2014

ALS Association, Muscular Dystrophy Association partner

Friday, December 5, 2014

The ALS Association, a national nonprofit based in Wash. D.C., and the Muscular Dystrophy Association (MDA), a Chicago-based nonprofit health agency, have joined forces to fund a research project aimed at finding a potential therapy for amyotrophic lateral sclerosis, also known as ALS or Lou Gehrig’s disease. Both nonprofits are focused on finding treatments and cures for ALS and providing services for those affected with the debilitating, fatal disease.  

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FDA approves Blincyto (Blinatumomab) for leukemia

Thursday, December 4, 2014

The FDA has granted approval of Amgen’s Blincyto (blinatumomab) for the treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval.

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FDA issues final rule on changes to pregnancy and lactation labeling information

Thursday, December 4, 2014

The FDA has published a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.

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First MS patients in the U.S. receive Genzyme’s Lemtrada following FDA approval

Thursday, December 4, 2014

Genzyme, a Sanofi company, has announced that the first U.S. patients have initiated treatment with Lemtrada (alemtuzumab) in the commercial setting following its Nov. 14 FDA approval for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

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CluePoints wins award for Best Technological Development in Clinical Trials

Thursday, December 4, 2014

CluePoints, a Cambridge, Mass.-based provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, was awarded Best Technological Development in Clinical Trials at the 2014 Scrip Awards. The award, sponsored by the MCT Congress, recognizes CluePoints in the Cloud as the ultimate quality oversight and risk-based monitoring (RBM) application developed to determine the quality and integrity of clinical trials data.

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BTG acquires PneumRx for up to $475 million

Thursday, December 4, 2014

London-based BTG will acquire PneumRx, a Mountain View, Calif.-based interventional pulmonology company in a deal worth up to $475 million, based on an initial consideration of $230 million and up to $245 million in performance-related milestone payments. BTG is an international specialist healthcare company active in interventional medicine and specialty pharmaceuticals. 

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