Pharmaceutical Technology Editors

ICH Steering Committee Approves Revised Guideline for Genotoxicity Testing and Data Interpretation for Medicines.

We have changed the brand of our stoppers for a product that we freeze-dry in vials. Since the change, we have observed a significant increase in rejects for collapsed cakes. Why are the cakes collapsing? What can we do to prevent this problem?

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the November 2011 edition from Sartorius Stedim Biotech and Thermo Fisher Scientific.

Implementing a zero-waste strategy is not merely an option, it can be seen as a crucial business imperative.

Until now, the industry has adhered to the tradition of producing three batches of product to validate its manufacturing processes. But FDA?s new process-validation guidance does not prescribe any number of batches that is necessary for compliance.

Procter & Gamble and Teva Pharmaceutical Industries Enter into Consumer Healthcare Partnership; USP Makes Several Executive Appointments; and More.

On Sept. 27, 2011, FDA sent Genentech a Form 483 listing several violations at the company's South San Francisco, California, plant. The violations included problems with investigations into batch failures, inappropriate equipment design, and insufficient protection against contamination. FDA visited the plant, which produces the cancer drug Avastin, 13 times in September 2011 and made four observations.

EMA Issues Concept Paper for Public Consultation on Development of Toxicological Guidance for use in Risk Identification.

A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other private and public organizations.

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.

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

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.

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.

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.

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.'

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.

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.

GE Healthcare, the health business of General Electric, will dedicate $1 billion of its total R&D budget during the next five years to its technologies for manufacturing biopharmaceuticals and for cancer research. Part of the money will go toward expanding the company's cancer-diagnostic and molecular-imaging capabilities, as well.