Bush Administration

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

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

Budget has mandate for biogeneric approvals

Tue, 05 Feb 2008 06:59:57 -0500

Buried in the modest 5.7 percent budget hike for the FDA is a provision that the government will seek authority to begin approving generic versions of biologics. Despite heavy support for the measure, lawmakers failed to get a bill in 2007 that would mandate a regulatory pathway for follow-on biologics, or biogenerics. The 1984 generic drug law excludes most biotech products, a feature that has enhanced the sector for investors and aroused the fiercely protective nature of a host of industry lobbyists. This time around, though, biogeneric legislation could get the boost it needs if the White House actively pursues it.

- read the report in the Wall Street Journal

ALSO: Opponents of a patent reform bill that changes the way damages are assessed in patent reform cases got a boost from the Bush Administration. Report

PLUS: Any big fix at the FDA may have to wait for a new president. The White House's proposed budget includes a funding increase of just 5.7 percent for the agency, a hike that's significantly absorbed by inflation. Report

Related Articles:
Waiting game continues for biogenerics. Report
Dr. Reddy's make risky biogenerics move. Report
Lawmakers propose pathway for approving biosimilars. Report

Big Pharma brings home the cash, slices payroll

Tue, 24 Jul 2007 06:59:56 -0400

The Bush Administration was looking for new jobs when it announced a tax amnesty program aimed at encouraging multinationals to repatriate foreign profits. The New York Times reports that the drug industry was the most enthusiastic sector when it came to bringing the money home--to the tune of $100 billion. But instead of adding new jobs, the pharma companies have been cutting them. And now that the two-year program is over, the drug companies are once again turning to shelters to move their money into other markets. In some cases that involves designating other markets as more profitable than their U.S. market, even though the U.S. has traditionally served as pharma's global cash cow.

- read the article from The New York Times

Related Articles:
Nabi cuts jobs, explores company sale. Report
Bayer axes 6,100 jobs in wake of Schering deal. Report
Pfizer cuts 10,000 jobs. Report
Abbott eliminates hundreds of jobs in restructuring. Report
Lilly to Icos: Merry Christmas, you're fired. 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

Politics turns to the left

Thu, 21 Dec 2006 19:01:37 -0500

After six years of a steady trade wind of Republican influence, the climate on Capitol Hill has suddenly shifted. For an industry like biotech, which always has a finger in the air to see what's blowing their way, there is reason for both comfort and concern. Comfort comes from seeing a majority of voters around the country clearly backing stem cell research, electing federal and state officials who are opting for science over fundamentalism. Soon enough the Democrats now in control of the House and Senate are going to put President Bush's veto of the recent stem cell bill to the test and see if they now have the votes to push through new federal funds for the field. They might pull it off, but it will be tough. President Bush has made it clear that he isn't budging on this one inch, leaving a dwindling number of Republicans willing to defend a position that has grown clearly out of favor with the electorate. The concern is justified, too. Democrats are making drug costs an issue again, vowing to do everything they can to lower the bill.

What hurts Big Pharma's pocketbook hurts biotech too, because those are the pockets deep enough to provide the big buyouts and licensing deals we've been seeing. But anything likely to crimp Big Pharma's revenue is also likely to whet its appetite even more for new therapies to sell, so don't look for the bidding and buyouts to temper anytime soon.

Congress is also likely to add to the pressure for new legislation creating a regulatory pathway for biosimilars, or follow-on biologics, if you prefer the phrase employed by BIO. If you threaten a company's patents in this business, you'll drive down its value. But with the Democrats out of favor for so long now, Congress hasn't even held any hearings on this issue in the recent session. Insiders say you should look for a push, but most don't expect any legislative conclusions before 2008. But with the Europeans moving ahead on this, change is a comin'. It will, as always, be interesting to watch.

