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On the 62nd anniversary of the founding of the Jewish state, a reminder of what David ben Gurion said regarding Israel's ability to thrive -- "to be a realist, one must believe in miracles." ( CMPI has been a proud partner of program based at the Tel Aviv University School of Management to support life science entrepreneurship in Israel for the past three years. “Health Care Technological Innovation - From Idea to Commercialization.” ) Israel's robust contribution to biomedical innovation -- despite the threat of terrorism and annihilation -- is truly miraculous:
According to the WEF 2007-2008 Competitiveness Report, Israel has the 5th highest number of patents pending in the world and ranks 3rd in technological readiness. Israel is ranked in 1st in the world for Medical Device Patents per capita, and ranks third in Europe for the number of clinical trials in progress.
Fourth in the world in biotechnology patents per capita, Israel not only has the talent to innovate, but the skills to transform technology into successful enterprise. A generous government incentives program is a major factor for pushing progress forward.
Entrepreneurship in Israel
Israel has the largest number of startups in the world per capita. In absolute numbers, Israel is only second to the US. Israeli startup companies are known for their creativity, innovation, and originality. Israeli ingenuity can be found in some of the world's leading products and technologies: voice mail, billing systems, internet security, instant messaging, ingestible video cameras, and generic pharmaceuticals.
Investments in Israel
Israel has the largest number of companies listed on the NASDAQ outside of the United States and approximately 70 Israeli companies are traded on various European exchanges.
According to the Israel Venture Capital Research Centre, Israel requires approximately $1.5 Billion of new investment annually to support its developing companies. Israel continues to attract capital both locally and from abroad. However, there continues to be a strong need to fuel the capital requirements of early-stage companies
Many major multi-nationals have chosen to run core activities in Israel including: HP, Microsoft, Intel, IBM, Siemens, GE, SAP, Philips, Time Warner, Sony, Cisco, Google, eBay, Analog Devices, Computer Associates, Berkshire-Hathaway, Applied Materials, Sun Microsystems, 3Com, Motorola, Pfizer, J&J and more.
Israel’s high tech industry in particular is extremely profitable and attractive to foreign multinationals.
2007 witnessed over 40 international Mergers & Acquisitions.
Mergers and Acquisitions in Israel
Major foreign firms have stepped up their local M&A activities, and direct foreign investment in Israel has exceeded $2 Billion annually.
2006 saw a record number of Mergers & Acquisitions - a total of 76 Israeli companies were acquired. Warren Buffet's Berkshire-Hathaway made its first international investment when the company made its monumental acquisition of Israeli ISCAR for $4 billion, HP acquired Mercury for $4.5 billion and SanDisk acquired M-Systems for $1.5 billion. Other examples of multinational companies that have acquired Israeli companies include: Microsoft, Motorola, Intel, HP, Siemens, Samsung, IBM, GE, Phillips, Lucent, AOL, J&J, Applied Materials, Sun Microsystems, EMC, Boston Scientific, eBay, HP, Kodak, Cisco and Xerox.
M&A activity involving Israeli companies that were either acquired or merged totaled $3.2 billion in 2007 in 75 deals – the second highest number of M&A deals in any one year to date.
Mergers and acquisitions of VC-backed Israeli companies in 2007 totaled $1.9 billion and consisted of 32 deals.
Venture Capital in Israel
With 100 active funds and over $10 billion under management, Israel’s venture capital industry thrives like in no other country. In 2004, foreign funds committed over 50% of the total dollars invested, demonstrating that Israel is an internationally sought after and sound investment (Israel ’s Ministry of Industry, Trade and Labor).
In the past 10 years, Israeli VC's attracted a total of $10.6 Billion. According to IVC, $2 Billion in capital is currently available for investment by Israeli VC's, of which $1.2 billion is intended for First investments in high-tech companies and the remainder reserved for Follow-on investments. $800 Million is expected to be raised in 2008 by Israeli VC's for investment in Israeli high technology over the next few years. (IVC Online)
In 2007, 462 Israeli high-tech companies raised $1.76 Billion from local and foreign venture investors, 8.5 percent above the $1.62 billion raised in 2006 and 31.5 percent above 2005 levels.
