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The study, which was presented at the annual conference of the International Pharmaceutical Federation in Lisbon, tested 97 adults and found 61 percent measured the wrong dose, 17 percent measured an overdose and 44 percent did not give enough medicine. The study involved 53 moms, 7 dads and 47 daycare workers who gave meds to the under-5 crowd.

Read more here

Established in 1992, ISCT works to foster international translational research; inform national and global regulatory framework development and harmonization; drive commercialization strategies; and educate principal investigators, lab directors, technologists, regulators and commercial stakeholders, according to the society’s website.

The society’s industry task force, which includes these biotechs, has unveiled a series of recommendations to re-charter the ISCT Commercialization Committee to drive the creation of forums for discussion of shared concerns on process and product development, business models, and clinical development, and to catalyze the development of consensus standards.

“Working in partnership to develop standards around cell characterization and potency as well as treatment approaches and trial endpoint design we aim to facilitate entry into the cell therapy space for large healthcare and pharmaceutical companies, those members of the industry most reliably able to initiate and maintain advanced phase clinical trials. Ultimately, this will expedite the maturation of the field and bring cell therapy treatments to patients faster,” says Ed Horwitz, president of ISCT, in a statement.

- check out ISCT’s release

Related Article:
Money, money, money and medical innovation

Read more from the original source
ISCT works with industry to launch cell therapy partnership

The Organon employees call this a relay demonstration, according to The Dutch News. So far 250 employees have volunteered and the protest is expected to continue for months. Do the math and you can understand why it will take that long. The move follows a recent public march by employees, during which economist Arnold Heertje described the layoffs as “a horrible excrescence of finance capitalism,” according to SP International. Meanwhile, the works council of Organon, a labor group, plans to make its case against the reorganization to court on Sept. 2.

Read more here

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LOS ANGELES (MarketWatch) — Dassault Systemes (FR:DSY) said Thursday its second-quarter profit totaled 48.6 million euros ($63.2 million), or €0.40 a share, from €25.6 million, or €0.22 a share, in the same quarter a year before, according to International Financial Reporting Standards. Revenue for the quarter was €385.6 million, rising from €310.9 million in the year-ago period. The company also raised its revenue growth outlook to “about 22% to 25% in constant currencies” for the second half of the year. The company said it benefited from its acquisitons of French firms Exalead and Geensoft, as well as from its various strategic partnership.

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Q2 2010 Earnings Call

July 22, 2010 8:30 am ET

Complete Story »

The companies’ decision is based on promising results from two Phase IIb trials, SPRING-1 and VIKING, being presented this week at the XVIII International AIDS Conference in Vienna, Austria. If it performs well in tests, analysts believe ’572 could reach the market in 2013, according to Reuters. Furthermore, success with ’572 could signal the re-emergence of GSK as a significant player to rival Gilead in the HIV arena, according to Sanford Bernstein analyst Geoffrey Porges. As Reuters notes, GSK was a long-time leader in the HIV field, but ceded this position to Gilead.

But GSK is aiming to bounce back. Last year, it joined with Pfizer to form a new joint company majority-owned by GSK, called ViiV Healthcare, with an eye on regaining market leadership. The new compound ’572 is the first of two similar integrase inhibitors being developed by ViiV.

- read the announcement
- see the Reuters coverage

Related Articles:
GSK, Pfizer launch new HIV drug venture
Activists ask GSK to pool HIV patents
Glaxo promises $97M for new AIDS R&D initiative

Read more from the original source
Shionogi, GSK move HIV drug into PhIII

As it happens, Haffner felt just fine several years earlier when he allegedly had an Avandia study ghostwritten for him. Documents released today by the US Senate Finance Committee appear to indicate Haffner, a University of Texas Health Science Center at San Antonio researcher, was to be the author of a paper that was targeted at the American Journal of Cardiology, according to an internal email from 2001 (please see Attachment H, which is on page 58). “Please find attached the Haffner manuscript,” David Harrison, the Avandia publication strategy manager writes. “The manuscript is currently in rough form and has not been sent to author yet.” There is another email on page 111.

