Bristol-Myers Squibb has initiated a voluntary recall of 10 lots of BiCNU (carmustine for injection) previously manufactured by Ben Venue Laboratories, a former, third-party contract manufacturer for the company, to the user level.

The European Medicines Agency has launched a public consultation concerning its inventory of pediatric medicines with the aim of highlighting where further R&D efforts are required. The consultation is the first of its kind in this area.

Q&A on GDUFA implementation with Aloka Srinivasan, PhD, a principal consultant with Parexel and former team leader in FDA's Office of Generic Drugs.

PDA's strategic plan calls for maintaining valuable and effective relationships with global regulators.

Ties between the biotechnology industry and university research are crucial.

International trade can be great for business, but breaking border laws can put one in hot water.

Identifying and classifying rouge can help to determine CAPA.

USP optimizes identification tests and impurities procedures.

Brazil takes first steps towards gaining quality requirements for pharmaceutical excipients.

Policymakers must balance fundamental issues involving access to medicines and pricing.

The Johnson & Johnson subsidiary Janssen Pharmaceuticals has announced a settlement and consent decree with 36 states and the District of Columbia in regards to previously disclosed allegations related to the company's marketing and promotional practices relating to Risperdal (risperidone).

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.