AiCure

United States

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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Acorda Therapeutics to acquire Civitas Therapeutics

Thursday, September 25, 2014 12:48 PM

Acorda Therapeutics, a biotechnology company based in Ardsley, N.Y., has entered into an agreement to acquire Civitas Therapeutics, a Chelsea, Mass.-based, privately held biopharmaceutical company, for $525 million in cash. Acorda will obtain worldwide rights to CVT-301, a phase III treatment candidate for OFF episodes of Parkinson’s disease (PD). The acquisition also includes rights to Civitas’ proprietary ARCUS pulmonary delivery technology and manufacturing facility with commercial-scale capabilities.

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Shire to pay $56.5M to U.S. government

Thursday, September 25, 2014 12:43 PM

Shire has reached a final agreement with the U.S. Attorney’s Office to resolve a civil investigation of its sales and marketing practices for a period ending in 2010 relating to Adderall XR, Vyvanse, Daytrana, Lialda and Pentasa. Shire will pay $56.5 million, plus interest, fees and costs.

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Atara Biotherapeutics, Memorial Sloan-Kettering Cancer Center ink agreement

Wednesday, September 24, 2014 01:25 PM

Atara Biotherapeutics, a California-based, privately held drug development company, has entered into an exclusive option agreement with New York’s Memorial Sloan Kettering Cancer Center (MSK) for the development and commercialization of allogeneic T-cell therapies for the treatment of certain cancers and persistent viral infections. Atara will have the option to acquire a worldwide license to three clinical stage T-cell therapies, consisting of:

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Navidea awarded $1.67M to evaluate Lymphoseek for cervical cancer

Wednesday, September 24, 2014 01:20 PM

Navidea Biopharmaceuticals, a Dublin, Ohio developer of precision diagnostics and radiopharmaceutical agents, has received an initial notice of award for a Fast Track Small Business Innovation Research (SBIR) grant providing for up to $1.67 million from the National Cancer Institute (NCI), a part of the NIH, to fund evaluation of Lymphoseek (technetium Tc 99m tilmanocept) Injection in women with cervical cancer.

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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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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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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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