FDA Policy/General
Panel to Review Jardiance sNDA Federal Register notice: FDA announces an 11/13 Endocrinologic and Metabolic Drugs Advisory Committee meeting to review a Boehringer Ingelheim supplemental NDA for Jardiance. 10/04/2019 Clinical Data Standards Pilot: Correction Federal Register notice: FDA corrects a notice that appeared in 8/20 Federal
FDA Policy/General
DEVICES FDA has cleared an AtriCure 510(k) for its AtriClip PRO2 Left Atrial Appendage (LAA) Exclusion System that is designed for “increased functionality” than its previous model when occluding the LAA during surgical procedures. The device features an “ambidextrous locking and trigger-style clip closing mechanism, handle-based active
FDA Policy/General
Federal Register notice: FDA announces an 11/13 Endocrinologic and Metabolic Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Boehringer Ingelheim Pharmaceuticals supplemental NDA for Jardiance (empagliflozin) oral tablets, seeking an indication as an adjunct to insulin therapy to improve glycemic control in adults with Type 1
Drugs
As part of FDA’s Safe Use Initiative, CDER director Janet Woodcock has announced a “funding opportunity for individuals and organizations to conduct further research about the safe use of medications in order to inform the development of innovative methods to mitigate or reduce risks related to medication use.” Research
FDA Policy/General
As the latest number of reported cases and deaths associated with vaping products grows, FDA has updated a consumer alert to warn against using vaping products containing tetrahydrocannabinol (THC), the primary psychoactive component found in the cannabis plant. “Additionally, consumers who choose to use any vaping products should not modify
Biologics
FDA has accepted for review a DBV Technologies BLA for its investigational Viaskin peanut immunotherapy for treating peanut-allergic children ages four to 11 years. The once-daily, epicutaneous patch is designed to potentially reduce the risk of life-threatening allergic reactions due to accidental exposure to peanuts by delivering
Drugs
Is the pharmaceutical industry secretly plotting the demise of president Trump and supporting the current impeachment inquiry in the House of Representatives? That is what Trump suggested to supporters (see White House transcript) at an event in the Villages development in central Florida 10/3. Without citing any evidence, Trump
FDA Policy/General
Federal Register notice: FDA has corrected a notice that appeared in the 8/20 Federal Register announcing a “Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide: Version 3.1.” The document was published with the incorrect
Drugs
FDA has approved AstraZeneca’s self-administration version of Fasenra (benralizumab) Pen in a pre-filled, single-use auto-injector as an add-on maintenance treatment for severe eosinophilic asthma. The approval is based on data from the Phase 3 GRECO trial and the Phase I AMES trial. “The safety
Devices
United Health Products has submitted a PMA for HemoStyp, an absorbable hemostatic dressing for use in abdominal, cardiovascular, thoracic and vascular surgical procedures. The device is derived from regenerated oxidized cellulose, which is designed to absorb exudate/drainage from superficial wounds, and helps control bleeding. “Once HemoStyp has dissolved in
Drugs
FDA has granted Janssen Pharmaceutical a breakthrough therapy designation for niraparib, an orally-administered poly ADP-ribose polymerase inhibitor, for treating patients with BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer who have received prior taxane chemotherapy and androgen receptor-targeted therapy. The designation is based on data from
Drugs
Public Citizen says the Trump administration “has been unable to enact a single meaningful reform to bring down drug prices. That happens when you hire pharma execs to regulate pharma execs. Now the president is turning to the Council of Economic Advisers (CEA) to invent the drug pricing victory he
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment.” The document is intended to help sponsors design and conduct nonclinical studies needed in (XXX SUBSTITUTE XXX) human clinical trials, ongoing clinical development, and marketing approval for such products. To view the
Drugs
The Koch-supported Taxpayers Protection Alliance has issued a report, Reforming the FDA: Saving Money, Saving Lives, calling on the agency to “pursue a series of reforms that, if enacted, would save consumers millions of dollars and millions of lives. Across all divisions of the agency, a more permissive approach
Drugs
FDA says a “Bioanalytical Methods Template” technical specifications guidance is available for industry to use. An agency notice says the guidance provides ready-to-use templates that sponsors can use to submit summaries of bioanalytical methods used in clinical pharmacology studies that require pharmacokinetic concentration evaluation. Templates in the guidance
Drugs
FDA has approved Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for use in at-risk adults and adolescents weighing at least 35kg for HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex.
Drugs
Nippon Shinyaku says it has completed submission of a rolling NDA for its viltolarsen that is under development to treat Duchenne muscular dystrophy amenable to exon 53 skipping. The company says the drug is expected to generate functional dystrophin proteins and be effective for Duchenne muscular dystrophy amenable to dystrophin
Devices
FDA has cleared a Biofourmis 510(k) for its machine-learning and artificial intelligence (AI)-powered Biovitals Analytics Engine as a medical device for ambulatory physiological monitoring. The device “receives physiologic data such as heart rate, respiratory rate and activity in near real-time from FDA-cleared sensors and leverages
FDA Policy/General
Federal Register notice: FDA has corrected a 6/4 Federal Register notice withdrawing approval of five ANDAs for pemoline products because it contained an incorrect Web site address for an archived Web page of a Postmarket Drug Safety Information for Healthcare Professionals communication that the agency issued 10/2005. That
Drugs
FDA has denied three requests included in a 5/6 citizen petition submitted on behalf of Zydus Pharmaceuticals relating to its Mephyton (phytonadione) vitamin K1 tablets. The company had asked that the agency: * require that manufacturers of generic phytonadione tablets establish sameness with the reference-listed-drug (RLD) Mephyton by
Drugs
FDA has granted Verastem an orphan drug designation for Copiktra (duvelisib) for use in treating T-Cell lymphoma. The therapy is currently approved in the U.S. for treating chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies have failed, and accelerated approval in follicular lymphoma after
Drugs
FDA says it has opened a new Web page — FY 2018 GDUFA Science and Research Outcomes — to provide greater transparency into “the important work the agency engages in to advance the science of generic drugs and provide generic drug developers, applicants, and FDA reviewers essential tools and information to help