embryonic stem cell

FDA's delay of Geron ESC trial raises concerns

Thu, 15 May 2008 06:59:57 -0400

Getting an embryonic stem cell therapy through clinical trials in the U.S. is looking like an increasingly tough challenge after Geron announced that the FDA is delaying a study of its experimental therapy for spinal cord injuries. Geron, which has been racing to become the first biotech with a hESC therapy in clinical trials, says it was given verbal notice that regulators are putting a hold on the planned trial. The company's shares plunged 20 percent on the news.

No details were offered on the reasons for the delay, though Geron's Dr. Thomas Okarma noted that "we are disappointed with this action given the interactions we had with the FDA." Analysts also note that FDA delays can be routine and of short duration.

Advanced Cell Technology has also been in the running to launch an ESC trial, which they hope to get approval for this year.

- check out Geron's release
- read the report from the San Jose Mercury News

Stem cell developers shift focus to FDA hearings

Thu, 10 Apr 2008 06:59:54 -0400

Everyone involved in embryonic stem cell programs will be paying close attention to hearings the FDA is holding on how they plan to regulate the field. Developers want a much clearer idea of the regulatory pathway they'll have to follow to gain approvals. And they're looking for some assurances that the agency won't adopt the political leanings of the Bush administration--a longtime opponent of ESC research--when it comes to making critical decisions. It's a tough position to be in, notes Richard Garr, CEO of Neuralstem, which is advancing adult stem cell therapies. Garr's "nightmare" scenario: Unresolved safety issues surrounding stem cells could cause the agency to apply the brakes on considering new therapies.

- read the story in The Wall Street Journal

ALSO: In new work that has both political as well as scientific implications, a team of scientists has been able to reprogram skin cells into functioning neurons and used them to eliminate symptoms of Parkinson's disease. Report

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Stem cell outfits a winner in upcoming election

Wed, 27 Feb 2008 06:59:56 -0500

The nation's top biotech analysts have looked over the field of presidential candidates and announced a big winner: Stem cell companies. All of the three major presidential candidates have given their blessings to pumping up federal funding of research in the field--in a marked reversal to President Bush's steadfast stand on restricting funds related to embryonic stem cell research.

"Any candidate is going to have a better policy on stem cells than our current president," Ren Benjamin, biotech analyst for Rodman & Renshaw, tells CNNMoney. "If that's the case, then it will be good news not only for the companies working in the space, but for the space in general."

- read the CNNMoney report

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The 2008 Election: What does it mean for drugmakers? Report
NIH chief breaks with Bush on stem cell research. Report
Stem cell advance runs into conservative roadblock. Report
Stem cell researchers dour after Bush veto. Report

The 2008 Election: What does it mean for drugmakers?

Maureen Martino — Wed, 06 Feb 2008 09:02:01 -0500

The winner of the 2008 election will be faced with making key decisions on a number of issues important to drug developers. Questions as to whether there will be more federal funding for stem cell research, a faster path for biogenerics, or a change to the structure of the nation’s healthcare system will have to be addressed by the next president, and how they tackle those issues will have serious repercussions for the industry. Here’s a look at the front-runners’ stance on several topics vital to the biotech and pharmaceutical industries.

Barack Obama supports:

Reimportation of drugs
Greater generic drug use by Medicare, Medicade, ect
Establishing a government institute for comparative research between drugs.
Allowing the government to purchase prescription drugs in bulk to reduce costs.
Universal healthcare
Embryonic stem cell (ESC) research

Hilary Clintion supports:

Doubling NCI and NHC funding
Increaseing the number of patients involved in cancer clinical trials.
A pathway for biogenerics
Lower prescription drug costs and universal health care
Giving Medicare the power to negotiate prescription drug prices
Stricter control of drug advertising
ESC research

John McCain supports:

A pathway to approve biogenerics
An increase use of generic drugs
Reimportation of drugs
Allowing the government to negotiate lower prices for prescription drugs for the Medicare Part D program
ESC research

- see this Motley Fool article for more

In research, stem cells make another breakthrough

Fri, 21 Dec 2007 06:59:54 -0500

Long before the most successful biotech companies advance a new therapy into the clinic, there was a scientist at work doing some painstaking research in the lab. To get a good look at biotechnology's future, you have to study the preclinical research going on around the world. And despite some serious funding limitations, the science of drug discovery has had another remarkable year.

