Drugs
Teva is suing FDA in DC federal court over the agency’s refusal to transition the company’s Copaxone (glatiramer acetate) from an NDA to a BLA on 3/20 as required under the Biologics Price Competition and Innovation Act (BPCIA). The suit says that Copaxone is a leading drug
Drugs
FDA has accepted an Innocoll Holdings NDA resubmission for Xaracoll (bupivacaine hydrochloride collagen-matrix implants), an investigational agent for managing postsurgical pain after open inguinal hernia surgery. The agency set a user fee goal date of 8/26. Xaracoll is a surgically implantable and bioresorbable bupivacaine-collagen matrix that uses
Drugs
FDA has approved Xellia Pharmaceuticals’ Cleveland, OH manufacturing site to make anti-infective drug products for the U.S. market. The specialty pharmaceutical company says it acquired the site in 2015 and subsequently upgraded the facility. In January, FDA conducted a comprehensive GMP inspection at the facility, and this month
Drugs
FDA has approved Bristol-Myers Squibbs’ Zeposia (ozanimod), a new oral treatment for relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The company says Zeposia is the only approved sphingosine-1-phosphate receptor modulator that offers relapsing multiple sclerosis patients an
Devices
FDA has authorized Pear Therapeutics’ Somryst nine-week prescription digital therapeutic to treat patients age 22 and older with chronic insomnia. Pear says it is the first product submitted through FDA’s 510(k) pathway and simultaneously reviewed through the agency’s software precertification pilot program. Somryst reportedly can be
Devices
FDA says that digital health technologies can provide tools for public health officials and the public to use in managing the Covid-19 response by helping public health officials reach and communicate with a vast number of people more quickly, efficiently, and effectively. An online post says the agency does
Devices
FDA has extended the comment period on a 2/25-26 public workshop on the “Evolving Role of Artificial Intelligence in Radiological Imaging.” Comments can be submitted until 6/30, according to an agency notice.
Drugs
CDER director Janet Woodcock says FDA has decided to end the Clinical Data Summary Pilot Program that evaluated whether disclosing certain information included in clinical study reports following approval of an NDA improves public access to drug approval information. In an online statement, Woodcock says the pilot tested a new
Drugs
The coronavirus-related economic stimulus legislation that is quickly moving to become law includes language to allow FDA to create a new user fee program for over-the-counter (OTC) drugs. The Coronavirus Aid, Relief, and Economic Security (CARES) Act would authorize such fees for OTC monograph drug reviews effective
Drugs
Gilead Sciences says it has asked FDA to rescind the orphan drug designation it was recently granted for the investigational antiviral remdesivir for treating Covid-19. A company statement says Gilead is waiving all benefits, such as seven-year exclusivity, that come with an orphan drug designation. The company had
Biologics
A 10/4-10/11/19 FDA inspection at California IVF Fertility Center, Sacramento, CA, found significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. A just-released 2/26 Warning Letter says the specific deviations were: * failing to test a specimen from an
Devices
FDA late 3/25 issued an immediately-in-effect guidance: Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency. The agency said it “believes the policy set forth in this guidance may help address urgent public health concerns by helping to expand
Biologics
In a filing with the Securities and Exchange Commission, Moderna says the Phase 1 clinical trial of its mRNA-1273 potential vaccine against the novel coronavirus SARS-CoV-2 (Covid-19) is proceeding according to protocol. The study is being led by the National Institutes of Health, the filing says,
Drugs
Alston Bird attorneys say that as a result of FDA’s 3/18 decision to temporarily postpone routine surveillance domestic inspections due to the coronavirus outbreak, regulated industry “must be prepared for FDA’s expanded use of its existing authorities, creative alternatives to ensure the safety of FDA-regulated products
Drugs
Due to coronavirus concerns, Bristol Myers Squibb (BMS) says it will not initiate any new clinical trials globally before 4/13. The freeze could extend longer if the company decides that it is necessary, according to a company notice. For ongoing studies, BMS says new patient enrollment can continue if
FDA Policy/General
Federal Register notice: FDA has canceled a 4/14 public meeting entitled “International Cooperation on Cosmetics Regulation (ICCR) — Preparation for ICCR-14 Meeting.” To view the notice, click here.
Drugs
FDA says funds are available for projects to support the agency’s understanding of the potential use of real-world data (RWD) to generate real-world evidence (RWE). An online announcement says FDA is particularly interested in projects that compare the use of RWD and generation of RWE with more
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it is concerned that a planned FDA study of promotional implications of proprietary prescription drug names “will not produce data that will appropriately inform or meaningfully improve FDA’s regulation of proprietary drug names and, therefore, that it will not provide information
Biologics
FDA has approved a Samsung Bioepis supplemental BLA for a 420 mg multi-dose vial of Ontruzant (trastuzumab-dttb), a biosimilar referencing Genentech’s Herceptin. Ontruzant was approved 1/2019 as a 150mg single-dose vial for use in treating HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric
FDA Policy/General
Federal Register notice: FDA has announced its process for making available guidance documents related to the coronavirus public health emergency. The process is intended to allow the agency to rapidly disseminate important virus-related recommendations and policies. For example, FDA notes that prior public participation will not be feasible or
Drugs
FDA has accepted for priority review a Jazz Pharmaceuticals NDA JZP-258 (oxybate), an investigational drug for treating cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy. The agency has set a 7/21 user fee review action target date. The company says
Devices
FDA has cleared an Align Technology 510(k) for the iTero Element 5D Imaging System. The intraoral scanner features near-infrared imaging technology to scan the internal structures of teeth (enamel and dentin) in real time, the company says. Its visualization tools are intended improve patient engagement and communication to