For those who may not recall, SmithKlineBeecham (which Glaxo subsequently purchased) began its Cassper program in 2000 to promote certain drugs, including the Paxil antidepressant, in the medical community. As the memo on page 57 indicates (please refer to the link above), Cassper (or Case Study Publications for Peer Review) was designed to “offer assistance in the preparation and publication of case studies and other short communications relevant to the clinical use of Avandia.” A scary prospect? Well, you can read the manuscript, too, which founds it way into Circulation.

In a statement, however, Glaxo denies doing any ghostwriting for Haffner or that his paper was part of the Cassper program. “GSK follows established authorship practices modelled after the International Committee of Medical Journal Editors (ICMJE) guidelines, which require ’substantial contributions’ by authors as well as final approval of the article before publication. The article referenced by (the Senate committee), ‘Effect of Rosiglitazone on Nontraditional Markets of Cardiovascular Disease with Type 2 Diabetes Mellitus,’ was authored by Dr. Steven Haffner, and reflects his substantial input and his views. This article was not part of the Case Study Publication for Peer Review programme, which was discontinued for rosiglitazone in 2004 and produced only two articles.” Our thought: How is ‘substantial contribution’ defined. And given the e-mail, the impression runs to the contrary.

This October will mark the 30 year anniversary when a few young gay men in San Francisco and New York were treated for Pneumocystis Carnii pneumonia,  reported by the Centers for Disease Control in June 1981.

The following year, the Gay Men’s Health Crisis (GMHC) in New York was founded and I began working as a volunteer lawyer doing deathbed wills for men my age, which was 27.  Eventually I became the Director of Legal Services at GMHC where I oversaw a range of legal services to thousands and thousands of people with AIDS.  The first 16 years of the epidemic were brutal.  In the earliest days, you began each day with a glance over your body for lesions, a feel of your lymph nodes for lumps.  And nearly every day I lost clients and I lost friends.  In my office, we had “RIP” sheets distributed so that I could keep up with the clients who had died.

During that time, I attended several of the International AIDS Conferences staged in many cities around the globe. At each, one looked desperately for some sign of hope that the sheer carnage of human life that was taking place because of the disease might abate.   And then in Vancouver at the XIth International AIDS Conference, a new class of drugs was unveiled that would change the course of the epidemic entirely.  For the first time, medical treatment began attacking the underlying cause of AIDS – the virus, instead of treating the symptoms.

Seven conferences later, everything has changed and nothing has changed.  Mortality has abated (though not disappeared) and many people today are living who otherwise would not have been had there not been treatment breakthroughs that people could access.

In anticipation of this year’s conference, there is more hope.  Good news released this past week whereby researchers discovered two antibodies that may neutralize HIV strains.  If so, this discovery could advance the development of therapeutic vaccines for other diseases as well as HIV. It is a discovery that, like the advent of protease inhibitors, could change the course of the epidemic.

But there is also cause for concern.  In the U.S., the backbone for access to life-saving medications is through funding of the Ryan White CARE Act – federal legislation that, among other things, funds state programs called AIDS Drug Assistance Programs (ADAP).  States have been facing a shortfall in funding, meaning that they are having to create waiting lists for access to care.  This prompted the Obama Administration to announce last week the reallocation of $25 million to fund the program for states.  That will not be a long-term solution and how longer term solutions are addressed may depend on political wrangling.

Access issues are not confined to the U.S.  In addition, the President’s Emergency Plan for AIDS Relief (PEPFAR) also faces funding challenges and HIV advocates have complained that funding for the program has not matched amounts allocated in 2008.

The clock cannot turn back to pre-1996.  We must watch news out of the conference next week for that which will support our best hopes, but at the same time, address our worst fears.  For those wanting to follow news, the International AIDS Society will be running a blog from the conference and the Kaiser Family Foundation will be providing on-going coverage.

Read more here
The XVIII International AIDS Conference – Everything Has Changed

According to Mr Lechleiter:

• A recent study ranked the U.S. sixth among the top 40 industrialized nations in innovative competitiveness, but 40th out of 40 in “the rate of change in innovation capacity” over the past decade.

• The industry I know best, biopharmaceuticals, is facing unprecedented pressure. R&D costs continue to rise, fewer potential new medicines gain regulatory approval, and key products lose patent protection. In fact, the number of new molecular entities approved by the FDA over the past five years—92—is lower than in any other five-year period since I entered the industry in the late 1970s.