In the fourth quarter, 115 Israeli high-tech companies raised $503 million, a 21 percent increase from the $414 million raised by 108 companies in the third quarter and a 5 percent increase from Q4 2006. (IVC Online)
In 2007, Israeli VC's invested $678 million in Israeli high-tech companies. The Israeli VC share of the total amount invested in Israeli high-tech companies was 39 percent.
Israeli VC's invested $50 million in foreign companies during 2007 (in addition to their investments in Israeli high-tech companies), compared to $60 million in 2006 and $95 million in 2005. Three of the 39 investments were first investments and the remainders were follow-on.
In 2007, 78 Seed companies attracted $151 million, the highest amount raised since 2001.
Important reporting from today’s edition of the Wall Street Journal:
“An unusual clinical trial involving four different drugs offered promise that guiding treatment based on the molecular traits of a tumor can improve survival from lung cancer. Researchers said the study amounted to "proof of concept" for a new approach to clinical trials that could improve the efficiency of cancer-drug development and eventually shorten the time it takes to get new treatments to market.”
The “Battle” study involved 255 patients with advanced lung cancer.
According to Edward S. Kim, a cancer researcher at M.D. Anderson and principal investigator of the Battle study, "This is a first step to find biomarkers that may help supplant existing toxic therapies and to find the right population for a particular drug," said.
The WSJ writes, “The adaptive design is gaining interest among researchers and drug companies because it could help identify drugs that don't work sooner, and identify biomarkers that would be used to enroll patients in late-stage studies required for market approval.”
Currently large clinical trials typically take all comers without evaluating their biomarker status. "The problem is that when you take a drug that has a specific target, but you treat everybody, you dilute the effect" of the drug, said Dr. Kim.
Researchers say that is why many targeted cancer drugs fail in late-stage or Phase III studies.
"This is the future," Tyler Jacks, a cancer researcher at Massachusetts Institute of Technology and president of the AACR, said of the Battle trial. "This is how drugs will be developed and clinical trials organized."
Important news. Good news. Potentially life-saving news. And interesting news considering that some are using the current PDUFA reauthorization debate to suggest the FDA demand comparative effectiveness studies as part of the agency’s drug approval process – something that no other drug licensing agency in the world does.
If the Battle study proves nothing else – it’s that we don’t know enough about how new medicines work once approved ("in the real world"). And that’s particularly true for cancer drugs. So what does “comparative effectiveness” really mean? And should it be applied to the global gold standard of safety/efficacy or, if you prefer, risk/benefit. Lung cancer is a good example, considering that average survival on chemotherapy is about eight months. What’s the value in asking about pre-approval “comparative effectiveness? Compared to what? "Best practice" treatment? And compared how?
Those who call for such a third leg are on a price jihad (cost effectiveness). That’s their privilege – but they had better understand the consequences such a move inside the FDA process would have on pharmaceutical innovation.
But first, there are some things they should understand, more generally about innovation itself:
Innovation is slow. As any medical scientist will tell you, there are few "
Innovation is expensive. In 2003, researchers at
Comparative effectiveness is an interesting health policy issue -- but the PDUFA reauthorization process is the wrong place for the conversation.
Memorial Service In Tribute of The Life of Rep. Bob Franks
A memorial service will be held in tribute of the late Former U.S. Representative Bob Franks. Below is information on the service:
Saturday, April 17, 2010, 11:00AM Cathedral Basilica of the Sacred Heart 89 Ridge Street Newark, NJ 07104 (973) 484-4600 Speakers: Governor Chris Christie Former Governor Jon Corzine Former Governor Tom Kean Former Governor Christine Todd Whitman Roger Bodman, Godfather to Abigail Franks Alfred Fasola, Godfather to Sara Franks Former Congressman John Kasich, Godfather to Kelly Franks Donations: The Franks family asks that in lieu of flowers, donations should be directed to the New Jersey National Guard State Family Readiness Council, http://www.nationalguardsfrc.org/.
