United States

Selecta, Sanofi to develop antigen-specific immunotherapies for life-threatening allergies

Friday, November 30, 2012 10:55 AM

Selecta Biosciences, a Watertown, Mass.-based clinical-stage biopharmaceutical company developing a new class of synthetic vaccines and immunotherapies, has entered into a strategic global collaboration with global healthcare company Sanofi to discover highly targeted, antigen-specific immunotherapies for life-threatening allergies.

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Rib-X Pharmaceuticals closes first tranche in $67.5M financing

Friday, November 30, 2012 10:28 AM

Rib-X Pharmaceuticals, a New Haven, Conn.-based biopharmaceutical company developing new antibiotics to treat serious and life-threatening infections, has closed the first tranche of a $67.5 million Series 2 preferred stock financing. A second tranche is anticipated to close around the end of 2012.

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Aptiv Solutions opens new office

Thursday, November 29, 2012 01:52 PM

Reston, Va.-based Aptiv Solutions, a biopharmaceutical and medical device development services company with a focus on adaptive clinical trial design, simulation and execution, opened a new office in Durham, N.C., combining offices with its subsidiary Trio Clinical Resourcing.

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Abbott board approves separation of AbbVie

Thursday, November 29, 2012 01:46 PM

The board of directors of Illinois-based Abbott has approved the separation of its research-based pharmaceuticals business, to be known as AbbVie, and declared a special dividend distribution of all outstanding shares of AbbVie common stock.

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FDA approves Cometriq to treat rare type of thyroid cancer

Thursday, November 29, 2012 08:00 AM

The FDA has approved Cometriq (cabozantinib) to treat medullary thyroid cancer that has spread to other parts of the body.

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Curis licensed IAP inhibitor GDC-0917 from Genentech

Wednesday, November 28, 2012 01:54 PM

Curis, a Lexington, Mass.-based drug development company focused on targeted small molecule drug candidates for cancer treatment, has licensed from San Francisco-based Genentech, a member of the Roche Group, exclusive worldwide rights for the development and commercialization of GDC-0917, a small molecule that is designed to promote cancer cell death by antagonizing inhibitor of apoptosis (IAP) proteins.

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IntelliCell BioSciences inks research agreement with Rutgers’ N.J. Center for Biomaterials

Wednesday, November 28, 2012 11:16 AM

IntelliCell BioSciences, a regenerative medicine company developing novel technologies that address the regenerative, curative and preventative conditions of disease states with high unmet clinical needs, has entered a sponsored research agreement with the New Jersey Center for Biomaterials at Rutgers, the state university of New Jersey.

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Rhythm expands Series B financing to $33M with Pfizer investment

Wednesday, November 28, 2012 10:48 AM

Rhythm, a Boston-based biotechnology company developing peptide therapeutics that for metabolic diseases, has raised an additional $8 million to complete a $33 million Series B financing.

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CRA enters strategic alliance with Quintiles

Tuesday, November 27, 2012 11:42 AM

Tempe, Ariz.-based Clinical Research Advantage (CRA), a community-based network of clinical trial sites, has entered into a strategic agreementĀ  with CRO Quintiles to facilitate a higher level of clinical trial participation with an emphasis on safety, improved study efficiencies and quality data.

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FDA issues draft guidance for IRBs

Tuesday, November 27, 2012 11:28 AM

The FDA on Nov. 20 issued a draft guidance titled Draft Guidance for IRBs, Clinical Investigators and Sponsors--IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed.

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December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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