News

Before we can intelligently set the limits of process variation, we need to know what the clinical impact of that variation will be.

Washington, DC (Feb. 22)-The Biotechnology Industry Organization criticized two separate studies respectively released by the Pharmaceutical Care Management Association and Express Scripts, Inc. regarding the cost-savings, interchangeability, and market penetration of follow-on biologics.

DSM, Crucell, Genentech, More

Brussels (Feb. 13)-The European Generic Medicines Association raised concerns over what it terms ?the serious lack? of resources available to member states in the European Union (EU) to deal with the regulatory workload and bottleneck in new registrations caused by the new Decentralized Procedure (DCP) for approving drugs in Europe.

Enschede, Netherlands (Feb. 26)-Scientists from the University of Twente?s MESA+ Institute for Nanotechnology have designed a novel delivery system by combining synthetic iron-containing polymers with DNA macromolecules.

London (Feb. 22)-AstraZeneca unveiled further details of its plan to reduce staff at certain production facilities and announced a $120-million investment in a new process research and development (PR&D) facility in the United Kingdom.

Rockville, MD (Jan. 5)-The US Food and Drug Administration issued a Warning Letter to Bell-More Laboratories following the agency?s August 2006 inspection of the company?s Hampstead pharmaceutical facility.

Rockville, MD (Feb. 1)-The US Food and Drug Administration issued a revised warning letter to Actavis Totowa, LLC, citing ?significant deviations from the current Good Manufacturing Practice regulations.?

Continuing an ambitious growth strategy, SAFC eyes CGMP manufacturing capacity in India for its custom-synthesis business and seeks to gain large-scale organics manufacturing capacity in China for raw-materials supply. And, its biosciences segment seeks opportunity in single-use disposable manufacturing.

As the supply-chain strategies of the pharmaceutical industry evolve, managing risks in outsourcing takes on greater importance. A recent program by the Drug, Chemical, and Associated Technologies Association examined approaches to mitigating risk and improving the pricing-and-cost model in the outsourced relationship.

Princeton, NJ (Feb. 15, 2007)-Ranbaxy Inc., confirmed that federal officials conducted a search of its New Jersey offices on Feb. 14, 2007 and commented on its reported plan to acquire Merck's generics business.

Aptuit, AstraZeneca, Corautus, FDA, more

Hafnarfjordur, Iceland (Feb. 13)-Generic drug manufacturer Actavis acquired the active pharmaceutical ingredient (API) division of Sanmar Specialty Chemicals, Ltd. (SSCL), a subsidiary of the Sanmar Group.

InformexUSA, San Francisco (Feb. 14?16)-Several contract manufacturing organizations (CMOs) and technology providers used InformexUSA to announce plans to expand manufacturing capabilities, increase service offerings, and ramp up other investments.

Geneva, Switzerland (Feb. 16)-During a two-day meeting, the World Health Organzation announced ?encouraging progress? in the development of a pandemic influenza vaccine but admitted that the industry still ?lacks the manufacturing capacity to meet potential pandemic influenza vaccine demand.?

Actavis, Cardinal, FDA, more

InformexUSA, San Francisco (Feb. 12?Feb. 14)-Custom manufacturers of active pharmaceutical ingredients and intermediates are gathered at InformexUSA this week, with companies announcing investment plans and unveiling new technology

InformexUSA, San Francisco (Feb. 14)-The Synthetic Organic Chemical Manufacturers Association is launching a new sustainable chemistry initiative, the International Center for Sustainable Chemistry.

InformexUSA, San Francisco (Feb. 14)-NPIL Pharma unveiled a $100-million investment program in formulation development and manufacturing services.

InformexUSA, San Francisco (Feb. 14)-Almac Sciences plans to collaborate for cytotoxic fill-and-finish services with the Center for Pharmaceutical Science and Technology (CPST) at the University of Kentucky.

Washington, DC (Feb. 14)?A congressional team has reintroduced the ?Access to Life-Saving Medicine Act,? which establishes a process through which the US Food and Drug Administration can approve generic copies of biologic drugs.

London, UK (Feb. 1)?Researchers at the University of London?s School of Pharmacy have chemically modified carbon nanotubes to enable them to enter human cancer cells.

Cambrex, Lonza, EaglePicher, more

Washington, DC (Feb. 7)-The Synthetic Organic Chemical Manufacturers Association (SOCMA) submitted comments to the US Department of Homeland Security in response to proposed DHS regulations on chemical site security, asking DHS to take into consideration the unique nature of the specialty batch manufacturing sector.

Washington, DC (Jan. 26)-The US Department of Health and Human Services has granted targeted liability protections for manufacturers of a vaccine to prevent a pandemic of influenza A (H5N1).

New York, NY (Jan. 31)-Pfizer, Inc. scored a victory over Synthon IP in a patent infringement lawsuit over the manufacturing process for ?Norvasc? (amlodipine).

St. Louis, MO, (Feb. 8)-SAFC, the custom manufacturing and fine chemicals unit of Sigma-Aldrich Corporation, is seeking to build a footprint in Asia, eying possible acquisitions in India and China.

Rockville, MD (Jan. 30)-The White House proposes a record $2 billion budget for FDA for the year that starts Sept. 30, 2007, an amount that consists of $1.6 billion in appropriated funds, plus some $450 million user fees for drugs, biologics, medical devices and other products.

Osaka, Japan (Feb. 2)-Tanabe Seiyaku Co. Ltd. and Mitsubishi Pharma Corporation agreed to merge, with the closing planned for merger scheduled to take effect Oct. 1, 2007.

The injunction blocks rules that required secondary wholesalers to supply pedigrees tracing the chain of custody to the maker.