News

In response to the increase in drug shortages over the past three years, President Obama issued an executive order on Oct. 31, 2011 that directs FDA to take several steps to prevent and reduce drug shortages.

Pfizer Completes Acquisition of Icagen; 3M Drug Delivery Systems Names James Ingebrand Vice-President and General Manager; and More.

The Medicines and Healthcare products Regulatory Agency (MHRA) launched a public consultation on the consolidation of United Kingdom (UK) medicines legislation on Oct. 26, 2011. Seeking to greatly simplify and elucidate the law regulating medicines in the UK, the MHRA invited interested parties to contribute to legislation development.

On Oct. 26, 2011, FDA dedicated $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation. The centers, which will be located at the University of Maryland and at Georgetown University, will focus on the scientific knowledge and training needed to modernize and improve the ways the agency reviews and evaluates drugs and medical devices.

Novartis AG and Novartis Pharmaceuticals Corporation have been focusing research efforts on rare diseases since the company was established in 1996.

With the cardiovascular disease burden in Europe increasing, policymakers, regulators and other healthcare stakeholders are seeking to raise awareness and lessen the threat.

Norwich Pharmaceuticals Increases Pilot-Scale Production Capabilities; Sanofi Appoints David Meeker as CEO of its Subsidiary Genzyme; and More.

Merck, Sharpe, and Dohme (MSD) and Singapore's Economic Development Board jointly announced plans for significant investments by MSD to improve its existing manufacturing facilities in Singapore, as well as for new manufacturing, marketing, and research activities.

Abbott has unveiled a plan to separate into two publicly traded companies, one focusing on diversified medical products and the other on research-based pharmaceuticals.

The European Commission has launched an antitrust investigation to examine whether contracts between Johnson & Johnson and Novartis were designed to delay the market entry of generic versions of Fentanyl in the Netherlands.

Pfizer Signs Drug-Development Pact with GlycoMimetics; Lilly Announces Changes in Senior Management; and More.

Roche signed a definitive agreement to acquire Anadys Pharmaceuticals. The two companies have entered into a definitive merger agreement for Roche to fully acquire Anadys at a price of $3.70 per share in an all-cash transaction.

Last week, FDA published a final guidance for pharmaceutical manufacturers that plan to incorporate physical–chemical identifiers in solid oral dosage forms as an anticounterfeiting strategy.

Switzerland's Acino Pharma has agreed to buy Cephalon's combined Middle East and African business in a transaction worth approximately EUR 80 million ($110 million). Acino will pay 60 million Euro ($82.5 million) in cash and an additional EUR 20 million ($27.5 million) will come through shares.

The US Senate and House of Representatives passed last week three separate free-trade pacts with South Korea, Colombia, and Panama. The Society of Chemical Manufacturers and Affiliates and the Pharmaceutical Research and Manufacturers of America both issued statements expressing support for the legislation.

At the request of the US Senate Subcommittee on Federal Financial Management, Government Information, Federal Services, and International Security, the Government Accountability Office conducted an investigation into doctor shopping in Medicare Part D.

Recent recalls have contributed to the pharmaceutical industry?s heightened awareness of glass delamination (i.e., the formation of glass flakes in a vial), which could affect drug quality and patient safety. To confront this growing problem effectively, drugmakers must understand its causes.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the October 2011 edition from Edwards and Moyno.

The future, and increasingly the present, for aseptic operations is isolated robotics. Companies that wish to gain competitive advantages in their operations are stepping up and taking notice.

The European Commission has adopted revised proposals clarifying the information that industry can supply to the public on prescription-only medicines, while maintaining a strict ban on direct-to-consumer advertising.

FDA, CMS, Medicaid Launch Pilot Program to Conduct Parallel Reviews of Medical Devices.

Last week, FDA awarded a grant to the National Institute for Pharmaceutical Technology and Education to improve drug development and manufacturing. The grant could be worth as much as $35 million over the next five years.

After announcing the official appointment of Guido Rasi as new executive director, the EMA management board also endorsed the implementation plan for the agency's 'Road Map to 2015.'

In response to concerns about the sustainability of US drug-development efforts, FDA has released a report that outlines several steps that FDA will take to spur biomedical innovation and ensure that such innovation can be quickly translated into safe and effective therapies.

AstraZeneca is investing $200 million in a new manufacturing site in China. The new site represents AstraZeneca's largest investment in a single manufacturing facility globally.

Vetter Opens New Facility in Chicago; Merck Announces Retirement of Chairman and Former CEO Richard T. Clark; and More.

FDA may consider whether to add specific search criteria (e.g., those that would enable product-specific or violation-specific searches) to its inspections database to make it user-friendly and improve data analysis. The idea was included in a list of eight draft proposals for increasing transparency that the agency published on Oct. 3, 2011.

Merck Serono and Ono Pharmaceutical Sign MS, Cancer Pacts; Roche Names Rainer Metternich Head of Small-Molecule Research; and More.

EMA released two concept papers for consultation that address the need to revise existing guidelines on biosimilar medicines and influenza vaccines.

The CRO Pharmaceutical Product Development (PPD) will be acquired by the Carlyle Group and Hellman and Friedman in a deal valued at approximately $3.9 billion. PPD shareholders will receive $33.25 per share in cash, and PPD will become a privately held company after completion of the transaction.