Stem cell research

Michigan voters supporting use of ESCs in research

John Carroll — Wed, 05 Nov 2008 11:18:18 -0500

Voters in Michigan appeared on the verge of endorsing a proposal to allow researchers to use discarded embryos from fertility clinics to devise new embryonic stem cell lines. The proposal had been fiercely contested by the state's Catholic hierarchy and right-to-life groups. With 87 percent of the votes counted, though, the initiative was winning 52-48.

The argument over the future of ESCs in disease research dominated much of the discussion. Opponents of the initiative noted that the use of reprogrammed adult stem cells was making any use of ESCs unnecessary. But proponents argued that a better understanding of ESCs is needed as new work on adult stem cells advances.

- read the report from the Detroit Free

MIT lists top young scientists in biotechnology

John Carroll — Tue, 19 Aug 2008 12:11:21 -0400

Anyone looking for a peek at the top young minds in biotechnology should check out this year's list of the 35 most innovative young scientists in the U.S. from MIT Technology Review. UC Berkeley's Michelle Chang, for example, is investigating new, more efficient ways to make organic molecules. While Harvard's Konrad Hochedlinger has helped improve the transformation of adult cells into stem cells. They are among the eight young brains who promise to help transform biotechnology.

--read the article in MIT Technology Review

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

California grants ignite a boom of lab construction

Wed, 07 May 2008 06:59:56 -0400

After four years of litigation and detailed planning, the first $271 million in facilities grants is just about ready to be doled out by the California stem cell institute. And that in turn will trigger more than three-quarters of a billion dollars worth of new construction for the laboratories that are being designed to develop the stem cell therapies of the future.

In the Bay Area alone four projects are vying for funding. If all four win, builders will construct $443 million in new stem cell laboratories.

California's $3 billion stem cell initiative--which was bitterly opposed by conservative groups--has inspired universities in the state to come up with ambitious plans for new research centers, leveraging the bond money with hundreds of millions of dollars of their own money. The state's plans involve stepping in where the federal government has refused to tread for seven years, and they are well on their way to making the state a world leader in the field.

- read the report in the San Francisco Chronicle

San Diego institutes plan $115M stem cell lab

Mon, 21 Apr 2008 06:59:58 -0400

Four of San Diego's biggest research institutions are teaming up to form the San Diego Consortium for Regenerative Medicine, a group aimed at advancing stem cell work. The four research bodies--UCSD, Scripps Research Institute, the Salk Institute and the Burnham Institute for Medical Research--are planning a $115 million research "collaboratory" that would open in 2010. Each of the institutes brings something different to the Consortium. Salk and the Burnham Institute both have strong stem cell programs, Scripps is know for it medicinal chemistry, and UCSD has a stem cell program, medical engineers and access to patients who could participate in tests for therapies. Consortium members hope that by pooling their strengths they can quickly identify breakthrough drugs based on stem cell research.

"We have this vision of getting people with common interests in the same place so you get a synergy that enhances everyone's individual capacity and makes things go faster," said Larry Goldstein, a Howard Hughes Institute stem cell researcher at the University of California San Diego.

Some of the project's funding will come from the $3 billion stem cell initiative California approved in 2004. An unnamed donor contributed $30 million to the project and the Consortium will have to scrape together $72 million more. The center will be based in San Diego in the Torrey Pines biotech cluster.

- here's the report from the San Diego Union-Tribune
- and check out the AP report

Related Articles:
California--Top Five Regions Targeting Biotech, 2008. Report
Stem cells take center stage in San Diego summit. Stem cell report
California biotech: Strong, growing but worried. California report

What's in store for stem cell treatments?

Fri, 11 Apr 2008 06:59:55 -0400

At yesterday's hearing on stem cells, the FDA set a high bar for the treatments, saying that any therapies would have to have very compelling data in order to move into human trials. The FDA's wariness is due to uncertainty about stem cells effects on the body. While the treatments show promise, researchers do not yet have all the answers regarding the long-term effects of such treatments. Tumors, in particular, are a concern. Geron, Novocell, Neuralstem and Advanced Cell Technology are nearing human trials--uncharted territory for stem cell therapies.