ALSO NOTED: Glaxo wins approval for Hycamtin; Affymax forecasts share price;The best (and worst) biotech stocks of 2006; and mu

Thu, 30 Nov 2006 19:01:30 -0500

> President Bush has signed a new law that expands the powers of federal authorities targeting the activities of animal rights groups. Report

> GlaxoSmithKline has won EMEA approval to market Hycamtin, a combinatorial therapy for cervical cancer. Report

> Affymax has forecast a share price of $22 to $24 a share on the 3.5 million shares it plans to sell in its IPO. Report

> Analysts say that Allos Therapeutics is likely to release positive data for two major cancer trials in December. Report

> Eli Lilly will close its Mont St. Guibert operation and take a charge of $100 million to $110 million. Report

> Talecris Biotherapeutics has set up its European headquarters in Frankfurt, Germany. Release

> Researchers have used RU-486 to ward off tumors in mice bred with a gene that promotes breast cancer. Release

> Chutes & Ladders: Amgen has appointed Yuji Orihara president and representative director of Amgen in Japan. Release

> Dutch biotech Crucell has won contracts worth a collective $230 million for two of its vaccine. Report

> New research appearing in the Journal of Biology shows that even low doses of chemotherapy are killing brain cells and cancer drugs are more malignant to healthy cells than diseased cells. Report

> According to a newly-issued report from PriceWaterhouseCoopers predicts the top 7 trends for the healthcare history in 2007. Report

> The best (and worst) biotech stocks of 2006. Report

And Finally…The Clinton Foundation has announced a new deal that will significantly cut the cost of AIDS drugs for children. Article

FDA approves surging number of NDAs

Wed, 29 Nov 2006 19:01:36 -0500

The FDA approved 15 NDAs in October, the biggest month of the year for the agency. In the UPI story, analysts say that year-to-date approvals put this year in line with 2004, the best year for regulatory approvals in the Bush administration. Analysts are sounding worried, though, that a new Democratic majority will push through regulations that slow FDA actions. But where's the research and analysis on the number of new NDAs that are directed at the FDA? The regulators aren't acting in a vacuum. A rising tide of approvals has to be directly tied to an increase in the number of successful clinical trials. One analyst says that the new emphasis on safety at the FDA is likely to benefit companies that provide much of the work in the field, like clinical research organizations.

- read the UPI report on the NDA trend

Related Article:
Democratic win could be bad news for pharma industry. Report

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

Editor's Corner

Sun, 05 Nov 2006 19:01:39 -0500

It's hard to imagine any outcome in tomorrow's election that would have a truly profound impact on the drug development world. If the Democrats take the House, it is likely that Henry Waxman would take up the NIH conflict controversy as the new chair of the House Committee on Government Reform. Democrat Bart Gordon is in line to chair the House Committee on Science, which could make for some interesting hearings on the political manipulation of science and federal scientists under the Bush administration. Perhaps the biggest single potential change would be a push to allow Medicare to negotiate prices directly with big pharma companies, which have undoubtedly gained windfall profits from the new federal drug benefit. Some of that money has been going to pay for some pricey biotech acquisitions.

On the other hand, if Republicans pull off an upset and retain control of both chambers, we'll stay on familiar ground. Either way, President Bush will continue to influence science and healthcare in general. No one is forecasting that the Democrats will have the votes to overcome a presidential veto.

Regardless of who's running the committees, the critical need for new resources to push through a more ambitious supervision of drug applications--along with a more aggressive federal support of biomedical research--is likely to be sidetracked by continuing federal deficits. The most likely outcome will be two years of gridlock, with Republicans and Democrats pushing and shoving for position under a lame duck president. Almost immediately, the jockeying for the 2008 election will begin in this new era of the unending campaign. - John Carroll