• When it comes to sustaining innovation, the burden remains on enterprising businesses.

• The one thing that industry has a right to ask of public policy is to help preserve the environment in which innovation is possible.

• While the legislation would extend the R&D tax credit, the bill also includes international tax revenue raisers that will hurt the U.S. economy and deplete American jobs.

• The final and most important elements are the seeds of innovation, which equate to talented people and their ideas. Human beings—with their talent and energy, creativity and insights—are a priceless resource, but one that is woefully underdeveloped in this country.

This is a very compelling argument but at the heart of any innovation is change: change in the way business is done and change with the pharmaceutical industry has been reluctant to embrace. Like I have said many times before these changes did not happen overnight, they have been coming for a long long while and companies that can’t see and prepare for the future are going to sustain damage that will effect strategic shareholder value.

One of the areas of change that the industry has not embraced is the addiction to blockbuster drugs. Again and again we have seen attempts to replace aging blockbusters with new and improved versions of drugs even though insurers are now asking for proof that new brands are substantially better than generics. Authors have been pointing to the Long Tail, a business model where you have several brands selling well rather than one really big brand that is a blockbuster, but still the drug industry wants that gold ring to keep cash coming in and keep the Street happy.

As for public policy to keep innovation possible it’s kind of hard to ask for legislation favoring innovation for the drug industry when politicians and consumers view the drug industry as money hungry corporations who put profits ahead of patients. What has the pharma industry done to change these perceptions ?

I’m not even going to go into the international tax revenue debate. While Forest Laboratories Inc. sells Lexapro only in the U.S. their creative accounting ensures most of its profits aren’t taxed here — and they face little tax anywhere else. Forest cut its U.S. tax bill by more than a third last year with a technique known as transfer pricing, a method that carves an estimated $60 billion a year from the U.S. Treasury as it combines tax planning. Transfer pricing lets companies such as Forest, Oracle Corp., Eli Lilly & Co. and Pfizer Inc., legally avoid some income taxes by converting sales in one country to profits in another — on paper only, and often in places where they have few employees or actual sales.

Finally there are the talented people. How many “talented people” have lost jobs in the pharma industry this year while pharma CEO’s continue to rake in millions of dollars in salaries and perks ? How can the pharma industry expect to recruit talented people in marketing when even if you do a great job you could quickly find your position eliminated when your brand comes off patent ?

I live for DTC marketing and it is my passion but the atmosphere in which a lot of marketers work is slowly draining their passion because of processes that are outdated and because of company politics. When I was at Lilly I kept a copy of Sidney Taurel’s booklet on leadership (the the CEO at Lilly) on my best and every time I tried to use on of his principles I faced enormous roadblocks by people who were more interested in their titles than doing what was best for patients. I was lucky enough to fight through those roadblocks and earn a Marketing Excel award at Lilly but only because I had an excellent brand team leader (Matt) and manager Diana & Paula) who believed in me.

If the pharma industry is going to survive John it has to change the way it does business internally. You need to go to more of an open leadership model and meet with everyone to let them know that patients come first not The Street. Your decision to put more money into R&D while others are putting less is a great first step but innovation starts with people and right now those people are shell shocked and choked by matrix organizations that stifle innovation.

Read more here
How many “talented people” have lost jobs in the pharma industry this year? A response to John Lechleiter on America’s Growing Innovation Gap

For those of us living in Orrin Hatch’s world here in the US, this will certainly be a change of pace. US readers know how it works – listen to the ads, with the first two sentences delivered as a low-decibel mutter: “Sold as a nutritional supplement only. Not intended to treat, cure, or modify any disease. But the hell with that! It’ll grow hair, regenerate your liver, detoxify your colon, improve your memory, and boost your immune system! You’ll lose weight, have more energy, sleep better, and you’ll have to fight off the attentions of the opposite sex with whatever weapons come to hand! And it’s all-natural! Call now for a free thirty-day supply!”

No, the EU isn’t letting this stuff pass. Want to claim that your cranberry drink reduces the risk of urinary tract infection? Show us your clinical data – and no, not from someone else’s study. From yours, with your product. Glucosamine for arthritis? Got some data to back that up? Green tea for cholesterol, or as an antioxidant? Show them some numbers, or go home. The marketers aren’t too happy:

Ioannis Misopoulos, director general of the International Probiotics Association (IPA), is openly hostile.

