United States

Biogen Idec Foundation donates $100,000 to Teach for America STEM education

Monday, August 20, 2012 09:22 AM

The Biogen Idec Foundation andTeach For America have formed a new collaboration in support of Science, Technology, Engineering and Math (STEM) education.

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Biomedical Systems to collaborate with Mass. General Hospital

Friday, August 17, 2012 03:19 PM

The imaging division of Biomedical Systems, a global provider of centralized diagnostic services, has formed a collaboration with Massachusetts General Hospital (MGH) to evaluate the efficacy of new drugs and devices.

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Enzalutamide adds 5 months survival in late-stage prostate cancer

Friday, August 17, 2012 02:52 PM

Results of a phase III clinical trial of the drug Enzalutamide, recently published in the New England Journal of Medicine, show the drug extends life by an average five months in the most advanced stages of prostate cancer.

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FDA approves first generic Actos to treat type 2 diabetes

Friday, August 17, 2012 02:33 PM

The FDA has approved the first generic version of Actos (pioglitazone hydrochloride) tablets, used in conjunction with diet and exercise to improve blood glucose control in adults with type 2 diabetes. Mylan Pharmaceuticals, based in Morgantown, W.V., gained FDA approval for 15mg, 30mg and 45mg pioglitazone tablets.

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FDA solicits industry input about open, consensus-based standards

Friday, August 17, 2012 09:19 AM

The FDA is announcing a meeting “Regulatory New Drug Review: Solutions for Study Data Exchange Standards,” on Nov. 5, to solicit input from industry, technology vendors and the public regarding the advantages and disadvantages of current and emerging open, consensus-based standards for the exchange of regulated study data. The FDA also is seeking input from stakeholders on pre-meeting questions discussed below. Registration is required in advance and will be limited.

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Codeine in certain children may lead to rare, but life-threatening AEs or death

Wednesday, August 15, 2012 01:48 PM

The FDA is reviewing reports of children who developed serious adverse effects or died after taking codeine for pain relief after tonsillectomy or adenoidectomy for obstructive sleep apnea syndrome.

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Zenobia partners with Alzheimer's Drug Discovery Foundation

Wednesday, August 15, 2012 11:54 AM

Zenobia Therapeutics, a fragment-based discovery company focused on central nervous system (CNS) disease based in San Diego, has formed a strategic partnership to provide Alzheimer's Drug Discovery Foundation (ADDF) researchers access to Zenobia's discovery platform.

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HealthPartners, VitalSims partner to improve diabetes care

Wednesday, August 15, 2012 11:01 AM

HealthPartners, a not-for-profit health maintenance organization of Bloomington, Minn., and VitalSims, a healthcare education company of Minneapolis, Minn., are partnering to improve care for patients with chronic diseases through a joint venture, SiMCare Health.

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Peter Alterman named COO of SAFE-BioPharma

Monday, August 13, 2012 03:13 PM

Peter Alterman, Ph.D., who held numerous senior information security positions within the U.S. federal government, has been named chief operating officer of SAFE-BioPharma Association, the strategic, non-profit collaboration responsible for the global SAFE-BioPharma digital identity and digital signature standard used in the life science and healthcare sectors.
 
Alterman recently retired after 33 years of government service where, most recently, he was senior advisor to the national program office of the National Strategy for Trusted Identities in Cyberspace (NSTIC), NIST. Before that he served as senior advisor to the NIH CIO for Strategic Initiatives, Assistant CIO for e-authentication at the National Institutes of Health and chair of the U.S. Federal PKI Policy Authority. His role in Internet technology started in 1989 as a member of the Federal Research Internet Coordinating Committee.
  
In addition to responsibilities for a variety of association management functions, Alterman will serve as SAFE-BioPharma’s primary liaison with the FDA and other global regulatory authorities and represent the association’s interests on global standards and policy bodies.

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Elcelyx extends Series B financing for weight loss and diabetes

Monday, August 13, 2012 02:51 PM

Elcelyx Therapeutics, a San Diego-based biotechnology company, has secured $4 million of a $7 million extension of its Series B private equity financing. Existing investors Morgenthaler Ventures, Kleiner Perkins Caufield & Byers and Technology Partners all participated in the extension.

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CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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