Editor's Corner

Sun, 20 Aug 2006 20:01:40 -0400

On Friday Barr Laboratories resubmitted its application to make Plan B available without a prescription. Given the FDA's sudden willingness to work out a marketing plan for the contraceptive, Barr has a good shot at finally obtaining an approval that should have come through in 2004. More importantly, it's a chance for the FDA to demonstrate that science and not ideology dictates how it reviews a therapeutic. Given the Bush administration's clear preference for ideology, the FDA may have more difficulties ahead. But for now, there's reason for hope. - John Carroll

Editor's Corner

Sun, 23 Jul 2006 20:01:40 -0400

No doubt many scientists greeted last week's announcement that President Bush had exercised his veto power for the first time to stop a bill expanding federal funding for stem cell research with the sound of gritting teeth. At this stage, just about everyone with an interest in research knows his grand compromise doesn't work. Those existing lines of stem cells proved too few and too easily corrupted to give researchers something real to work with. But the lopsided votes in Congress provide hard evidence in an election year that most politicians know only too well that this position is unpopular with a majority of the citizens. California Governor Arnold Schwarzenegger understood that when he authorized $150 million in state loans to get its own stem cell program underway. Once George W. Bush is gone from office, his stem cell policies will disappear from view and federal obstacles will dissolve. And that is very likely to hold true no matter who wins the next election.

Also, kudos to the FDA for moving to clarify its conflict-of-interest rules (see below). Hopefully, we'll at least be given some clear standards to understand. Researchers deserve a chance to know where the ethical lines are drawn and what standards they must abide by. - John Carroll

Bush vetoes stem cell bill, override fails

Wed, 19 Jul 2006 20:01:39 -0400

As promised, President Bush used his first-ever veto to reject a bill on embryonic stem-cell research that would lift the 2001 ban on public funding of stem cell research. In a 235-193 vote, House lawmakers were unable to override his veto, falling just two votes short of the two-thirds majority it needed. President Bush cited ethical concerns about the new legislation and stated that new treatments could be derived from other forms of stem cells rather than those taken from embryos slated for destruction.

The bill was supported not just by Democrats but also by some Republicans, meaning that the issue will likely rise again at a later date. "This important legislation will become law. It's only a matter of when," Rep. Diana DeGette (D-CO) told The Wall Street Journal. President Bush's 2001 decision to limit federal support to existing stem cell lines triggered alarm that the U.S. would lag behind in that research area. Since then four states, including biotech hub Maryland, have passed their own stem cell funding initiatives.

- here's the article from the Wall Street Journal (sub. req.)
- and read the text of Bush's veto message

ALSO NOTED: Osiris files IPO; Amgen initiates kidney disease study; and much more...

Sun, 16 Jul 2006 20:00:50 -0400

> Baltimore-based stem cell therapeutic company Osiris Therapeutics announced an IPO at 3.5 million shares for about $11 to $13 each. Report

> Chutes & Ladders: Ann, Arbor, MI-based Aastrom Biosciences has named George W. Dunbar CEO and president. Release

> Melbourne-based CSL Limited will acquire biotech Zenyth Therapeutics for about $108 million. Release

> Amgen is initiating a 3,800-person study of Sensipar/Mimpara for kidney disease. Report

And Finally... The Senate will continue to debate three stem cell bills which President Bush has pledged to veto if passed. Article (WSJ sub. req.)

WP: VaxGen's vaccine program in doubt

Tue, 09 May 2006 20:01:38 -0400

The Washington Post has a follow-up to the ongoing travails of VaxGen's anthrax program. The report cites sources who say that the relationship between government officials and the company has becomes so contentious that the program's future is in doubt. Under its original contract, VaxGen was to start delivering anthrax vaccine by the end of this year. New revisions has pushed that back to 2008. The Bush Administration gave VaxGen the billion-dollar program to protect 25 million people from a potential bioterror attack.

