Drugs
FDA is urging drug compounders not to compound drug products using any remdesivir active pharmaceutical ingredient (API) due to its complex nature that makes it challenging to compound. “Remdesivir API is complex and neither a United States Pharmacopeia monograph nor other public quality standard for the API used in FDA-
Drugs
FDA has granted Ellodi Pharmaceuticals a fast track designation for APT-1011 (fluticasone propionate) oral disintegrating tablet for treating eosinophilic esophagitis, a rare, chronic allergic inflammatory disease characterized by eosinophilic infiltration in the esophagus. The designation was granted based on data from the Phase 2b study (FLUTE) evaluating histological remission
Drugs
FDA has granted TG Therapeutics accelerated approval for Ukoniq (umbralisib), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon for treating adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen, and with relapsed or refractory follicular lymphoma
Drugs
A 12/17/20 meeting of FDA and industry representatives to negotiate the reauthorization of GDUFA covered these topics, according to a meeting summary distributed by the agency: * industry asked the agency to consider harmonizing some technical terminology related to the mid-cycle discipline review letters with a publicly-facing
FDA Policy/General
FDA says it is developing guidances for developers of Covid-19 diagnostics, therapeutics and vaccines to help guide their need to adapt and pivot as new variants of coronavirus (Covid-19) are identified. “We have been actively assessing the impact of new strains on authorized products and continue to work
Drugs
FDA reviewers are taking issue with a Merck study supporting a new indication for Keytruda (pembrolizumab) for treating patients with high-risk early-stage triple-negative breast cancer (TNBC), in combination with chemotherapy as neoadjuvant treatment, then as a single agent as adjuvant treatment after surgery. FDA briefing documents released
Devices
FDA has granted a Signifier Medical Technologies de novo request to permit the marketing of a new prescription-only device, eXciteOSA, intended to reduce snoring and mild obstructive sleep apnea. “Unlike devices used while patients sleep, this is the first device used while awake that is intended to improve tongue
Biologics
FDA is limiting the emergency use authorization (EUA) for Covid-19 convalescent plasma after evaluating the most recent information available. “Based upon data from new clinical trials analyzed or reported since the original EUA was issued in August 2020, we have revised the EUA to limit the authorization to the
Drugs
Bristol-Myers Squibb 2/5 won BLA approval for (Breyanzi) lisocabtagene maraleucel (liso-cel), indicated for treating adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies. The BLA’s review was put on hold in November pending the completion of an inspection, which was
Drugs
Apotex has recalled two batches of enoxaparin sodium injection due to a packaging error resulting in some syringe barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) on the syringe barrel and vice versa.
Drugs
Three Morgan Lewis attorneys say a recent FDA guidance to facilitate the development of antisense oligonucleotide (ASO) drugs for patients with severely debilitating or life-threatening genetic disorders that are tailored to a patient’s specific genetic variant is targeted to academic investigators who may be less familiar with the
Drugs
The Clinical Trials Transformation Initiative (CTTI), a joint venture of FDA and Duke University, says it has identified eight best practices for designing and conducting Covid-19 treatment clinical trials. “While these best practices, comments, and quotes are specific to Covid-19 trials, CTTI recommends that these principles should be
Devices
FDA has cleared a Precision Spine 510(k) for its Dakota ACDF Standalone System for treating degenerative disc disease (DDD). The device features a titanium plate polyetheretherketone cage with cortical cancellous screws for maximum support and a generous cavity for autogenous bone graft to help facilitate fusion, the company says.
FDA Policy/General
An LA Times op-ed is endorsing CDER director and current FDA acting commissioner Janet Woodcock as the agency’s next leader. The piece was written by Massachusetts Institute of Technology professor Phillip A. Sharp, Friends of Cancer Research founder Ellen V. Sigal, and Sherry Lansing Foundation founder Sherry Lansing.
Biologics
Janssen Biotech has filed an emergency use authorization (EUA) application for its single-dose Covid-19 vaccine candidate. Last week, the company reported that its vaccine was 72% effective in the U.S. and 66% effective overall at preventing moderate to severe Covid-19. The vaccine’s Phase 3 data
Drugs
The 4th Circuit Court of Appeals has affirmed a federal district court’s summary judgment in favor of Greer Laboratories in a case in which whistleblowers said the company had sold custom mixes of allergenic extracts to doctors under an FDA general license rather than a required separate license for
Drugs
FDA’s Oncology Center of Excellence (OCE) annual report for 2020 describes OCE’s work on behalf of cancer patients affected by the Covid-19 pandemic. “OCE participated in writing a guidance emphasizing the flexibility that FDA would exercise with regard to conduct of clinical trials with decentralized trial procedures
Devices
FDA has cleared a B-Secur 510(k) for its HeartKey software library, which was developed to enable scalability of medical grade EKG/ECG across “Internet of Things” devices. The company says its suite of powerful EKG/ECG algorithms combine user identification, health and wellness to generate accurate data encrypted
Drugs
A decade-old, FDA-investigated case involving the unlicensed wholesale distribution of prescription drugs by Israeli citizen Boaz BenMoshe is finally coming to a close with his extradition to the U.S. and a sentencing date now scheduled for 4/1. According to the government, in 2009 BenMoshe pled guilty
Drugs
FDA says that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with Pfizer’s arthritis and ulcerative colitis drug Xeljanz (tofacitinib) and Xeljanz XR, compared to tumor necrosis factor (TNF) inhibitors. An agency drug safety communication says FDA required the
Drugs
FDA has approved a Durect NDA for Posimir (bupivacaine solution) for infiltration use in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. Approval was based on clinical trial data in patients undergoing arthroscopic
Drugs
FDA has announced a 3/29-30 public workshop on “Nitrosamines as Impurities in Drugs; Health Risk Assessment and Mitigation.” The agency says the workshop will include presentations on nitrosamines chemistry and toxicology, and on the findings of nitrosamines as impurities in drugs. It will also include an open discussion