United States

Panacea Pharmaceuticals engages Accelovance for clinical development

Wednesday, February 11, 2015 12:46 PM

Panacea Pharmaceuticals, based in Gaithersburg, Md., and Accelovance, a CRO headquartered in Rockville, Md., have established a clinical development services agreement to develop and advance Panacea's oncology immunotherapy pipeline. Accelovance will support Panacea's clinical development strategies by offering scientific/medical and regulatory experience, in addition to providing CRO support through project management, clinical monitoring, data management, biostatistics and safety services for Panacea's clinical trials.

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Lurie Cancer Center, NMDTI, Northwestern Memorial launch new research program

Friday, February 6, 2015 12:25 PM

The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, in collaboration with the Northwestern Medicine Developmental Therapeutics Institute (NMDTI) and Northwestern Memorial Hospital, has launched a new research program, Northwestern Onco-SET (Sequence, Evaluate, Treat), to provide a more personalized, precision medicine option for cancer patients by combining oncology with genomics. This program initially will focus on patients with any type of cancer that is not responsive to traditional therapies.

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Vyvanse is FDA-approved for moderate to severe binge eating disorder

Thursday, February 5, 2015 01:29 PM

The FDA has approved Shire’s Vyvanse (lisdexamfetamine dimesylate) Capsules (CII), the first and only medication for the treatment of moderate to severe binge eating disorder (BED) in adults, shown to significantly reduce the mean number of binge days per week. Vyvanse is not indicated or recommended for weight loss or the treatment of obesity. Other sympathomimetic drugs used for weight loss have been associated with serious cardiovascular reactions.

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Lubrizol, Cleveland Clinic ink collaboration to advance medical innovation

Thursday, February 5, 2015 12:12 PM

Lubrizol and Cleveland Clinic announce that as part of a new joint collaboration, Lubrizol LifeSciences and Cleveland Clinic Innovations are aiming to identify—and ultimately speed the development of—new, groundbreaking products for the medical device and pharmaceutical industries.

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Obama outlines his Precision Medicine Initiative

Friday, January 30, 2015 12:31 PM

Building on President Obama’s announcement in his State of the Union Address, the administration is unveiling details about the Precision Medicine Initiative, a new research effort to revolutionize how to improve health and treat disease.

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Shire's SHP609 receives FDA Fast Track designation

Thursday, January 29, 2015 01:27 PM

The FDA has granted Fast Track designation for Shire’s SHP609 (idursulfase-IT; also known as HGT-2310) for the treatment of neurocognitive decline associated with Hunter syndrome (mucopolysaccharidosis II or MPSII).

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FDA approves Natpara for blood calcium levels related to hypoparathyroidism

Thursday, January 29, 2015 01:15 PM

The FDA has approved Natpara (parathyroid horomone) to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism, a rare disease that affects approximately 60,000 people in the U.S.

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Dr. Robert Califf named FDA deputy commissioner for medical products and tobacco

Thursday, January 29, 2015 11:02 AM

FDA commissioner Margaret A. Hamburg, M.D., has appointed Robert Califf, M.D., a global leader in cardiology, clinical research and medical economics, as FDA deputy commissioner for medical products and tobacco.  

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Report: regulatory innovation should adapt to new health economy

Wednesday, January 28, 2015 01:25 PM

Consumers and drug and device manufacturers are changing practices and shifting attitudes toward the FDA.

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WCCT, Stanford University laboratory to collaborate

Wednesday, January 28, 2015 12:09 PM

WCCT Global, a CRO headquartered in Southern California, has established a collaboration agreement with researchers in Dr. Garry P. Nolan's laboratory from the department of microbiology and immunology at Stanford University. Together with the National Institute of Allergy and Infectious Diseases (NIAID), WCCT Global currently is conducting influenza infection studies in healthy volunteers and is the first CRO to conduct such studies in North America.

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CWWeekly

June 29

FDA and PatientsLikeMe collaborate to test social media adverse event reporting

Boston-area teaching hospitals launch web portal to attract life science companies

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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The CenterWatch Monthly

June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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