Stem cells continued to create excitement in '07, holding out a growing hope for potential cures for some of the world's most terrible diseases. And while the federal government has been keeping embryonic stem cell research in the cold, a dramatic advance in turning skin cells into cells that act like ESCs may well offer a shortcut around the unending controversy in the field. In the meantime, look for stem cell programs around the world to continue to generate headlines in 2008. A shift in the political winds could also put a quick end to the cash shortages that have hampered research programs.

The genetics revolution, meanwhile, has been making waves of its own. A future of personalized medicine, when drug regimens will be tailored to an individual's genetic profile, is still some distance ahead. But it's coming. Scientists have been having a field day linking genetic mutations to disease, offering up big targets for drug discovery. And diagnostic tests have been multiplying as well. New FDA rules urging genetic tests for some therapies--such as warfarin--are just the first sign of what is to come. A new era of personalized medicine is approaching, and it has enormous consequences for everyone in the biotech industry.

Nanotechnology, meanwhile, continued to spur a host of upstart companies focused on new drug delivery methods. Bind Biosciences, Tempo Pharmaceuticals, Avidimir Therapeutics, and Intradigm all made news as well on the venture scene. Better delivery methods can redefine the rules of efficacy and safety for cancer therapies and other drugs. It's fascinating to watch nanotechnology's progress into the clinic.

Related Articles:
In breakthrough, scientists reprogram skin cells into ESCs. Report
Warfarin label change spotlights molecular diagnostics. Report
Venture capitalists bet big on nanotechnology. Report

ALSO NOTED: Genitope's MyVax misses Phase III endpoint; Report: Pfizer looks at Danish biotechs; and much more...

Fri, 21 Dec 2007 06:59:50 -0500

> Genitope's MyVax, a treatment for follicular B-cell non-Hodgkin's lymphoma, has flunked a Phase III trial. There was no difference in progression-free survival between patients taking the drug and the control substance. On the bright side, however, the company noted that the MyVax arm of the trial "showed a highly statistically significant difference in PFS between patients who mounted a positive immune response to the tumor-specific target and those who did not." Genitope's shares took a beating on the news, dropping 50 percent. The company said that it would work with the FDA to determine the best path for MyVax. Release

> Report: According to the site Copenhagen Capacity, Pfizer is taking a close look at several Denmark-based drug developers. A number of Danish biotechs are working on therapies for obesity, diabetes and cancer, all of which may be of interest to Pfizer. Report

> Bavarian Nordic has gained a $25 million milestone payment as part of its deal with the Department of Health and Human Services to provide 20 million doses the smallpox vaccine Imvamune. Release

> The FDA has extended its review of Genta's advanced melanoma treatment Genasense by 60 days. Release

> Daiichi Sankyo will be marching three of its subsidiaries--Sankyo Chemica., Sankyo Organic Chemicals, and Daiichi Sankyo Chemical Pharma--in order to "management resources on the pharmaceutical businesses." Release

> Valeant Pharmaceuticals is selling the U.S. and Canadian rights to Infergen, a hepatitis C treatment. Three Rivers Pharmaceuticals will acquire the drug for $91 million. Valeant says it's selling Infergen in order to simplify its operations. Release

> Redwood City, CA-based A.P. Pharma is on the hunt for a new CEO. Report

And Finally... A group of scientists have derived four embryonic stem cell lines that could lead to the creation of cells that will not cause immune rejection. Report

NJ stem cell initiative shot down at the polls

Wed, 07 Nov 2007 06:59:57 -0500

By all accounts, New Jersey's referendum to back embryonic stem cell research with $450 million in borrowed funds--working much like California's heralded $3 billion program--was supposed to be something of a cakewalk. Instead, proponents like Governor Jon Corzine were body slammed with a resounding 53 percent of the electorate coming out against the ESC proposal. Analysts credit a loose alliance of conservatives and Catholics who unleashed a campaign against the proposal in the final days leading to yesterday's vote. Backers say that the real message is that the voters are wary of New Jersey's rising debt level and they may try again later. New Jersey made our 2006 list of the top five regions targeting biotech business.

- read the article from The New York Times

Related Articles:
NJ lawmakers back $270M stem cell program. Report
In New Jersey, biotech industry is booming. Report

Roche, GSK, AZ team up on stem cells

Wed, 03 Oct 2007 06:59:58 -0400

Three of Europe's biggest drugmakers have teamed up with the British government to launch Stem Cells for Safer Medicines (SC4SM), a non-profit that will develop stem cells for safety testing of new drugs. During the first phase of the five-year, £10 million ($20.4 million) project, researchers will focus on creating liver cells which will then be used to test new drugs for liver toxicity. Unexpected liver toxicity is often the death knell for experimental drugs. After that, SC4SM scientists will attempt to turn stem cells into heart cells.