The FDA took a key step as it began drafting a blueprint for how the stem cell therapy trials would be conducted. "We've talked about how long we need to monitor people for, and the answer is forever," said Gordon Weir, a panelist on the advisory committee. "We're putting in these cells, and we don't know what they're going to cause in terms of trouble." Drug developers are looking to the FDA to elucidate the regulatory hurdles they'll face as stem cell therapies move through clinical trials. Without clear guidelines, drugmakers will face an unclear development process complicated by uncertainty and controversy.

- check out the CNNMoney article
- read this Wall Street Journal report for more

Related Articles:
Stem cell developers shift focus to FDA hearings. FDA report
Stem cell outfits a winner in upcoming election. Election report
NIH chief breaks with Bush on stem cell research. Report
Stem cell advance runs into conservative roadblock. Stem cell report
Stem cell market shows signs of fast growth. Stem cell report

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

Related Articles:
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Stem cell market shows signs of fast growth

Sanofi makes moves in China

Fri, 04 Apr 2008 07:59:55 -0400

In the Wall Street Journal, Sanofi's R&D chief Marc Cluzel (photo) discusses the company's plans for expanding in China. Back in September Sanofi signed a deal to collaborate with the Chinese Academy of Medical Sciences on stem cell research. As many as five more deals will follow, though Cluzel declined to say which partners Sanofi has approached and how much money the company intends to invest in China. The company is hoping to work with universities and state-funded research institutions.

Despite recent concerns about the quality of Chinese-made medical products, the country is actively pursuing an increased role in biotech R&D. Cluzel says the talent pool and entrepreneurial spirit of Chinese researchers will help the country become a leader in the biotech industry. "I think the amount of people with a master's [degree] in biology in China is now bigger than the number of people with a master's in biology in the U.S. The number of people with a Ph.D. in biology in the U.S. is still higher than in China, but it's getting closer and closer," Dr. Cluzel said. "And they are doing some good fundamental science. One day or another there will be a payback."

- read the WSJ article for more

Related Articles:
Sanofi signs stem cell pact in China. Report
Sanofi to build vaccine plant in China. Report
China pushes drug development as R&D soars. Report

Stem cell institute in wrangle over office costs

Thu, 13 Mar 2008 07:59:55 -0400

California's stem cell institute says the property management company that promised to underwrite all their office operating costs in San Francisco appears to be reneging on the deal, and they're bringing out the legal guns to make them pony up as promised.

The dispute dates back to a deal negotiated by San Francisco's mayor to give the institute a 10-year, rent-free office in San Francisco as an incentive to lure them to the Bay area. As part of that deal, Stockbridge Capital Partners allegedly promised to cover almost half a million dollars in annual office overhead for utilities, parking and so on.

Stockbridge says that it's keeping its pledge to provide rent-free space and has been working with contributors to cover costs. The institute says it wants to make sure all i's are dotted and every t is crossed before operating costs stack up.

- read the article from the San Francisco Chronicle

Related Articles:
Stem cell institute to foster start-ups with loans. Report
California institute outlines stem-cell strategy. Report
California stem-cell institute open for business. Report
Wealthy supporters back California stem cell research. Report

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

Related Articles:
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

ALSO NOTED: Manhattan Pharma closes JV deal; Abbott, Genentech, WEHI in cancer collaboration; and much more...

Wed, 27 Feb 2008 06:59:50 -0500

> Manhattan Pharmaceuticals has closed on its joint venture agreement with Nordic Biotech Venture Fund II K/S to develop and commercialize Hedrin for head lice for the North American market. Manhattan Pharmaceuticals pocketed a $2 million cash payment plus $2.5 million of equity in the newly established joint venture, named Hedrin Pharmaceuticals K/S. Release

> Abbott, Genentech, and WEHI have joined in a tripartite research collaboration to discover anti-cancer drugs. Release

> Stem Cell Therapy International and South Korea's Histostem have announced plans to merge. "We are very pleased with the opportunity for us to be working with Histostem. They have made remarkable progress in the field of umbilical stem cell research and therapy," says Calvin Cao, CEO of SCTI. Release

