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 Glivec (sold as Gleevec in the U.S.) was rejected for not being sufficiently improved to warrant protection. This sets a dangerous precedent for the use of evergreening strategies in India, and may potentially spread to other markets.

Pharmalot profiles a report from PriceWaterhouseCoopers projecting that Asia will become the new center of gravity in drug developing, with everything from R&D to manufacturing being relocated to Asian shores.

Generic Biologics
The Wall Street Journal has a case study of Genzyme’s problems getting approval to make Myozyme, a treatment for Pompe disease, in large batches. These regulatory problems underscore the challenges of manufacturing biologic drugs.

The In Vivo Blog has details on the challenges Sandoz is facing in producing biogenerics, and the outlook for market share given the higher costs of production relative to generic pharmaceuticals.

Health Records
Venture Beat has a great article on the race to lead in healthcare record management. You might recognize some of the competitors: Google and Microsoft.

That concludes this edition.
For more information, see the Carnival of Biotechnology Homepage, or submit a link for the next edition. Interested in hosting a future Carnival of Biotechnology? Let me know.

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.

In other news, Signals Magazine reports that funding is on track for a record year.

Drug Pricing
Pharmalot has an update on the ongoing saga of international price controls. The New Zealand government’s drug buying agency has expressed their frustration at not reaching an agreement over pricing for cardiovascular drug Betaloc, accusing AstraZeneca of gambling with patients lives. Not exactly ‘building a golden bridge‘.

The Wall St. Journal has an interesting report on the efficacy of diabetes drugs: “Old, cheap diabetes drugs are as good as or better than newer, more expensive drugs at lowering blood sugar.”

Innovation
The New York Times has an article on on how a lack of FDA guidance is impeding innovation in biotech foods.

According to the Wall St. Journal, Japan’s drug development industry is facing a crisis: “Domestic drug makers are having trouble competing overseas and the world’s drug makers are passing over Japan when introducing new products.”

That concludes this edition.
For more information, see the Carnival of Biotechnology Homepage, or submit a link for the next edition. Interested in hosting a future Carnival of Biotechnology? Let me know.

Welcome to the June 25th 2007 edition of Carnival of Biotechnology.

Finance and business development
BusinessFund.com has a great post on 25 alternatives to venture capital — too many entrepreneurs assume that venture capital is the de facto way to fund a company, when there are many other avenues they should be exploring.

Industry Trends
As big pharma Abbott plans a spinoff to make generic drugs, biotech giant Amgen is doing the opposite. They’re buying two small-molecule drugmakers.

Regulatory
The http://www.patentbaristas.com/”>Patent Baristas report on a report asking Do Authorized Generics Deter Paragraph IV Certifications? Authorized generics are generic drugs sold indirectly through branded drug developers — effectively allowing innovators to compete with generics. A generic drug producer who successfully challenges an innovator’s patent is granted 180 days of marketing exclusivity under a paragraph IV certification. Because innovators can indirectly compete with generics through authorized generics (confused yet), the question at hand is: does this tactic discourage generic drug producers from challenging innovator patents in search of a 180-day marketing exclusivity?

Generic Pharmaceuticals & IP has an interesting post on a drug which was approved, but not being launched

Location
Pharmalot has a report from Paraxel, suggesting that India is lagging as a site for clinical trials. By assessing the country of residence of clinical trial investigators, they suggest that running clinical trials in India is not as prevalent as often suggested.

Pharmalot has a great post questioning Boston’s proposed $1 billion 10-year commitment to biotech: B is for Boston, biotech and also boondoggle

That concludes this edition.
For more information, see the Carnival of Biotechnology Homepage, or submit a link for the next edition. Interested in hosting a future Carnival of Biotechnology? Let me know.

Welcome to the May 25th 2007 edition of Carnival of Biotechnology.

Finance and business development
The big news on the web is Google’s investment in 23andMe, described here by the California Biotech Law Blog.

International biotech
Business Week has an article on The Rush To Test Drugs In China. This is a story with a number of potential upsides. Drug companies are having trouble finding sufficient numbers of clinical trial participants in North America, ultimately delaying the approval of vital medicines. Many Chinese patients are in need of cutting edge medicine. By conducting clinical trials overseas (clinical trials intended for FDA approval must meet American standards of care and ethics, regardless of where they are performed), drug companies can speed approval while simultaneously helping patients overseas.

