Archive for the 'Clinical Trials' Category

Pipeline to Soften Lilly Patent Losses

Eli Lilly (NYSE: LLY) is looking to its pipeline to fill the gaps left by a number of high-profile drugs coming off patent. In October 2011, blockbuster Zyprexa will fall to generic competition; additionally, about three-quarters of Lilly’s current revenue comes from eight drugs that will lose patent protection between now and 2017. ”We have the challenge of replenishing our product portfolio from our pipeline,” says CEO John Lechleiter in a USA Today interview. “Fortunately, we have the most exciting pipeline today in our history.”

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Merck KGaA’s Pancreatic Cancer Vaccine Ready for Testing

In the quest for a cancer vaccine, Merck KGaA is again stepping into the ring. Vaximm Holding AG, the company’s joint venture with a Switzerland’s BB Biotech Ventures III, will start testing a therapeutic cancer vaccine in patients next year. The vaccine, VXM01, harnesses the body’s immune system to fight cancer by using T-cells to close off the tumor’s blood supply. Roche’s Avastin also focuses on the tumor’s blood supply, but it focuses on eliminating a protein that creates the blood vessels to the tumor.

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Contract Manufacturing to see Double-Digit Growth

Hold onto your hats: The global market for contract manufacturing is headed for speedy growth over the next few years. According to a new report from RNCOS, pharmaceutical contract manufacturing is poised to grow about 12 percent per year from 2010 to 2012. Cost is one of the reasons, of course.

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Pfizer’s Litany of Pipeline Snafus Cause Analysts to Fret

The clock is ticking on Pfizer’s final, 18-month countdown on its $11.5 billion Lipitor franchise, but analysts are growing increasing fretful about the pharma giant’s ability to find new drugs to fill the looming revenue chasm. Pfizer had to admit that it suspended a slate of osteoarthritis trials after its highly touted pain drug tanezumab–billed as the world’s first likely biologic for pain–was linked to potentially perilous safety issues. And that came just two days after the company had to pull the cancer therapy Mylotarg from the market.

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MD Governor Touts a Booming Biotech Biz, New Jobs

While the overall economy may be flagging, Maryland says that its biotech industry is booming.  And the governor wants to keep the momentum going with a few new industry incentives.  Gov. Martin O’Malley told reporters that the biotech industry added more than a thousand jobs in the last three months; that’s 10 percent of the state’s total tally of new jobs. And he touted a report from Battelle Technology Partnership Practice claiming that the state’s biotech industry has been expanding aggressively for the last several years.

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FDA Imposes Hurdle for Cytori Breast Repair Device

Cytori Therapeutics may need to spend $10 million more than anticipated to get clearance for its first product because of a stricter-than-anticipated regulation. Cytori had laid out $200 million in eight years on the device and was seeking ”fast-track” clearance for the body-tissue repair device. But now it must take the slower regulatory path used for about one in every 10 experimental devices.

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Tetraphase Hauls in $45M to Back Antibiotic Work

Tetraphase Pharmaceuticals has hauled in a $45 million C round–a hefty chunk of cash that will open a development runway stretching out up to two-and-a-half years. Over that time, CEO Guy Macdonald says the company will put its technology for developing a better breed of tetracycline antibiotics to the clinical development test, taking a lead program–TP-434–through Phase II and ushering two more into the clinic. By the end of this stretch, the biotech should be able to position itself for a collaboration deal and possibly even an IPO.

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China Offers “Cheaper, Better Educated” Labor

Charles River Laboratories’ $1.6 billion acquisition of China’s WuXi PharmaTech positions the preclinical specialist to expand its contract work in drug discovery at a time that Big Pharma companies are consolidating and farming out a larger portion of their early-stage research work. And Charles River CEO makes it clear that the personnel in China who will be joining the company are one of the big attractions.

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Clinical Conductor Clinical Trial Management System Enjoys Record Growth

Bio-Optronics, Inc., a leader in healthcare workflow software, launches Clinical Conductor(TM) Enterprise, a new comprehensive, in-depth clinical study management system, at the Association of Clinical Research Professionals Global Conference & Exhibition in Tampa, Florida. The Clinical Conductor(TM) Enterprise CTMS is an extensive optimized clinical trial management system (CTMS) designed to centralize crucial information on patients and studies to ensure an accurate and efficient workflow throughout the clinical trial process. Specifically designed for CROs, SMOs, and sponsors, Enterprise CTMS builds on the well-established benefits offered by Clinical Conductor(TM) Site CTMS, which is already being used in over 600 sites worldwide, including the US, Canada, Mexico, Ukraine and South Africa.

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In-halable Measles Vax Holds Promise for Other Diseases

Researchers from the University of Colorado at Boulder believe a dry-powder, inhalable vaccine developed for measles prevention and slated for human clinical trials later this year in India may lead to similar–and cheaper–vaccines for illnesses ranging from tuberculosis to cervical cancer.

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