genetics

Novartis says genetic insights improve trial efficiency

John Carroll — Thu, 20 Nov 2008 09:41:58 -0500

Researchers for Novartis AG say that a better understanding of the role genetics plays in disease has allowed them to significantly cut the amount of research time it takes to prove the effectiveness of a new therapeutic. R&D can now identify smaller groups of patients based on a common genetic variation, increasing their chances of success and reducing their costs.

"Our intention always is to expand it to large populations later," Dr. Mark Fishman, president of the Novartis Institutes for BioMedical Research, told analysts gathered at the company's world research HQ in Cambridge, MA. "It's a little bit of the reverse of the standard approach, and it's helped us expedite all of our trials."

Fishman underscored the company's new approach to trials while Novartis officials touted a beefed up pipeline and a better track record of success. Novartis will need all the positive data it can get in order to make up for the blockbusters being lost to generic competition.

- read the article from the AP

ALSO: Eli Lilly says you can count on its belief in the personalized medicine approach to drug development as well. Chair Sidney Taurel says that smaller trials and higher efficacy rates are what R&D is all about these days. Report

Scripps to study how people react to genetic data

John Carroll — Thu, 09 Oct 2008 11:16:10 -0400

One of the big questions posed by the development of new genetic tests is how people will react when they learn more about their risk of disease. And now the Scripps Translational Science Institute will set out to determine the answer. Researchers will try and determine if the data will persuade people to live healthier lives, spur anxiety or lead to the inappropriate use of healthcare services.

Or if it has no effect at all.

"There has been a lot of conjecture about the potential benefits to individuals and how they may change their behaviors" after getting personal DNA data, Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University, tells the Wall Street Journal.

Navigenics, Affymetrix and Microsoft will fund the study. Navigenics will provide its test to participants for a fraction of its current price. Affymetrix will run the genome scan and Microsoft Health Vault will store the data.

- see the release from Scripps
- read the article in the Wall Street Journal

CellCyte in 'precarious' shape after shares collapse

Tue, 15 Apr 2008 06:59:57 -0400

After a brief period as a high-flying stem cell company, CellCyte Genetics' share price has fallen back to earth, wiping out much of the $440 million market valuation achieved last fall and leaving it in "precarious" financial shape. The Seattle Times is reporting that CellCyte has about five months worth of working capital on hand with shares trading at 45 cents each, down from a high of $10.01 hit last year after an intense period of stock promotion. The stem cell company now faces shareholder lawsuits and an investigation by German regulators of its stock promotion work. Documents filed with regulators on Monday say the company has raised $400,000 from investors since the end of the year. CellCyte had discussed plans of starting clinical trials of stem cell therapies this year at a cost of $7 million in 2008.

- read the report in the Seattle Times

Related Articles:
Report: CellCyte stock up after promoter touts shares. Cellcyte Report
Falling dollar, falling drugmaker prices. Stock report

Study finds big gaps in clinical trial process

Thu, 03 Apr 2008 07:59:57 -0400

A new report out says that the clinical trial process routinely ignores women, the elderly, minorities, the disabled and people living in rural America. And the practice of ignoring large groups is creating a trial process that often avoids the very patients the drugs are intended to serve, according to the Chronic Disease Prevention & Control Research Center at Baylor College of Medicine. The elderly, for example, are often excluded from trials that test new drugs for Alzheimer's, Parkinson's and other conditions that primarily afflict older people. Excluding minorities, meanwhile, skews the data in such a way that trials fail to discover how genetics and cultural factors can affect outcomes.

"We've got a big problem," said Daniel S. Goldberg, chief policy adviser for the report. "And it's extremely urgent that we fix it. Because we're trying to figure out how to streamline healthcare and make people healthy, of course. And the fact that we have under-representation in clinical trials undermines both of these goals and undermines the quality of the evidence we come up with."

Altogether there are some 80,000 clinical trials mounted every year in the U.S. Many are duplications of other trials that have already been completed or are underway. And less than one percent of the population is recruited to participate.

- read the article in the Washington Post

Related Articles:
Researchers fight for ethnic diversity in trials. Report
Report: FDA lax in clinical trial oversight. Report
Safety oversight a rare feature in child drug trials. Report
Duke, FDA join forces to overhaul clinical trials. Report

ALSO NOTED: Novartis licenses MedImmune vaccine IP; Rumor Mill: Dr. Reddy bids for Bradley; and much more...

