Drugs
New clinical data show that Gilead’s investigational antiviral remdesivir may block Covid-19 and lead to quicker recoveries for those stricken with the virus, NIH National Institute of Allergy and Infectious Diseases (NIAID) director Anthony Fauci said in remarks made at the White House 4/29. A preliminary data
Drugs
A Government Accountability Office (GAO) report says FDA and other federal agencies should be doing more to better determine the magnitude and reduce the impact of antibiotic resistance. GAO says it was asked to review federal efforts to address antibiotic resistance. Its report looked at federal efforts and challenges related
Drugs
FDA has rescheduled for 6/30 a public meeting to discuss possible agency-level approaches to modernizing FDA’s data strategy, including approaches to data quality, data stewardship, data exchange, and data analytics. A meeting notice says the agency also is soliciting public comments on the topic. A 9/2019
Drugs
Sanofi and Regeneron Pharmaceuticals have stopped a Libtayo (cemiplimab) Phase 3 trial early after the primary endpoint of overall survival (OS) was met. The trial was comparing the PD-1 inhibitor to platinum doublet chemotherapy in patients with first-line locally advanced or metastatic non-small cell lung cancer that
Drugs
FDA says it is refusing entry into the U.S. of fraudulent Covid-19 products or substandard products when it discovers them. The statement came to FDA Webview after our request for comment on a story indicating that the agency has increased its seizure of prescription drugs mailed to American
Drugs
A 12/10/18-1/28/19 FDA inspection at Professional Compounding Pharmacy (Health Solutions Pharmacy Center), Corvallis, OR, found that the drug products produced by the pharmacy failed to meet conditions for exemption from certain provisions of the Federal Food, Drug, and Cosmetic Act. A just-released 3/31
Drugs
FDA has granted Takeda Pharmaceutical a breakthrough therapy designation for its investigational drug mobocertinib (TAK-788) for treating patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. Mobocertinib is a
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FDA says it is aware that the Covid-19 pandemic may affect the conduct of bioequivalence studies intended for submission in ANDAs. “For example,” an online statement says, “challenges may arise from quarantines, site closures, travel limitations, interruptions to the supply chain for the proposed generic product or the reference-
Drugs
FDA says that over 1,500 additional manufacturers have registered with the agency to produce hand sanitizer. An agency statement says it also is addressing safety concerns related to products being sold that are not in line with agency policy and others being marketed with unproven claims. The statement says
Drugs
FDA has sent Prefense LLC (Muscatine, IA) a Warning Letter for marketing unapproved hand sanitizers for preventing Covid-19. The agency objected to numerous claims on the company’s Web site and social media platforms, such as “Sanitize your hands with Prefense nonalcoholic Hand & Skin sanitizer that can protect
Drugs
FDA has approved a Neurocrine Biosciences NDA for Ongentys (opicapone) 25 mg and 50 mg capsules as an add-on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes. As the disease progresses, patients taking levodopa/carbidopa may begin to experience “off” time between treatment doses
Drugs
Janssen Pharmaceutical has submitted two supplemental BLAs for Simponi Aria (golimumab) for treating polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis in patients two years of age and older in combination with methotrexate. Juvenile Idiopathic Arthritis (JIA) is a disorder group characterized by arthritis persisting for at least six weeks
Drugs
FDA has issued a MedWatch safety alert on off-label hydroxychloroquine or chloroquine use for Covid-19 outside of a hospital setting or a clinical trial due to risk of heart rhythm problems. President Trump and his allies have been touting the drug for weeks until recently when new data
Drugs
FDA has issued Warning Letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) that violate the Federal Food, Drug and Cosmetic Act. BIOTA Biosciences received one letter for marketing and distributing injectable CBD products for serious diseases and as an alternative to opioids. Homero Corp DBA Natures
Drugs
Rep. Rosa DeLauro (D-CT) has written to secretary of veterans affairs Robert Wilkie asking that the agency stop using hydroxychloroquine to treat Covid-19 patients pending further evaluation. In a 4/23 letter, DeLauro said the National Institute of Allergies and Infectious Diseases released 4/22 guidelines establishing that
Drugs
FDA has published an immediately-in-effect guidance, Temporary Policy on Repackaging or Combining Propofol Drug Products During the Covid-19 Public Health Emergency, to describe the enforcement discretion it will exercise on the repackaging or combining of propofol general anesthesia drug products by a licensed pharmacist in a state-
Drugs
ProPharma Group says pharmaceutical companies should always be ready for planned and unplanned internal and external inspections. In an online post, “Although there are various types of audits and inspections,” the post says, “and in the current landscape there has been a shift to virtual audits, there is a trend
Drugs
CNS Pharmaceuticals has requested an FDA orphan drug designation for its lead product berubicin for treating glioblastoma, one of the most aggressive forms of cancer. The request is based on Phase 1 trial data showing a significant improvement in progression free survival, the company says. A Phase 2 trial evaluating
Drugs
During the Covid-19 pandemic, FDA has stepped up seizures of prescription drugs mailed to American customers from pharmacies in Canada and other countries, according to a Kaiser Health News article reprinted online by Salon. Often, it says, the recipients are individuals trying to avoid trips to a pharmacy because
Drugs
FDA has accepted for review a Mallinckrodt NDA for terlipressin, indicated for treating hepatorenal syndrome type 1 (HRS-1). Terlipressin is a potent vasopressin analog selective for V1 receptors, Mallinckrodt says. The agency set a 9/12 user fee review action target date, and the company expects an FDA advisory
Drugs
FDA has approved an Immunomedics BLA for Trodelvy (sacituzumab govitecan-hziy) for treating adult patients with triple-negative metastatic breast cancer. The agency says that patients must have received at least two prior therapies before taking Trodelvy. The accelerated approval was granted one month ahead of its user fee review
Drugs
The Physicians Committee for Responsible Medicine (PCRM) says it welcomes FDA support for replacing and reducing animal use in testing and encouraging sponsors to consult with reviewers when considering a non-animal testing method. In a comment on an agency revised draft guidance on nonclinical safety evaluation of the immunotoxic