Drugs
FDA says it is aware that some prescribers and pharmacies have had difficulties recertifying in the modified Transmucosal Immediate-release Fentanyl (TIRF) risk evaluation and mitigation strategies (REMS) that was fully implemented 3/29. “FDA is working with manufacturers of TIRF medicines to address these concerns,” an agency notice says.
Drugs
FDA has granted priority review for Takeda’s NDA for mobocertinib (TAK-788) to treat adults with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive metastatic non-small cell lung cancer as detected by an FDA-approved test who have received prior platinum-based chemotherapy. The company says mobocertinib
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)
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
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
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
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
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,
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
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
Drugs
President Biden has signed into law two FDA-related bills that are intended to help lower drug/biologic prices. The Advancing Education on Biosimilars Act of 2021 (S 164) requires FDA to advance education and awareness programs for health care providers on biological/biosimilar products, including by developing or improving
Drugs
The House Energy and Commerce Health Subcommittee has announced a 5/4 hearing to discuss legislative proposals to lower prescription drug costs. Focal point of the hearing will be the Elijah E. Cummings Lower Drug Costs Now Act, a bill to require HHS to negotiate maximum prices for: (1) insulin
Drugs
FDA has announced a 6/9 workshop entitled “The Nonprescription Drug Facts Label in a Changing Consumer Marketplace 2021” that will evaluate data and information currently available on consumer comprehension of the nonprescription Drug Facts Label (DFL) and discuss areas where improvements could be made to its format and content.
Drugs
FDA says it supports increasing use of pharmacometric models in drug development because once validated against independent empirical data they allow it to better understand drug effects in individuals and populations who were not part of the clinical trials and to explore additional real-world scenarios. “For example, a model
Drugs
The International Conference for Harmonization (ICH) has released for adoption a revised guideline entitled ICH Q3C(R8) Guideline on Impurities: Guideline for Residual Solvents. The document was revised to include the permitted daily exposure levels for three solvents — 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tertiary butyl alcohol. Additionally, an introductory
Drugs
The FTC says it will advocate for Congress to act quickly and advance legislation to strengthen its powers in the wake of a 4/22 Supreme Court decision that curtails its authority to seek monetary restitution from companies engaged in deceptive practices, such as pharmaceutical company anticompetive measures. The unanimous
Drugs
Federal Register notice: FDA has determined that Hospira’s sodium chloride 14.6% solution for injection (50 milliequivalent/20 milliliters) in plastic containers was not withdrawn due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory
Drugs
A Texas state senator has introduced the “Truth in Medicine Act” to allow drug companies, doctors, and patients to freely discuss medical options, including potentially life-saving medications that have not been approved by FDA. Sen. Paul Bettencourt (R) told State of Reform that while providers are legally permitted to