Regulation

Overseas regulators toughens clinical trial stance

John Carroll — Mon, 01 Dec 2008 11:03:12 -0500

The Wall Street Journal weighs in this morning with a feature looking at the increasingly tough stance overseas regulators are taking to the clinical trials being conducted around the world. India, for example, is probing the screening measures used in a vaccine trial after a baby in the study died. Polish investigators want to know why two seniors died while taking an experimental bird flu vaccine being developed by Novartis. Age limits should have excluded both from the study.

For drug developers, the investigations underscore a heightened awareness of the dangers inherent in every clinical trial. And in developing countries, there's a growing concern that their citizens are being used to test new drugs that will later be sold in more affluent markets. Developing nations offer a prime opportunity to lower development costs. And drug investigators also say it's easier to enroll patients abroad, where access to medications may be barred by high costs.

The WSJ notes that in 2005 some 40 percent of all clinical trials took place in low or middle-income countries.

- read the article in the Wall Street Journal

Mass. Governor to sign $1B incentives plan

John Carroll — Mon, 16 Jun 2008 07:16:55 -0400

Thousands of biotech execs flocking to San Diego for the annual BIO meeting are likely to hear an earful from Massachusetts Governor Deval Patrick, who will be arriving with a freshly approved, $1 billion incentives program to woo biotech companies. Lawmakers had signed off on the legislation late last week, leaving Patrick just enough time to sign the bill today before hopping a flight to the West Coast confab.

The best thing that Massachusetts has going for it is a thriving cluster of life science companies that have created a legion of experienced executives and top scientists--many of whom work among the universities in and around Boston. That kind of cluster effect--added to a new slate of incentives--is likely to make the state much more effective at attracting more companies to the area. It should also help overcome many of the bureaucratic barriers that start-ups faced in Massachusetts.

Massachusetts made FierceBiotech's list of top economic development areas for the industry this year--a first for the state.

- read the story from the Boston Globe

Massachusetts closer on biotech bill

John Carroll — Thu, 12 Jun 2008 11:20:58 -0400

Lawmakers in Massachusetts are edging ever closer to approving the state's ambitious $1 billion incentives program to help foster its thriving biotech industry. That gives Governor Deval Patrick just enough time to sign a new bill before flying off to the BIO meeting in San Diego. Report

Developer blueprints $1B Cambridge biotech complex

Thu, 22 May 2008 06:59:56 -0400

Alexandria Real Estate Equities is blueprinting a billion-dollar, 1.5 million-square-foot complex of laboratories in Cambridge, MA to cater to the region's bustling life sciences industry. The project envisions six buildings occupying 16 acres between Kendall Square and the CambridgeSide Galleria in Cambridge. Industry observers say it's a positive signal that Massachusetts' biotech hub will continue to thrive for years to come, especially after lawmakers complete a long-awaited $1 billion incentive program to support the industry in Massachusetts.

Rising demand for lab space in the region has already doubled rents as vacancies dwindle and disappear. And Alexandria knows that better than anyone; the company manages 40 properties in Massachusetts.

- read the story in the Boston Globe

Are Mass. lawmakers 'anti-biopharmaceutical'?

Mon, 12 May 2008 06:59:56 -0400

After coming up with a billion-dollar program to encourage the growth of the state's biotech industry, you'd think that BIO and the biopharma biz would be giving great bear hugs to Massachusetts lawmakers. Instead, GSK wrote a letter to the governor castigating the bill for demonstrating "a strong anti-biopharmaceutical streak." And BIO complained that the bill included a provision that threatened research as well as patient treatment.

The target of all this ire? A provision that bans any and all gifts from a drug company to a physician. That's any and all, as in free lunches, trips to swanky resorts or even cheap pens with company logos on them.

Nonsense, replied state senator Mark Montigny. Lawmakers felt that the gifts--which don't include drug samples--encouraged the use of expensive branded drugs without really benefiting patients.

- read the AP report

Biotech's next big opportunity: Follow-ons?

Thu, 24 Apr 2008 06:59:56 -0400

Follow-on biologics are often cited as major long-term threat to the biotech industry, which so far has not had to face a future where generic therapies are allowed to slice and dice the market for approved therapies. But new analysis from the RPM Report notes that biotech companies--along with the Big Pharma companies--may be much better positioned than generic drug developers to capitalize on the market.

The rationale is that developing follow-on proteins will demand exactly the kind of expertise that the biotech industry has on staff. Teva, meanwhile, has been on a buying spree and may be the only big generic developer that can compete in this space. Of course, before anyone produces follow-ons in the U.S. market, lawmakers have to agree on new legislation. And some proposals are calling for lengthy periods of exclusivity for biologics.

- read the analysis in the RPM Report

Harvard prez says NIH funding system is broken

Thu, 24 Apr 2008 06:59:55 -0400

Harvard President Drew Faust has crunched the numbers on NIH funding of extramural research programs and concludes that the government-backed system to support biotech research efforts is broken. Out of the 47,455 grant requests made in the last fiscal year, only 10,100 were funded by NIH, says Faust. And that represented less than $4 billion of the NIH's $28 billion budget.

