News

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.

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.

MedImmune, the global biologics arm of AstraZeneca, announced that it is restructuring its infectious disease and vaccines R&D and operations. This will result in the closure of MedImmune's sites in Mountain View and Santa Clara, California.

Sandoz announced it has completed the acquisition of Fougera Pharmaceuticals, a maker of generic dermatology products, for $1.5 billion.

The UK's Medicines and Healthcare products Regulatory Agency has launched a public consultation regarding a scheme that could provide patients with access to unlicensed medicines in Phase II or III clinical trials.

The European Commission is looking to provide Sweden with EUR4.3 million to help 700 workers affected by AstraZeneca job cuts to find new work.

Bristol-Myers Squibb Begins Tender Offer to Acquire Amylin Pharmaceuticals; FDA Approves Gilead's Truvada for Reducing the Risk of Acquiring HIV; and More.

The author discusses the regulatory requirements for electronic records contained in Title 21 CFR Part 211 and how they overlap with the requirements set forth in Title 21 CFR Part 11.

GlaxoSmithKline has announced that it will acquire Human Genome Sciences (HGS) for $14.25 per share in cash, or approximately $3.6 billion on an equity basis.

Par Pharmaceuticals, a maker of generic drugs, has entered into an agreement to be acquired by the private investment firm, TPG, for $1.9 billion.

FDA promotes supply chain pilot program. EMA opens pharmacovigilance legistation up for public consultation. USP Calls for Somatropin Cell-Based Bioidentity Method.

Global spending on medicines is estimated to reach nearly $1.2 trillion by 2016.

Amgen Completes Acquisition of KAI Pharmaceuticals; Renaissance Acquisition Holdings Acquires DPT Laboratories; and More.