> Genentech has expanded its license regarding Sagamo BioScience's proprietary zinc finger DNA-binding protein nuclease (ZFN) technology. Release

> Tough luck to unwary buyers, Chinese regulators say. The country's drug safety agency said today that it strictly controls chemicals for use in pharmaceuticals but it's not ultimately responsible for product safety. Report

> A new analysis of the blockbuster anemia drugs sold by Amgen and Johnson & Johnson concludes they raise the risk of death among cancer patients by about 10 percent. Report

> The FDA piggy bank isn't near full enough to overhaul operations as they ought to be, agency chief Andrew von Eschenbach admits. And that's a big admission; von Eschenbach is in essence agreeing with critics who've said his agency simply isn't up to the task of ensuring drug and food safety. Report

> Here's a study guaranteed to put almost every drugmaker on the defensive. Researchers analyzed every antidepressant study they could get their hands on--including a bunch of unpublished data obtained via the U.S. Freedom of Information Act--and concluded that, for most patients, SSRI antidepressants are no better than sugar pills. Report

And Finally… Cases of drug-resistant tuberculosis have spiked to their highest level ever and may start spreading even faster. The highest rate was in a city in Azerbaijan, where one in four cases of TB is unresponsive. Article

ALSO NOTED: North Carolina steps up biotech funding; Petra Group plots start-up; ProMetic in development deal; and much more...

Tue, 26 Feb 2008 06:59:50 -0500

> North Carolina lawmakers have boosted their support of the biotech field, adding $83 million to support research, training and manufacturing initiatives. Report

> The Petra Group in Kuala Lumpur is in talks to create a new biotech company devoted to biophotonics with the University of St. Andrews. Report

> Dr. Giuseppe Giaccone has presented the final results from a positive double-blind, placebo-controlled Phase II trial with talactoferrin alfa in non-small cell lung cancer. This was the second successful, randomized, double-blind, placebo-controlled trial with oral talactoferrin in NSCLC. The first was with talactoferrin in combination with first-line chemotherapy. Release

> ProMetic Life Sciences will garner $2 million over the next 12 months in upfront fees and milestones after inking a deal with Kedrion to develop two hyperimmunes. Release

> Lotus Pharmaceuticals has raised $5 million in a private placement. Release

> In a study that may change the way that cancer drugs are developed and prescribed, scientists have determined that genetic mutations are different in every cancer patient, suggesting that drugs will need to be "tailored" for small groups. Report

> The International Stem Cell Forum is meeting in San Francisco, bringing together 21 stem cell research institutes and representatives from 19 countries to review such issues as the moral and ethical guidelines needed for research and the registry of ESCs lines. Report

> High rainfall, biodiversity and rapidly growing populations are considered breeding grounds for new outbreaks of diseases like SARS and Ebola. Report

And Finally… Patients most likely to benefit from genetic testing are either avoiding it altogether or paying for it themselves to keep hereditary disease out of their health records--and most importantly, off the books of their insurers. Report

Q Therapeutics raises $15M

Fri, 15 Feb 2008 06:59:55 -0500

Salt Lake City-based Q Therapeutics has raised $15 million in a second round of financing. The company is developing cell-based therapies for the central nervous system. It is currently running preclinical studies and hopes to file an IND for a treatment for transverse myelitis, a rapidly paralyzing subset of multiple sclerosis. Q expects clinical trials to begin in 2009. VSpring Capital led the round, and Invitrogen was among a group of investors that also participated.

"This investment will help accelerate our efforts to bring important new treatments to the clinic for these extremely debilitating neurodegenerative diseases. As a leader in providing many of the necessary tools for stem cell research and production, Invitrogen's participation will further enhance our development going forward."

- see this release for more

Related Articles:
Invitrogen puts up $57M for CellzDirect buyout. 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

SPOTLIGHT: Election 2008: What does it mean for drugmakers?

