The Volokh Conspiracy - Regulatory Reform:

The Volokh Conspiracy - Regulatory Reform::

"Economists have long observed that regulators at, say, the Food and Drug Adminstration face unbalanced incentives. When people die because an unsafe drug got FDA approval, everybody blames the commissioners. When people die because a potentially lifesaving drug never made it to the marketplace (or was never developed in the first place because of costly regulations), the FDA's role is largely invisible. Therefore the commissioners are biased toward excessive caution."

A problem to be worsened by what will surely be riskier follow on biologics approval?

Pharmalot: Kennedy Circulates Biogenerics Bill

Pharmalot: Kennedy Circulates Biogenerics Bill:

"Ted Kennedy is reported to be circulating draft legislation which would provide an approval pathway at the FDA for generic versions of biotech drugs. His proposed bill would also provide a period of market exclusivity for brand-name biotechs before generic versions of their products could come to market.

The Democrat, who chairs the Senate Help, Education, Labor and Pensions committee, began circulating his proposals this month after the committee voted 15-5 in favor of the Food and Drug Administration Revitalization Act (S 1082), which he co-sponsored with the panel's ranking member, Republican Senator Mike Enzi.

That bill would reauthorise the Prescription Drug User Fee Act, which expires on September 30, for another five years, and increase by $50 million the amount which has been agreed between the FDA and industry to fund drug safety activities. It would not, however, create a biogenerics approval pathway at the FDA, although Kennedy forecast after the vote that this would be added before the bill goes to the Senate floor for a full vote, which he expected would be some time in June."

Still curious to see who takes the fall when we have the biotech generic equivalent of a Vioxx scandal. I don't think the supporting legislators who create the pathway should be off the hook.

More Local Biotech

Biosink:

Nevada Development Authority (NDA) has selected Boston for its next targeted campaign in its ongoing effort to recruit life science and bio tech companies in the region. NDA will be exhibiting at Boston's BIO 2007 International Convention from May 6-9 at the Boston Convention & Exhibition Center. It is NDA's goal to educate the approximate 20,000 convention attendees on the growing life science and bio tech infrastructure in Las Vegas while promoting the substantial benefits of a favorable tax climate, overall low costs of doing business and less bureaucratic, business-friendly state and local governments.

Ironically Nevada was even more business friendly when Vegas politics dominated the state less than they do now. But it's all relative.

Biogenerics, Now In The House

Here:

Reps. Jay Inslee (D-Wash.), Gene Green (D-Texas) and Tammy Baldwin (D-Wis.) on Thursday introduced legislation ( HR 1956) that would allow FDA to approve follow-on biologics, CQ HealthBeat reports. Follow-on biologics are lower-cost versions of biotechnology drugs. FDA has no approval process for follow-on biologics. Under the measure introduced Thursday, drug makers would receive 14 years of data exclusivity for new follow-on biologics, with the possibility of an additional year if the HHS secretary approved the drug for a new indication that offered a "significant clinical benefit" during the 12 years following its authorization. The measure would allow the HHS secretary to issue guidance describing the data that would be required for approval of follow-on biologics in a particular class. The measure also would allow FDA to make a science-based determination about the data and information needed for approval of such drugs, including factors such as complexity and immunogenic reactions of the original product. In addition, FDA would be permitted to request comment from patient groups, brand-name drug manufacturers and generic manufacturers throughout the approval process. To ensure the safety of such drugs, FDA would be allowed to request nonclinical studies and clinical trials "at appropriate levels," according to the legislation.

The Patent System

Broken?

Vonage, a leading Internet telephony company, appears before a federal appeals court today to argue that it should be allowed to continue signing up new customers while it appeals the recent verdict that its products infringe three of Verizon's patents. A Virginia jury last month ordered Vonage to pay Verizon $58 million for infringing the patents, and Vonage was barred from signing up new customers. Given Vonage's precarious financial position, a permanent ban on signing up new customers would effectively be a death sentence for the company.

The case raises some troubling questions about America's patent system, which seems to allow a deep-pocketed incumbent to drive an innovative competitor out of business. Vonage pioneered the Internet telephony market, and has enticed more than two million customers away from Verizon and other telephone industry incumbents. But while Verizon hasn't been able to stop Vonage's momentum in the marketplace, they've found more success in the courtroom.

Dendreon

Approval?

Banc of America has some positive comments on Dendreon (NASDAQ:DNDN) saying they anticipate an approval decision on Provenge by May 15th, under the condition of completing the Ph III IMPACT trial, and expect potential stock price appreciation in the near term. This view is based on firm's recent interviews with an ex-FDA general counsel, a regulatory executive in a major pharmaceutical company and CBER panel members.

Pharmos: Mixed Trial Data

Forbes:

Drug developer Pharmos Corp. said Tuesday its postoperative pain treatment candidate showed mixed results in a midstage study.