"The responses to rejected grants are downsized labs, lay-offs of post docs, slipping morale, and more conservative science that shies away from the big research questions," Faust told lawmakers. "Today, China, India, Singapore and others have adopted biomedical research and the building of biotechnology clusters as national goals. Suddenly, those who train in America have significant options elsewhere."

- read the report in Genetic Engineering

NJ officials want to expand biopharma biz

Wed, 26 Mar 2008 07:59:54 -0400

A state economist for New Jersey has spelled out some of the biggest threats to the Garden State's biopharma industry. In a recent address, James Hughes underscored that New Jersey is losing its reputation as the country's "medicine chest," reports Gannett. Its high concentration of pharma jobs has slid badly during this decade while states like Texas have come up with major new programs to back research into cancer drugs.

Former Pennsylvania Gov. Mark S. Schweiker told the group that the best way to expand biopharma was to adopt a regional approach, with south New Jersey, southeastern Pennsylvania and Delaware joining forces to promote a "Greater Philadelphia" approach. Schweiker, it should be noted, is now president and CEO of the Greater Philadelphia Chamber.

- read the article from Gannett

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Canadian regulators forging new biosimilar pathway

Tue, 25 Mar 2008 07:59:55 -0400

While U.S. lawmakers jawbone about a regulatory pathway for biosimilars, or biogenerics, Canada has moved to do it. Health Canada has posted draft guidelines for its regulatory approach to biosimilars. Manufacturers would have to show their products were similar to an existing biologic with interchangeability and substitutability decided on a case-by-case basis. New guidances are being drafted for various product classes.

In the U.S., meanwhile, there have been growing signs that any new legislation on biosimilars could be delayed past the current election year. But in Europe, regulators are busily approving a new slate of follow-on therapeutics.

- check out the report from FDA News
- read the article on the EMEA's approvals in Motley Fool

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Follow-on legislation follows a twisted path in DC

Mon, 17 Mar 2008 07:59:57 -0400

BIO is toasting proposed new legislation that would provide more than 14 years of patent protection on a biologic. Needless to say, the generics crowd is just a tad disappointed by the bill, saying that patients would have to wait decades before they could benefit from any lower prices. "For the countless patients who are choosing between paying for their medicines and putting food on their tables, waiting decades is simply not an option," said the Generic Pharmaceutical Association. BIO feels a lengthy period of patent protection is the only fair option, given the time it takes to move a biologic to regulatory approval.

As the Wall Street Journal's blogsters point out, new legislation providing a regulatory pathway for biologics gets a thumb's up from most everyone--but no one agrees just how lawmakers should do it. One other commonly agreed point: Starting out, the FDA is likely to take it one biologic at a time, deciding when and how for each program.

- read the Generic Pharmaceutical Association statement
- read the report from the Wall Street Journal

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Debate over follow-ons focus on market exclusivity

Mon, 03 Mar 2008 06:59:54 -0500

The Boston Globe weighs in with a lengthy look at the tussle over biogenerics--a.k.a. follow-ons and biosimilars. The smart money is betting that at some point in the not-too-distant future Congress will get around to giving the FDA authority to approve biogenerics on a case-by-case basis. But don't expect the biotech lobbyists to back off of this issue anytime soon. As a concession, BIO is seeking 14-year market exclusivity for biotech drugs to compensate developers for the time it takes to gain approvals for these complex therapies. And they may come close: Lawmakers including Massachusetts' Ted Kennedy are backing a 12-year period of exclusivity.

- read the article in the Boston Globe

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Mass. House backs $1B life sciences initiative

Thu, 28 Feb 2008 06:59:54 -0500

In a preliminary vote, the Massachusetts House provided overwhelming support for a $1 billion initiative to back the state's biotech industry over the next 10 years with new money for capital projects, research and some significant tax credits. The bill also pays for two new research institutions in the University of Massachusetts system. Gov. Deval Patrick has made passing the bill one of his chief priorities, promising to create 250,000 new jobs through the measure. A number of people have poked holes in that figure, but he's managed to build significant support for the bill among lawmakers eager to tout new opportunities throughout the state.

- read the story from the Eagle Tribune

ALSO: Massachusetts--Top Five Regions Targeting Biotech, 2008. Report

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Columnist lambastes Massachusetts on incentives

Wed, 27 Feb 2008 06:59:55 -0500

In a column in the Boston Globe, Jim Stergios, executive director of the Pioneer Institute, criticizes Massachusetts' plan to provide Shire with $48 million in incentives for an expansion project in Lexington. State government, he insists, should not be a venture capital group; the payoff is years away and why should life sciences be favored over industries like the financial services industry, which creates more jobs. Besides, he adds, money that goes to a company like Shire is just less funding for infrastructure. There were other points, but you get the gist. Gov. Deval Patrick has made it clear that he wants to do something big for biotech in his state, and there's a lot of competition out there. It all adds to why Massachusetts made the list of the top five economic development regions this year.