Fri, 24 Aug 2007 06:59:50 -0400

> Rumor Mill: Generic drugmaker Dr. Reddy's Laboratories is said to have submitted a bid for U.S.-based Bradley Pharma. FiercePharma

> Novartis has licensed MedImmune's reverse genetics intellectual property. Novartis will use the IP to support development of vaccine strains for seasonal, pre-pandemic and pandemic influenza vaccines. Financial details of the deal were not disclosed. Release

> Precision Therapeutics, which makes tests to analyze tumor cells, is planning an $80.5 million IPO. Report

> Two Massachusetts General Hospital researchers describe a way of creating novel enzymes that, for the first time, do not require prior understanding of exactly how the enzymes work. FierceBioresearcher

> A group of neurologists have been studying the role a particular enzyme plays in creating memories, saying that blocking the enzyme could offer a new approach to treating post-traumatic stress disorders as well as chronic pain. FierceBioresearcher

And Finally... The FDA wants more detailed sunscreen labels. Report

Acceleron takes a lesson from the giant Belgian blue

Mon, 16 Jul 2007 06:59:55 -0400

The Boston Globe profiles the drug development work of Acceleron, which hopes to develop a therapy that regulates body tissues and systems. To help illustrate its efforts, researchers point to a picture of the Belgian blue, a white bull with enormous muscles. The company believes the same kind of genetics at work in the Belgian blue would help repair the harsh physical damage of such diseases as ALS, muscular dystrophy, and cancer. The company has raised $56 million from top-tier venture capital groups.

- read the Boston Globe article

Related Article:
Acceleron garners $30M in venture capital. Report

ALSO NOTED: Depomed surges on new data; FDA OKs Biomira study; and much more...

Mon, 11 Dec 2006 19:01:30 -0500

> Shares of Depomed surged on the news that a Phase II trial has produced data that demonstrates significantly reduced pain scores for patients taking one of two doses of its Gabapentin GR painkiller. Report

> Biomira and the FDA have agreed on a clinical trial design to test Stimuvax for advanced lung cancer. Report

> Genentech announced that an interim analysis shows that a randomized Phase III clinical study of Avastin in combination with interferon alfa-2a therapy in patients with first-line metastatic renal cell carcinoma met the primary analysis endpoint by significantly improving progression-free survival compared to interferon alfa-2a therapy alone. Report

> Alnylam Pharmaceuticals is selling 4.7 million common shares. Report

> Gloucester Pharmaceuticals has released interim data for romidepsin, its histone deacetylase inhibitor. Release

> Newly-launched London Genetics plans to facilitate partnerships between industry and academic centers of excellence in genetics and genomics-based research across London. Release

And Finally… Scientists have been making progress in developing new tests that can detect Alzheimer's at an early stage. Article

Illumina to buy Solexa for $600M

Sun, 12 Nov 2006 19:01:35 -0500

Illumina has agreed to buy Solexa, which makes genetics analysis systems, for $600 million. Illumina will also provide $50 million for Solexa, which specializes in whole genome sequencing. Illumina says it will maintain Solexa's operations in California and Cambridge, England. Solexa CEO John West becomes a senior vice president in the combined life science research firm.

- here's the report on the buyout from MarketWatch

C&L: Cell Genesys COO Vallner resigns

Tue, 31 Oct 2006 19:01:32 -0500

Cell Genesys announced that Joseph J. Vallner, Ph.D., the company's president and COO, has resigned to become the CFO of an early-stage, private biotechnology company.

Le@p Technology has named Dr. Donald J. Ciappenelli as CEO and chairman.

Access Genetics has named industry veteran George M. Hoedeman as its CEO.

Ilypsa has named William D. Waddill CFO.

ARCA Discovery has appointed Thomas A. Keuer as executive vice president of pharmaceutical operations.

Taro Pharmaceutical Industries said its CFO, Kevin Connelly, resigned after a critical auditor's report.

DeCODE Genetics has appointed Jakob Sigurdsson as senior vice president, corporate development.

Koronis Pharmaceuticals has appointed Stephen Becker, M.D., chief medical officer.

Kosan has appointed Robert De Jager as chief medical officer.

Gene Express has appointed John C. Anders, Ph.D. as vice president of operations.

Michael Ostrach has joined Dynavax as vice president, chief business officer and general counsel.

Dr. Yuan-Chi Su has accepted a position with Industrial Biotechnology to assist and oversee the process development and scale up of targeted compounds prior to large scale production and manufacturing.

Schering-Plough Corporation has appointed Eduardo Cortes as general manager, Schering-Plough Argentina.

Clarus Ventures announced Dr. Jeff Leiden, former president and COO of Abbott's Pharmaceuticals business, has joined the firm's Cambridge office as Partner.

Jody M. LoMenzo has joined Insmed as director, investor relations and corporate communications.

