The Life Sciences in New York State

Generic epo about to hit the market in Europe

Novartis wins the race to bet a generic version of epo approved in Europe. Truly a watershed day in biotech, in my view. Will we ever see generic epo in the US? That's the question...

Bloomberg.com: Germany

Novartis is first in a race among generic companies including Germany's Stada Arzneimittel AG to enter the $7 billion market dominated by Johnson & Johnson and Amgen Inc's branded versions of the drug. Sandoz sued U.S. regulators last year to win approval to copy the human growth hormone.

Other than that, it's a fine product

What strikes me about this is that there doesn't seem to be anything positive about Exubera.

Great idea + poor design = unsuccessful product

Exubera becoming a big disappointment for Pfizers

With patients put off by Exubera's difficult dosing device, insurers reluctant to foot the bill and doctors concerned about its long-term impact on patients' health, sales of Pfizer's inhaled-insulin diabetes therapy have fallen dramatically behind initial projections.

Company moves to New York

Welcome to Delcath Systems.

Delcath Systems, Inc. Moves Headquarters to New York

Delcath Systems is the developer of percutaneous perfusion technology for organ- or region-specific delivery of therapeutic and chemotherapeutic agents. The Delcath system is currently being tested with the drug melphalan in a Phase III trial of patients with metastatic ocular and cutaneous melanoma in the liver, and a Phase II trial of patients with primary liver cancers and metastatic tumors in the liver from neuroendocrine cancers and adenocarcinomas, as well as patients with melanoma who previously received isolated perfusion.

Entelos + Iconix = A very logical match

I've followed Entelos for a number of years, and they've made great strides this year. Earlier this year, they in licensed a series of Phase I candidates from J&J. Now their acquisition of Iconix is quite interesting. Given Entelos' historical focus on efficacy, their acquisition of a tox-oriented company sounds like a great fit.

Entelos Acquires Iconix Biosciences

"We believe the combination of our predictive efficacy models with Iconix's toxicology expertise can create a new paradigm for discovering and developing drugs," commented James Karis, President and CEO of Entelos, Inc. "Drug failures are often due to efficacy or toxicity issues, and while Entelos' predictive disease models address efficacy, Iconix's toxicology databases help to address toxicities. In addition, Entelos' recently announced collaboration with the FDA to build a model of drug-induced human liver injury to identify patients at risk for developing hepatotoxicity and the addition of Iconix will expand our capability for drug safety assessment."

Coming to a virtual bookstore near you...

Best Practices in Biotechnology Business Development, edited by Yali Friedman, is a collection of essays on a wide range of topics related to business development. I will have a chapter in the book tentatively entitled "Top Five Mistakes." In this chapter, I  discuss just some of the common mistakes made by entrepreneurs when seeking external financing. I believe these lessons also apply to internal corporate executives seeking funding for their projects as well. The book will be published in early 2008.

China overtakes India...or does it?

I'll take their word for it. But without seeing how this study was actually conducted, it's hard to make any definitive conclusions. For example, are they counting trials being outsourced into the country versus those for domestic approval and commercialization?

China overtakes India in drug testing

...China now has a cumulative total of 510 completed or ongoing trials compared with 471 in India, which had until recently been ahead on both measures. The trend reflects intensifying interest by the healthcare sector in China, which is growing rapidly as a result of rising income and expanding health coverage and is already forecast to be the world's fifth-largest pharmaceuticals market by 2010.

Dr Reddy's to acquire Bradley

This may be pure speculation at this point, but the rationale is interesting: increased presence in US and a hedge against declining margins on generics.


DRL to acquire Bradley Pharma?

After buying out Germany's Betapharma, Dr Reddy's has been looking at increasing its presence in the US market. Analysts have said that rapidly thinning margins from the US generics market will compel companies to look for value-added products.

Diabetics overly focused on serum blood glucose

Great point. Once Type II diabetes is diagnosed, "simply" lowering glucose is insufficient to improve risk of cardiovascular events. Many doctors that I've spoken with in the past place their patients on statins even before their patients start insulin.

The flip side is that diabetics wind up with incredibly complex regimens: insulin, statins, anti-hypertensives...and on and on...

Looking Past Blood Sugar to Survive With Diabetes

But in focusing entirely on blood sugar, Mr. Smith ended up neglecting the most important treatment for saving lives — lowering the cholesterol level. That protects against heart disease, which eventually kills nearly everyone with diabetes. He also was missing a second treatment that protects diabetes patients from heart attacks — controlling blood pressure. Mr. Smith assumed everything would be taken care of if he could just lower his blood sugar level.

Zingo approved

If you've ever had a child who needed an IV, you would appreciate the value of a product like this.

Anesiva Receives FDA Approval for Zingo

Zingo is a ready-to-use, single-use, needle-free system that delivers sterile lidocaine powder into the epidermis of the skin and provides topical, local analgesia in one to three minutes after administration. This rapid onset, which may be especially useful in pediatric populations and busy emergency room settings, means the product can be incorporated into a medical procedure allowing uninterrupted care, an important advantage over current options.

This makes me one in a million...

I've been Skype-less since I opened the shop this morning. It's an odd feeling when the phone systems are not working, and this is no different. It's the quiet that can be unnerving. I'm sure this will be resolved quickly.

Skype Users Unable to Make Calls

Skype, the popular computer program that lets its users make long-distance phone calls over the Internet, said Thursday that software problems have left many of its millions of users without service worldwide.