Communications
John Mack at Pharma Marketing has two interesting pieces. First, he offers some advice to GlaxoSmithKline on Avandia: Don’t do what Merck did! Next, he investigates Centocor’s “disease awareness” movie INNERSTATE.

Investing
Forbes presents an educational article on Chasing Down Biotech Zombie Stocks - biotech firms operating with minimal revenues and no real chance of sustainable growth.

That concludes this edition.
For more information, see the Carnival of Biotechnology Homepage, or submit a link for the next edition. Interested in hosting a future Carnival of Biotechnology? Let me know.

Welcome to the April 10, 2007 edition of Carnival of Biotechnology.

Finance and business development

On Pharma presents a report that tens of thousands of pharma sales reps are suing current and former employers for overtime - $1 billion in settlements could be at stake.

H.S. Ayoub presents The Biotech Industry: 30 Years of Failure posted at BioHealth Investor.

H.S. Ayoub presents Biotechs Ahead of Pharmas after All? posted at BioHealth Investor.

Bloomberg reports that biotechnology companies can’t find enough scientists to hire, threatening to slow one of the industries bolstering U.S. job growth.

In the pipeline has a cautionary post about Amgen’s attempt to expand the indications of Epogen, resulting in new warning labels on drug packaging and potential charges that it has recklessly endangered patients’ lives.

Investing

H.S. Ayoub presents Bruker BioSciences: Earnings Growing, Insiders Buying posted at BioHealth Investor.

Science

biologyfool presents Micro RNAs: The Last Frontier of Medicine? posted at Baby Biotechs.

Stem Cells

Some interesting developments in stem cells.

First, Venture Beat asks, Is Big Pharma tiptoeing into embryonic stem cells?.

Then, the California Biotech Law Blog and Patent Baristas present the fall of the Wisconsin Alumni Research Foundation’s stem cell patent claims.

That concludes this edition.
For more information, see the Carnival of Biotechnology Homepage, or submit a link for the next edition. Interested in hosting a future Carnival of Biotechnology? Let me know.

For more information, see the Carnival of Biotechnology Homepage, or submit a link for the next edition. Interested in hosting a future Carnival of Biotechnology? Let me know.

PharmaGossip has an illuminating excerpt from The End of Medicine describing a method to invest in drug companies as they progress through clinical trials.

Ted Love, CEO of Nuvelo Inc., explains how biotechnology companies are frequently able to recover from seemingly disastrous clinical trial failures.

Patents

When manufacturers seeking to sell generic drugs challenge patents in order to try and enter the market, the patent holders will sometimes settle out of court and pay the generic company to wait until the patent expires. There is growing opposition in congress to this practice, with some lawmakers calling it anticompetitive.

In order to challenge a patent, a challenger must either have been sued for infringement, or be able to demonstrate that they are likely to be sued for infringement. This can place licensees in a dilemma where they must decide to license a patent they feel is invalid, or infringe a patent and challenge it but risk paying triple damages for willful infringement. A ruling in the case of Medimmune v. Genentech has strengthened the case for licensees, permitting them to pay licensing fees “in protest” and still challenge a patent.

International

The Chinese biotechnology and pharmaceutical sectors are rapidly growing as increasing numbers of expatriates are returning, bringing skills and connections from abroad back home. Chemical Engineering News profiles the Chinese pharmaceutical industry and investigates the challenges it still faces.

Sir Chris Evans, founder of Merlin Biosciences, blames British biotech investors for having a ’sick garden syndrome’, stating “We keep pulling the flowers up every six months to look at the size of the roots, and ram them back in the ground wondering why they struggle to grow.”

The MaRS Blog has a captivating story of Canada’s recent major diabetes discovery. The first discovery, in 1920, elucidated insulin’s central role in diabetes. The most recent discovery, also from the University of Toronto, has found a strong link between diabetes, pain nerves, and inflammation. Researchers were able to prevent and even reverse diabetes in mice modulating the neuroinflammatory mechanism without any serious side effects.

In the Pipeline issues a dose of realism for the overly-optimistic news of a potential anti-cancer drug found by mistakenly using a high concentration of compounds not previously known to have an anti-cancer effect.

Patents and Regulation
I always like a good inequitable conduct case, and the Patent Baristas have got a fresh one! Amphastar and Teva successfully challenged Sanofi-Aventis’s Lovenox patent by convincing the court of deceptive intent by Sanofi.

