Archive for 2007

Drug approvals fall. Who’s to blame?

The FDA approved 38 drugs through July this year, down 31 percent from 55 approvals for the same period last year. Who’s to blame? According to Friedman, Billings, Ramsey, the FDA. Why? Vioxx. For details on extra scrutiny being applied by the FDA, see this CNNMoney summary.

Carnival of Biotechnology

Welcome to the second August 2007 edition of Carnival of Biotechnology. International Biotechnology The Times (UK) has a report on the UK biotech sector, calling for consolidation to overcome a lack of capital. The Wall Street Journal has an article on Novartis’ lost patent case in India, where a patent on an improved version of […]

Journal of Commercial Biotechnology

I’ve recently joined the Journal of Commercial Biotechnology as managing editor. Drop me a line if you would like to make a submission. The most recent issue, edited by Neil Henderson, has just been published: Volume 13, Issue 3 Articles When should you fire the founder? PDF William Bains Constructing a processual model of communication […]

Call for chapters: Best practices in biotechnology business development

I’m in the final stages of preparing a book on best practices in biotechnology business development, and am looking for 1-2 more chapters. The chapters I’ve received so far are: Top Five Mistakes Communicating With Investors and The Media Securing Intellectual Property From The Inside Out Aggressive Intellectual Property Strategies Biotechnology Transfers And Models Facilitate […]

Drug Patent Expirations in August 2007

Courtesy of Drug Patent Expirations in August 2007*Drugs may be covered by more than one patent Tradename Applicant Generic Name Patent Number Patent Expiration ACCUPRIL Pfizer Pharms quinapril hydrochloride 4,743,450 AUG 24,2007 ACCURETIC Pfizer Pharms hydrochlorothiazide; quinapril hydrochloride 4,743,450 AUG 24,2007 ANTARA (MICRONIZED) Oscient fenofibrate 4,800,079 AUG 10,2007 CEREBYX Parke Davis fosphenytoin sodium 4,925,860 […]

Carnival of Biotechnology

Welcome to the August 2007 edition of Carnival of Biotechnology. Industry Trends Singapore-based ES Cell International, the company that was poised to lead in stem cell therapeutics, has abandoned its plans for stem cell therapies. Sometimes its hard for a company to live up to the high expectations they engender in their quest for financing. […]

Expanding the bandwidth of life science investments: Increasing investment viability

Guest content Contributed by Jayme Norrie, Chief Strategic Officer, Incite World From what we have experienced, angel investors are shoring up the gap in new innovations coming forward. However, they seem to be more naive than VC’s in terms of due diligence prior to investing. Scientists from the company march in with charts and scientific […]

Offshoring and U.S. Biotech Labor Shortages

Guest content contributed by Agnes Shanley, Editor in Chief, Pharmaceutical Manufacturing Every day we read about severe shortages of skilled biotech workers in the U.S.. At the same time, the trend to pharma offshoring and outsourcing is becoming more pronounced, and is moving from traditional pharma to biopharma. We recently touched on some of these […]

`Til Death Do Us Part, But First, the Pre-Nup: Why CAPA Needs to Evolve

A guest editorial from Emil Ciurczak, Contributing Editor, While reading a trade magazine recently, I was struck with the detailed information on how to design and implement a Corrective and Preventive Action (CAPA) system. ISO 9001:200, Clause 8.5.2 states, “…the organization shall take action to eliminate the cause of nonconformities encountered…” For medical devices, […]

Drug reimportation: Where are the dead Canadians?

A common retort in the debate over drug reimportation is “Where are the dead Canadians?” If the FDA deems that import of drugs from Canada is potentially dangerous, why aren’t Canadians dying from drugs they buy in Canada? Well, there’s an answer to that: Most Canadians buy their drugs from drugstores, not over the Internet. […]

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