Biotech sector keeps surging / Cancer drug news and FDA approvals create optimism
Industry observers say the sector’s sea change from pessimism to optimism comes from two sources: Good news about experimental cancer drugs from a major scientific meeting this month; and a set of recent approvals by the Food and Drug Administration, whose new leadership is seen as more company-friendly.
Early stage biotechnology collaborations
The range of deals an early stage biotechnology company may enter into is wide (see box ‘What is an early stage biotechnology collaboration?’). This chapter examines, by reference to a few of the types of agreements that an early stage company may enter into, some of the key intellectual property (IP) and other legal issues that arise when undertaking such deals
FDA chief looks to speed diabetes, obesity drugs
Mark McClellan, commissioner of the Food and Drug Administration, said he wants to apply a fast-track review process normally reserved for drugs for terminal cancer and AIDS patients to drugs for diabetes and obesity.
Pfizer sues over counterfeit Lipitor
Pfizer Inc. said Tuesday it was suing two companies connected to counterfeit versions of its cholesterol fighter, Lipitor, the world’s top-selling prescription medicine.
The ImClone Story: A Hyped Drug, a Tainted Icon
It was, in retrospect, a festival of hype emblematic of the boom years, when technology stocks seemed to have nowhere to go but up.
Five Hurdles for Biotech
The science is hot and the stocks are up. Here’s what’s needed to deliver on the promise.
Thanks to a fruitful partnership of academia and private enterprise, a vibrant biotech industry keeps on replicating itself.
Puncturing The ImClone Hype
Could ImClone Systems’ Erbitux be a powerful cancer fighter after all? Maybe.
A new study presented June 1 at a meeting of oncologists seems to boost that contention. But there are still reasons to doubt that Erbitux will be approved soon or that it will eventually be a blockbuster.
China’s Killer Headache: Fake Pharmaceuticals
An estimated 192,000 people died last year in China because of fake drugs, according to the Shenzhen Evening News, a government-controlled newspaper. Some die from toxins in counterfeit medicines, and others from infection because they are swallowing bogus pills instead of antibiotics
Looking beyond Patent Expiry
The problem of patent protection loss and associated revenue loss will continue to trouble major companies, with estimated revenue losses of US$2.2 billion in 2004 from patent expiries on 18 drugs, increasing to an estimated US$5.3 billion in 2005.