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FDA

BioAlliance Pharma, Topotarget to merge

Wednesday, April 16, 2014 01:18 PM

BioAlliance Pharma, an innovative company specialized in developing drugs within orphan oncology diseases, and Topotarget, a Scandinavian-based biopharmaceutical company, intend to merge to create an orphan oncology company with highly complementary pipelines of late-stage products addressing significant unmet medical needs.

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CRF Health eCOA webinar series

Trial results for AbbVie’s Hepatitis C candidate heat up race for effective treatment

Monday, April 14, 2014 12:51 PM

The race to replace interferon with a far more effective treatment for hepatitis C has become one of the most promising and lucrative battles in drug development, as AbbVie, Gilead Sciences, Merck and Bristol-Myers Squibb vie for the finish line.

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HHS Secretary Sebelius, proponent of clinical research, resigns

Friday, April 11, 2014 03:33 PM

Health and Human Services Secretary Kathleen Sebelius—whose agenda included keeping clinical research a priority—has resigned on the heels of the Affordable Care Act (ACA) web site turmoil last October, even though more recently she had achieved the goal of 7.5 million registrations for coverage.

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FDA approves expanded indication for certain pacemakers and defibrillators

Friday, April 11, 2014 01:38 PM

The FDA has approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization defibrillators (CRT-D), expanding the indication for use to patients with atrioventricular (AV) block and less severe heart failure.

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Pharmacyclics files sNDa for IMBRUVICA

Friday, April 11, 2014 01:16 PM

Pharmacyclics has submitted a supplemental New Drug Application (sNDA) to the FDA, based on data from the randomized, multi-center, open-label phase III RESONATE study, PCYC-1112, a head-to-head comparison of single agent IMBRUVICA (ibrutinib) versus ofatumumab in 391 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who had received at least one prior therapy. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech.

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Report: clinical trial management system market to reach $1.85B in 2019

Friday, April 11, 2014 12:00 PM

According to a new report from Transparency Market Research, a global market intelligence company, the global clinical trial management system market was valued at $844 million in 2013 and is expected to grow at a CAGR of 14% from 2014 to 2019, to reach an estimated value of $1.85 million in 2019.

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Roche acquires IQuum to strengthen offerings in molecular diagnostics

Wednesday, April 9, 2014 12:40 PM

Roche has acquired IQuum, a privately held company focused on developing point-of-care offerings for the molecular diagnostics market. Roche will pay IQuum shareholders $275 million upfront and up to $175 million in contingent product-related milestones.

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Mallinckrodt acquires Questcor for $5.6 billion

Monday, April 7, 2014 01:17 PM

Fulfilling a strategy to substantially invest in the specialty pharmaceutical business, Mallinckrodt announced this morning it has entered into a definitive merger agreement with Questcor Pharmaceuticals, a high-growth biopharmaceutical company, in a transaction valued at about $5.6 billion.

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Tisch MS Research Center uses crowdfunding to finance clinical trial

Friday, April 4, 2014 11:07 AM

Culminating 10 years of stem cell research for the treatment of progressive multiple sclerosis (MS), the Tisch MS Research Center in New York has raised more than $244,000 through donation-based crowdfunding in less than three weeks for a 20-patient phase I clinical trial that researchers say has the potential to repair the damage caused by the chronic disease that attacks the central nervous system.

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FDA grants IND approval for CardioCell’s phase IIa itMSC Therapy trial

Wednesday, April 2, 2014 03:41 PM

CardioCell, a global biotechnology company, has just received the FDA’s Investigational New Drug (IND) approval for a U.S.-based, phase IIa clinical study using its allogeneic stem-cell therapy to treat subjects with chronic heart failure (CHF), which generates more than one million hospitalizations annually. Preparation is underway to initiate the study at Emory University, Northwestern University and the University of Pennsylvania in May 2014.

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CWWeekly

April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

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The CenterWatch Monthly

April

Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

Global clinical trial laboratories decentralize
Regional labs reducing complexity, delivering cost and time savings

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The CenterWatch Monthly

March

Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
New study finds high potential but infrastructure, resources are lacking

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