Drugs
Some 51 states and U.S. territories have filed their third complaint in Connecticut federal court stemming from an ongoing antitrust investigation into what is described as a “widespread conspiracy by generic drug manufacturers to artificially inflate and manipulate prices, reduce competition, and unreasonably restrain trade for generic drugs sold
Devices
An FDA grant and a philanthropic gift from Mei Xu, founder of e-commerce platform Yes She May, will fund the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), a product development competition focused on Covid-19-related pediatric medical devices that support home health monitoring and telehealth diagnosing
Biologics
FDA has approved a Viela Bio BLA for Uplizna (inebilizumab-cdon) injection for intravenous use for treating neuromyelitis optica spectrum disorder (NMOSD) in adult patients with a particular antibody (patients who are anti-aquaporin-4 or AQP4 antibody positive). The rare autoimmune disease of the central nervous system affects the
Biologics
CNN reports that vaccine experts it contacted are concerned that President Trump will exert political pressure to get a Covid-19 vaccine on the market before it has been fully studied and approved. The report says the experts are asking FDA for assurance that it will not authorize a vaccine
Drugs
FDA says that Apotex, Amneal, Marksans, Lupin, and Teva have recalled certain extended-release metformin products because the agency’s testing showed N-Nitrosodimethylamine above the acceptable intake limit in certain lots. “There are additional companies that manufacture ER metformin and supply a significant portion of the U.S. market,
FDA Policy/General
The Alliance for a Stronger FDA reports in its Friday Update that the House and Senate appropriations committees will hold mark-up sessions in late June and July for the FY 21 appropriations bill. They have not yet indicated specific dates for consideration of specific bills. The online newsletter’s
Biologics
Officials from CDER and CBER told a Biotechnology Innovation Organization digital conference that they anticipate a busier agency workload after the emphasis on the Covid-19 pandemic eases. An online report on the meeting posted by the Regulatory Affairs Professionals Society says that while drug companies and FDA officials are
Drugs
FDA has approved ViiV’s Tivicay (dolutegravir) tablets and Tivicay PD tablets for suspension to treat HIV-1 infection in pediatric patients at least four weeks old and weighing at least 6.61 pounds in combination with other antiretroviral treatments. An agency statement says the drug is intended for patients
FDA Policy/General
Federal Register notice: FDA has extended until 10/15 the comment period on (XXX INSERT, DELETE XXX) a draft guidance for industry #256 entitled “Compounding Animal Drugs from Bulk Drug Substances.” FDA is taking this action in response to requests for an extension to allow interested persons additional time to
Drugs
FDA has approved Mylan’s Semglee (insulin glargine) indicated to improve glycemic control in adult and pediatric patients with Type 1 diabetes and in adults with Type 2 diabetes. Upon approval, the NDA was deemed to be an approved BLA and thus it can be a reference product for a
Drugs
IntelGenx says that a 6/10 meeting with FDA was “very productive” and the company is completing the work required to resubmit its Rizaport VersaFilm NDA as a treatment for migraine headaches. The company had received a 3/27 complete response letter indicating that the Rizaport VersaFilm NDA could not
Drugs
Following a meeting with FDA staff on the Lannett clinical advancement program for its biosimilar insulin glargine product candidate, the company says it received positive feedback on the clinical and CMC (chemistry, manufacturing, and controls) advancement of its product. “Our path forward is clear with regard to what is expected
Devices
FDA says it will host a virtual town hall on 6/17 from 12:15 to 1:15 pm EDST for clinical laboratories and commercial manufacturers that are developing or have developed SARS-CoV-2 diagnostic tests. An agency notice says the meeting is to help answer technical questions about
Drugs
Three Mintz Levin attorneys say the next phase of the over-the-counter (OTC) reform process coming from provisions in the CARES Act “will entail sweeping changes to the process for bringing OTC drugs to market and will impose some significant burdens on FDA and manufacturers alike.” Writing in a
Drugs
The Alliance for Natural Health USA is asking FDA to issue a regulation requiring all makers of proton pump inhibitors for humans to expand the existing label Warnings to include information about an increased risk of pneumonia. The group’s petition says “the causes of PPI-associated pneumonia are believed
Drugs
FDA has published a Manual of Policies and Procedures (MAPP), Conversion of ANDA Approval to Tentative Approval Because of Court Order, describing the policies and procedures of the CDER Office of Generic Drugs for converting the approval status of an ANDA from final approval to tentative approval (TA) following a
Drugs
FDA has granted CNS Pharmaceuticals an orphan drug designation for its lead product berubicin for treating malignant gliomas. The designation is partially based on Phase 1 data showing that 44% of patients treated with berubicin demonstrated a significant improvement in progression free survival, and one patient experienced a complete response.
Drugs
FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) for patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy. An agency notice says the drug’s efficacy was investigated in the ATTRACTION-3 trial involving 419 patients. The trial demonstrated a
Drugs
FDA says its review of three Web sites and a Facebook page operated by OutoftheBoxRemedies.com found that the sites are offering iodine products for sale in the U.S. for the mitigation, prevention, treatment, diagnosis, or cure of Covid-19 in people. A 6/10 Warning Letter sent to
Drugs
FDA has approved Pfizer’s Nyvepria (pegfilgrastim-apgf), a biosimilar to Amgen’s Neulasta (pegfilgrastim) for decreasing the incidence of infection as manifested by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive drugs associated with a clinically significant incidence of febrile neutropenia. The company says the approval was
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision for “Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form FDA 3601a” (OMB Control Number 0910-0511).The revision adds form FDA 3601a, the Device Facility User Fee Cover Sheet.
Drugs
FDA and the Federal Trade Commission say that the Web site www.organic-beauty-recipes.com is participating in the Amazon Associates program that pays the site owners a commission for promoting the sale of essential oil products. A 6/8 Warning Letter says the agencies’ review of the Web