FDA Gives PTO Review Period Data to Support Nine Patent Extensions

Nine brand drugmakers have sought patent term extensions recently, and the FDA has now forwarded relevant product review information to the PTO to help with its decisions.

New Form 483 Slows Impax Pipeline, Adds to Hayward Remediation Plan

Amid ongoing efforts to address a previous FDA warning, Impax Laboratories has been hit with a fresh Form 483 after a general inspection unearthed additional quality issues at the company’s Hayward, Calif., facility, further complicating a growing ANDA backlog, the drugmaker says.

Hospira’s Rocky Mount Mending, But GMP Issues Persist, CEO Says

Ongoing remediation at Hospira’s Rocky Mount, N.C., plant is on track with the aid of new hires and consultants, the company says.

Ask the Expert

Since taking the helm as CEO of GPhA last September, Ralph Neas was thrown into the fire, immediately facing a drug shortage crisis, generic user fee program negotiations and FDA development of a biosimilars review pathway and user fee program (Generic Line, Sept. 14, 2011).

FDA’s 2013 Appropriations Flat, Leaving Questions on Biosimilars

Senate appropriators overwhelmingly approved a fiscal 2013 spending bill that provides $2.5 billion for the FDA but leaves no new money for biosimilars reviews needed for the agency to collect user fees.

Mylan, Teva Settle Nuvigil Dispute Allowing Generic Launch in 2016

Mylan can launch its generic version of Teva Pharmaceutical’s sleep drug Nuvigil in June 2016 under a settlement agreement between the two companies announced April 30.

Sponsors Forced to Repeat Studies in Light of Suspect Cetero Data

Some generic-drug makers who used the discredited contract research organization (CRO) Cetero Research will need to reanalyze or repeat studies, while others will need to conduct an independent third-party data audit, the FDA told drugmakers.

Third-Largest Generic Company Made With $5 Billion Watson-Actavis Deal

Watson Pharmaceutical’s purchase of Actavis firmly positions it as one of the top generic-drug makers in the world, giving it access to Asian and European markets it didn’t have before.

Hamburg: FDA Actions Helped Cut Shortages in Half Since Last Year

The FDA has seen a dramatic uptick in early shortage notifications from drugmakers and the number of drug shortages cut in half in the six months since President Barack Obama ordered the agency to request more action from industry.

ViroPharma Loses in Motion To Block Vancocin Generics

The U.S. District Court for the District of Columbia has denied ViroPharma’s motion for a temporary injunction to require the FDA to withdraw its approval of three generics of the gastrointestinal antibiotic Vancocin.

MHRA Criticizes EU Drug Verification Plan as Costly

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is taking issue with an EU plan to scan all drugs at the point of dispensing, saying the cost of providing scanners at all healthcare outlets is too burdensome.

MHRA’s New Falsified Medicines Strategy Takes Aim at Internet

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) unveiled a new anti-counterfeiting strategy that builds off a 2007 strategy with increased international collaborations to fight the expanding risk of fake drugs online.

EMA Outlines Plan to Ensure Quality of Foreign Clinical Trials

The European Medicines Agency must increase inspections of foreign trials and work with regulators and ethics bodies in other countries to ensure there is a robust framework for the oversight and conduct of clinical trials, a new EMA report concludes.

EU Regulators Detail Plan to Boost Clinical Trial Raw Data Access

Full clinical trial reports with raw data should be publicly available, but regulatory authorities must develop engagement and standards to ensure that meta- and re-analysis of data are of high quality, a group of European regulators say.

EMA Calls for Documentation of Biologic Manufacturing Processes

Drugmakers seeking approval for biologics trials in the EU must describe and justify their manufacturing processes and process controls, ideally with a flow chart of all steps, the European Medicines Agency (EMA) says.

EMA Biosimilars Q&A Aims to Clarify Presubmission Issues, Review Timelines

The European Medicines Agency (EMA) has published a question-and-answer guideline on marketing applications for biosimilars, providing advice on a number of presubmission issues, such as requesting an accelerated assessment, and giving detailed answers about review timing.

Process Validation Should Encompass Complete Lifecycle of Drug, EMA Says

Drugmakers should apply a lifecycle approach to process validation — tying together data on product and process development, the commercial manufacturing process and maintenance and consistency of the process during routine commercial production, according to the European Medicines Agency (EMA). Includes the full text of EMA Draft Guideline On Process Validation for Drugmakers.

EU Court: Financial Regards Not Enough to Justify Import of Unapproved Drugs

The European Court of Justice has struck down a section of a 2001 Polish law that allows doctors and hospitals to import cheaper, unapproved drugs equivalent to drugs legally authorized in the Polish marketplace.

MHRA Reminds Drug Companies to Provide Updates on Drug Statuses

Companies with drugs authorized in the UK are being asked to update the Medicines and Healthcare products Regulatory Agency (MHRA) on the marketing status of their products.

Harmonizing U.S., EU Orphan Protocol Guidance Could Speed Access to Therapies

To help drugmakers speed new therapies to patients with rare diseases, U.S. and EU regulators should harmonize their philosophies around orphan drug development and generate common guidance on trial requirements, experts say.