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Sunday, 21 April 2013 05:23 |
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Founder seeks to sell his holdings. South Korea-based Celltrion has stopped clinical development of its own version of the blockbuster Rituxan, the latest stumble in the fledgling area of biosimilars. |
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Saturday, 06 April 2013 21:08 |
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It’s been a year since the JOBS Act became law, easing regulatory demands on emerging growth companies seeking to raise capital through initial public offerings. We spoke to Alan Mendelson, partner at Latham & Watkins and co-chair of the firm’s Emerging Companies Practice and Life Sciences Industry Groups, about the law, how it’s changed the process of going public for life sciences companies, and what’s been learned since its enactment.
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Saturday, 06 April 2013 21:03 |
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Could provide an alternative to use of injectable biologics for the disease. A novel therapeutic target may pave the way for simple eye drops to replace current eye injection therapies for wet age-related macular degeneration, a leading cause of age-related irreversible vision loss has been identified. |
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Saturday, 06 April 2013 20:49 |
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Long-time chair turns over reins to David Haslam. The United Kingdom’s healthcare cost watchdog, the National Institute for Health and Clinical Excellence, is recasting its name as it moves to bridge the gap between health and social care services by issuing evidence-based guidance and standards in the social care sector. |
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Saturday, 06 April 2013 20:42 |
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Deal focused on biotech’s next generation antibody drug conjugate technology. Astellas Pharma and San Diego-based biotech Ambrx have entered into a potential $300 million collaboration to discover and develop antibody drug conjugates, or ADCs, in oncology. |
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Saturday, 06 April 2013 20:23 |
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The weekly round-up of failed trials, missed targets, and other business mishaps. Pfizer lost in an appeals court case brought by several large health insurers as plaintiffs. The plaintiffs sought to both reverse a previous judgment in favor of Pfizer and combine their claims that Pfizer engaged in racketeering in marketing off-label use for its anticonvulsant drug, Neurontin. Though Harden Manufacturing was the lead plaintiff in the appeal, pursued on behalf of Blue Cross Blue Shield of Louisiana and other third-party payers, the ruling is applicable to additional cases against Pfizer brought by Kaiser and Aetna. Pfizer and its Warner-Lambert unit were accused by the insurers of promoting Neurontin for uses not approved by the U.S. Food and Drug Administration, including bipolar disorder, in order to boost profit. |
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Sunday, 31 March 2013 13:28 |
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Agreement extends collaboration with Otsuka in difficult area to meet growing market. Otsuka Pharmaceutical is paying Lundbeck a $150 million in upfront fees to license an early-stage Alzheimer's therapy, advancing an alliance the neurology-focused companies struck in 2011. The deal could provide an additional $675 million in milestone payments. |
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Sunday, 31 March 2013 13:24 |
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Company shifts to focus on synthetic biology program with partner, Intrexon. Ziopharm Oncology’s shares plummeted as the company revealed data showing that its lead program, development of the drug palifosfamide to treat soft tissue sarcoma, failed to significantly extend patient lives in a global trial. |
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Sunday, 31 March 2013 13:18 |
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Firm says it will start 16 new companies over next few years. While many venture capital firms have struggled to raise money for healthcare-focused funds, with some leaving the field altogether, Third Rock Ventures said it closed its third fund, raising $516 million to continue its strategy of launching, building, and supporting healthcare companies. It brings the total raised by the venture capital firm to $1.3 billion in the past six years. |
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Sunday, 31 March 2013 13:07 |
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The weekly round-up of failed trials, missed targets, and other business mishaps. The contract research organization PRACS Institute filed for chapter 7 bankruptcy after dismissing more than 300 workers without severance, leaving clinical trial subjects unpaid, and abandoning more than 30 clinical trials in the United States and Canada. When the bankruptcy and shutdown of facilities in North Dakota, Florida; Missouri; Toronto and Ontario occurred, roughly three-dozen trial participants in St. Louis were in the final hour of a 51-hour study for a new pain-killer. According to the bankruptcy document, between 100 and 200 creditors are owed a collective $100 million to $500 million, but the company listed only $10 million to $50 million in assets. PRACS Institute was formed out of the previously bankrupt company, Cetero Research, which the FDA had found to have falsified clinical trial data. PRACS Chief Restructuring Officer Michael Gries said the company will make efforts to transfer study materials back to the pharmaceutical companies sponsoring the studies. Nearly 200 companies and their affiliated sites are listed as creditors. |
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Sunday, 21 April 2013 05:19 |
