Drugs
FDA has informed MacroGenics that it no longer plans to hold an Oncologic Drugs Advisory Committee meeting to discuss the company’s BLA for its margetuximab as a treatment for HER2-positive metastatic breast cancer. The agency also said it still expects to meet the 12/18 PDUFA goal date
Drugs
As part of its ongoing testing and investigation into high levels of a possible cancer-causing impurity in some marketed drugs, FDA has added diabetes drug metformin to its watch list of drugs with potential safety concerns. The agency says it is notifying companies whose drugs had N-nitrosodimethylamine (NDMA)
Drugs
Researchers from several academic facilities are proposing a system of “quality scores” to enable health systems and other purchasers and payers of medication to differentiate among drug products according to evidence-based metrics. Writing in a MedRxiv pre-print, the researchers say that currently buyers and payers of pharmaceuticals have
Drugs
FDA has approved Astellas Pharma’s VESIcare LS (solifenacin succinate) oral suspension to treat neurogenic detrusor overactivity (NDO), a form of bladder dysfunction related to neurological impairment, in children age two and older. VESIcare tablets were approved in 2004 to treat overactive bladder in adults age 18 and older. An
Drugs
GlaxoSmithKline has submitted additional materials to FDA regarding the company’s 11/1/19 petition about four categories of information concerning the use of Zofran (ondansetron) in pregnancy. The 5/22 GSK letter says that the company is aware that FDA and Novartis, the current Zofran NDA holder, may be
Drugs
FDA has accepted for review a Fresenius Kabi BLA for a pegfilgrastim biosimilar candidate (MSB11455) that references Amgen’s Neulasta, indicated for reducing the incidence of infection associated with febrile neutropenia, a serious side effect of chemotherapy. The drug works by stimulating the body’s own production of white blood
Drugs
FDA has cleared a 4DMedical 510(k) for its XV Technology, a patented four-dimensional lung imaging process that is intended to rapidly and automatically analyze any functional lung impairment from a single X-ray. “It provides critical information about the functional and structural state of a patient’s lungs
Drugs
FDA has approved an Amivas NDA for artesunate for injection 110 mg, powder and solvent for solution, indicated for the initial treatment of severe malaria in adult and pediatric patients. Approval was based on data from three studies, including the South East Asian Quinine Artesunate Malaria Trial (SEAQUAMAT) and the
Drugs
A 3/25-4/19/19 FDA inspection at Altaire Pharmaceuticals, Aquebogue, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals that were repeated violations from three previous inspections. A just-released 3/12 Warning Letter said the specific violations were: * failing to establish an
Drugs
A 10/17-10/25/19 FDA inspection at Samchundang Pharm Co., Seoul, South Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 5/13 Warning Letter says specific violations were: * failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of test
Drugs
CDER director Janet Woodcock has accepted a detail in the Office of the Commissioner to “start-up” the Trump Administration’s therapeutics initiative under its recently announced “Operation Warp Speed” for Covid-19 treatments, according to FDA commissioner Stephen Hahn. “While she focuses on this work, CDER deputy director Dr.
Drugs
FDA has approved a Sanofi BLA for Dupixent (dupilumab) for children aged six to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is a monoclonal antibody that inhibits the signalling of the
Drugs
FDA has posted a draft International Conference for Harmonization (ICH) guideline, Recommendations for the Permitted Daily Exposures for Three Solvents — 2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol — According to the Maintenance Procedures for the Guidance of Q3C Impurities: Residual Solvents. The agency says the draft was published in
Drugs
FDA says it has updated two guidances for the temporary compounding of certain human drugs during the Covid-19 public health emergency. An online notice says the updates “clarify certain policies to address urgent needs for hospitalized Covid-19 patients.” The guidance for temporary compounding of certain drugs by outsourcing
Drugs
FDA has published a list of 10 drugs in various forms and dosages for which new medication guides are available. The drugs are AbbVie’s Depakene (valproic acid), AbbVie’s Depakote (divalproex sodium), Apopharma’s Ferriprox (deferiprone), AstraZeneca’s Lynparza (Olaparib), Genentech’s Tencentriq (atezolizumab), Hoffmann LaRoche’s Zelboraf (vemurafenib)
Drugs
Hikma Pharmaceuticals has received approval from FDA for its icosapent ethyl capsules, 1 gm, the generic equivalent of Amarin Pharmaceuticals’ Vascepa. In March, a Nevada federal court invalidated six key Vascepa patents owned by Amarin. That decision is currently being appealed. Vascepa is indicated for use with statins to reduce
Drugs
FDA has approved Sunovion’s Kynmobi (apomorphine hydrochloride) to treat the so-called “off-time” when Parkinson’s disease symptoms are not well controlled with oral medication. The Michael J. Fox Foundation for Parkinson’s Research says this is the second agency approval of a drug the foundation helped to
Drugs
FDA has approved a Takeda Pharmaceutical Company NDA for Alunbrig (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. This approval expands Alunbrig’s current indication to include the first-line setting. The potent and
Drugs
FDA has approved a Chiesi Global Rare Diseases NDA for Ferriprox (deferiprone) twice-a-day tablets for treating patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. The company says the new formulation of twice-a-day Ferriprox 1,000 mg oral tablets eliminates
Drugs
FDA has issued a request for information (RFI) seeking a potential contractor with expertise in pattern recognition, statistical process control and other emerging concepts to simplify regulatory oversight functions within the CDER Office of Business Informatics. An online GovConWire report says interested parties must have the capacity to provide analyses
Drugs
CalciMedica says it is transitioning an ongoing randomized open-label study to a blinded placebo-controlled trial for Auxora (formerly called CM4620-IE) in patients with Covid-19 pneumonia. The move was recommended by FDA after reviewing a submission of a recent interim analysis of Auxora in patients suffering from
Drugs
Following a 5/19 closed-door lunch for President Trump and Republican senators, Sen. Chuck Grassley (R-IA) said Trump indicated he still wants congressional action on legislation to lower drug prices despite the Covid-19 public health emergency. As reported online by The Hill, Grassley asked Trump if he