The partnership marks the first time large drug developers have become involved in the controversial field of embryonic stem cell research. "It has taken a long time to set up because of the sensitivities," noted Philip Wright, science director at the Association of the British Pharmaceutical Industry, who will also serve as chief executive of SC4SM. "We have an ethical framework that says we should only use existing embryonic stem cell lines [in the UK stem cell bank] and next year we will have an independent ethics advisory board to provide further advice." More companies are expected to join the consortium in the future.

- see the report from the Financial Times

Related Articles:
In breakthrough, mice produce human liver cells. Report
Stem cell researchers create tiny livers. Report
More doubts raised about embryonic stem cell project. Report
New method for embryonic stem cells research. Report

Texas'$3B cancer program draws controversy

Tue, 04 Sep 2007 06:59:56 -0400

Texas voters will have the final say on a proposed $3 billion effort to support cancer research over 10 years inside the Lone Star state. This is the brainchild of the governor, who's clearly anxious to match the $3 billion stem cell program underway in California. And even though it emphatically has no connection to embryonic stem cell work, Texas' proposed program is already generating controversy.

Some researchers are uncomfortable with the way an 18-member panel is supposed to be selected to manage the money. Some say that with half of the committee made up of non-voting representatives of schools and the other half drawn from cancer groups, physicians and treatment centers, a majority may not have a very solid understanding of what they should be evaluating. Others want a significant number of non-Texans to be involved in peer review to help eliminate any conflicts that could arise.

- read the report from the Wall Street Journal

Related Articles:
Texas touts $3B plan for cancer research. Report
Mass. governor files $1B biotech bill. Report
California stem-cell institute open for business. Report

SPOTLIGHT: Calif. stem cell agency struggles to keep talent

Mon, 27 Aug 2007 06:59:53 -0400

Assembling and keeping talent at California's stem cell agency continues to be a sore point. Interim scientific director Arlene Chiu has announced her resignation. The group is now the single largest supporter of embryonic stem cell research, but so far it has not been able to line up a group of top administrators. Report

House passes stem cell bill, waits for veto

Thu, 11 Jan 2007 19:01:34 -0500

As expected, the House passed a new bill that supports expanded federal grants for embryonic stem cell research. But the vote, 253-174, fell short of the two-thirds majority that would be needed to overturn a presidential veto--which is a certainty. According to the White House, the bill "would use federal taxpayer dollars to support and encourage the destruction of human life for research."

The recent election produced a host of wins for supporters of the bill, but support for the bill grew by only 15 votes as many of the Republicans votes out of office were moderates who had favored the measure.

- here's the report on the vote from The Wall Street Journal (sub. req.)

ALSO: The U.K.'s fertility watchdog has decided that it can't decide whether or not to approve the use of human/animal embryos in research work, saying that it needs more feedback on the issue. Report

Related Articles:
U.S. lawmakers aim for new stem cell law. Report
Poll shows support for Democrats' stem cell agenda. Report
Bush vetoes stem cell bill, override fails. Report

Poll shows support for Democrats' stem cell agenda

Maureen Martino — Thu, 04 Jan 2007 12:35:35 -0500

All eyes are on Washington D.C. as Democrats regain control of Congress today, and one of the incoming party's top priorities will be making easier for Americans to buy cheaper prescription drugs from other countries. An Associated Press-AOL News poll found that 69 percent of respondents support legislation that would makes these inexpensive drugs easier to acquire. "Importing prescription drugs to the United States is illegal, but the FDA generally does not bar individuals from bringing in small amounts for personal use," explains the AP. Some medications cost significantly less in other countries than they do in the United States; however, officials don't think that this will force down the price of prescription drugs in the United States.

To a lesser degree, the poll found that Americans also support the Democrat's plan to relieve restrictions on federal stem cell research funding. In July President Bush used his first-ever veto to reject a bill on embryonic stem-cell research that would have lifted the 2001 ban on public funding of stem cell research. Democrats plan to revive the issue, which could force the Presdident to veto the bill again. Last time this bill was vetoed House lawmakers were unable to override his veto, falling just two votes short of the two-thirds majority it needed. The new Democratic majority promises to have a significant impact on the issue of federal funding for stem cell research.

