Drugs
A new Government Accountability Office report finds that generic drug prices fell 59% from the first quarter of 2010 through the second quarter of 2015. However, the report says, a group of 1,441 established generic drugs saw increases after their prices first declined. “More than 300 of the 1,
Drugs
A new Manual of Policies and Procedures (MAPP) describes the organizational structure, roles, and responsibilities of the Drug Safety Oversight Board (DSOB) and its staff within CDER. The document says the DSOB was created in 2005 to provide oversight for the management of drug safety issues in FDA and to
Drugs
The next U.S. president should ask Congress to roll back a number of monopolies granted to the drug industry over the years in a move to make drugs less costly. That’s the recommendation of retired intellectual property attorney and generic drug industry counsel Alfred Engelberg, who was instrumental
Drugs
Three FDAers say their content analysis of prescription oncology drug Web sites directed to consumers and healthcare professionals showed that the sites contain a large amount of quantitative information about the drugs’ risks and benefits. Writing in the Journal of Cancer Education, the researchers say they analyzed the content of
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says that Web sites operated by Durect Corp. and Pain Therapeutics Inc. are promoting Remoxy ER (oxycodone) extended-release capsules, an investigational new drug, as being safe and effective for the purposes for which it is being investigated. A 9/8 Notice
Drugs
The Washington Legal Foundation (WLF) has asked the 8th Circuit Court of Appeals to overturn a Missouri federal court decision that said plaintiffs who lived outside of Missouri could still sue Pfizer there alleging damages from taking the company’s Lipitor. The WLF amicus brief says that the claims alleged
Drugs
Array BioPharma has reached agreement with FDA on a special protocol assessment (SPA) for BEACON CRC, a global Phase 3 trial involving encorafenib and Erbitux (cetuximab), with or without binimetinib, versus standard of care in patients with BRAF-mutant colorectal cancer (CRC) who have previously received first-or second-line
Drugs
Three Pepper Hamilton attorneys say that an FDA 5/31 decision awarding Amarin Pharma five years of new chemical entity (NCE) exclusivity for its Vascepa overturned the agency’s previous rejection of NCE exclusivity due to a DC federal court ruling that vacated and remanded the FDA administrative decision. “The
Drugs
FDA has published an International Council on Harmonization draft guidance, Q&As on Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies, with questions and answers on the assessment of systemic exposure in toxicity studies. The document says it focuses on points to consider before
Drugs
FDA says a Web site operated by Harrington House, Danville, VA, takes orders for seven Abbey St. Clare products that are promoted through claims that establish them as drugs. A 9/2 Warning Letter says that the products are not generally recognized as safe and effective for their intended uses
FDA Policy/General
FDA is looking for public input on its efforts to mitigate antimicrobial resistance by focusing for the first time on medically important antimicrobials used to treat human disease that are placed in animal feed or water that have at least one therapeutic indication without a defined duration of use. A
Drugs
CDER says it will develop a guidance this year on “Comparative Analyses of the Device Constituent of a Drug-Device Combination Product Submitted in an ANDA.” The Center disclosed the new guidance in a periodic update to its Guidance Agenda. Combination product review processes and procedures have recently been getting
Drugs
The Washington DC District Court has ruled against FDA in granting a Ferring motion for reconsideration over how FDA decided not to retroactively apply a 2014 interpretation on five-year new chemical entity (NCE) exclusivity awarded to certain fixed-combination drug products (see earlier story). An agency guidance outlined the
Drugs
FDA reviewers say they identified concerns with the “ascertainment of the primary neuropsychiatric adverse event outcome that impacts interpretation” of an agency-required postmarketing trial which evaluated neuropsychiatric adverse effects in patients taking Pfizer’s Chantix (varenicline) and GlaxoSmithKline’s Zyban (bupropion). Pfizer has submitted a supplemental NDA that seeks
Drugs
FDA has granted BioVie an orphan drug designation for BIV201 for treating ascites due to all causes except cancer. The company currently is preparing an IND, with plans to begin a U.S. clinical trial next year. The active ingredient in BIV201 is a potent vasoconstrictor, and its mechanism of
Drugs
Novo Nordisk has recalled six batches of its GlucaGen HypoKit due to two customer complaints involving detached needles on the syringe with sterile water for injection. The product is indicated for treating severe hypoglycemia (low blood sugar) in patients with diabetes who are treated with insulin. “Untreated hypoglycemia can eventually
Drugs
A Jazz Pharmaceuticals citizen petition asks FDA not to approve any generic applications that reference its Xyrem (sodium oxybate) oral solution if they carve out labeling about a drug interaction with divalproex sodium. The petition also asks the agency not to approve any generic Xyrem that does not include the
Drugs
Emmaus Life Sciences has submitted an NDA for its orally administered pharmaceutical grade L-glutamine (PGLG) for treating sickle cell disease. If approved, the drug would be the first treatment for pediatric patients, and the first potential new treatment in nearly 20 years for adults. Emmaus is requesting a priority
Drugs
United Exchange Corp. (Cerritos, CA) has recalled five lots of its Family Care Eye Wash due to microbial contamination. The company learned of the potential issue after receiving a product complaint. “Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a
Drugs
FDA has posted an International Conference (ICH) on Harmonization draft guidance on “General Principles for Planning and Design of Multi-Regional Clinical Trials” that describes how best to design drug trials so as to increase their data’s acceptability in multiple regulatory jurisdictions. The document addresses strategic program issues as
Drugs
The “Cancer Moonshot” Blue Ribbon Panel has issued a report with 10 recommendations it says could lead to significant advances in the understanding of cancer and how to intervene in its initiation and progression. The Blue Ribbon Panel included cancer researchers, oncologists, patient advocates, and representatives from government and the
Drugs
A tripartite meeting last week between FDA, European Medicines Agency and Japan’s Pharmaceuticals and Medical Devices Agency shared information on data requirements for approving new antimicrobial agents under limited circumstances (limited number of patients, limited therapeutic tool, targeting single species). The regulatory agencies agreed that a robust response to