary sclerosing cholangitis. The company says it stopped all seladelpar clinical trials 11/25/19 after atypical histologic findings with no clinical or laboratory correlates were
Devices
FDA has approved an Abbott PMA to allow use of the company’s Patient Controller app on compatible personal Apple smartphone devices. The app allows patients living with neurological conditions, including chronic pain or movement disorders, the ability to manage therapy directly from their personal smartphone, the company says. The
Drugs
FDA has approved a Jazz Pharmaceuticals NDA for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for treating cataplexy or excessive daytime sleepiness in patients seven years of age and older with narcolepsy. Approval was based on data from a global Phase 3 double-blind, placebo-controlled study in
Drugs
FDA has published tables summarizing the current number of drug development tool qualification projects, grouped overall by program and development tool stage. The document says the development tool stage is determined by the last submission accepted by the agency. The tables are updated and reported twice a year. The overall
Drugs
FDA says it is requiring that labeling for opioid pain medicines and medicine used to treat opioid use disorder be updated to recommend that healthcare professionals routinely discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment. An agency drug safety communication says healthcare professionals
Drugs
Fresenius Kabi has recalled two lots of dexmedetomidine HCl in 0.9% sodium chloride injection due to the possibility of a trace amount of lidocaine present in the two lots. The drug is approved for intravenous use and indicated for sedation of non-intubated patients prior to or during surgical
Drugs
Three FDA Centers and the Federal Trade Commission say that Web sites and YouTube channels operated by Create Wellness Clinics (21st Century LaserMed Pain Institute), Garden Grove, CA, are offering products for sale in the U.S. that are intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P): Minimal Manipulation and Homologous Use.” The guidance supersedes the guidance of the same title dated 11/2017 and corrected 12/2017. The new document revises
Drugs
An unnamed client represented by Lassman Law & Policy is asking FDA not to issue a BLA to Mesoblast for its Ryoncil (remestemcel-L) (ex-vivo culture-expanded adult human mesenchymal stromal cells suspension for intravenous infusion) to treat pediatric patients with steroid-refractory acute graft-versus-host disease (aGVHD)
Drugs
The CDER Biomarker Qualification Program has responded positively to a C-Path Predictive Safety Testing Consortium/Duchenne Regulatory Science Consortium qualification plan for glutamate dehydrogenase (GLDH) as a safety biomarker for drug-induced liver injury. A C-Path statement says the two consortia “provided scientific evidence supporting the use of