For more on the poll:
- read this AP

report

Related Articles:

Democratic win could be bad news for pharma industry. Report

Bush vetoes stem cell bill, override fails. Report

Fewer drugs coming in from Canada. Report

Stem cell research advances

Thu, 21 Dec 2006 19:01:36 -0500

Whatever the political climate, embryonic stem cell research has weathered a tough year and come out on top. Biotechnology is a global business, and what can't be done in one house can easily move next door. Australia has opened up while Singapore, the U.K. and other countries are doing all they can to make researchers in the field feel welcome. South Korea had its international hoax, but other scientists in the field are quickly advancing there as well. In the U.S., though, fresh funds are being made available in some states. And private donors have come in with millions more to lift the long-delayed California program off the ground.

As the scientific evidence of efficacy grows, so will the demand to fund new research programs. The potential benefits are extraordinary, and many patients--including some well known celebrities--are well aware that their best hopes for a cure lie in this field. But while embryonic stem cell research advances, let's not forget the promise of adult stem cell work as well. New research is pointing to some very versatile types of adult stem cells. And research in cardiology will be putting some of the theories to a human test in the year ahead.

ALSO NOTED: Celgene buys plant; Roche data positive on Xeloda; Merck, Vertex to advance MK-0457; and much more...

Sun, 10 Dec 2006 19:01:30 -0500

> Celgene is buying an active ingredient plant from Switzerland's Siegfried for $46.5 million. Report

> Roche announced that its latest Phase III trial for Xeloda hit its primary endpoint in a study on progression-free cancer survival. Release

> Merck and Vertex announced that MK-0457 will move into Phase II for leukemia after successfully completing a dosing study. Report

> Bristol-Myers Squibb is touting the positive results of a Phase III trial of Sprycel among patients resistant to Gleevec. Report

> AEterna Zentaris has released positive interim data from a mid-stage trial of Perifosine for multiple myeloma. Release

> Biogen Idec released positive Phase I/II data for lumiliximab. Report

> Health Discovery Corporation has executed a license agreement with Pfizer for its pattern recognition technology. Release

> Synerx Pharma has inked an agreement with Teva Pharmaceutical Industries in which Synerx will develop and secure FDA approval for a number of undisclosed products. Release

And Finally… Connecticut is moving aggressively in its support of embryonic stem cell research, handing out $20 million for 21 programs. Report

ALSO NOTED: Pfizer vows to triple number of late-stage drugs; Arpida touts superbug drug data; and much more...

Wed, 29 Nov 2006 19:01:30 -0500

> In a meeting with analysts, Pfizer executives said that they would triple the number of experimental drugs in Phase III by 2009. The pharma giant also raised its earnings guidance for 2006. Report

> Switzerland's Arpida saw its shares rise after the drug developer announced that a late-stage trial of its superbug drug iclaprim proved equally effective as a rival therapy from Pfizer. "Iclaprim demonstrated a clinical cure rate which was statistically non-inferior to that of (Pfizer's) linezolid...thereby achieving the primary endpoint of the trial," Arpida announced. Release

> Novo Nordisk says it plans to increase its diabetes sales force in the U.S. by 60 percent, hiring 700 new reps. The new hires will be made in the first half of 2007. Report

> House Speaker Nancy Pelosi has queued up a new bill backing expanded federal support for embryonic stem cell research. But no one's betting that backers can override a presidential veto, which would almost certainly greet any new provision in Congress. Report

> Thailand says it expects to see 100 new biotech companies operating by 2009. Report

And Finally... The National Kidney Foundation says it will investigate whether kidney patients are receiving dangerous overdoses of anemia drugs. Article

The growing biotech debate in politics

Maureen Martino — Thu, 16 Nov 2006 12:51:49 -0500

It started with a controversial video and ended with the victory of Democrat Claire McCaskill in Missouri. At issue was a ballot measure that would protect embryonic stem-cell (ESC) research. Both McCaskill and her Republican opponent Jim Talent campaigned hard, with supporters claiming that the measure would save lives and critics opposing the abuse of embryos for research. At Slate, William Saletan observes that both candidates warped the truth to suit their cause, yet “each side's warning was essentially true. If you block ESC research, you're closing off what might be the quickest path to saving many lives. And if you promote the research, along with the embryonic cloning that makes it therapeutically useful, you're seriously messing with the foundations of life.” What’s more, he observes, the tensions over this science will only intensify as baby boomers strive to live longer, healthier lives.

