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FDA

CDISC, TransCelerate release new standards for diabetes, cardiovascular disease

Wednesday, November 26, 2014 11:45 AM

The Clinical Data Interchange Standards Consortium (CDISC), a global nonprofit, and King of Prussia, Pa.-based nonprofit TransCelerate BioPharma have made available therapeutic area standards for diabetes and cardiovascular (CV) disease areas through the Coalition for Accelerating Standards and Therapies (CFAST), a joint initiative of CDISC and the Critical Path Institute (C-Path).

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BioMarin to acquire Prosensa for $680M

Tuesday, November 25, 2014 08:30 AM

BioMarin Pharmaceutical, based in San Rafael, Calif., will acquire Prosensa for $17.75 per share, for a total up-front consideration of approximately $680 million. In addition, two approximately $80 million contingent milestones are payable for the approval of drisapersen in the U.S. no later than May 15, 2016, and Europe no later than Feb. 15, 2017, respectively.

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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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AstraZeneca to expand its Maryland biologics manufacturing center, add 300 jobs

Monday, November 24, 2014 02:44 PM

AstraZeneca plans to expand its biologics manufacturing center in Frederick, Md. The more than $200 million project will increase production capacity at the facility to support AZ’s maturing pipeline, and will help the company keep pace with a growing demand for the development and use of biologics, which currently represent nearly 50% of AZ’s overall pipeline.

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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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Global oncologists share insights into cancer immunology

Monday, November 24, 2014 08:00 AM

Cancer immunotherapy has become one of the hottest fields of clinical research in decades.

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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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Study: global spending on medicines to increase 30% by 2018, to $1.3 trillion

Thursday, November 20, 2014 01:38 PM

More specialty drug innovation, greater patient access to medicines and reduced impact from patent expiries will be the primary drivers of an increase in global medicine spending of up to 30% by 2018.

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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

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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