“It can take three years to get these kinds of human studies together but in the meantime the claims are going to be wiped away,” he said. “The regulation is killing this industry and the job losses are already being felt.”

Cry me a procreating river, dude. Or come over here to where you can’t get near the market without going through the clinic first – and for a lot longer than three years, I might add. And where every claim you make for your product is hammered out with the regulatory authorities, and if they catch you stretching out past them you can get fined out the wazoo. So they won’t even let you keep running the ads while you go fetch some evidence, eh? Well, it gets worse:

Not surprisingly, the process has left many manufacturers here in the UK angry. Some say EFSA is demanding the same kind of clinical evidence which prescription medicines would require.

“EFSA is rejecting most of the proposed food supplement claims,” says Jenny Baillie of the York-based health foods company Power Health, “even established claims like cranberry for urinary tract health, which will mean that there will be no information on packs for the consumer to assess what the product is supposed to do.”

She believes the regulation may even drive consumers into buying from less reputable sources.

To which I am tempted to reply: Mundus vult decipi, ergo decipiatur. Except in the EU.

Read more here
The Horror Of Asking For Data

“The latest data shows that poor productivity in 2009 continued to be exacerbated by the low success rate for drugs in late stage development and a decline in sales from new drugs launched within the last five years,” said Hans Poulsen, head of consulting at CMR International, which compiled the 2010 Pharmaceutical R&D Factbook. “The increase in NME launches compared with 2008 offers some positive news. However, with data indicating a continued drop in overall success rates, it remains to be seen if the industry can reverse a 10-year trend in declining R&D output.”

Some highlights:

• The number of Phase III projects killed in 2007 to 2009 doubled the rate seen in the previous three years.
• Analysts expect that Big Pharma will continue to cut research budgets as they reshape their R&D efforts.
• Drugs launched in the previous five years accounted for seven percent of all sales in 2009, down from eight percent in 2008.

- here’s the report from Reuters

Related Articles:
Fitch projects 23 new drug filings for 2010
Analysis: Fewer approvals may prove R&D is getting tougher
The FDA new drug approvals of 2009

Read more here
Pharma pipelines mired by poor productivity, shrinking R&D budgets

The merger into Valeant Pharmaceuticals International combines Valeant’s fast-growing dermatology pipeline with Biovail’s CNS therapies. Valeant, which now has seven therapies in development, has been on a long buying splurge, snapping up a string of companies like Aton Pharma and Vital Science while also forging new commercialization pacts. Both companies have been through wrenching changes in the past decade, with Biovail’s founder Eugene Melnyk and Valeant founder Milan Panic both departing after a sharp, losing fight for control of the company.

Once the deal is done by the end of this year, Biovail shareholders will hold on to 50.5 percent of the company with Valeant shareholders getting the remaining 49.5 percent.

J. Michael Pearson, the CEO of Valeant, boasted that the deal provides “tremendous value for stockholders of both companies as our business benefits from cost savings, greater scale, efficiencies from extending Biovail’s corporate structure, and enhanced financial strength and flexibility. We are committed to delivering the anticipated cost savings benefits and, as we did with Valeant over the past two years, transforming the new entity into a diversified, specialty pharmaceutical company focused on growth and cash flow generation.” Pearson will be CEO of the combined company with Biovail CEO Bill Wells taking over as non-executive chairman of the board.

- read the release for more
- here’s the story from Bloomberg

Related Articles:
In pursuit of CNS pipeline, Biovail buys compounds from Cortex
Biovail founder Melnyk sells his remaining stake
Valeant to buy orphan drug developer Aton for $318M
Valeant pays $115M for Dow Pharma drug rights
Valeant turns to acquisitions as it cuts DIY development

Read more here
Biovail, Valeant Pharma strike merger deal

Life Technologies Corporation (LIFE) is aiming big in the field of stem cell research. The company presented its offering of stem cell research at the annual meeting of the International Society for Stem Cell Research (ISSCR).

Over the past 5 years, Life has invested in various collaborations and partnership programs to strengthen its offer of stem cell products. The company recently launched GIBCO Cell Therapy Systems (CTS) to support cell therapy applications.

