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 releases guidance documents on PET drugs, labeling of OTC sunscreen, and the use of certain phthalates as excipients.

Myriad Genetics reports that the US Supreme Court has granted certiorari agreeing to hear the company's gene patentability case.

The company issues voluntary recall of certain lots due to possible contamination with small glass particles.

The European Medicines Agency has published a plan to help Europe?s regulatory network prevent, mitigate and manage shortages of important medicines following manufacturing problems.

Eli Lilly released its annual report containing updates on progress and new initiatives in corporate responsibility.

As the battle against counterfeits gains momentum, PharmTech speaks to Mark Davison, CEO of Blue Sphere Health, and Craig Stobie, global life sciences sector manager at Domino Printing Sciences, about the challenges involved.

In addition to globalisation, high financial rewards and low penalties for counterfeiters are contributing to the rise in fake medicines.

Nathan Jessop reviews the pharmaceutical industry's experience with the first year of Germany?s new pricing policy.

To ensure the accuracy of scientific testing, protect the subjects to avoid data contamination.

A look at the year's leaders in innovation strategy, including the top bio/pharmaceutical companies and award recipients from AAPS, PhRMA, and CPhI.

Domestic companies are changing their business models in response to recent drug price cuts.

Clean-in-place systems should be optimized during design and commissioning and after validation.

The EMA brought together European and US expert representatives from regulatory authorities, academia, industry and a health-technology-assessment agency on Nov. 18, 2011 to discuss the use and importance of subgroup analysis in the assessment of clinical trials.

Takeda Forms New Global Medical Affairs Department; UCB, NewBridge Pharmaceuticals Partner for Middle East and African Markets; and More.

EMA addresses drug supply shortage.

GlaxoSmithKline announced its intent to increase ownership in its publicly-listed, consumer-healthcare subsidiary in India and in GlaxoSmithKline Consumer Nigeria as part of its emerging-markets investment strategy.

Novartis announced that it has received FDA approval for a seasonal influenza vaccine produced in cell culture, the first seasonal vaccine produced by this method to be approved in the US.

The European Medicines Agency (EMA) recently conducted a workshop on clinical-trial data and transparency in London following the agency's decision to proactively publish all data from clinical trials and enable interested parties to access to full data sets.

The European Commission (EC) is seeking to introduce a black symbol to identify medicines that are subject to additional monitoring.

Boehringer Ingelheim has entered into a non-exclusive technology and commercial license option agreement with BaroFold. Under the terms of the agreement, Boehringer Ingelheim will license BaroFold's pressure-enabled manufacturing technology (PreEMT).

German Court Finds AstraZeneca's Seroquel XR Formulation Patent Invalid; FDA Advisory Committee to Recommend Approval of GSK's H5N1 Influenza Vaccine Candidate; and More.

More favourable conditions for the pharmaceutical industry, including a "golden era of renewed productivity and prosperity" have been forecast in a new report from analyst firm PricewaterhouseCoopers (PwC).

As-found data is a crucial component of pipette calibration for laboratories that must comply with GMP regulations.

FDA announced the availability of the guidance “Q11 Development and Manufacture of Drug Substances†in the Nov. 20, 2011 edition of the Federal Register.

Thermo Fisher Scientific has officially opened its new manufacturing facility in Suzhou, China. The $20-million plant will manufacture life-sciences consumables and equipment as well as establish local production capabilities to meet increasing demand in China and other regions in Asia Pacific.

USP announces new drug naming policy and FDA releases two guidance documents.

House Democrats have requested the Government Accountability Office (GAO) to conduct an inquiry into factors leading to an increased reliance on compounded products.