Drugs
Bristol-Myers Squibb is shutting down its Opdivo (nivolumab) program to use the immuno-onology drug in treating newly-diagnosed brain cancer patients. Endpoints News reports that Opdivo plus standard-of-care temozolomide (Merck’s Temodar) plus radiation performed no better than placebo in extending overall survival in patients with
Drugs
HHS and the Defense Department have signed a $356 million contract with Merck for between 60,000 and 100,000 doses of its MK-7110, an immune system modifying antibody that the company recently acquired in its buyout of OncoImmune. The doses would be produced by this June. The administration
Drugs
Attorney Joanne Hawana (Mintz) says the most important thing FDA did in authorizing two mRNA Covid-19 vaccines at the end of 2020 was to be as transparent as possible. Writing in an online year-end review of FDA’s Covid drug and biologic activities, Hawana says the publicly available
Drugs
FDA has approved Amphastar Pharmaceuticals’ generic glucagon for injection, 1mg/vial packaged in an emergency kit, for treating severe hypoglycemia that may occur in patients with diabetes. An agency statement says the drug also is indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel,
Devices
FDA has authorized the marketing of Interscope’s EndoRotor system to resect and remove necrotic tissue for patients with walled-off pancreatic necrosis. An agency statement says the system includes a power console, foot control, specimen trap, and single-use catheter, and is used in a direct endoscopic necrosectomy. The
Drugs
FDA has sent Warning Letters to five companies selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act. An agency notice says that the letters address illegal marketing of unapproved CBD products claiming to treat medical conditions. They include products that are especially concerning
Devices
FDA has published a guidance, Product Labeling for Laparoscopic Power Morcellators, with recommendations on the content and format for certain labeling information for laparoscopic power morcellators (LPM). The document says the recommendations reflect the state of the science and available technology regarding the use of LPMs and are being made
Drugs
FDA says its testing of Herbacil Antiseptic Hand Sanitizer produced by Broncolin, Iztacalco, Mexico, found that the product is adulterated and misbranded. A 12/21 Warning Letter says agency laboratory testing determined that the product contained large amounts of methanol, even though it was labeled to contain ethanol. The letter
Drugs
FDA says Sunstar Americas has expanded its nationwide recall of Paroex chlorhexidine gluconate oral rinse 0.12% due to microbial contamination. The expanded recall covers products bearing an expiration date from 12/31/20 to 9/30/22, according to an agency notice. The notice says the product may be
Devices
FDA says the Cook Medical 11/24/20 recall of Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers is Class 1. An agency notice says the two products are catheters that have a coated shaft, a valve, a dilator, and markers that show on an x-ray.
Drugs
FDA has approved Ridgeback Biotherapeutics’ Ebanga (ansuvimab-zykl), a human monoclonal antibody, to treat Zaire ebolavirus infection in adults and children. An agency notice says Ebanga blocks binding of the virus to the cell receptor, preventing its entry into the cell. The agency says that Zaire ebolavirus is one of
Drugs
FDA says it has taken steps to strengthen the Risk Evaluation and Mitigation Strategies (REMS) program for transmucosal immediate-release fentanyl (TIRF) products to help ensure that the drugs’ benefits continue to outweigh their risks. An agency statement says that despite the decline in the use of TIRF products in
Drugs
FDA has published a guidance, Providing Regulatory Submissions in Electronic Format—Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling, to describe the format requirements for the electronic submission of the content of a risk evaluation and mitigation strategy (REMS) document under section 745A(a) of
Drugs
FDA has published a guidance, Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment is Needed During the Covid-19 Public Health Emergency, with information on review timelines the agency will use during the Covid-19 public health emergency. The document applies to applicant responses to
Drugs
FDA has published a guidance, Consumer Antiseptic Final Rule Questions and Answers, to help small businesses understand and comply with the antiseptic rub final rule that applies to active ingredients used in over-the-counter (OTC) consumer antiseptic rub products, sometimes referred to as rubs, leave-on products, or hand
Drugs
Washington Legal Foundation (WLF) has submitted an amicus brief urging the 7th Circuit Court of Appeals to affirm an Illinois federal court decision in a case involving drug patents under antitrust law. A WLF statement says UCFW Local 1500 Welfare Fund v. AbbVie challenges a settlement between AbbVie and several
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) is calling on FDA to withdraw its 9/24/20 Request for Proposals (RFP) Regarding Insulin Reimportation Programs. A 12/17/20 petition also calls on the agency to: * refrain from reimportation of insulin under section 801(d)(2) of the Federal Food,
Drugs
FDA has published a draft guidance, IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations, to help sponsor-investigators develop such drug products for a severely debilitating or life-threatening genetic disease. The document focuses on the administrative and procedural aspects of interacting with FDA on development
FDA Policy/General
The follow are the Federal Register notices published the week ending 1/01/2021: Federal Register notice: FDA has announced the renewal of the Cellular, Tissue and Gene Therapies Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/
FDA Policy/General
The follow are the Federal Register notices published the week ending 12/25/2020: Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Export of Food and Drug Administration-Regulated Products: Export Certificates” (OMB Control Number 0910-0498). To view the notice, click here. Federal Register
FDA Policy/General
FDA has posted the latest Warning Letters posted the weeks ending 12/25/2020 and 1/1/2021. They can be accessed by clicking on the link following each letter. Clientele, Sunrise, FL (12/3/2020): FDA inspected the firm in February 2020 and cited significant GMP violations for finished
Drugs
Despite challenges from balancing resources to navigate the Covid-19 pandemic, FDA approved 53 new molecular entities in 2020, which is five (10%) more than it approved in 2019 and six shy of 2018’s record 59 approvals. A quick look at the approvals shows that many were for treating