News

The Dow Chemical Company (Midland, MI) has agreed to acquire Wolff Walsrode, a manufacturer of cellulose products and a business unit of the Bayer Group (Leverkusen, Germany, www.bayer.com).

Biotechnology stocks dropped 14% in 2006, giving up more than half of the value they'd picked up during a "stellar" 2005, according to G. Steven Burrill, CEO of Burrill & Company (www.burrillandco.com), the venture and merhant banking company. "Overall, it wasn't a great year for biotech," said Burrill in a year-end analysis, indicating that the biotechnology industry will finish the year with its collective market capitalization essentially unchanged, at approximately $490 billion. As for the future, biotechnology will continue to fuel a the transformation in healthcare, a tansformation emphasizing earlier disease detection, more targeted treatments, and adjunctive support through enhanced nutrition. We will see further progress on the personalized, predictive, preventative front...with new products targeting the "individualization" of medicine in the marketplace. Other predictions for 2007 include...

Washington, DC (Dec. 13)-After considerable debate and negotiation, Congress this week passed four bills poised to affect pharmaceutical and biotechnology research, development, and manufacture. All are currently awaiting signature by the President.

Rockville, MD (Dec. 12)-Citing serious safety concerns, the US Food and Drug Administration is ordering unapproved quinine drugs from the market, including those containing quinine sulfate and any quinine salt.

Basel, Switzerland (Dec. 5)-Lonza Group Ltd. and Singapore?s Bio*One Capital have formed a joint venture, Lonza Biologics Tuas, to build a large-scale mammalian cell-culture facility in Singapore for as much as $350 million.

Rockville, MD (Dec. 12)-The US Food and Drug Administration is proposing amendments to its final rule regarding labeling requirements for convenience-size over-the-counter human drugs.

Bothell, WA (December 12)?If the shareholders of biotechnology company Icos Corp. approve a proposed buyout by Eli Lilly and Co., all of Icos?s 700 employees will lose their jobs.

Dec. 11, 2006 (Rockville, MD)-Effective Jan. 16, 2007, Scott Gottlieb, MD, deputy commissioner for medical and scientific affairs at the US Food and Drug Administration, will leave the agency and will return to the American Enterprise Institute.

Brussels, Belgium (Dec. 5)-The debate over biosimilars in Europe was heightened last week between the European Generics Association and the International Alliance of Patients Organizations, a patient advocacy group that issued a briefing paper on biosimilars to the European Parliament, the legislative arm of the European Union (EU).

Abbott, Enanta, BASF, Celgene, More

Princeton, NJ (Nov. 30)-Rockwood Holdings, Inc. agreed to sell its Group Novasep subsidiary for EUR 425 million ($567 million) to a consortium of buyers consisting of Glide Buyout Partners BV, Banexi Capital, and Group Novasep management.

Rockville, MD ( Dec. 4)-The U.S. Pharmacopeia plans to open a 10,500-square-foot site in Shanghai in February 2007. The facility, in Shanghai's Zhangjiang Hi-Tech Park, will support collaborative testing, technical assistance, customer service, and training.

Whitehouse Station, NJ, (Dec. 6)-Merck & Co., Inc. expects the initial phase of its cost-reduction program, first announced in 2005, to yield cumulative pretax savings of $4.5?5.0 billion from 2006 through 2010, with roughly $2 billion of that coming from implementing its manufacturing supply strategy.

3M, Actavis, Kos, Abbott, more

Dublin, OH (Nov. 30)-Cardinal Health has announced plans to divest its Pharmaceutical Technologies and Services (PTS) segment, "a business that manufactures or packages 100 billion doses of medication every year for pharmaceutical and biotech firms, employs approximately 10,000 at more than 30 facilities worldwide and generates $1.8 billion in revenue," according to a company statement.

London (Dec. 8)-GlaxoSmithKline PLC agreed to acquire Domantis Ltd., a developer of antibodies for £230 million ($454 million) in cash.

Washington, DC (Dec. 7)-One of the last acts of outgoing Senate majority leader Bill Frist (R-Tenn) was to push through confirmation of Andrew von Eschenbach as the official head of the Food and Drug Administration.

The integrated services model is the "next big thing" in CMC and early development services.

Poor support of drug- and process-development training programs will affect industry's future growth.

Makers of injectable drugs can increase their market share and stay competitive by devising a product life-cycle management strategy.

We really knew what we were doing-until we opened the column for a routine repacking.

Proof of concept is a new development paradigm.

Years of concentrating its political support on one side of the political spectrum may have eroded the industry's ties to the new majority.

The refusal to sell was motivated by a desire to maximize GSK's profits, and GSK had not shown that not having these profits would prejudice consumers by restricting GSK's R&D.

London (Nov. 22)-The European Medicines Agency reports a defect in some vials of Herceptin (trastuzumab), the anticancer treatment by Roche, which have been distributed in Europe. As a result, The EMEA's Committee for Medicinal Products for Human Use outlined a plan, formulated in conjunction with Roche, for the visually reinspecting and replacing defective vials.

Ann Arbor, MI (Nov.15)-Scientists at University of Michigan?s Comprehensive Cancer Center have devised a nanoparticle system that delivers a photodynamic drug directly to brain-cancer tumors

AAI, Mallinckrodt, ATMI LifeSciences, More

Basel, Switzerland (Nov. 17)-Novartis plans to submit additional information to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on manufacturing issues to support the approval of its antifungal drug "Mycograb." The CHMP issued a negative recommendation for the drug.

Washington, DC (Nov. 13)-The Biotechnology Industry Organization is urging the World Health Organization to assign a distinct international nonproprietary name (INN) to each unique biological product, including follow-on biologics or biosimilars.

Argonne, IL (Nov. 9)-Researchers from Argonne National Laboratory?s Chemistry Division and Xradia have developed a novel X-ray microscopy technique that allows molecular observations of the reactivity of solid surfaces at the nanometer scale, including interfacial reactions such as ion adsorption and catalytic reactions.