News

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.

Takeda Pharmaceutical Company has completed its acquisition of Nycomed for EUR 9.6 billion ($12.9 billion) on a cash-free, debt-free basis. In addition, Takeda has named Frank Morich, Takeda's executive vice-president of internal operations (Americas/Europe), as Nycomed's CEO.

Servier and the Belgium-based biotechnology company Galapagos are embarking on a multiyear strategic alliance to develop new cancer therapies. As a result of the alliance, Galapagos could receive milestone payments of more than EUR 250 million ($332 million).

Europe establishes new collaborative system to track products.

AAPS Global Health Focus Group's Kishor M. Wasan discusses new initiatives.

Getting the most value out of M&As requires proper upfront legwork.

Corporate management must be held accountable for quality at all levels.

Expanding the organization's mandate will strengthen inspections.

Letting contamination build up can cause multiple headaches.

In an effort to balance bilateral trade, India is urging China to increase Indian pharmaceutical imports.

Despite new hurdles, industry must move forward and fulfill its mission.

Electronic prescribing has grown strongly in the US but its future as a European-wide approach in healthcare has been uncertain; new regulatory interest could change the playing field.

Although the European market is approximately 50% smaller than the US in terms of landmass, the population of Europe is approximately 50% larger and this presents a huge market opportunity.

As editor of Pharmaceutical Technology Europe, I often have the opportunity to visit the sites of a wide variety of companies within the industry. Though differing vastly in the technologies and staff they employ, they all share one thing in common for me: the "you learn something new every day!" factor.

The latest meeting of the EMA's Committee for Medicinal Products for Human Use has concluded with more than 15 positive opinions for new and generic drugs and the adoption of key concept papers.

Week of Sept. 26, 2011: BMS collaborates with Ambryx; Merck & Co. opens new R&D center; Teva acquires joint venture interest; and More.

FDA has published a guidance on Marketed Unapproved Drugs-Compliance Policy Guide, which describes the agency's enforcement priorities with regard to products that lack regulatory approval or that are not marketed in accordance with the over-the-counter drug review.

FDA has issued a guidance titled User Fee Waivers, Reductions and Refunds for Drug and Biological Products that outlines FDA's policies for issuing waivers, refunds or reductions in prescription drug user fees.