Drugs
Amgen says it has agreed to an FDA-proposed post-marketing requirement to conduct a multi-center randomized clinical trial to compare the safety and efficacy of Lumakras (sotorasib) at 960 mg once daily versus a lower daily dose of the drug. “Based on the preclinical, pharmacokinetic, and clinical data,
Drugs
An independent analysis funded by the Pharmacy Compounding Foundation and conducted by Berkeley Research Group says FDA should not rely on or consider a 2020 FDA-funded report published by the National Academies of Science, Engineering, and Medicine (NASEM) on the safety and utility of compounded bioidentical hormone therapy (cBHT)
Devices
The 3/17 FDA/industry MDUFA 5 reauthorization meeting covered these seven topics: FDA presentation of stakeholder feedback from various sources; FDA perspective on MDUFA 4 performance; MDUFA 4 financial information; FDA overview of digital transformation; fully-loaded full-time equivalent cost model methodology; industry perspective on reauthorization, and FDA
Drugs
FDA’s Oncologic Drugs Advisory Committee has voted 7 to 2 to recommend the continuance of Genentech’s accelerated approval for Tecentriq (atezolizumab) plus nab-paclitaxel for treating treat patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1. The panel review is
Biologics
FDA has authorized Hope Biosciences Stem Cell Research Foundation to conduct a Phase 2 trial to assess the efficacy and safety of multiple intravenous infusions of autologous adipose-derived mesenchymal stem cells to improve activities of daily living and quality of life in patients with Parkinson’s disease. The company
Drugs
FDA has sent a notice of noncompliance to Acceleron Pharma for failing to submit required summary results information to ClinicalTrials.gov. An online notice says Acceleron has 30 days in which to submit the information from a trial that evaluated the safety and effectiveness of dalantercept in combination with axitinib
Biologics
FDA has issued Protalix BioTherapeutics a Complete Response Letter (CRL) for its BLA seeking accelerated approval for pegunigalsidase alfa (PRX–102) for treating adult patients with Fabry disease. The letter did not cite any safety or efficacy concerns regarding the therapy, according to the company. The letter also noted that
Devices
FDA has cleared a Pixee Medical 510(k) for its Knee +, a surgical platform designed to assist orthopedic surgeons by providing real-time positioning of instruments in their field of view. Pixee Medical says the device comprises proprietary software using computer vision and artificial intelligence algorithms that runs on connected
Drugs
FDA has released summaries of three FDA/industry steering committee meetings for reauthorization of the Biosimilar User Fee Act. The initial meetings set ground rules for negotiations and a virtual environment. At the 3/16 meeting, the two sides discussed general rules for negotiations and virtual environment, FDA perspectives on
Drugs
FDA’s Oncologic Drugs Advisory Committee 4/28 voted to recommend continued accelerated approvals separately for Merck’s Keytruda and Genentech’s Tecentriq in bladder cancer patients until further confirmatory data are presented. Until recently, the standard-of-care treatment for patients with advanced or metastatic bladder cancer who can
Biologics
Enzyvant has resubmitted a BLA for RVT-802 (cultured human thymus tissue), a tissue-based regenerative therapy designed to treat pediatric congenital athymia, a rare and deadly condition associated with complete DiGeorge anomaly, Charge syndrome, and FoxN1 deficiency, according to the company. The submission addresses a 12/2019 Complete Response
Drugs
An FDA-required preapproval inspection delay due to Covid-19 has pushed back Sol-Gel Technologies’ NDA review for Epsolay (benzoyl peroxide) 5% topical cream for treating rosacea inflammatory lesions of rosacea in adults. Sol-Gel says it recently reached agreement with the agency on the final labeling content. The
Drugs
FDA has published a draft guidance, Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases, to inform sponsor-investigators about the nonclinical information that the agency recommends to support an IND for an antisense oligonucleotide being developed to treat a severely debilitating or life-
Drugs
A recent 5th Circuit Court of Appeals decision in a case involving a reverse payment from Endo to Impax for Endo’s Opana ER (oxymorphone) is important for two reasons, according to attorney Sara Koblitz (Hyman, Phelps & McNamara). Writing in her firm’s FDA Law Blog, Koblitz says the
Devices
FDA has granted Medtronic a breakthrough device designation for the Emprint ablation catheter kit, which is intended to be used in conjunction with the Emprint microwave generator and Medtronic lung navigation platform for localized treatment of malignant lesions in the lung. “Using an endoluminal approach, the Emprint ablation catheter kit
Devices
FDA says that after 5/30, it will no longer accept Quality in 510(k) Review files. The agency recommends that companies consider using eSTAR going forward. The Quality in 510(k) Review Program pilot was launched on 9/6/18 to evaluate ways to simplify how manufacturers submit certain
Drugs
Saniona says its efforts to gather information to respond to an FDA request will delay the start of a Phase 2b clinical trial of its Tesomet for Prader-Willi syndrome and hypothalamic obesity into the second half of 2021. The company says it requested FDA feedback on its proposed chemistry,
FDA Policy/General
Former FDA acting assistant commissioner for media affairs Erica Jefferson is returning to the agency as associate commissioner for external affairs. An agency announcement says that in her new position Jefferson “oversees agency-wide communications activities regarding FDA’s public health and regulatory activities. This includes the development, coordination, and
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. American Specialty Pharmacy, Branch, TX (4/5): FDA inspected the outsourcing facility 8/2018 and determined that drugs produced do not meet outsourcing facility requirements. It also noted serious
Drugs
FDA has accepted for filing and granted priority review to Axsome Therapeutics’ NDA for its AXS-05 (dextromethorphan bupropion) for treating major depressive disorder (MDD). The company says AXS-05 is a novel, oral, investigative NMDA receptor antagonist with multimodal activity. FDA has set 8/22 as the PDUFA action
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases. The document focuses on such products being developed to treat rapidly progressing, severely debilitating or life-threatening disease attributable to a unique genetic variant
Drugs
FDA has lifted a clinical hold against Voyager Therapeutics and its planned clinical trial for VY-HTT01 for treating Huntington’s disease. The hold removal followed a comprehensive review of the company’s chemistry, manufacturing and controls information previously submitted to the agency, according to the Voyager. The company plans