Complete Story »

In a release out this morning the Gaithersburg, MD-based GenVec (GNVC) said that Wells Fargo Securities will “conduct a comprehensive review of strategic alternatives aimed at enhancing shareholder value.” The review will explore the possible sale of company assets, partnering or other collaboration agreements, or a merger/sale of the developer.

GenVec scrapped its TNFerade program after researchers determined that it wouldn’t hit its primary endpoint in a Phase III trial for pancreatic cancer. But the company has other programs in the pipeline. GenVec inked a $213 million pact with Novartis for its preclinical program for hearing loss and balance disorders earlier this year. And GenVec landed a $22 million development deal with Science Applications International last November to develop new HIV and flu vaccines.

GenVec shares were trading at 50 cents this morning, down from the $3 mark just ahead of the Phase III debacle.

- here’s the GenVec release

Related Articles:
GenVec gets another NASDAQ warning
GenVec shares implode on pancreatic cancer trial failure
GenVec scores $213M licensing deal with Novartis
GenVec wins $22M vax development contract

Read the original here
Struggling GenVec on the auction block as it ponders options

The law involved is known as the Alien Tort Statute and it was cited by several Nigerian families who accuse Pfizer of violating international humans rights law – various provisions from the Nuremberg Code; the World Medical Association’s Declaration of Helsinki; the International Covenant on Civil and Political Rights; guidelines from the Council for International Organizations of Medical Services; the Universal Declaration of Human Rights; and a United Nations General Assembly Resolution.

The 1996 Trovan study was conducted on about 200 children and took place during a meningitis epidemic that killed 12,000 children, but Pfizer was accused of failing to obtain proper regulatory approval and for misleading parents. The study allegedly left 11 children dead and the others were deformed. Pfizer denied the charges and settled the bulk of litigation this summer by agreeing to pay $75 million to settle civil and criminal charges brought by the Kano State government in Nigeria. There is currently a dispute over DNA testing (see this).

The Solicitor General didn’t comment specifically on the merits of the case. And of course, the Supreme Court may still decide to grant Pfizer’s request. “The court is very interested in this particular, because they took the trouble to request that the Solicitor General file a brief,” Richard Samp, chief counsel of the Washington Legal Foundation, tells us. “That by itself means there is a reaonsably good chance the court will grant review.” The WLF, by the way, filed a friend of the court brief in support of Pfizer’s position.

The case is being closely watched, in part, because it raises some points near and dear to multi-national corporations – whether such a company can be sued under the Alien Tort Statute and whether violations of this statute encompass activities conducted overseas. “This is an abuse of the American court system and not what Congress ever intended,” says Samp, “and poeple are trying to make political points about what they see as important conducdt of overseas corporations.”

“India has emerged as an attractive market for the global pharma sector, as evident from increasing investment flows into the country. We offer huge cost advantages with high value of services,” says Shaw, the chairperson of Biocon. Shaw cited clinical data management and discovery work as two key areas that India has developed key expertise on. And with developers the world over looking for more efficient ways to develop new therapies, Shaw estimates that the overall revenue for the industry will soon break the $5 billion mark.

Speaking to a biotech summit held in Bangalore, the industry outlined plans for a new venture fund to back start-up biotechs, with new biotech schools being planned as well. “Sector specific biotech parks will be set up at Mysore, Mangalore, Dharwad and Bidar in north Karnataka,” said Karnataka Chief Minister B.S. Yeddyurappa. “Similarly, a bio-cluster will be set up in the Bangalore Biotech Park on a public-private partnership mode.”

India’s biotech sector has had a mixed record over the years. And recently much of the international biopharma focus has shifted to China, where major pharma companies have been creating huge new R&D complexes as they plot rapid growth in the emerging market.

- here’s the story from the Economic Times

Related Articles:
Indian biotech exec predicts a $10B industry boom
India’s R&D spending on the rise
India’s biotech industry grows at 20% clip
India drawing more clinical trials

Read more from the original source
Boom spurs India’s biotech industry to hatch expansion plans

Lupin never bothered to put an announcement on its website, but we have a copy of the letter sent to its wholesalers (see this). The heist yielded a slew of generic cholesterol-lowering pills, namely generic Zocor and Mevacor, as well as generic Depakote, which is taken by epileptics and is sensitive to temperature, and the Cefadroxil antibiotic.

