News

AstraZeneca Names Pascal Soriot CEO; The Merck Group Agrees to Acquire Biochrom; and More.

The Observational Medical Outcomes Partnership (OMOP), which is managed by the Foundation, desires feedback on proposed research priorities and tasks.

The European Medicines Agency has recommended that the anticancer medicine DepoCyte be recalled from EU countries following the discovery of manufacturing deficiencies at Pacira Pharmaceuticals' San Diego site.

Pfizer and Mylan have agreed to establish an exclusive long-term collaboration to develop, manufacture, distribute, and market generic drugs in Japan. The products included in the collaboration are expected to be sold under the Pfizer brand with joint labeling.

FDA Extends Pfizer's Action Date for Tofacitinib NDA; United Drug to Acquire Bilcare GCS; and More.

Eli Lilly has received $1.3 billion for payment of financial obligations from Amylin Pharmaceuticals following Bristol-Myers Squibb's acquisition of Amylin Pharmaceuticals earlier this month.

Myriad Genetics reported that a US federal appeals court has ruled that the company's composition of matter claims covering isolated DNA of the BRCA 1 and BRCA 2 genes are patent-eligible material under federal patent law. The court, however, denied the company's effort to patent methods of "comparing" or "analyzing" DNA sequences.

GlaxoSmithKline (GSK) is selling the majority of its 'classic brands' in Australia to Aspen Global for approximately £172 million ($271.1 million) in cash.

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.

After a series of government reforms that are appealing to both domestic and foreign players, the Japanese pharmaceutical market is making a comeback.

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.