United States

Catalent, Cingulate Therapeutics ink agreement for new ADHD treatments

Tuesday, September 30, 2014 09:00 AM

Catalent Pharma Solutions, headquartered in Somerset, N.J., has reached an exclusive development and licensing agreement with Cingulate Therapeutics (CTx), a Morristown, N.J.-based, privately held biopharmaceutical company, to support development of a series of new prescription pharmaceutical products for the treatment of attention deficit/hyperactivity disorder (ADHD) using Catalent's OSDrC OptiDose drug delivery platform.

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Novo Nordisk establishes obesity research unit in Seattle

Tuesday, September 30, 2014 08:00 AM

Novo Nordisk will establish a new obesity research unit in Seattle, Wash. The new unit is a result of Novo Nordisk's increasing focus on obesity. Its main task will be to identify novel approaches and targets for obesity treatments, while increasing the scientific understanding of existing obesity targets.

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Soligenix awarded $24.7M NIAID contract for heat stable RiVax vaccine

Friday, September 26, 2014 03:05 PM

Soligenix, a Princeton, N.J.-based late-stage biopharmaceutical company developing products that address unmet medical needs in inflammation, oncology and biodefense, has been awarded a contract valued at up to $24.7 million inclusive of options by the U.S. Department of Health and Human Service's NIH, specifically funded by the National Institute of Allergy and Infectious Diseases (NIAID). The objectives of the contract are to advance the development of Soligenix's thermostabilization technology, ThermoVax, combined with the company's ricin toxin vaccine, Rivax, as a medical countermeasure (MCM) to prevent the effects of ricin exposure.

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Aethlon Medical, Exosome Sciences to collaborate with BU CTE Center

Friday, September 26, 2014 03:00 PM

Aethlon Medical and its New Jersey-based diagnostic subsidiary Exosome Sciences (ESI) have established a clinical collaboration with the Boston University (BU) CTE Center to advance a blood-based diagnostic candidate that could identify Chronic Traumatic Encephalopathy (CTE) in living individuals.

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Amgen submits BLA for investigational BiTE immunotherapy blinatumomab

Thursday, September 25, 2014 02:55 PM

Amgen has submitted a Biologics License Application (BLA) to the FDA seeking approval for its investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab. The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow.

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Braeburn Pharmaceuticals' probuphine study hits enrollment milestone

Thursday, September 25, 2014 02:50 PM

Braeburn Pharmaceuticals has surpassed the midway point for patient enrollment in its phase III study of Probuphine, which began in July. Probuphine is a buprenorphine subdermal implant being studied for the maintenance treatment of opioid dependence. Completion of the study is on track for the middle of 2015, with submission of the New Drug Application to the FDA expected to follow later in the year.

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Highland Therapeutics appoints Dr. Floyd R. Sallee chief medical officer

Thursday, September 25, 2014 02:29 PM

Highland Therapeutics has appointed Dr. Floyd R. Sallee as chief medical officer of Ironshore Pharmaceuticals & Development, Highland's wholly owned principal operating subsidiary.

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Iodine launches web site, turns real-life experience into data-driven tools

Thursday, September 25, 2014 12:53 PM

Iodine, a provider of online interactive tools, has officially launched at www.iodine.com and has begun offering consumers in the U.S. a new way to find and interact with information about their medications. Iodine creates data-driven tools that allow consumers to engage with massive amounts of data in personalized ways, letting any one individual filter data according to demographic information, such as gender and age, to better understand what happens to real people in real life with hundreds of medications.

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Bristol-Myers Squibb to build state-of-the-art campus in New Jersey

Thursday, September 25, 2014 12:52 PM

Bristol-Myers Squibb plans to build a 650,000-square-foot office building on company-owned land in Lawrenceville, N.J. Construction is expected to begin in the fall and the new facility is expected to open by the end of 2016.

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Baxter, Merrimack Pharmaceuticals ink agreement for MM-398

Thursday, September 25, 2014 12:50 PM

Baxter International and Merrimack Pharmaceuticals have announced an exclusive license and collaboration agreement for the development and commercialization of MM-398 (nanoliposomal irinotecan injection), also known as nal-IRI. Baxter gains exclusive commercialization rights for all potential indications of MM-398 outside the U.S. and Taiwan, and Merrimack retains commercialization rights in the U.S.; the rights in Taiwan are held separate/news-online/company/EMAly.

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December 22

DaVita combines its two research CRO units to create an end-to-end CRO focused on kidney, end-stage renal disease

New crop of clinical trial matching services use patient’s molecular, genomic data for better fit

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Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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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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