WASHINGTON (AP) -- Opposition to President Barack Obama's health care law jumped after he signed it - a warning to Democrats running for re-election this fall that his victory could become their liability.
A new Associated Press-GfK poll finds Americans oppose the health care remake 50 percent to 39 percent. Before a divided Congress finally passed the bill and Obama signed it at a jubilant White House ceremony last month, public opinion was about evenly split. Another 10 percent of Americans say they are neutral.
Disapproval for Obama's handling of health care also increased from 46 percent before the bill passed to 52 percent currently - a level not seen since last summer's angry town hall meetings.
Nonetheless, the bleak numbers may not represent a final judgment for the president and his Democratic allies in Congress. That's because only 28 percent of those polled said they understand the overhaul extremely or very well, and a big chunk of those remain neutral.
Democrats hope to change public opinion by calling attention to benefits available this year for seniors, families with children transitioning to work and people shut out of coverage because of medical problems.
"There are some things I like, because I think that there are some people who need health care," said Jim Fall, 73, a retired computer consultant from Wrightwood, Calif.
But "I don't like the idea of the government dictating what health care should be like," added Fall. "Nor do I like them taking money out of Medicare. They are going to create more waste and they are going to take away benefits."
Seniors - reliable voters in midterm congressional races - were far more likely to oppose the law. Forty-nine percent were strongly opposed, compared with 37 percent of those 64 and younger. Seniors' worries that Medicare cuts to insurers, hospitals and other providers will undermine their care are a formidable challenge for Democratic congressional candidates this fall.
Analysts said such wariness on a major piece of social legislation is unusual.
"The surprise of this poll is that you would expect people to be more supportive of the bill now that it's the law of the land - and that's not the case," said Robert Blendon, a Harvard public health professor who follows opinion trends on health care. "The election for the House is going to be competitive, and health care is clearly going to be an issue."
The nearly $1 trillion, 10-year health care remake would provide coverage to nearly all Americans while also attempting to improve quality and slow the ruinous pace of rising medical costs.
Nonpartisan congressional budget analysts say the law is fully paid for. Its mix of Medicare cuts and tax increases, falling mainly on upper-income earners, would actually reduce the federal deficit. And people covered by large employers may even see a dip in their premiums.
The public doesn't seem to be buying it.
Fifty-seven percent said they expect to pay more for their own health care, contrasted with 7 percent who expect to pay less. And 47 percent said they expect their own medical care to get worse, compared with 14 percent looking forward to an improvement.
"Based on the little information we know, somebody's going to have to pay for it, so it makes sense that taxes would go up," said Lang Fu, 48, an oil and gas engineer from Houston.
Politically, Americans are polarized. Democrats support the overhaul by 68 percent to 18 percent, while Republicans oppose it 85 percent to 9 percent. Whites oppose it by 57 percent to 32 percent, while minorities support it 61-27.
Political independents are roughly even, with 44 percent opposed and 40 percent in favor - within the poll's margin of error. Some may be swayed by appeals from Obama and the law's supporters.
Donna Christian of Kingsport, Tenn., is an independent leaning in favor of the law. A bad heart forced Christian, 45, to leave her job as a supervisor at a wireless phone company a few years ago. She and her 10-year-old daughter make do on a limited income, and have coverage through Medicaid.
"I think Americans are going to be better off in the long run even if they don't see that now," Christian said. "More will have coverage, and they'll be able to go to the hospital when they need to."
Ron Pollack, head of Families USA, a liberal advocacy group that supports the overhaul, said it will be "a real task" to turn public opinion around, but he's confident.
"When you dig deeper, individual provisions of the law have enormous support," he said. Pollack believes current polls reflect public disgust with a "very lengthy and messy process."
But Rep. Dave Camp, R-Mich., says Democrats already lost their chance to persuade the public.