Wed, 06 Feb 2008 06:59:53 -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 four front-runners' stance on several topics vital to the biotech and pharmaceutical industries. Report

Stem cell institute to foster start-ups with loans

Mon, 04 Feb 2008 06:59:57 -0500

Wanted: Biotech companies with no cash flow, facing a high risk and in need of money to back translational development efforts. California's stem cell institute has been putting out just that kind of call, looking to loan money to developers aiming to push products closer to marketing and the orbit of traditional venture backers.

Robert Klein, chairman of the California Institute for Regenerative Medicine, tells the San Diego Union-Tribune that a lending program could help them leverage a $500 million portfolio into $1.5 billion over 21 years. A task force is working out the details and no doubt plenty of biotech companies are waiting to take part.

"In the biotech industry, if you're an early-stage company and not yet at the stage of commercialization, you're always out there trying to obtain money and looking for alternative funding sources," said William Caldwell, chief executive of Advanced Cell Technology in Alameda.

- check out the report from the San Diego Union-Tribune

Related Articles:
California institute outlines stem-cell strategy. Report
California stem-cell institute open for business. Report
Wealthy supporters back California stem cell research. Report

California biotech: Strong, growing but worried

Thu, 24 Jan 2008 06:59:54 -0500

An industry group sees steady growth in California's biotech sector, but warns that looming new government regulations could throttle its advance. The state's biotech businesses ginned $73 billion in revenue in 2006, up 20 percent from the year before, says a report compiled by PriceWaterhouseCoopers. And if you combine devices and diagnostics with the biotech companies, the group claimed 40 percent of the $7.4 billion in venture money invested in the state--three times the sum brought in by Massachusetts' life sciences sector.

"There's an enormous market for the products of the industry as they're developed," says David Gollaher, CEO of the California Healthcare Institute and co-author. Gollaher adds that the state's biotech business is vulnerable to a recession but one big blockbuster approval could prevent the numbers from heading down.

- read the AP report

ALSO: Lobbyists in California are asking for $150 million in state funds to back incubators operated by the University of California system. That could be a tough sell, though, as the state faces a severe budget crunch. Report

Related Articles:
BayBio touts local biotech industry. Report
It's San Francisco vs. South San Francisco. Report
New report claims signs of bay area brain drain. Report
Bay area biotechs plan new lobbying strategy. Report
California delivers millions for stem cell research. Report

ALSO NOTED: Cephalon, NitroMed make cuts jobs; IonGate gains funds; and much more...

Wed, 16 Jan 2008 06:59:50 -0500

> Cephalon is cutting jobs as it restructures, shifting manufacturing work from Minnesota to Salt Lake City and relocating some R&D work from Salt Lake City to Minnesota. Report

> NitroMed is in trouble. The company is not only shutting down its sales force and laying off 70 of the 90 people work work there, but asking the investment bank Cowen & Co. to advise it on "strategic alternatives." Report

> IonGate Biosciences has garnered €4.6 million in its third venture round. Heidelberg Innovation and KfW (Kreditanstalt für Wiederaufbau) led the round. Release

> Nycomed is looking for partners in the U.S. following the FDA's approval of Alvesco, its asthma inhaler therapy. Release

> ExonHit Therapeutics has created two commercial business units: the Molecular Diagnostics and Genomic Services Unit and the Therapeutics Unit. Release

> Germany's MorphoSys has acquired patent rights on protein inhibitors from the University of Melbourne, advancing its work on an experimental rheumatoid arthritis therapy. Release

> Teva Specialty Pharmaceuticals and UCB have signed a commercialization pact on Teva's respiratory products. Release

> MAP Pharmaceuticals and the FDA have reached a protocol agreement for a clinical study of MAP0004, a migraine therapy. Release

> Scientists in Singapore are advocating new rules that would permit researchers to splice human DNA into animals to further stem cell research. Report

> Research groups were left shaking their heads in disappointment over news that next year's budget for the National Institutes of Health--the largest single supporter of biomedical research in the U.S.--will boost spending by a meager 0.5 percent. Report

> Science has taken another big step in the direction of building new body organs from stem cells. A team of scientists have constructed a new rat heart, injecting cells from newborn rodents onto a scaffold of valves that were left intact after dead heart cells were removed. Report

