News

Last week, Senator Charles Grassley (R-IA) sent letters to 16 drugmakers, including Pfizer (New York), AstraZeneca (London), and Eli Lilly (Indianapolis), asking them about their current policies regarding whistleblowers?employees who file complaints under the False Claims Act (FCA).

The US House of Representatives passed on July 1, 2010, HR 4899, the Supplemental Appropriations Act of 2010, which included provisions restricting patent settlements between innovator-drug and generic-drug companies, a move that drew criticism from both sectors of the pharmaceutical industry.

Ethics Group Calls on FTC to Investigate Drug Pricing

Eli Lilly to Acquire Alnara Pharmaceuticals; Exelixis CEO Leaves for Biogen Idec; And More.

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

Led by sustainability efforts by Walmart, a new tool emerges for quickly evaluating the environmental and human-health profile of formulated products.

Acumen Fund, a nonprofit venture-capital fund, uses patient capital to build economically sustainable businesses involved in poverty alleviation.

The merger Novartis has been trying to unilaterally impose on Alcon cannot go ahead without the approval of Alcon's Independent Director Committee (IDC), according to a legal expert, and at the moment the IDC still believes that Novartis's offer is vastly inadequate.

Pfizer Suspends Tanezumab Program; Actavis Appoints CEO; And More.

The US Food and Drug Administration's website now features a free online 90-minute training program on the "Past, Present, and Future of FDA Human Drug Regulation."

The US Food and Drug Administration issued on June 25 a draft guidance for industry, "CMC Postapproval Manufacturing Changes Reportable in Annual Reports," to provide recommendations to drug applicants about the types of changes that may be included in annual reports.

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.

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.

A timely new book explains techniques for conformational analysis.

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.