FDA Policy/General
In a sign that the Biden Administration and FDA commissioner-nominee Robert Califf’s lobbying efforts are beginning to pay off, Senate majority leader Chuck Schumer filed cloture 2/10, which will likely send the nomination to a Senate floor vote early next week. The move to file cloture is
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Development of Non-Opioid Analgesics for Acute Pain.” The document provides information about product development-related issues, “opioid-sparing” claims, and expedited programs. To view the notice, click here.
Drugs
A 2/3 petition submitted by the Axinn law firm asks FDA to: * deny any Injectafer (ferric carboxymaltose injection) sNDAs for labeling changes based on the FAIR-HF and CONFIRM-HF trials, including any supportive data from AFFIRM-AHF, unless intended to add or strengthen a Contraindication, Warning, Precaution, or
FDA Policy/General
Federal Register notice: FDA is posting notice that a BLA applicant for a biosimilar product has notified the agency that an action for patent infringement was filed in connection with the applicant’s BLA. FDA is required to publish notice of any complaint received under Section 351(l)(6)(C)
Drugs
FDA has denied petitions submitted by attorney Jordan Thomas (Labaton Sucharow) asking the agency to halt two Cassava Sciences trials of its novel Alzheimer’s drug simufilam pending an FDA audit of concerns raised in the petitions. The initial petition called on FDA to audit: * the publications relied on by
Drugs
FDA has accepted for priority review a Sanofi sBLA for Dupixent (dupilumab) as an add-on maintenance treatment for children aged 6 months to 5 years with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The
Drugs
Harvard Medical School and Engelberg Foundation researchers say it is time for drug manufacturers to offer the U.S. government reasonable prices for drugs discovered using federal funding. Writing in the New England Journal of Medicine (registration or subscription required), the researchers say the alternative is for the government to
Drugs
FDA has granted Bayer a fast track designation for its investigational blood thinner asundexian (BAY2433334) as a potential treatment for secondary prevention in patients with a non-cardioembolic ischemic stroke. The company describes asundexian as an oral inhibitor of Factor XIa (FXIa) that Bayer is developing as a potential treatment
Drugs
Public Citizen is petitioning FDA and the Drug Enforcement Administration to open proceedings to place gabapentin (Almatica Pharma’s Gralise and Pfizer’s Neurontin) and gabapentin enacarbil (Arbor’s Horizant) into Schedule V of the Controlled Substances Act. The petition says scheduling the drugs is necessary because they have a
Drugs
FDA’s Oncologic Drugs Advisory Committee 2/10 voted 14 to 1 that Innovent Biologics and Eli Lilly’s “me too” checkpoint inhibitor sintilimab plus chemotherapy, indicated for treating metastatic non-small-cell lung cancer (NSCLC), requires an additional clinical trial demonstrating applicability to U.S. patients and U.S.
Drugs
The national sales director for the now-defunct New England Compounding Center (NECC), Robert Ronzio, has been sentenced in Massachusetts federal court to time served in connection with conspiring to defraud FDA. Ronzio pleaded guilty in 2016 and cooperated with the government, testifying at the trials of three other NECC
FDA Policy/General
What had seemed like an easy-to-confirm nomination of Robert Califf to be FDA commissioner, based on the 89-4 confirmation vote he received in 2016 when he served as commissioner in the Obama administration, is now stalled in a closely divided Senate and may not succeed. That’s
Drugs
FDA has approved a Sanofi BLA for Enjaymo (sutimlimab-jome) for decreasing the need for red blood cell transfusions due to hemolysis in adults with cold agglutinin disease (CAD). The rare autoimmune hemolytic anemia is caused by antibodies (cold agglutinins) binding to the surface of red blood cells, which causes
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Generic Drug User Fee Program” (OMB Control Number 0910-0727). The collection is being revised to include the current generic drug user fee agreement, or ‘‘goalsletter,’’ as reflected in the document “GDUFA Reauthorization Performance Goals and Program
FDA Policy/General
Federal Register notice: FDA is debarring for five years Brenda K. Marmas from personally importing any drug into the U.S. The agency based its action on evidence that Marmas engaged in a pattern of importing or offering for import misbranded drugs (i.e. in an amount, frequency, or dosage
Drugs
FDA has told Axsome Therapeutics that it will now meet its inspection deadline on inspecting the company’s contract manufacturing facility related to a 9/2021-submitted NDA for AXS-07 (meloxicam-rizatriptan) for the acute treatment of migraine. Previously, the agency had notified Axsome that due to Covid-19
Drugs
FDA has published a draft guidance, Development of Non-Opioid Analgesics for Acute Pain, as required by the Substance-Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. The document addresses the agency’s current thinking on three specific topics — development of non-opioid analgesic
Devices
Some 11 senators, led by Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA), are calling on FDA to finalize its proposed rule on over-the-counter (OTC) hearing aids without delay. In a 2/8 letter, the senators say the public comment period on the proposal closed 1/
Drugs
AstraZeneca says a need remains to develop additional medical products with alternate methods of action to address the burden of chronic sinusitis with nasal polyps. The company commented in response to an FDA draft guidance, Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment. It says the draft “serves as
Devices
AdvaMed says an FDA discussion paper on 3D printing of medical devices at the point of care needs to include a “firm statement … that 3D printing of repair parts or remanufactured devices should fall within the auspices of this guidance.” The association comment letter says AdvaMed agrees with the FDA
Biologics
Gamida Cell has begun a rolling BLA submission for omidubicel, indicated for patients with blood cancers in need of stem cell transplant. The company says the submission should be completed before 6/30. The BLA is based on data from a Phase 3 study showing that omidubicel achieved a statistically
Drugs
FDA has approved several safety-related labeling changes for Allergan’s Celexa (citalopram hydrobromide), a selective serotonin reuptake inhibitor indicated for treating depression. Psychiatric Times reports the changes include new dosage recommendations and Warnings for a higher risk of adverse reactions in pediatric and geriatric populations. The labeling also includes