Theorem Clinical Research

United States

Seattle Children's launches $100M fundraising initiative to cure childhood cancer

Wednesday, December 3, 2014 01:01 PM

Seattle Children's Hospital and Research Foundation has launched a $100 million, multi-year fundraising initiative to support research that scientists believe has the ability to cure some types of childhood cancer in the next five to 10 years.

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Quest Diagnostics

Edison Nation Medical, Mount Sinai Health System collaborate

Wednesday, December 3, 2014 12:59 PM

Edison Nation Medical, a marketplace for healthcare and medical device innovation headquartered in Charlotte, N.C., has partnered with Mount Sinai Health System, a New York-based integrated healthcare network providing medical care and medical research. Edison Nation Medical will work closely with Mount Sinai Innovation Partners (MSIP), Mount Sinai's technology development and commercialization group, to prioritize and bring to market medical device and consumer related healthcare inventions from the Mount Sinai community.

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CytRx announces partial clinical hold affecting aldoxorubicin clinical trials

Monday, November 24, 2014 02:58 PM

CytRx, a biopharmaceutical R&D company specializing in oncology, has received notice from the FDA that its clinical trials for aldoxorubicin have been placed on partial clinical hold. All currently enrolled patients can continue receiving aldoxorubicin treatment, or comparator drugs, as per study protocols, but no new patients can be enrolled until the clinical hold is lifted.

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Report: 80% of pharma outsource some of their government reimbursement budgets

Monday, November 24, 2014 02:53 PM

Eighty percent of surveyed pharma companies outsource some portion of their government reimbursement budgets, including third-party audits that can help companies remain compliant to changing industry guidelines, according to Cutting Edge Information, a Research Triangle Park, N.C.-based pharmaceutical business intelligence provider.

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Sanofi names chief scientific officer Gary Nabel as Sanofi Ebola response coordinator

Monday, November 24, 2014 02:30 PM

As part of its contribution to the global response to the Ebola epidemic, Sanofi has appointed chief scientific officer Dr. Gary J. Nabel, M.D., Ph.D., as its Ebola response coordinator.

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HedgePath Pharmaceuticals files IND application

Monday, November 24, 2014 02:23 PM

HedgePath Pharmaceuticals, a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative therapeutics for patients with cancer, has filed an IND application with the FDA.

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FDA approves hydrocodone product with abuse-deterrent properties

Monday, November 24, 2014 02:08 PM

The FDA has approved Purdue Pharma’s Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids—Evaluation and Labeling.

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Research Across America hires Matt Lowry as director, business development

Monday, November 24, 2014 02:03 PM

Matt Lowery, CCRC, has joined Research Across America (RAA) as director of business development. Lowery will oversee the development and growth of new business. Additionally, he will continue to develop and maintain CRO and sponsor relationships.

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HHS, NIH to enhance transparency of clinical trial results

Friday, November 21, 2014 11:31 AM

The U.S. Department of Health and Human Services has issued a Notice of Proposed Rulemaking (NPRM), which proposes regulations to reporting requirements for clinical trials subject to Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA).

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BerGenBio receives Orphan Drug designation from FDA for AML treatment

Thursday, November 20, 2014 01:25 PM

The FDA has granted Orphan Drug designation for BerGenBio’s BGB324 for treatment of acute myeloid leukaemia (AML).

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CWWeekly

March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

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The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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