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The weekly round-up of failed trials, missed targets, and other business mishaps. The U.S. Food and Drug Administration failed to protect people from dubious medicines and remove drugs approved in part on faulty trial data, says a new report published by ProPublica. Nearly 100 approvals for drugs, ranging from blood thinners to chemotherapeutics and painkillers, relied on falsified data from the contract research organization, Cetero Research, according to the publication. While the European Medicines Agency has recalled seven of the drugs, the FDA has done little to address the problem, according to ProPublica. |
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Saturday, 06 April 2013 21:05 |
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Barriers to progress temper companies’ enthusiasm for biosimilars opportunity. Teva Pharmaceutical and Lonza Group says they're reevaluating their joint venture to develop, manufacture, and market a portfolio of biosimilars. |
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Saturday, 06 April 2013 20:54 |
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Three-year low for IPO exits, 18 year-low for M&A exits. Passage of the JOBS Act and new highs in the stock market have yet to open the door any wider for venture capitalists to exit investments through initial public offerings. In fact, a new report from the National Venture Capital Association and Thomson Reuters finds venture-backed exits through IPOs hit a three-year low. |
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Saturday, 06 April 2013 20:47 |
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Industry groups say it will hinder innovation and investment in the country. The Office of the U.S. Trade Representative is reviewing the recent ruling by India’s Supreme Court that denies Novartis patent protection for Glivec, known as Gleevec in the United States. The decision, handed down on April 1, ends a seven-year court battle and allows Indian drugmakers to continue making generic versions of the cancer drug. |
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Saturday, 06 April 2013 20:36 |
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New funding for brain research imaging and computational tools are on the horizon. President Obama announced that the National Institutes of Health and other government agencies will dedicate critical funding to a controversial project aimed at understanding the human brain. |
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Sunday, 31 March 2013 13:31 |
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The U.S. Supreme Court recently heard arguments in a case that could put an end to so-called pay-for-delay settlements between branded pharmaceutical makers and their generic competitors. Critics of these agreements argue that they are anticompetitive, costing consumers billions of dollars by delaying competition from entering the market. Others, though, say that these agreements benefit consumers because they actually bring generic drug competition to the market faster. We spoke to Gregory Conko, senior fellow at the Competitive Enterprise Institute, about the case, why he thinks the Federal Trade Commission has taken the wrong position on it, and why listening to Justice Stephen Breyer may provide the best insight into the court’s thinking.
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Sunday, 31 March 2013 13:26 |
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Study finds that limiting hours for medical residents offers uncertain value. The percentage of first-year medical residents who reported concerns about making a serious medical error has risen with growing workloads, calling into question the benefits of a mandated cutback in their work hours, according to a new study. |
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Sunday, 31 March 2013 13:19 |
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Nationwide survey indicates little progress in promoting value-based care. Top private health plans in the United States took a big step toward value-based care in the last two years, but still have a long way to go, according to a survey of health insurers that collectively cover 67 percent of privately insured Americans. It found that about 11 percent of payments to doctors and hospitals are value-oriented, up from an estimated 1 to 3 percent in 2010.
“We make the vast majority of payments for healthcare on a fee-for-service basis without any rewards for quality and efficiency,” says Suzanne Delbanco, the group’s executive director. “We know traditional fee-for-service payment creates incentives for waste and inappropriate care.” |
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Sunday, 31 March 2013 13:12 |
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Agreement focuses on inherited mitochondrial diseases and their application for adult CNS disorders. Edison Pharmaceuticals has entered into a research, development, and commercialization agreement with Japanese pharmaceutical Dainippon Sumitomo for the development of two of its small molecule investigational compounds, the oral small molecules EPI-743 and EPI-589, in Japan. Edison retains 100 percent ownership of the compounds and will direct their development outside Japan. |
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Sunday, 31 March 2013 13:03 |
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No consensus exists on which federal agency, if any, should regulate research labs possessing dangerous pathogens. The FBI is investigating a research lab owned and operated by the University of Texas because of a missing vial containing a virus that causes hemorrhagic fever, a deadly virus and a potential agent of bioterrorism. The last time the vial was used was November 2012, but it wasn’t until the lab prepared for a scheduled inspection by the Centers for Disease Control and Prevention in late March that it was noted as missing. |
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