Biologics
FDA has issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prevention of Covid-19 in certain adults and pediatric patients. An agency notice says the monoclonal antibody product is only authorized for those individuals who are
Drugs
Teligent Pharma has recalled two lots of lidocaine HCl topical solution USP 4%, 50ml in screw cap glass bottles, due to internal testing determining the product is super potent. The company made its determination based on out-of-specification (OOS) results obtained at the nine-month (Lot 16345) and 18-
Drugs
Gilead Sciences has recalled two lots of Veklury (remdesivir 100 mg for injection) after confirming a complaint about the presence of glass particulates. Administrating an injectable product that contains glass particulates may result in blocked blood vessels in the heart, lungs or brain which can cause stroke and even lead
Biologics
Former FDAers Joshua Sharfstein and Peter Lurie say a recent agency draft guidance on benefit/risk assessment indicates that FDA “intends to embrace the broader view of its authority in certain circumstances, a promising alignment of the tools of regulation with the agency’s mission to protect public health.” Writing
FDA Policy/General
Federal Register notice: FDA is publishing an order on its final determination involving a petition requesting exemption from premarket notification (510(k)) requirements for the generic device type: powered patient transport (product code ILK). FDA has determined that premarket notification is necessary to provide a reasonable assurance of the safety
Devices
FDA has updated its SARS-CoV-2 Viral Mutations: Impact on Covid-19 Tests Web page with information on the omicron variant. The agency says the update added new information about: * FDA recommendations for clinical laboratory staff and healthcare providers; * the Tide Laboratories DTPM Covid-19 RT-PCR test that
Drugs
FDA has issued two draft guidances for individualized antisense oligonucleotide drug products for severely debilitating or life-threatening diseases. The first draft contains clinical recommendations for sponsors developing such drug products. Its focus is to describe important clinical considerations for IND submissions to support initial and continued administration, dosing, and
Drugs
The Natural Products Association (NPA) has filed suit against FDA to make the agency cease its “unlawful retroactive application of the Federal Food, Drug, and Cosmetic Act against N-acetyl-L-cysteine (NAC).” NPA says it is “defending the industry’s right to provide a product with an exceptional 30-
Devices
FDA says a 6/15-6/29 inspection at the Induction Therapies medical device operation in Louisville, KY, determined that the firm manufactures Collagen P.I.N., a microneedling product. An 11/23 Warning Letter says the device is offered for sale and distributed in the U.S. without marketing
Drugs
The Senate Health, Education, Labor & Pensions Committee has announced a 12/14 hearing on the nomination of Robert Califf to be the next FDA commissioner. The times have changed in the past five years since Califf served as FDA commissioner at the end of the Obama Administration, and prresumably
Drugs
As FDA continues to use alternative inspectional tools, such as remote interactive evaluations, the prolonged Covid-19 pandemic will likely see the agency “continue to adapt and utilize new strategies for accomplishing oversight activities that were previously conducted primarily through FDA in-person inspections,” according to a Kleinfeld, Kaplan &
Drugs
Writing in a MedCity News “influencers” online post, Susan Dallabrida and Craig Gravina say that while researchers have been talking about the potential benefits of using real-world data (RWD) in clinical trials, it has been difficult to accomplish. “The primary reason is that RWD has been largely unavailable to
Biologics
CBER’s Office of Tissues and Advanced Therapies (OTAT) is swamped with new product submissions to the extent that the office is considering restructuring and revamping processes to help move products along the regulatory pathways. OTAT regulates cell therapies, gene therapies, as well as plasma derived products, such as immunoglobulins
FDA Policy/General
Former FDA commissioner Stephen Hahn has been named CEO of Flagship Pioneering’s new Harbinger Health startup. Flagship describes Harbinger as a bio-platform company pioneering the detection of early cancer with a simple blood test that combines artificial intelligence (AI) and machine learning advances with its recent discoveries about
Drugs
FDA reviewers have cast doubt on the effectiveness of Reata Pharmaceuticals’ bardoxolone to slow the loss of kidney function in Alport syndrome (AS) patients and reduce the risk of kidney failure with chronic use. In a briefing document released ahead of a 12/8 Cardiovascular and Renal Drugs Advisory Committee
Biologics
Theratechnologies has submitted a supplemental BLA for Trogarzo (ibalizumab-uiyk) and an intravenous (IV) push form of administration for treating, in combination with other antiretrovirals, human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults. The company recently announced results from the TMB-302 study, which it
FDA Policy/General
Federal Register notice: FDA is seeking industry organizations interested in participating in selecting nonvoting industry representatives to serve on CDRH’s National Mammography Quality Assurance Advisory Committee. To view the notice, click here.
Drugs
An FDA-ordered drug class warning (see earlier story) has begun appearing in labels of Janus kinase (JAK) inhibitors — Pfizer’s Xeljanz (tofacitinib), Eli Lilly’s Olumiant (baricitinib) and AbbVie’s Rinvoq (upadacitinib). In September, the agency ordered the warning after reviewing a recent clinical trial that showed an increased
Devices
FDA has granted RefleXion Medical a breakthrough device designation for its biology-guided radiotherapy for use in treating lung tumors. The device uses injected radiotracers to produce active signals, called emissions, from each tumor to guide treatment delivery, according to the company. It uses positron-emission tomography imaging data to
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage 2B or 2C melanoma following complete resection. Additionally, the agency expanded the anti-PD-1 therapy’s indication to include adjuvant treatment for Stage 3 melanoma following complete
Drugs
FDA has approved Genentech’s Rituxan (rituximab) in combination with chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL). Approval was based on data from the Inter-
FDA Policy/General
Regulatory Review Period Determined for Dojolvi 12/2/2021 Federal Register news: FDA has determined for patent extension purposes the regulatory review period for Ultragenyx’s Dojolvi (triheptanoin), indicated as a source of calories and fatty acids for treating pediatric and adult patients with molecularly confirmed long-chain fatty acid