Eye on Pharma has some recomendations for the FDA. After years of being simultaneously blamed for being too lax on safety and not moving quickly enough on safety, this nine-step plan for change aims to restore the agency’s credibility.

I’ve railed about Michael Crichton’s misguided NYTimes Op-Ed’s before, and his most recent anti-patent screed is as misguided as his previous posts. I rather liked Nobel Intent’s take on the matter: “It is becoming a truism that if there are two sides to a scientific debate, Michael Crichton can usually be found on the wrong one.”

Marketing

John Mack at Pharma Marketing has another excellent post on what I’d call “excessive creativity” in pharmaceutical marketing. Whereas branded websites providing information on drugs must carefully meter their statements, the same does not hold true for unbranded sites. Through a little investigative journalism, Mack has discovered a thinly veiled promotional agenda for weight-loss drug Alli.

Industry Trends

Yet another industry giant enters the biotechnology fray. Following the path laid by IBM, Motorola, Corning, and others, General Electric is investing in biotechnology - specifically in medical diagnostics.

Industry Trends

Forbes presents Genentech’s Next Act. his dialogue with Genentech’s chief officers acknowledges the longshot Genentech was in its early days and plots the future paths Genentech is pursuing to continue to grow.

The Economist presents Billion dollar pills — a profile of the overhaul transpiring at Pfizer. The magnitude of the hanges taking place at Pfizer, the world’s largest drug company, cast a dark omen over the rest of the industry.

In a departure from the typical “David and Goliath” partnerships between typically small biotech firms and typically large pharmaceutical firms, pharmaceutical giants AstraZeneca and Bristol-Myers Squibb have formed a partnership to develop diabetes drugs. Could this be the start of a new trend? The Mars Blog gives you their take.

Wrapping up M&A activity in 2006, Signals Magazine finds M&As still sizzling.

Regulation and Patents

Fighting Aging has an interesting take on medical tourism. Beyond just offering lower prices due to lower operating costs, Medical Tourism Means Medical Competition because it can also skirt patent and regulatory burdens.

The Patent Baristas ask Is it Worth it for Generics to Challenge Branded Drugs? The case of Apotex’s generic Plavix highlights many of the motivations for generic firms to challenge drug patents, and questions how far a generic firm should press.

An Nobel laureate in economics posts an editorial in the British Medical Journal challenges the belief that intellectual property rights promote innovation in Scrooge and intellectual property rights and proposes “medical prize fund” in place of patents.

Commercialization

The Scientist’s article The trouble with tech transfer examines the issues
impeding the proression of inventions from research laboratories to the marketplace. The vigorous discussion in the comments section complements the article quite well!

In the light of the mass layoffs of sales workers, Pharmamarketing asks and answers the question, Are Sales Reps Necessary?

News and Trends

The Washington Times has an update on the signing of the Animal Enterprise Terrorism Act. Bolstered by recent bombings and other acts of vandalism against biotechnology firms, the bill is designed to make it easier for federal agents to wiretap and prosecute animal rights extremists who have mounted successful campaigns of harassment against researchers.

More welcome news for the industry, a recent study finds that FDA drug approvals are on the rise.

Sign on San Diego has a detailed article on the loss of American biotechnology jobs to offshoring. An important note is that while the impact on workers who have lost their jobs is certainly negative, the prospect of reducing R&D can only serve to bolster the industry.

In what is being billed as an affirmation of Merck’s strategy to challenge the thousands of Vioxx cases one at a time, a federal jury has cleared Merck in the 11th Vioxx Trial. Just 24,000 more cases to go!

torcetrapib

There has been so much buzz about the high profile failure of Pfizer’s cholesterol drug, it merits it’s own category.

Pharma Marketing has two posts on the issue: questioning the $800mm price tag associated with the failure and examining the many impacts that the failure will have.

Paul Kedrosky comments on the impact on the future of drug development, concluding that drug development is “broken.” More justification for this conclusion would have been greatly appreciated.

In the Pipeline has, as expected, an series of excellent and very detailed posts on the reasons for torcetrapib’s failure, and the greater impact on Pfizer.

Biotechnology around the world

Signals Magazine’s post Global Aid from Presidents and Billionaires profiles the many activities dedicated to ensuring that the world’s poor are able to benefit from the latest innovations in healthcare.

While India’s drug manufacturers are often alluded to, there is little detailed information on the actual companies that comprise this industry. Wired profiles Indian Cipla, a company regarded as a pirate among the competitors in developed countries, and a godsend among people in developing countries.