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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 Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids—Evaluation and Labeling.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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Ricerca Biosciences acquired by equity investment group Main Market Partners

Wednesday, November 19, 2014 02:14 PM

Ricerca Biosciences, based in Ohio, has been acquired by Main Market Partners, a middle-market growth investment fund in the same region. Terms of the sale have not been disclosed.

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Tufts CSDD: Developing, winning marketing approval for a new drug now cost $2.6 billion

Tuesday, November 18, 2014 02:22 PM

Developing and gaining marketing approval for a new prescription medicine, a process often lasting longer than a decade, is estimated to cost $2,558 million, according to a new study by the Tufts Center for the Study of Drug Development (CSDD).

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November 24

Tufts CSDD’s $2.6 billion price tag to develop and bring a new drug to market raises questions, criticisms

Medidata joins GlaxoSmithKline in study to evaluate the impact of wearing mobile devices in clinical trials

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The CenterWatch Monthly

November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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The CenterWatch Monthly

October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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