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Cloud Pharmaceuticals ratifies board of directors

Friday, November 7, 2014 01:42 PM

Cloud Pharmaceuticals, a therapeutics company focused on cloud-based drug design and development, has ratified its board of directors. Members of the board include Cloud Pharmaceuticals chairman and CEO Ed Addison, chief scientific officer Shahar Keinan, Ph.D., and chief information officer Lawrence Husick. Other members of the board include:

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Spark Therapeutics receives FDA Breakthrough Therapy designation for SPK-RPE65

Friday, November 7, 2014 01:29 PM

Spark Therapeutics, a late-stage gene therapy company developing treatments for debilitating genetic diseases, has announced that its lead product candidate, SPK-RPE65, has received Breakthrough Therapy designation from the FDA. Breakthrough Therapy designation is intended to expedite the development and review of investigational therapies for serious or life-threatening conditions where initial clinical evidence demonstrates a significant improvement over existing therapies. SPK-RPE65 targets a group of blinding conditions known as inherited retinal dystrophies (IRDs) caused by autosomal recessive mutations in the RPE65 gene, and for which there currently is no pharmacologic treatment available.

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Perrigo to acquire Omega Pharma for $4.5 billion

Friday, November 7, 2014 01:26 PM

Perrigo, a Dublin, Ireland-based global provider of healthcare products, will acquire Omega Pharma, an OTC healthcare company headquartered in Nazareth, Belgium, for $4.5 billion, including a $3.1 billion purchase price plus assumption of $1.4 billion in debt. The transaction will enhance Perrigo's OTC product offering and expand its distribution through Omega's strong established platform. 

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BIND Therapeutics inks oncology agreement with Merck

Friday, November 7, 2014 01:25 PM

BIND Therapeutics, a Cambridge, Mass.-based clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called Accurins, has signed an R&D agreement with Merck, through a subsidiary, to discover and develop novel nanomedicines for oncology. This collaboration will leverage BIND's proprietary nanomedicine technology to create targeted Accurins based on novel, potent payloads from Merck's preclinical oncology portfolio.

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Bill & Melinda Gates Foundation awards PATH $156M for malaria research

Friday, November 7, 2014 01:23 PM

The Bill & Melinda Gates Foundation, of Seattle, Wash., has awarded $156 million to PATH, a Seattle-based international nonprofit organization, to support the PATH Malaria Vaccine Initiative (MVI) in building new vaccines that will interrupt the cycle of malaria parasite transmission and help realize the "accelerating to zero" agenda. Such vaccines would ensure parasite reintroduction is prevented by providing what could be called an "immunological bed net."

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Study: Medication nonadherence a barrier to long-term health and public safety

Friday, November 7, 2014 01:22 PM

One out of four samples collected from patients with serious mental illness (SMI) did not contain the prescribed antipsychotic medication, according to clinical research from Ameritox's Ingenuity Health, a Baltimore, Md.-based provider of monitoring solutions to behavioral health clinicians. Coupled with nearly 40% of samples testing positive for illicit drugs or non-prescribed medications, the study illustrates the pervasiveness of medication nonadherence among those with SMI and highlights the potential barriers to long-term health and public safety.

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EFPIA, Innovative Medicines Initiative form $348.2M Ebola+ program

Friday, November 7, 2014 01:19 PM

European Federation of Pharmaceutical Industries and Associations (EFPIA), a representative of the pharmaceutical industry operating in Europe, its specialized group Vaccines Europe and the Innovative Medicines Initiative have launched a $348.2 million call for proposals for an Innovative Medicines Initiative (IMI) program aimed to address the current Ebola crisis. The Ebola+ program will bring together the pharma industry and researchers in a collaborative program aimed to cover the current outbreak, as well as future needs in the space of hemorrhagic fevers.

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GVK BIO to acquire Vanta Bioscience

Friday, November 7, 2014 01:09 PM

GVK BIO, a Hyderabad, India-based discovery R&D organization, will acquire Vanta Bioscience, a full-service preclinical GLP toxicology and safety assessment CRO operating from Chennai, India.

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Leading BioSciences submits compassionate use IND for Ebola-related shock

Friday, November 7, 2014 01:03 PM

Leading BioSciences, a clinical-stage, platform pharmaceutical company focused on developing therapies and diagnostics to treat and halt multi-organ failure resulting from shock, has submitted an expanded access Investigational New Drug application (IND) with the FDA— also known as "compassionate use"—for its lead product LB1148.

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FDA issues response letter for Aeterna Zentaris' Macrilen NDA

Friday, November 7, 2014 12:58 PM

Aeterna Zentaris, is a specialty biopharmaceutical company, has received a complete response letter (CRL) from the FDA for its NDA for Macrilen (macimorelin), a novel orally-active ghrelin agonist, for use in evaluating adult growth hormone deficiency (AGHD). Based on its review, the FDA has determined that the NDA cannot be approved in its present form.

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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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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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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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