Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal (tumors with epicenter 1 to 5 centimeters above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation. The approval was
Drugs
FDA is proposing to include quinacrine HCl on the list of bulk drug substances (active pharmaceutical ingredients) that outsourcing facilities may use in drug compounding. A Federal Register notice says the substance is not a component of an FDA-approved drug and was nominated by the agency to compound oral
Drugs
The Department of Justice says Fresenius Kabi Oncology was sentenced to pay $50 million in fines and forfeiture for concealing and destroying records before a 2013 FDA plant inspection. A department statement says the company agreed to plead guilty to the misdemeanor offense. A Nevada federal judge accepted the company’
Drugs
FDA has given Cybrexa Therapeutics the green light to begin a clinical trial for solid tumor therapy CBX-12 (alphalex-exatecan). “Preclinical studies of CBX-12 show a strong efficacy and safety profile, and we expect that the Phase 1 clinical trial will help us learn more about the potential
Drugs
FDA says a Pfizer BLA for osteoarthritis drug tanezumab subcutaneous injection has a modest treatment effect and some safety concerns. In a briefing document released in advance of a 3/24-25 advisory committee meeting, agency reviewers said superior efficacy was not demonstrated with tanezumab over non-steroidal anti-inflammatory
Drugs
FDA issued Warning Letters to two companies for selling products labeled as containing cannabidiol (CBD). FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved NDA, the agency says. The letters explain that
Drugs
FDA has announced a 4/23 virtual public workshop entitled “Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea.” The workshop is intended to discuss nonclinical and clinical pharmacology data and clinical trial design issues for these drugs. Topic areas also include: * Animal models * Trial design considerations, such as
Drugs
FDA has accepted a Bristol Myers Squibb NDA for mavacamten, an investigational allosteric modulator of cardiac myosin for treating patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The agency has set a user fee review action target date of 1/28/2022. The submission was based on data from the pivotal
Drugs
An FDA safety alert advises that health care professionals not use Becton, Dickinson’s ChloraPrep 3 mL applicators due to microbial contamination risks. The affected drug product is labeled “CareFusion, El Paso, TX.” BD’s investigation “confirmed the product’s lid, when exposed to higher temperature and humidity, can fail
Drugs
FDA has approved a Janssen NDA for Ponvory (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 modulator for treating adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The approval was based on data from a
Drugs
FDA has approved a Kiniksa Pharmaceuticals NDA for Arcalyst (rilonacept) injection to treat recurrent pericarditis and reduce the risk of recurrence in adults and children 12 years and older. Recurrent pericarditis involves inflammation of the pericardium, a thin tissue sac surrounding the heart, which can cause chest pain, an agency
Drugs
FDA acting commissioner Janet Woodcock told an American Medical Association Webinar 3/17 the federal government is no longer distributing Lilly’s monoclonal antibody bamlanivimab in Arizona, California, and Nevada because of the presence of a viral variant that is not susceptible to the drug. Endpoints News reports that Woodcock
Drugs
CDER has created a new Web page to house scientific review documents supporting emergency use authorizations (EUAs) for drug and biological therapeutic products, including any amendments. The Center says that the page is intended to “promote public confidence in FDA’s scientific review process” and it is “consistent with our
Drugs
Janssen says long-term data from the Phase 3 DISCOVER-2a study show that the skin clearance, joint symptom relief, and safety of Tremfya (guselkumab), previously seen at 24 and 52 weeks in adults with active psoriatic arthritis, continued through week 112. “These findings also confirmed that the robust efficacy
Drugs
Three students in the Duke Science Regulation Lab, an interdisciplinary course offered through the Duke University law and graduate schools, recommend several steps FDA could take to improve a draft guidance, Investigational New Drug Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations. The comment letter says that
Drugs
GlaxoSmithKline says the first patient has been dosed in its SWIFT-2 trial as part of a Phase 3 clinical program investigating the safety and efficacy of GSK’294 in severe eosinophilic asthma (SEA). A company statement says GSK’294 is an investigational medicine with the potential to become the
Drugs
FDA acting commissioner Janet Woodcock and associate commissioner for regulatory affairs Janet McMeekin say the agency has used alternative oversight tools when the pandemic prevented investigators from entering facilities for inspections. Writing in an FDA Voice post, the two say the agency prioritized “mission-critical” inspections on a case-by-
Drugs
AbbVie says that the utility and scope of an FDA draft guidance on developing drugs to treat dry eye could be increased by including recommendations for the use of biomarkers as an efficacy endpoint for the signs of dry eye and the use of patient-reported outcomes/instruments in dry
Drugs
Lilly says its mirikizumab met the primary and all key secondary endpoints in the LUCENT-1 Phase 3 induction study evaluating the drug’s safety and efficacy in treating patients with moderate to severe ulcerative colitis. The company says LUCENT-2, a multicenter maintenance study in patients who completed the
Drugs
FDA has extended by three months its review of an AbbVie supplemental NDA for Rinvoq (upadacitinib) and its use in treating adult patients with active psoriatic arthritis. FDA approved Rinvoq in 2019, a once-daily oral Janus kinase inhibitor and follow-on therapy to its blockbuster rheumatoid arthritis drug Humira
Drugs
The Federal Trade Commission (FTC) says it is joining with the Justice Department, state attorneys general, the Canadian Competition Bureau, European Commission Directorate General for Competition, and the UK Competition and Markets Authority to form a working group to update their approach to analyzing the effects of pharmaceutical mergers. An
Drugs
FDA has accepted for priority review a Merck NDA for belzutifan for treating patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) that does not require immediate surgery. The NDA is based on data from the Phase 2 Study-004 trial, in which belzutifan showed a confirmed