News

Altana AG plans to sell Altana Pharma AG and its entire pharmaceuticals business to Nycomed for EUR 4.5 billion (about $5.7 billion).

FDA issued a Warning Letter from its Minneapolis District Office to Hawkins, Inc., part of a diversified chemical company and pharmaceutical repackager here.

As with pharmaceutical manufacturing as a whole, a risk-based approach is important in manufacturing highly hazardous or potent compounds. Industry groups are working with US Food and Drug Administration (Rockville, MD) to develop a baseline guide for a risk-management approach to determine containment controls required to minimize cross contamination.

Kevin Sharer has become chairman of the board of the Pharmaceutical Research and Manufacturers of America upon the resignation of Peter R. Dolan.

AstraZeneca, Schering AG, Bioxel Pharma

Specialty Pharmaceutical Company Bentley Pharmaceuticals has entered into an agreement with Cardinal Health for the scale-up of clinical supplies for Bentley's intranasal insulin product candidate.

Albemarle Corporation signed an agreement with DSM Pharmaceutical Products to buy the assets and the fine chemistry services and pharma chemicals business associated with DSM's South Haven, Michigan facility.

Merck KGaA has agreed to buy a majority stake in the European biotechnology company Serono SA for CHF 16.6 billion ($13.3 billion).

Baltimore, MD (Sept. 10)-Researchers at Johns Hopkins University have devised a new controlled-delivery system that applies an electrical pulse to release drug molecules, nanoparticles, biopolymers such as peptides and proteins, and protein assemblies such as viruses from thin fabricated gold electrodes. Developers hope the technique will allow biocompatible implantable chips for precisely dispensing small amounts of drug into the body.

Chemir Analytical Services has launched IQsynthesis, formerly known as Gateway Chemical Technology, Inc. Chemir acquired Gateway Chemical Technology, which provides custom synthesis and process development services, in May 2006.

Barr Pharmaceuticals,Inc.; Cardinal Health; GlaxoSmithKline

MedImmune, Inc. has broken ground on an expansion to its biologics manufacturing facility in Frederick, Maryland. The $250-million expansion is the first phase of a multi-phase construction project that MedImmune announced last fall.

Arlington, VA (Sept. 12)-At the American Association of Pharmaceutical Scientists meeting here, &quote;Real World Applications of PAT and QbD in Drug Process Development and Approval" (Sept. 11-12), chemical engineer and process modeler Michael L. Thompson, PhD, described how Procter & Gamble (West Chester, OH, www.pg.com) applies these mathematical tools to increase product quality and reduce development and trouble-shooting time for consumer and pharmaceutical products.

Washington, DC (Sept. 12)-The Office of New Drug Quality Assessment (ONDQA) in the Center for Drug Evaluation and Research (CDER) has approved one new drug application (NDA) under its CMC Pilot Program and has two more applications are under review. The pilot was established last year to provide an opportunity for FDA and industry to explore strategies for including Quality by Design (QbD) principles and process analytical technology approaches in regulatory submissions, explained ONDQA deputy director Chi-wan Chen at the PDA-FDA Joint Regulatory Conference here

Scientists from GlycoFi, Inc., a wholly owned subsidiary of Merck & Co, in collaboration with Dartmouth-Hitchcock Medical Center, have engineered yeast cells capable of producing a broad range of recombinant therapeutic proteins with fully human sugar structures (glycosylation).

Genzyme Corporation, Luitpold Pharmaceuticals, Kemwell Pvt. Ltd.

US District Court Judge Robert Junell issued a written opinion in Medical Center Pharmacy, et al. v. Gonzalez, et al., supporting the ten plaintiff pharmacies? assertion that the US Food and Drug Administration lacks the authority to regulate compounded drugs and inspect state-licensed retail pharmacies.

Washington, DC (Sept. 1) - In a Federal Register announcement the US Food and Drug Administration laid out its guidance agenda for the coming months.

Arthur R. Mlodozeniec, PhD, a member of Pharmaceutical Technology's advisory board and past president of AAPS, died on Sept. 4.

FDA will strengthen its collaborative relationships with federal agencies participating in the National Nanotechnology Initiative.

The worldwide market for biopharmaceuticals was estimated to be $50 billion in 2005. North America accounts for 60% in terms of revenue and R&D. Europe accounts for 20% and Japan 10%. It is also estimated that 400–500 biotech drugs are under clinical development for various disease conditions. Biopharmaceuticals are being developed to fight cancer, viral infections, diabetes, hepatitis and multiple sclerosis. The distinct families of biopharmaceuticals include

Cardinal Health halted production, sales, repairs, and installations of its "Alaris Signature Edition Gold" infusion pump after the US Food and Drug Administration (Rockville, MD) seized approximately 1300 units last Friday. The seized infusion pumps (model numbers 7130, 7131, 7230, and 7231) have a "key bounce" defect that may cause overinfusion of medications by more than 10 times the intended infusion rate.

The generic drug company Mylan Laboratories, Inc. (Pittsburgh, PA) plans to acquire a controlling interest (71.5%) in the Indian pharmaceutical company Matrix Laboratories, Ltd (Hyderabad, India) for $736 million.

Hemispherx Biopharma, Inc., Boehringer Ingelheim Chemicals, Inc., MedImmune, Inc.

Biovail Corporation is demanding that the US Food and Drug Administration (Rockville, MD) enforce the proper criteria for determining bioequivalence of extended-release generic versions of bupropion products.

Merck KGaA (Darmstadt, Germany) plans to invest 190 million euros ($245 million) to build a biopharmaceutical plant in Darmstadt, Germany. Production is expected to begin in 2010.

Washington, DC (Aug. 14)?A new report issued by the Pharmaceutical Research and Manufacturers of America identifies 418 drugs and vaccines developed through biotechnology. All of the biotechnology medicines and vaccines are now in clinical trials or awaiting approval by the US Food and Drug Administration (Rockville, MD).

West Point, PA (Jul. 31)?A survey of 150 US pharmacists found that nearly 80% believe that "multiple look-alike medications" make it difficult for consumers to identify the correct medication, especially when the drugs are moved to unlabeled containers.

Teva Pharmaceutical Industries Ltd. announced that the company will cease production at its manufacturing facility in Cidra, Puerto Rico during the fourth quarter of 2006.

The International Organization for Standardization (ISO, www.iso.org) has formally issued and published standard ISO 4644-8:2006, Cleanrooms and associated controlled environments-Part 8: Classification of airborne molecular contamination. The document covers the classification of airborne molecular contamination (AMC) in cleanrooms and associated controlled environments in terms of airborne concentrations of specific chemical substances (individual, group, or category) and provides a protocol to include test methods, analysis, and time-weighted factors within the specification for classification.