"They have had 16 months to explain this bill," Camp said. "Good luck trying to explain it in the next six."
The AP-GfK Poll was conducted April 7-12, 2010, by GfK Roper Public Affairs and Media. It involved interviews with 1,001 adults nationwide on landline and cellular telephones. It had a margin of sampling error of plus or minus 4.3 percentage points.
PS/ The Associated Press is not owned by Fox News.
While narrower bioequivalence margins might be necessary for certain categories of generic drugs, FDA's Pharmaceutical Science and Clinical Pharmacology Advisory Committee has determined that the specifications should not be tightened across the board for all generic drug approvals.
On April 13, the panel voted that current bioequivalence standards are not sufficient for generic versions of "critical dose" drugs, drugs where there is a narrow therapeutic index and deviations can result in therapeutic failure or adverse drug reaction. But on April 14, the committee pulled back from FDA's proposal to revise the bioequivalence margins for all generics, rejecting that idea in a 12-2 vote.
FDA officials presenting at the meeting signaled strong agency support for the move.
Here are the four component parts:
1. Information is presented in language that is readily understandable by consumers;
2. Audio information is understandable in terms of volume, articulation, and pacing used;
3. Textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily; and
4. The advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement.
Subjective. Subjective. Subjective. Subjective.
Nothing new -- just more of the same old ambiguity. And more excuses to write warning letters that serve no purpose other than to satiate the hunger of those on the Hill who see volume of letters as equaling more robust oversight.
Really?
For a good overview of the issue and some top notch opinions, see this article from the RPM Report.
If you're wondering why "net impressions" has become "net neutrality" -- it's because the FDA doesn't do impressions.
(And don't call me Shirley.)
Former Senator (and almost HHS Secretary) Tom Daschle keynoted the opening of the 19th Annual Partnerships in Clinical Trials conference.
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Okay, once more with feeling – “generic” does not equal “identical.” That’s why the FDA wants to tighten the bioequivalence standards for generic drugs. Bravo!
The Pharmaceutical Science and Clinical Pharmacology Advisory Committee voted unanimously, with one abstention, that critical dose drugs do constitute a distinct group and voted unanimously that FDA should develop a formal list of those drugs - although the terminology of "narrow therapeutic index" may be more appropriate. And in an 11-2 vote, the committee concluded that current bioequivalence standards are not sufficient for drugs in the narrow therapeutic index group.
According to the agency, although that methodology is "statistically rigorous" and accepted as a valid way to establish bioequivalence in most of the world, "many consumers and health professionals do not understand these statistical methods and the approval standards based on confidence intervals … Many wrongly assume that the FDA places the standards ... on the mean or average of the study data rather than the confidence intervals."
"Since the public seems to have a basic understanding of averages, the proposal to be discussed is for an additional criterion to be placed on the geometric mean (average or point-estimate) of the data limiting it to 90-111 percent." The agency surveyed 12 years of generic approvals and found that only approximately 2 percent to 3 percent of approved generic drugs would not have passed with the additional criteria.
According to a report in the Pink Sheet, “There is regulatory precedent in the definition of narrow therapeutic ratio, where drugs that meet certain parameters of median lethal dose and median effective dose are required to have careful titration and patient monitoring. But that definition is not necessarily clinically practical, FDA states, because the relevant parameters are not always available during drug development. Thus, the agency is asking the advisory committee whether it should consider CD drugs to be a distinct class, and how it should be defined. The agency also wants to know whether if the current bioequivalence standards are appropriate for CD drugs.”
The agency has already set up specific requirements for one drug product, asking manufacturers of generic versions of Sanofi-Aventis's insomnia drug Ambien CR (zolpidem) to compare partial AUCs over clinically relevant time intervals. An appendix considers the role of partial AUC for generics of modified-release methylphenidate products as well.
Its good news that the FDA is taking a strong stance in favor of the public health – because there will be many who seek to undermine this important initiative.
In the words of John Stuart Mill,
“One person with a belief is equal to a force of 99 who have only interests.”
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
