News

The Office of the Inspector General for the Department of Health and Human Services (HHS) issued a report, Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials, which evaluates the incidence of foreign clinical trials, the ability of the US Food and Drug Administration to oversee these trials, and recommendations to FDA on how to improve its oversight of foreign clinical trials.

We decided to dedicate this month's issue of PTE to a topic that affects all of our readers; the threat of counterfeit medicines.

Teva Pharmaceuticals in the US has admitted to including false statements in the physician prescribing information for its oral contraceptive product Gianvi, a generic version of Bayer Healthcare?s YAZ oral contraceptive.

Company and People Notes: Valeant and Biovail to Merge; GPhA Names Interim Director; And More.

European pharmaceutical companies are outdoing their US counterparts when it comes to making medicines available to developing countries, according to the Access to Medicine Index, which analyzes and ranks the access to medicine efforts of the world's largest pharma companies.

The European Medicines Agency and the European Monitoring Center for Drugs and Drug Addiction to Cooperate.

GSK Acquires Laboratorios Phoenix; Catalent Makes Executive Appointments; And More.

The American Association for the Advancement of Science rolls out several initiatives to increase partnerships and communication on human rights between scientific groups and between scientific and human rights groups.

A roundup of developments on corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other organizations.

A study conducted by the European Medicines Agency (EMA) has shown that statistical methods using EMA's EudraVigilance database of adverse drug reaction reports can be used to detect drug safety issues "significantly earlier" compared with routine pharmacovigilance.

Thermo Fisher to Acquire Fermentas; Pfizer Names Head of R&D; And More.

Regulatory Roundup: USP and Russia's Roszdravnadzor Sign MOU

The US Food and Drug Administration began a partnership with the website Drugs.com to expand access to the agency's consumer-health information.

The US House of Representatives held hearings last week to gain testimony on the potential benefits and risks associated with synthetic biology and synthetic genomics.

About one month after the announcement of McNeil Consumer Healthcare's recall of children's liquid pain and allergy medications , the US Food and Drug Administration testified before the US House Committee on Oversight and Government Reform about the issue.

USP membership meeting prepared the standards-setting body to meet modern challenges.

A timely new book explains techniques for conformational analysis.

Too much or too little control can actually lead to the same result.

Have you ever come across a new technology, process or problem in your profession and wanted to tell others or learn more about it?

Despite its potential, why is personalised medicine still not widely used in healthcare?

A collaboration involving GlaxoSmithKline and two British universities is looking to create faster acting medicines with a technology that prints APIs onto a tablet?s surface.

Bayer to Open San Francisco Innovation Hub; Lonza Bioscience Names COO; And More.

Fifty percent of the marketing authorization applications for human medicines submitted to the European Medicines Agency (EMA) in 2009 were for generic and hybrid medicines?60% higher than the agency's forecast.

FDA and NIH Launch New Safety Reporting Website; And More.

Genzyme (Cambridge, MA) signed a consent decree of permanent injunction that requires the company to correct manufacturing-quality violations at its Allston, Massachusetts, manufacturing facility.

Late last week, the US food and Drug Administration's Transparency Task Force published a series of proposals on public disclosure policies.

Signaling its interest to strengthen its presence in emerging markets, Abbott (Abbott Park, IL) has agreed to acquire Piramal Healthcare Ltd.'s (Mumbai, India) Piramal Healthcare Solutions business (domestic formulations) for $3.72 billion.

Pfizer has begun implementing the first phase of its Plant Network Strategy, which will result in the loss of approximately 6000 jobs over the next several years.

More acquisitions are expected as the patent cliff pushes the pharma industry into a critical phase, with many executives believing that the industry will be unable to innovate sufficiently from within to replace blockbuster drugs.

Lonza Acquires MODA; Sigma-Aldrich Exec to Retire; And More.