News

South Carolina-based Altec Medical pleaded guilty to one count of conspiring to defraud FDA and to commit federal offenses in connection with a drug-diversion scheme that lasted from 2007 to 2009.

Bristol-Myers Squibb Completes Acquisition of Amylin; Quintiles Acquires Expression Analysis; and More.

Regulatory Roundup: ISPE issues ozone sanitization guidance and EMA amends incident management plan

Flexible, scalable control systems use program batch sequencing.

Zoetis, a subsidiary of Pfizer, filed a registration statement with the US Securities and Exchange Commission for a potential initial public offering of Class A common stock.

AstraZeneca has paid approximately $3.2 billion to extend its diabetes alliance with Bristol-Myers Squibb (BMS), following BMS's recently completed acquisition of Amylin Pharmaceuticals.

Elan Corporation announced plans to spin off its discovery unit and Neotope Biosciences division to create an independent entity focused on R&D.

On Sept. 12, 2012, PhRMA is cohosting a brand new national awards program in Washington, DC, to honor individuals and organizations that have contributed significantly to the fight against Alzheimer's Disease.

The UK is to invest £8 million ($12.5 million) in a new center that will be dedicated to stem-cell biology and medicine, with the aim of developing new therapeutic approaches to illnesses that currently have no effective treatments.

Boehringer, Servier, Xoma Form Biomanufacturing Agreement; Teva Canada Completes Sale of Mirabel (Quebec) Facility to Halo Pharmaceutical; and More.

The European Medicines Agency (EMA) will soon be phasing out follow-up measures to marketing authorisations in place of a new system of classification that will be introduced in a stepwise manner.

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.

An internal investigation and voluntary disclosure by Pfizer led to a settlement with the US Department of Justice and Securities and Exchange Commission.

Novartis has entered into a global collaboration with the University of Pennsylvania in the US to research, develop and commercialise targeted cancer therapies.

Gilead Sciences announced that it is entering into agreements with Indian generic drug manufacturers to enhance access in developing countries to its anti-HIV medicine, emtricitabine.

Manufacturers willing to report bad news about the supply can help reverse the shortage trend.

New law provides FDA with the resources it needs to safeguard drug supply chain.

Meticulous system configuration can prevent machines from taking over.

FDA Issues Complete Response Letter to Luitpold Pharmaceuticals for Injectafer NDA; Novasep Invests to Expand API Manufacturing Capabilities; and More.

Germany has shifted from a market where the pharmaceutical industry could enjoy considerable pricing freedom to a sensitive market influenced by cost-containment policies.

A roundup of developments in corporate social responsibility (CSR) and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

FDA announces FY 2013 user fee rates and EMA furthers relationship with Japan.

Abbott forms a partnership with the US Secretary of State's International Fund for Women and Girls to support grassroots organizations that are working to advance health, education, and economic opportunity for women in Burma.

Prominent scientists and political leaders at the International AIDS Conference in Washington, D.C., in late July were optimistic for the first time about bringing an end to the global AIDS pandemic.

Pharmaceutical industry leaders Pfizer, Novartis, Merck, and other companies released second-quarter 2012 results, emphasizing growth of new products and strength in emerging markets.

Merck Serono will be closing down operations in Geneva as part of its restructuring activities, which includes a spin off of the its Parkinson's disease R&D portfolio to a new company named Prexton Therapeutics.

A report from the European Commission shows that fake pharmaceuticals were the top articles detained by European Union customs in 2011.

The European Commission has issued a statement of objections against Lundbeck and several other pharmaceutical companies with the preliminary view that Lundbeck formed agreements with generic-drug companies to prevent the market entry of cheaper versions of its antidepressant, citalopram.

Amicus Therapeutics, GSK Expand Fabry Pact; US District Court Rules in Favor of Pfizer, Northwestern University in Lyrica Patent Case; and More.

A roundup of industry regulatory news.