There is nothing sensational about a stolen trailer, of course, particiularly from Memphis, which is a big hub for Federal Express shipments. But the theft underscores a growing problem for drugmakers. Last year, there were 46 such thefts worth $184 million, up from $41 million in 2007, according to FreightWatch International, a logistics security provider that tracks commodity thefts (see this).

Of course, drugmakers fear the bad publicity over such heists, because they undermine confidence in the supply chain – stolen meds, particularly, low-cost generics, are likely to wind up on the Internet or used for counterfeiting. This may explain why Lupin notified its distributors, but not the public. Meanwhile, though, someone may be swallowing one of those generic Depakote pills right now, unaware that the meds were stolen off the back of a truck.

Below are the top ten current and former International Dividend Achievers (ranked by dividend yield) that trade as ADRs on the New York Stock Exchange. I had to choose the top ten because there are over 40 international Dividend Achievers that are within 20% of the low. This list is based on Mergent’s designation of companies that have had a history of dividend increases over "several" years in a row.

Symbol Name Price % from Low Yield STD Banco Santander $10.15 10.69% 9.20% NGG National Grid $40.54 3.10% 8.80% AZN AstraZeneca $42.25 5.47% 8.10% BP British Petroleum $42.95 5.76% 7.80% BTI British American Tobacco $58.55 9.77% 7.40% TEF Telefonica $57.37 5.36% 6.90% TOT Total S.A. $46.63 8.27% 6.60% RUK Reed Elsevier $27.99 5.74% 6.10% TMX Telefonos de Mexico $14.07 8.23% 5.60% GSK GlaxoSmithKline $33.46 4.07% 5.50%

Please be sure to calculate the payout ratios before buying these stocks. Payout ratios above 70% are cutting it close if you’re not prepared for the potential risk. The stock symbols next to the company names take you directly to the history of dividend payments. As always, only buy these stocks if you’re willing to accept 50% downside risk. Thanks again to the author of The Stock Market Advantage for the suggestion on including international dividend stocks to our universe.

Complete Story »

Minyanville’s biotech analyst David Miller may not recognize it, but Biovest International (BVTI.PK) appears to meet his qualifications for the next big success story in cancer vaccines.

Following the FDA’s April 2010 landmark approval of Dendreon’s (DNDN) Provenge as the first active vaccine for cancer, enthusiasm runs high for other immunotherapy companies to find similar success. But Miller appropriately urges caution.

Complete Story »

At issue are concerns that IMPACT’s actions, which include involvement in seizing counterfeit drugs shipped between countries, is partly a smokescreen for delaying shipment of legitimate, lower-cost generic drugs to poor nations. Developing nations view the seizurese as a way to bolster patent protection for brand-name drugmakers.

And so India, which has a large generics industry, and Thailand, which has rattled brand-name drugmakers with threats to issue compulsory licenses, introduced a resolution calling on the WHO to end its involvement with IMPACT, “which has not been approved by any governing body of WHO and that there are conflicts of interest in its composition.” They also want measures to ensure patent enforcement doesn’t restrict access to medicines.

“If multinationals cannot be prevented from shifting profits to low-tax jurisdictions, then it becomes impossible to maintain the domestic corporate tax base,” says Reuven S. Avi-Yonah, director of the international tax program at the University of Michigan Law School. If that bleeding can’t be stanched, he says, “we might as well abandon the income tax.” So how can Forest Labs sell 98% of Lexipro in the U.S. but report 25% of their pretax profits ? It’s called creative accounting. The same creativity that some drug companies have used to be transparent about their drug side effects and efficacy. It’s a key reason why the American public is skeptical of big corporations and at a time when services are being cut because of lower tax revenues Forest Labs should be ashamed of this story.

There is a big difference between doing that is simply legal and doing something that is both legal and right. The loss of that distinction is what caused the financial meltdown and caused a lot of people to lose their homes and jobs. Most of the big mistakes by pharma have been because pharma has decided that sales and dollars are more important than patients and customers. Pharma should not only ask “is this legal?”, they should also ask “is this the right thing to do?”

Sanofi-Aventis (SNY) is searching for an edge. Like other big pharmas, the company is undergoing a push to shift the balance between its internal and external research and development and is increasingly looking outside its own walls for breakthrough ideas.

Complete Story »

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