> The European Commission has launched a pharma antitrust probe, looking for evidence that industrial hijinks are keeping new products off the market and delaying cheaper generics. Report

> It didn't take long for allegations of improper marketing from two Amgen sales reps to attract the attention of government watchdogs. First, the New Jersey Attorney General formed a task force to investigate pharma-doctor interaction. And now, perpetual pharma bloodhound Sen. Charles Grassley (R-IA) is sniffing around the cases. Report

And Finally... A new genetic test kit is being marketed that will give men an advance warning on going bald. Report

ALSO NOTED: Tacere gains Pfizer deal; InterMune reports positive hep C results; ArQule CEO resigns; and much more...

Tue, 08 Jan 2008 06:59:50 -0500

> Tacere Therapeutics has inked a development deal with Pfizer for its preclinical hepatitis C drug. The deal is worth up to $145 million in potential milestones and Pfizer is paying an undisclosed upfront fee. Release

> Shares of InterMune jumped after the company announced that the Phase Ib trial of a new hepatitis C therapy delivered positive results. Report

> U.S. regulators have canceled an advisory board meeting regarding Jerini's icatibant, removing a possible obstacle to its approval. Release

> The CEOs of ArQule and Isolagen have announced plans to leave their respective companies. Report | Report

> Watson Pharmaceuticals says that its experimental gel therapy for overactive bladder met its goal in a late-stage trial. Release

> NextGen Sciences and Paragon Bioservices announced a marketing deal for their development services. Release

> NicOx signed an extension of its March 2006 collaboration agreement with Pfizer covering the exclusive right to apply its proprietary nitric oxide-donating technology to drug discovery research in the field of ophthalmology. Release

> China's biotech sector is small compared to its pharma activities, but it's growing fast. Report

> The very drugs prescribed to strengthen bones can spark stabbing limb and joint pain, according to a reminder from the FDA. Report

> A peptide produced by the brain to ward off the effects of fatigue could be the key to combating sleep disorders such as narcolepsy, according to new research. Report

> Looking to boost New York's reputation as a thriving center of scientific research, Gov. Eliot Spitzer has handed out the first series of grants from a new $600 million fund designed to support stem cell research programs. Report

> Prescription drug spending surged in 2006 as the government's benefits for the elderly kicked in, according to a federal study. Report

And Finally... House Democrats are investigating whether consumers are being misled by commercials in which Dr. Robert Jarvik (photo) endorses of Pfizer's Lipitor. Though Jarvik invented the artificial heart, he has never practiced medicine. Report

ALSO NOTED: Osiris inks $224M contract; Baxter and Nektar to collaborate;and much more...

Mon, 07 Jan 2008 06:59:50 -0500

> Osiris Therapeutics has inked a deal with the U.S. Defense Department to supply a potential $224 million worth of Prochymal for use in treating military personnel exposed to radiation. Release

> Osiris also regained all worldwide rights to Prochymal. Release

> Baxter International and Nektar Therapeutics are teaming up to investigate new therapies for a rare form of hemophilia. Report

> BrainStorm Cell Therapeutics has expanded its collaboration with Rutgers University aimed at curing spinal cord injuries through adult stem cell research. Release

> Jazz Pharmaceuticals has received orphan drug designation for an experimental epilepsy therapy. Report

> Waltham, MA-based Magen BioSciences has acquired the rights to dermatology compounds from Eli Lilly. Report

> Making a living off pharmaceutical companies suddenly isn't so lucrative: IMS Health, the market research company responsible for so much of the hard data on drug sales, is laying off about 10 percent of its work force. Report

> Celgene announced that it expects fiscal 2007 profits to double to $1.05 per share, as sales of its cancer drug Revlimid skyrocket. Report

> As if Amgen didn't have enough to worry about with its anemia drugs under fire. The company is defending itself against charges of bull-whipping sales reps into marketing drugs off label and violating patients' privacy. Report

And Finally... A pharma nightmare with an English accent: The UK government wants to slash prices for prescription drugs by 10 percent. Report