Drugs
FDA commissioner Stephen Hahn says that while an agency moratorium on on-site domestic and foreign facility inspections remains in place, the agency is working with the Centers on Disease Control “to develop a process that would govern how and where to return to on-site facility surveillance inspections in
Drugs
ICU Medical has recalled one lot of lactated ringer’s injection due to the presence of particulate matter identified as iron oxide. The company became aware of the issue through a single customer complaint, according to a recall notice. “Administration of a drug product that contains metal particulate matter could
Drugs
FDA has granted Daiichi Sankyo and AstraZeneca a breakthrough therapy designation for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating patients with HER2 positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab. The designation was based on results from the DESTINY-
Drugs
FDA has granted Eli Lilly accelerated approval three months ahead of schedule for Retevmo (selpercatinib) for certain patients with non-small cell lung cancer or thyroid cancer. Approval was based on data from the LIBRETTO-001 clinical trial. Data showed that in NSCLC patients the overall response rate (ORR) was
Drugs
FDA has cited RC Outsourcing (Lowellville, OH) for GMP issues after the drug outsourcing facility was inspected in February. For example, a just-posted FDA-483 said the firm did not follow written production and process control procedures when executing production and process control functions. The investigator also said there
Drugs
Senators Elizabeth Warren (D-MA) and Patty Murray (D-WA) have written FDA asking how the agency is tracking the use, safety, and effectiveness of scores of products on the market under emergency use authorizations (EUAs). Since 2/4, FDA has issued 112 EUAs for Covid-19-related medical products,
Drugs
A German researcher says that the Covid-19 pandemic is having a large impact on drug development, with over 1,000 trials having been stopped due to restrictions brought on by the virus. “The Covid-19 pandemic has also caused a setback for entire programs of human research, possibly delaying
Drugs
Apotex has agreed to pay a $24.1 million criminal penalty and admit that it conspired with other generic drug sellers to artificially raise the price of pravastatin, a cholesterol-lowering drug that lowers the risk of heart disease and stroke. According to the one-count felony charge filed in
Drugs
FDA has granted Bexion Pharmaceuticals an orphan drug designation for BXQ-350 and its use for treating malignant glioma, including diffuse intrinsic pontine glioma (DIPG), which primarily affects children. The company says DIPG makes up 10-15% of all brain tumors in children, with about 150-300 new diagnoses per
Drugs
FDA says that as of 5/7 it has issued 42 Warning Letters to companies making bogus Covid-19 claims, including a seller of fraudulent chlorine dioxide products, equivalent to industrial bleach, frequently referred to as Miracle Mineral Solution or MMS. An agency scam update says that after the MMS
Drugs
A study conducted by Medscape in collaboration with FDA found that short-form messaging combined with digital continuing medical education (CME) to clinicians reduced the inappropriate prescribing of antibiotics. The study examined whether short-form messages (e-mails, Web alerts, and mobile alerts) and digital CME could affect the volume
Drugs
TG Therapeutics has announced positive topline results from the UNITY-CLL Phase 3 trial evaluating the combination of umbralisib plus ublituximab (U2) compared to obinutuzumab plus chlorambucil in patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia (CLL). A prespecified interim analysis found that the 420-subject trial met
Drugs
A whistleblower report by ousted Biomedical Advanced Research and Development Authority (BARDA) director Rick Bright details the roles of senior FDA officials involved in allowing the broader use of malaria drugs chloroquine and hydroxychloroquine during the Covid-19 pandemic. Bright says he filed the complaint after being removed from his
Drugs
FDA has issued a guidance, Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease, to assist sponsors in the clinical development of drugs to prevent cytomegalovirus (CMV) disease in patients who have undergone solid organ transplantation or hematopoietic stem cell transplantation. The document addresses the agency’s current thinking
Drugs
FDA has approved AstraZeneca’s Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization for heart failure. Previously, Farxiga, which is a sodium-glucose co-transporter 2 inhibitor, was approved to improve glycemic control in adults with
Drugs
FDA has granted Cabaletta Bio fast track status for DSG3-CAART (Desmoglein 3 Chimeric Auto-Antibody Receptor T cells) for treating mucosal pemphigus vulgaris (mPV). The therapy is designed for improving healing of mucosal blisters in patients with mPV, the company says. It targets B cells that express pathogenic autoantibodies
Drugs
FDA has extended by three months its review of a Bristol Myers Squibb BLA for lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for treating adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies. After the BLA was
Drugs
FDA has approved a Novartis Pharmaceuticals NDA for Tabrecta (capmatinib) for treating adult patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body. “Tabrecta is the first FDA-approved therapy to treat NSCLC with specific mutations (those that lead to mesenchymal-epithelial transition
Drugs
The Association for Accessible Medicines says that by updating the Purple Book, FDA is “increasing transparency for patients, providers, payers, manufacturers, and other stakeholders. This will help close educational and regulatory gaps, and it will improve patient access and adoption of lower-cost FDA-approved biosimilars.” The association’s comment
Drugs
TherapeuticsMD is petitioning FDA to not receive or approve any marketing application that references its Imvexxy (estradiol vaginal inserts) unless the application is submitted as a 505(j) ANDA and the ANDA product is manufactured qualitatively the same as Imvexxy, including the teardrop shape. Alternatively, the petition says, the generic
Drugs
Retired CDER Division of Psychiatric Products director Thomas Laughren says a trend of increasing placebo response in trials of schizophrenia drugs should be “alarming not only to pharmaceutical companies and regulators but also to clinicians, the academic community, and of course patients and their families.” In a commentary on an
Drugs
A 10/15-10/22/19 FDA inspection at Shriram Institute for Industrial Research, Delhi, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients (API) in its work as a contract testing laboratory. A 4/15