Drugs
U.S. Rep. Abigail Spanberger (D-VA) has introduced a bill entitled the Banning Misleading Drugs Act that is intended to prevent manufacturers from obscuring dangerous side effects of their prescription drugs in their advertisements and to help consumers make informed decisions. The measure would require FDA to finalize a
Drugs
HRA Pharma, a Perrigo company, has submitted an NDA that, if approved, would be the first over-the-counter (OTC) birth control pill in the U.S. The Rx-to-OTC switch application is for the company’s Opill (norgestrel .075 mg), a progestin-only daily birth control pill (also
Drugs
Former CDER Office of Generic Drugs Division of Legal and Regulatory Support deputy director Martin H. Shimer II has joined Lachman Consultants after a 22-year career at the agency. At the ANDA consulting firm, Shimer will “assist clients with regulatory submissions and strategy, communications with FDA, and navigating the
Drugs
The National Hemophilia Foundation says FDA should require Risk Evaluation and Mitigation Strategies (REMS) if it approves two investigational gene therapies to treat hemophilia. The foundation’s 7/1 petition says REMS should be required for BioMarin’s valotocogene roxaparvovec, under regulatory review to treat severe hemophilia A, and CSL
Drugs
FDA has revised the emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir and ritonavir) to authorize state-licensed pharmacists to prescribe the Covid-19 treatment to eligible patients with certain limitations to ensure appropriate patient assessment and prescribing. An agency statement says that allowing pharmacists to prescribe Paxlovid could
Drugs
Two Covington & Burling attorneys say the Federal Food, Drug, and Cosmetic Act preemption provision for over-the-counter medications is “expansive. Although there are a few outlier cases in the food labeling context, courts have interpreted the preemption provision for OTC medications to mean what it says: state law
Drugs
A CDER Office of Pharmaceutical Quality (OPQ) self-audit comparing approved drug regulatory submissions that employ continuous manufacturing versus traditional batch processes has identified regulatory and patient advantages to continuous manufacturing. In a CDER podcast, OPQ deputy director Mahesh Ramanadham says the audit found that applications that used continuous manufacturing
Drugs
Intercept Pharmaceuticals says that based on results from the Phase 3 REGENERATE trial of its obeticholic acid (OCA) in patients with liver fibrosis due to nonalcoholic steatohepatitis, it will resubmit an NDA to FDA. The company received a 2020 complete response letter to its original NDA submission. An Intercept announcement
Drugs
FDA is warning about a possible increased risk of death with the Secura Bio cancer drug Copiktra (duvelisib) compared to another medicine to treat leukemia and lymphoma. A Drug Safety Communication says the risk was seen in results from a clinical trial that also found Copiktra was associated with a
Drugs
FDA has issued AFT Pharmaceuticals a complete response letter on its NDA for Maxigesic IV, a combination of 1,000 mg paracetamol and 300 mg ibuprofen solution for infusion for treating post-operative pain. According to AFT’s development partner, Hyloris Pharmaceuticals, the letter took issue with the submission’s
Drugs
Pfizer has submitted an NDA to FDA for Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) to treat Covid-19 in both vaccinated and unvaccinated individuals at high risk for progression to serious illness from Covid-19, consistent with the current emergency use authorization. A company statement says final results
Drugs
FDA has placed a partial clinical hold on a Sanofi Phase 3 trial of tolebrutinib for use in treating multiple sclerosis and myasthenia gravis. The partial clinical hold pauses new enrollments in the trial, the company says. The Sanofi statement says the agency's action was based on a
Drugs
Five major drug companies have commented on and suggested changes to an FDA draft guidance on developing drugs to treat ulcerative colitis. Novartis says it finds the draft to be clear and helpful for the future development of drugs to treat ulcerative colitis and recommends some changes that may further
Drugs
Janssen says a plan by the CDER Office of Prescription Drug Promotion to study how patients and doctors value different aspects of medical product labels “is invaluable in improving clinical care by assessing both what patients and physicians value when considering medical products and how these values may lead to
Drugs
FDA has granted breakthrough therapy designation for Janssen’s talquetamab to treat adult patients with relapsed or refractory multiple myeloma, who have previously received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. The company describes talquetamab as an investigational,
Biologics
FDA has published a draft guidance, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments, the third in a series of four methodological patient-focused drug development guidances that describe how stakeholders such as patients, caregivers, researchers, medical product developers, and others, can collect and
Drugs
FDA has accepted for review a Regeneron sBLA for Eylea (aflibercept) injection for an every 16-week 2 mg dosing regimen, after an initial monthly dose, in patients with diabetic retinopathy. The target date for a review decision is 2/28/23. Regeneron says Eylea was approved in 2019 to
Drugs
The HHS Office of Inspector General (OIG) is recommending that FDA “identify and implement additional ways to improve the timeliness of its foreign for-cause drug inspection program.” In an audit report, the OIG says its audit objective was to determine whether FDA’s foreign drug inspection process has improved
Drugs
Santhera Pharmaceuticals says that a planned NDA submission for vamorolone in Duchenne muscular dystrophy (DMD) has been postponed by four to six months after a third-party contract manufacturing organization (CMO) communicated a delay in reaching FDA-inspection readiness. The completed rolling NDA is now expected sometime in the fourth
Drugs
Some 100 members of the House and Senate, led by Sen. Elizabeth Warren (D-MA) and Rep. Lloyd Doggett (D-TX) are calling on HHS secretary Xavier Becerra to “swiftly act and use his existing authorities to lower prices on critical prescription drugs.” A release (includes the text of a
Drugs
University of Colorado researchers say two FDA-approved drugs — imipramine and olanzapine — block apolipoprotein E4 (apoE4)-catalyzed polymerization of amyloid-beta, making them potentially useful in preventing Alzheimer’s disease. Writing in the open-access journal Alzheimer’s Research and Therapy, the researchers say the two drugs also show evidence
Drugs
FDA has released the FDA-483 issued following a 2/23-3/4 inspection at Expert Compounding Pharmacy, a Lake Balboa, CA, producer of non-sterile drugs. The six inspection observations were: * producing hazardous drugs without providing adequate cleaning of utensils to prevent cross-contamination; * non-microbial contamination was observed