The debate over how far scientists should to in order to preserve and improve life represents a whole new kind of policy argument which falls outside the national security, economic, and cultural issues which have historically dominated politics. “[B]iotech politics didn't start in Missouri, and it won't end there…With polls on their side, Democrats have declared ESC research one of their top six priorities for the new Congress. Republicans, scrambling for alternatives, are proposing new stem-cell derivation methods that tamper more ambitiously with the human recipe” Expect the exploding biotech debate to become a staple political issue in the years to come. Editorial

Drug stocks damaged by Democrats' success

Tue, 07 Nov 2006 19:01:38 -0500

The big returns for the Democrats--or was it against the Republicans?--ushers in a new group of political leaders for the House and possibly the Senate. That was enough to send most of the mainstream pharma stocks down as analysts considered the possibilities of an upcoming assault on the way the Medicare drug legislation prohibits the agency from negotiating prices. A switch on the negotiating stance is likely to cut the amount the government pays for drugs and lower revenue for big pharma. Merck, meanwhile, also had to deal with the fallout from its election-night announcement that it will have to fight up to $5.58 billion in U.S. and Canadian tax liabilities.

The big winner in biotech last night was the embryonic stem cell field. A Democratic victory parade spells additional political support in Washington to pull back federal restrictions on research in the field. The outcome, though, is unlikely to influence President Bush's stance on the issue. He's been unwavering in his refusal to reconsider his position on the subject and used his only veto to block an effort to relax the restrictions. He'll continue to have the veto for another two years. Now supporters of the research field will have to count heads in Congress to see if they have enough votes to overcome another veto.

- check out the the report on investors' response from MarketWatch
- read this The Wall Street Journal article on Merck's new woes (sub. req.)

Related Articles:
Democratic win could be bad news for pharma industry. Report
Bush vetoes stem cell bill, override fails. Report
Stem cell advance runs into conservative roadblock. Report

New Mexico gov. calls for stem cell center

Thu, 02 Nov 2006 19:01:34 -0500

New Mexico Governor Bill Richardson is proposing $10 million in state funding for embryonic stem cell research. The funds would include money for a new research center at UNM along with money to hire researchers and train students. Embryonic stem cell research has emerged as a wedge issue for the Democrats in some states as they battle for control of Congress.

- here's the report on Richardson's initiative from the Albuquerque Tribune

Related Articles:
Democratic win could be bad news for pharma. Report
Stem cell advance runs into conservative roadblock. Report
Biotechs cautious about stem cell project. Report

Novocell scientists create insulin-producing cells

Thu, 19 Oct 2006 20:01:38 -0400

Novocell has managed to turn embryonic stem cells into insulin-producing pancreatic cells, a major step in a long journey toward curing patients with Type 1 diabetes. Vanderbilt's Dr. Mark A. Magnuson told The New York Times that Novocell's scientists had reached an efficiency of cell conversion that was in "orders of magnitude higher than anything previously accomplished." But he noted that significantly more work needs to be done. Novocell's scientists took embryonic stem cells and tweaked them with growth factors, mimicking the process in the creation of pancreatic cells. Novocell still has a considerable amount of testing to do. Animal studies are planned in '08, with human trials scheduled to get underway in '09. And that's the best-case scenario.

"The efficient, reproducible production of human embryonic stem cell-derived, insulin-producing endocrine cells through a process that mirrors the development of human pancreatic cells represents a critical step toward providing a renewable source of cells for diabetes therapy," said Emmanuel Baetge, Ph.D., chief scientific officer of Novocell and senior author of the publication. "This provides a foundation upon which we can build a standardized process for generating functional insulin-producing cells for the treatment of diabetic patients."

- read the report on the research from The New York Times

Scientists use dead embryos to create cell lines

Thu, 21 Sep 2006 20:01:35 -0400

A Serbian scientific team has come up with a way to develop new embryonic stem cell lines without deliberately destroying an embryo. Taking 13 "arrested," or dead embryos in which cells have stopped dividing, the researchers were able to create one new embryonic stem cell line. Their work is published in the journal Stem Cell.

In vitro fertilization clinics typically dispose of the arrested embryos once the cells stop dividing. The hope of the scientific team is that this use of "dead" embryos avoids any intentional destruction of embryos, which the Bush administration and many of its supporters find morally repugnant. Whether it is enough to satisfy opponents, though, is uncertain at best. When recently presented with the theoretical possibility of developing new embryonic stem cell lines without harming a living embryo, the Bush administration as well as the Vatican quickly turned thumb's down.

- here's a report on the research from The Guardian