- read the column in the Boston Globe

ALSO: Plenty of other states are reviewing new initiatives for biotechnology. Colorado's House of Representatives gave its preliminary approval Tuesday to a bill that provides $26.5 million in biotech grants over the next five years. Report

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Incentive bill open only to MA-based biotechs

Fri, 15 Feb 2008 06:59:54 -0500

The Massachusetts Biotechnology Council got a surprise when the state's $1 billion biotech incentive bill was unveiled yesterday. As it turns out, only companies that have their U.S. headquarters based in Massachusetts are eligible for the funding, meaning that 40 members of the Mass BIO are out of luck if they don't relocate operations. "If we're going to spend a billion dollars, we would like to get as many corporate headquarters here as we can," said Rep. Dan Bosley (D), who was involved in drafting the bill. Mike Webb, Mass BIO's chairman, wasn't expecting that requirement but said he doesn't foresee it being a problem. Massachusetts lawmakers, including chief proponent Gov. Deval Patrick, say the massive funding bill is necessary to help Massachusetts keep its edge in the biotech economic development race.

- check out this report

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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

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Foundation draws charges of industry influence

Mon, 07 Jan 2008 06:59:56 -0500

The Reagan-Udall Foundation was created by Congress to ramp up innovation in drug science, help the FDA sort through complex new technologies and improve drug safety. But before it even begins operations, lawmakers are charging that it's vulnerable to manipulation by a widely mistrusted pharma industry and includes one board member charged with muting claims that a diabetes drug raised heart risks. For some observers, the controversy surrounding the foundation underscores the awful reputation of the pharma industry and threatens the utility of the new group. For now, the Foundation appears to be ready to proceed using mostly private funds--which won't do anything to improve its reputation among Congressional critics.

- read the report from the Star-Ledger

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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

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New drug approvals lag in 2007

Fri, 02 Nov 2007 07:59:54 -0400

The FDA has suffered no small amount of criticism recently, and, according to the Wall Street Journal, the agency's efforts to protect itself from naysayers have contributed significantly to the low number of new drugs approved in 2007. So far this year, the FDA has approved only 15 new molecular entities (NMEs) and is on track to approve about 18 by December. That's down from 22 NMEs in 2006, 20 in 2005 and 36 in 2004.

- read this summary for more
- see the full WSJ article

PLUS: The bad news for the FDA keeps getting worse. Testifying before Congress, a GAO director said the FDA can't guarantee the safety of the U.S. drug supply because its oversight of foreign drug manufacturers is horribly lax. Report

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Bill could improve funding for small biotechs

Fri, 05 Oct 2007 06:59:55 -0400

In a victory for small biotech, the U.S. House passed a bill that allows small companies to be eligible for federal small-business programs even if they're majority-owned by VC firms. Biotechs can often go for a decade or more before marketing a product, and they rely on investment from VC firms to keep the company going through the early stages of drug development. However, by the time a biotech has a marketed drug, VCs can own a large chunk. This means that the small company isn't eligible for Small Business Innovation Research (SBIR) awards.

The new legislation will lift current restrictions, giving small biotechs access to SBIR awards as long as VC firms own less than half of the company. "Private investment in small business is a good thing and should be encouraged, not discouraged," said Rep. Sam Graves (R-MO), the bill's co-sponsor. However, among other concerns, critics say opening up SBIR awards to more established companies will make competition harder for small start-ups.

- read the Baltimore Business Journal article

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Pfizer's future rests with biotech

Maureen Martino — Thu, 13 Sep 2007 11:00:07 -0400

At this week’s Bear Stearns Healthcare Conference, Pfizer discussed its plans for the future with analysts. As we all know, Pfizer is facing a major loss of sales when its best-selling drug Lipitor goes off patent in 2010. This wasn’t a major cause for concern until January, when Pfizer abandoned development of Torcetrapib due to concerns about mortality and cardiovascular events. Torcetrapib was slated to replace Lipitor, and the stunning loss of the progam left a gaping hole in Pfizer’s pipeline. In addition to concerns about Lipitor, both Viagra and Geodon, a schizophrenia therapy, will be faced with generic competitors by 2014. All told, Pfizer has to find a way to replace an annual $19 billion in sales when these drugs go off patent.

So how is Pfizer planning to deal with this loss? Company officials told analysts that Pfizer would increase its focus on biologics, which are much more difficult to make generic copies of. Lawmakers and healthcare professionals both here and abroad have embraced generic pharmaceuticals, which are relatively easy for generic drugmakers to produce. But Congress and the FDA have been slow to greenlight a faster approval process for generic biologics (on the other hand, the EMEA has had a regulatory pathway in place for almost three years). Pfizer has already announced a plan to invest $10 million a year for the next five years to help start-up biotechs in San Diego. Expect to see Pfizer snapping up biologics from smaller drug developers and investing more money in biotech companies in the months and years to come.

- read the Motley Fool article for more

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