Drugs
Actavis is asking FDA to assign an AP therapeutic equivalence code to its Azacitidine for Injection, 100 mg/vial, which was approved 4/29 in a 505(b)(2) NDA. The petition says that the product meets all applicable requirements for therapeutic equivalence and interchangeability with Celgene’s Vidaza (azacitidine
Drugs
FDA has released the FDA-483 issued at the end of a 7/11-7/22 inspection at Advanced Pharma, Houston, TX. Specific inspection observations included: * failing to establish procedures to prevent microbiological contamination of drug products purporting to be sterile; * failing to have written test procedures relative to appropriate
Drugs
Australia-based Novogen has submitted an IND for TRX-E-002-1 (cantrixil) for treating ovarian cancer. The submission includes data on preclinical pharmacology and toxicity, manufacturing, quality control, and clinical development plans. Cantrixil is described as a first-in-class development candidate which is being studied as a therapy
Drugs
FDA has approved a Heron Therapeutics for Sustol (granisetron) extended-release injection, a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline
Drugs
The 2nd Circuit Court of Appeals has upheld a New York federal court ruling that granted Acorda Therapeutics’ motion to dismiss an Apotex anti-trust claim and also granted summary judgment to Acorda on Lanham Act false advertising claims. The appeals court decision says the case concerned two distinct questions:
Drugs
FDA has given Eisai the green light to move its early Alzheimer’s disease drug E2609 into Phase 3 clinical studies. During a recent end-of-Phase 2 meeting, the agency confirmed there were sufficient data to support the advancement of the novel investigational oral beta-secretase cleaving enzyme (BACE)
Drugs
Eli Lilly says that after a pre-planned interim analysis of its MONARCH 2 study involving abemaciclib, an independent Data Monitoring Committee recommended to continue the study without modification because the interim efficacy criteria were not met. The study compares abemaciclib plus fulvestrant versus placebo with fulvestrant in women with
Drugs
OpenTrialsFDA says it is working to make FDA drug approval packages (DAPs) from the agency Web site easily searchable and accessible and to link them to documents and data related to clinical trials. In a description of their work, the app developers say that DAPs are published at an agency
Drugs
New York pharmacist Ira Gross and his shell company, Chaparral Services, were found guilty in state court of distributing HIV medication illegally obtained from the black market to patients. Gross faces a state prison sentence of up to twenty-five years, according to the NY State Attorney General’s office.
Drugs
A Utah federal court has granted summary judgment to Biogen Idec and Elan, dismissing a negligence case brought against them by a man whose wife died from progressive multifocal leukoencephalopathy (PML) after being prescribed Tysabri (natalizumab) for her multiple sclerosis. The suit claimed negligence, negligent failure to warn, and negligent
Drugs
FDA says that PharmaTech has expanded its 7/16 recall to include all liquid products due to possible Burkholderia cepacia contamination. The products were manufactured in the firm’s Davie, FL, facility, the agency says, and were distributed and labeled by six firms. The initial recall announcement covered all non-
Drugs
AstraZeneca has reported disappointing results from a Phase 3 trial (SELECT-1) of its MEK 1/2 inhibitor, selumetinib, in combination with docetaxel chemotherapy as second-line treatment in patients with KRAS mutation-positive locally-advanced or metastatic non-small cell lung cancer. “The results showed that the trial did
Drugs
FDA has accepted for priority review two Marathon Pharmaceuticals NDAs for the investigational drug deflazacort — one for an immediate-release tablet formulation and the other for an oral suspension formulation — for treating patients with Duchenne muscular dystrophy (DMD). The submissions are expected to receive a user fee review target date
Drugs
Attorneys John Hillebrecht and Rebecca McKnight (DLA Piper) say that after years of Justice Department focus on off-label promotion, kickbacks, and false claims, it appears that the focus may be shifting to current good manufacturing practice issues, especially data integrity. Writing in an online post, the two cite a
Drugs
CDER Division of Nonprescription Drug Products deputy director Karen Mahoney says that FDA is taking steps to assist potential sponsors in submitting applications for an OTC form of naloxone, the prescription drug that can stop or reverse the effects of an opioid overdose. Writing in an FDA Voice blog post,
Drugs
CDER has decided to scrap its 2015 new draft guidance on Request for Quality Metrics, and it plans to replace it with a revised draft document later this year on Submission of Quality Metrics Data. “After carefully considering the numerous technical and regulatory comments received to the docket for the
Drugs
FDA has ordered a partial clinical hold on an Adaptimmune Therapeutics planned pivotal study of NY-ESO SPEAR T-cell therapy in myxoid round cell liposarcoma. This trial is not yet active at any investigational sites, and has not recruited any patients, according to the company. The hold was issued
Drugs
An 8/3-8/5/15 FDA inspection at Concept Products Limited, Tianjin, China, identified significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a 7/26 Warning Letter. Specific violations observed during the inspection included: * failing to have, for each batch of drug product, appropriate
Drugs
A 2/1-2/16 FDA Bioresearch Monitoring Program inspection at North Hills Medical Research, North Richland Hills, TX, found that Dr. John Gabriel did not adhere to applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects by failing to ensure
Drugs
Presumably tired of waiting for FDA to make sense of its position on off-label promotion given many First Amendment losses in the courts, Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) have issued their own industry practice principles on off-label communications. Attorney James
Drugs
Alkermes has filed a supplemental NDA for a two-month dosing interval for Aristada (aripiprazole lauroxil) extended-release injectable suspension for treating schizophrenia. FDA approved the drug last year as the first long-acting atypical antipsychotic with once-monthly and once-every-six-weeks dosing options, according to the company.
Drugs
An 8/4-8/14/15 FDA inspection at Adamson Analytical Laboratories, Corona, CA, identified significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to an 8/2 Warning Letter from the agency’s Los Angeles District Office. Specific violations and deviations included: * failing to exercise appropriate