Drugs
An HHS Office of Inspector General (OIG) audit says the National Institutes of Health (NIH) failed to ensure that all clinical trial results were reported to ClinicalTrials.gov under federal requirements. The OIG audit found that most NIH-funded clinical trials that were completed in 2018 did not have their
Drugs
CDER deputy director for regulatory programs Douglas Throckmorton told the GMP by the Sea conference that domestic drug inspections of facilities have been at “standard operational levels” since 10/2021 and foreign inspections have been performed for six months, except in China. Attorney Douglas Farquhar (Hyman, Phelps & McNamara) reports
Drugs
FDA has released the Warning Letter issued following a 2/7-2/18 inspection of the drug manufacturing facility at Cangene BioPharma, doing business as Emergent BioSolutions, Baltimore, MD (see previous story) The 8/10 Warning Letter says specific violations were: * failing to clean, maintain, and, as appropriate for the
Drugs
FDA has published a technical specifications document, FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products, to assist submitters in transmitting electronic individual case safety reports and attachments to the FDA Adverse Event Reporting System (FAERS) database. The document describes
Drugs
FDA has accepted for review a Roche supplemental BLA for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for treating people with previously untreated diffuse large B-cell lymphoma (DLBCL). The agency set a user fee review action target date of 4/
Drugs
FDA has accepted for priority review an AstraZeneca supplemental NDA for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for treating adult patients with metastatic castration-resistant prostate cancer (mCRPC). The submission is based on data from the PROpel Phase 3 trial that showed Lynparza in combination with
Drugs
While the recently passed Inflation Reduction Act authorizes Medicare to negotiate the prices of 10 high-cost drugs in 2026 and 10 more in 2029, a new analysis finds that drugs launched so far this year have a median annual cost of $257,000 — a 43% increase above the annual
Drugs
FDA has issued Emergent BioSolutions an 8/10 Warning Letter citing the firm’s Camden, MD manufacturing facility based on a February inspection. The 87,000-sq. ft. contract manufacturing facility in Baltimore provides drug product manufacturing for sterile injectables, according to the company. It offers clinical and commercial non-
Drugs
Alain Bouaziz, a French national and Hexim Pharmaceuticals chief executive officer, has pleaded guilty to making false statements to FDA to gain control of the rights to sell a weight-loss drug in the U.S. Beginning in 2018, The U.S. Justice Department says Bouaziz submitted forged documents and
Drugs
FDA has approved a Roche a supplemental NDA for Xofluza (baloxavir marboxil) for treating acute uncomplicated influenza in children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours. Additionally, the agency approved Xofluza for preventing (post-exposure prophylaxis) influenza in
Drugs
An Avadel CNS Pharmaceuticals suit filed in July challenges FDA’s authority to compel patent certifications when a section viii statement has been submitted. Attorney Sara Koblitz (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that the case involves Avadel’s Lumryz, a sodium oxybate drug
Drugs
FDA has informed France’s MaaT Pharma that its clinical hold on the company’s IND for a Phase 3 trial of its MaaT013 drug candidate in patients with steroid-resistant acute graft-versus-host disease remains in place. MaaT says FDA acknowledged that it received satisfactory answers from the
Drugs
Italy’s Menarini Group, with support from Radius Health, has submitted an NDA to FDA for elacestrant in patients with ER+/HER2- advanced breast cancer. An announcement says the companies requested a priority review. The companies say the submission is based on positive Phase 3 data from the EMERALD study
Drugs
The New Jersey federal court hearing the Proton-Pump Inhibitor Products Liability Litigation is considering a challenge to a former FDAer who was to appear as an expert witness. Attorney James Beck (Reed Smith) writes in a Drug & Device Law post that the witness was challenged under a federal
Drugs
FDA has granted full approval to Novartis for its previously accelerated-approved Tabrecta (capmatinib) for treating adult patients with metastatic non-small cell lung cancer whose tumors have a mutation leading to mesenchymal-epithelial transition exon 14 skipping (as detected by an FDA-approved test). Accelerated approval was gained 5/
Drugs
The Biosimilars Forum says it is concerned that an FDA draft guidance on risk management plans (RMP) to mitigate the potential for drug shortages “is not well tailored to achieving this purpose.” The forum’s 8/4 comment letter says the draft guidance “is not consistent with the law and
Drugs
The Colorado Society of Addiction Medicine, supported by similar societies in eight states, is calling on FDA to update the labeling of sublingual buprenorphine products to treat opioid use disorder. The society petition wants the labeling to indicate that following initiation, the buprenorphine dose should be titrated based on the
Drugs
FDA says that to avoid a shortage, it will not object to the temporary distribution of sitagliptin (Merck’s Januvia) with the nitrosamine impurity Nitroso-STG-19 (NTTP) above the acceptable intake limit of 37 ng/day and up to 246.7 ng/day. An agency notice says FDA recently
Drugs
Janssen says an FDA draft guidance on clinical pharmacology considerations for human radiolabeled mass balance studies is well written and provides sponsors with much-needed guidance when conducting mass balance studies. The firm’s comment also has specific suggestions for strengthening the draft. AbbVie says recent microtracer approaches using accelerator
Drugs
An 8/4 FDA Warning Letter notifies Amazon.com that two mole and skin tag remover products it is marketing through its Web site and distributing through Amazon fulfillment services are unapproved new drugs and are not generally recognized as safe and effective for their intended uses. The letter references
Drugs
A day after updating investors that the company had submitted additional data to FDA to support its efficacy data in a recent NDA for omaveloxolone, indicated for treating patients with Friedreich’s ataxia, Reata Pharmaceuticals now says the agency notified it that the submission’s review is being extended by
Drugs
The 2nd Circuit Court of Appeals has upheld the decision of a New York federal court to grant summary judgment to FDA and Sarepta Therapeutics in a Freedom of Information Act (FOIA) case. The appeals court decision says science writer and journalism professor Charles Seife sought records from FDA relating