The drug, an intravenous cannabinor, reduces pain versus placebo in a low-dose section of the Phase IIa clinical trial, at 12-milligrams, but failed to do so in higher doses of 24-milligrams and 48-milligrams.

"This is an unexpected pattern of results and the company continues to explore possible explanations," Pharmos (nasdaq: PARS - news - people ) said in a statement.

Shares of Pharmos rose 52 cents, or 35 percent, to $2.02 on the Nasdaq Stock Market (nasdaq: NDAQ - news - people ) in morning trading. The stock has traded between $1.36 and $2.58 over the last 52 weeks.

China Biotech

"China Aoxing Pharmaceutical Signs Letter of Intent to Acquire Shijiazhuang Le Ren Tang Pharmaceutical"  more...

Amarin Shares Down

Press release at FierceBiotech: 

Amarin Corporation Says Huntington's Disease Drug Failed in Trials

LONDON, April 24 -- Amarin Corporation plc ("Amarin" or the "Company") today announces top-line results from its two Phase III clinical trials of Miraxion to treat Huntington's disease (HD). The Company conducted two Phase III double-blind, placebo-controlled studies in which HD patients were randomized to receive either placebo or 2 grams (1 gram twice daily) of Miraxion daily for six months. Study data showed no statistically significant difference in either study between Miraxion and placebo with regard to the primary and secondary endpoints.

These top-line findings are inconsistent with earlier clinical trial data that showed statistical significance in a subset of HD patients with a CAG repeat length of less than or equal to 44.

The primary endpoint of the trials was a change in the Total Motor Score 4 (TMS-4) component of the Unified Huntington's Disease Rating Scale (UHDRS). TMS-4 has been shown to be a sensitive measure of movement disorder in patients with HD. In addition, secondary endpoints included cognition and Total Functional Capacity outcomes. Miraxion was found to be safe and well-tolerated by patients.

Commenting on today's announcement, Rick Stewart, Chief Executive Officer of Amarin, said, "We are extremely surprised and disappointed by these top-line results, and we are analyzing the data in order to better understand the full and complete data set and outcomes. We are particularly disappointed that, at this time, we are not in a position to bring any positive news to those patients who are suffering from this devastating disease and to the broader HD community."

Celeb's at BIO

"Biotechnology industry leaders from around the world will hear from an exciting selection of world renowned keynote speakers during the 2007 BIO International Convention being held at the Boston Convention & Exhibition Center from May 6-9.

Keynote speakers include founder of the Michael J. Fox Foundation for Parkinson's Research, Michael J. Fox, Her Majesty Queen Noor of Jordan, and U.S. Senator Edward Kennedy. Each speaker will provide insights on key biotechnology-related topics with respective addresses focusing on translating research into therapies, global health, and pressing public policy issues." 

more...

Ausy Biotech

"Western Australia will become home to a new multi-million dollar clinical trials facility which has the potential to test new treatments for cancer, diabetes and heart disease."  more...

AstraZeneca to buy MedImmune

Bizjournals.com

London-based pharmaceutical giant AstraZeneca plans to acquire MedImmune, the region's hallmark biotech company, in a $15.6 billion cash deal expected to close in the next two months.

Neurochem Playing Defense?

Fool.com:

Couched in Thurday's press release regarding the study was the announcement that Neurochem's statisticians were making an "adjustment to the initial statistical model, as set out in the statistical plan, (that) would be necessary to provide accurate results."

Yikes! Nothing about that statement appears positive in any way.

U.S. Venture Cap up 8 Percent to $6.96 Billion

Details here.   There's also this informative regional breakdown:

California dominated the venture capital activity in the first quarter, representing 44% of the nation's deal flow and 48% of the capital invested. The report showed that by major regions:

* The San Francisco Bay Area remained a stronghold for venture capital with 189 deals and $2.20 million invested. Although this is seven fewer deals than completed in the first quarter of 2006, the capital investment increased 10%.

* For the third quarter in a row, Southern California saw more capital investment than New England. In total, $1.10 billion was invested in 66 deals. This is the first time Southern California investment has topped $1 billion in a single quarter since 2000.

* New England remains the second most active region of the country in terms of deal flow, with 73 completed financings, which raised $927.9 million.

* The New York metropolitan area declined slightly, with $320.1 million invested here in the first quarter, down 38% from the same quarter of 2006. Deal flow, at 39, was basically flat with the same period.

* Investment in Washington state increased 21% over the same quarter a year ago to total $397.1 million in 27 deals.

* Capital investment more than doubled in the Research Triangle region although deal flow was flat, with a total of 11 deals and $202.8 million invested in the first quarter.

* Texas also posted an increased in capital investment, by 17% to $280.8 million, although there were seven fewer deals than in the first quarter of 2006.