NeoStem has named Julio C. Guerra, MD, ABP, as the company's director of sales and marketing.

Cleveland BioLabs has named John Gordon, Ph.D. director of clinical operations.

GammaCan International has named Lynn Schuchter M.D. to the company's Scientific Advisory Board.

Pharmaceutical industry experts Dr Richard Jones and Dr Roy Bullingham have joined Xceleron's Scientific Advisory Board.

Avalon Pharmaceuticals has named Todd R. Golub, M.D., to the newly created position of chairman, Scientific Advisory Board.

OMRIX Biopharmaceuticals has named Joseph Akers as a new member of the board of directors.

Heiner Dreismann, Ph.D. has been named Nanogen's board of directors.

The board of directors of Zila elected Dr. David Sidransky to join its ranks.

Inspire Pharmaceuticals has appointed Nancy J. Hutson, Ph.D. to the company's board of directors.

Panacos Pharmaceuticals has named Laurent Fischer, M.D. to its board.

Sciele Pharma has named Jerry C. Griffin, M.D., to its board.

MedImmune gets nod for new vaccine tech

Thu, 06 Jul 2006 20:01:38 -0400

MedImmune announced that the FDA has approved its use of reverse genetics to make new vaccines. The new procedure significantly narrows the number of gene segments researchers study when creating a new vaccine, allowing a manufacturer like MedImmune to better target its research efforts and speed development. MedImmune has already used reverse genetics to develop an experimental vaccine for the H5N1 virus. It currently is in Phase I.

- check out the report on MedImmune from the Washington Business Journal

Reverse genetics used to create new vaccine

Wed, 14 Jun 2006 20:01:39 -0400

Using reverse genetics, a group of researchers at St. Jude's in Memphis has inactivated the avian flu virus and used it to successfully vaccinate ferrets. Researchers said that the vaccine also worked against two other strains, raising the prospect that the therapy could be used against mutated versions of avian flu. Reverse genetics also offers a new way to produce large amounts of vaccine in relatively short periods of time. No one knows when or if a pandemic may erupt, but avian flu has helped generate an intense burst of new research that may help revolutionize the decades-old technology that is now used in the labor-intensive vaccines business.

- here's the article from UPI on the vaccine research

ALSO NOTED: BMS gets priority review for dastatinib; FDA votes to recommend Cubicin; and much more...

Mon, 06 Mar 2006 19:00:50 -0500

> Bristol-Myers Squibb has gained priority review status for its oncology therapy dastatinib. Report

> An FDA committee has voted to recommend Cubicin. Release

> Biovail has restructured and announced that its chief scientific officer is stepping down. Report

> Advanced Magnetics plans to raise $31.7 million in a stock offering. Release

And Finally... Researches think genetics may be the underlying cause of anorexia. Article

Perlegen strikes collaboration deal with Genentech

Thu, 05 Jan 2006 19:01:35 -0500

Perlegen Sciences has inked a collaboration deal with the cancer drug pioneer Genentech to study the genetics of cancer. Their work is aimed at developing new therapies and diagnostic tools for cancer. Perlegen's high throughput oligonucleotide array approach utilizes Affymetrix GeneChip technology. Growing knowledge about genetics is expected to play a major role in developing a new generation of cancer drugs. Terms of the deal were not disclosed. This is the second big pact for Perlegen in 10 days, following an announced tie-up with Pfizer.

- read this release for more

ParAllele inks licensing deal for genotyping tech

Wed, 06 Jul 2005 20:01:37 -0400

ParAllele BioScience has inked a deal with Merck to use its genotyping technology to track the genetic variations that influence a person's susceptibility to cancer and their response to therapeutics. No financial terms were disclosed. "Merck has pioneered the application of genetics to cancer, and we are excited about this opportunity to broaden our collaborative relationship," said Hywel B. Jones, PhD, ParAllele's senior director of business development. "Our high-throughput technologies allow the determination of changes in copy number in tumors in a very efficient manner."

- read this press release for more

Amgen disputing payments to Mass General

Mon, 27 Jun 2005 20:01:35 -0400

Lawyers for Amgen have triggered a ruckus with Massachusetts General Hospital over royalties for its blockbuster rheumatoid arthritis drug Enbrel. Amgen paid Mass General $41 million in royalties last year alone for its role in developing the drug, but lawyers for Amgen, which purchased the drug when it bought Immunex in 2001, say they've found language in the contract that is open to interpretation. Mass General says it doesn't read the contract that way. The payments have been used to fund the genetics laboratory of Brian Seed, a Harvard biophysicist whose work contributed to the development of Enbrel.

- read this story from the Boston Globe for more