- here's The Washington Post report for more

Despite curbs, feds increase stem cell funds

Mon, 03 Apr 2006 20:01:37 -0400

Despite controversial federal restrictions on embryonic stem cell research, federal support for the field grew 60 percent in 2005, to $37 million. President Bush's decision to limit federal support to existing stem cell lines had triggered alarm that the U.S. would become laggards in the research area. The government had identified 60 supplies of existing embryonic stem cells it would continue to fund research on, but only a half dozen lines are actually available to U.S. researchers. Some 154 projects were funded last year, including a $4.2 million national stem cell bank in Madison, WI.

- here's the Wall Street Journal article (sub. req.)

Maryland passes $15M stem cell funding bill

Wed, 29 Mar 2006 19:01:37 -0500

Yesterday Maryland became one of only four states to fund stem cell research, passing legislation that will grant up to $15 million in funds to both private biotech researchers and universities. Decisions regarding public funding of stem cell research has fallen to the states following a 2001 decision by the Bush administration to limit federal funding of this research. Not surprisingly, this proved to be one of the most controversial bills tackled by the Maryland legislature this year and compromises had to be made by those on both sides of the issue.

- read this Washington Post article for more

Von Eschenbach nomination faces challenges

Wed, 15 Mar 2006 19:01:38 -0500

President Bush nominated Andrew von Eschenbach to the permanent post of FDA commissioner, but the nomination is in trouble from the get-go, with senate leaders vowing to hold the nomination hostage to a firm decision from the agency on making the controversial Plan B contraceptive available over the counter. Scientists at the FDA have been clear that the contraceptive is safe and effective, but top regulators have pushed Plan B into regulatory limbo. Conservatives see Plan B as a tacit encouragement to promiscuity, which some internal and external critics say shouldn't be an issue at all.

Plan B was a major snag for Lester Crawford, who left abruptly after only a brief period following his controversial nomination process. But with both sides vowing to hold on and fight to the bitter end, it's likely to be some time before von Eschenbach prevails. That is likely to continue the prolonged sense of uncertainty that has plagued the FDA during the bulk of President Bush's administration.

- read this Los Angeles Times report

Report: Von Eschenbach to get FDA nomination

Thu, 09 Mar 2006 19:01:38 -0500

Several sources are reporting that President Bush is expected to nominate Andrew von Eschenbach as the permanent head of the FDA, including a source in the administration, saying that the announcement was expected sometime in the next few days. Von Eschenbach has been the interim chief of the FDA since last September, just months after Lester Crawford had been given the official title. Crawford's abrupt departure has never been fully explained.

Von Eschenbach had to give up his day-to-day duties as head of the National Cancer Institute to take the interim post at the FDA. Industry leaders have been repeatedly calling for a permanent chief to manage the agency and set its course. Von Eschenbach has been an enthusiastic advocate of personalized medicine, the development of targeted therapeutics that can address an individual's ailments. The movement toward personalized medicine will require a much greater focus on pharmacogenomics and data that indicates which subsets of a population are most likely to benefit from a drug.

- here's The Wall Stret Journal report (sub. req.)

Bush updates plan to combat avian flu pandemic

Mon, 31 Oct 2005 19:01:37 -0500

President Bush outlined a new plan to spend $7.1 billion to stockpile medications to combat an outbreak of human transmissible bird flu at a speech at the National Institutes of Health. The thrust of the plan is to prepare the country to identify an outbreak and contain it as swiftly as possible. Bush also discussed efforts to develop cell-based vaccines that can be produced much faster than today's vaccines and stockpile antiviral drugs like Tamiflu and Relenza. The country expects to have 4 million doses on hand by the end of the year, less than what the World Health Organization has recommended.

Whatever the country's plans, problems abound. Roche has made it clear that it is already back-ordered more than a year on Tamiflu, and researchers are concerned that there won't be enough antiviral medicine available to blunt the global onslaught of a possible pandemic. A pandemic can only be triggered by a mutated H5N1 virus, which may not be affected by antiviral drugs or any of the vaccines currently in development. The US is also already significantly behind countries like France and the UK, where planning efforts have been far more detailed.

- read this article from CNN for more information