News

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.

The overall market size of the Southeast Asia region totals $7 billion, with a projected compound annual growth rate of about 13% through 2010.

Multinational, brand-name drug companies dominate 70% of the whole market, whereas local and generic drug companies dominate 30% of the market.

China's new Regulation for the Administration of Drug Packaging includes significant changes from the previous rule.

What if your country, even amid political turmoil, has been growing at a fast pace over the last several years and keeps doing quite well, but is nevertheless home to more than 14 million people living below the poverty line? What if, given this context, the retail prices of medicines are among the highest in the world and the major distributor is granted the privilege of a near monopoly? And what if, because of a huge predominance of multinational companies, lower-priced generic medicines are struggling to establish themselves (even though you passed a "generic drugs law" back in the '80s)? Well, if you are a proud and committed citizen of such a country and, above all, you deal on a daily basis with pharmaceutical-related issues, you must be very disappointed, if not upset. And yes, it's quite probable that you are a Filipino, as Roberto Pagdanganan, chairman of the Philippine International Trading Corporation (PITC), is. In fact, for a foreign observer, the problem of drug prices is one of the most..

Mid-size companies are forcing through their market positions by developing their niche competencies and their flexibilities to be recognized as serious market contenders.

Select large custom manufacturers expand capacity, private equity firms buy companies in transition, and players from India and China build their positions.

A major contributor to his most recent election victory, Thai Prime Minister Thaksin Shinawatra's "30 Baht Health Plan," first announced in 2001, was said to be born more out of populist politics than actual necessity for healthcare reform. This health plan is now draining the state-run hospitals, plunging them into perpetual debt and creating a mass exodus of overworked, underpaid doctors to the private sector. Nonetheless, this unprecedented universal healthcare policy's saving grace has been to provide affordable healthcare to nearly 50 million Thai, according to 2005 estimates by the National Health Security Office (NHSO).

I recently embarked on a quest: to investigate industry's use of the words, "generic" and "biosimilar" when describing a biologic molecule. An English major at heart, I was wrapped up in a news story that was partly about science, partly about words.

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

No matter how much we scamper about, the sheep just won't go where we want them to.

Apparently, the inspector would sneak off to visit his relatives on FDA time, instead of visiting us.

Now is the time to get ahead of the learning curve and explore options for meeting pedigree guidelines.

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

It's been a while since I last wrote my last editor's comment - a combination, during the last few months, of attending a variety of industry events (as the conference and exhibition season peaked before the summer) and being on holiday. I apologize for the poor excuses, but it's certainly better than saying the dog ate my homework.

With a finger on the pulse of an evolving market, the sales and marketing team can visually demonstrate trends and new market opportunities to the R&D team

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.