Theorem Clinical Research

FDA

FDA expands approved use of Opdivo to treat lung cancer

Thursday, March 5, 2015 01:42 PM

The FDA has expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

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Quest Diagnostics

AbbVie to acquire Pharmacyclics for $21B, boosting hematological oncology franchise

Thursday, March 5, 2015 12:38 PM

AbbVie has announced a definitive agreement to acquire Pharmacyclics and its flagship asset Imbruvica (ibrutinib), a treatment for hematologic malignancies. 

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FDA launches drug shortages mobile app

Thursday, March 5, 2015 12:34 PM

The FDA has launched the agency’s first mobile application specifically designed to speed public access to valuable information about drug shortages. The app identifies current drug shortages, resolved shortages and discontinuations of drug products.

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Blueprint Medicines, Alexion Pharmaceuticals ink $265M deal

Wednesday, March 4, 2015 12:55 PM

Blueprint Medicines is collaborating with Alexion Pharmaceuticals to discover, develop and commercialize novel drug candidates for an undisclosed activated kinase target, which is the cause of a rare genetic disease.

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FDA approves new antibacterial drug Avycaz

Thursday, February 26, 2015 01:12 PM

The FDA has approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.  

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Turing Pharmaceuticals launched

Wednesday, February 25, 2015 11:32 AM

Turing Pharmaceuticals officially has launched. New York-based Turing will focus on developing and commercializing innovative treatments for serious diseases and conditions across a broad range of therapeutic areas, for which there currently are limited or no treatment options.

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Shire acquires Meritage Pharma

Wednesday, February 25, 2015 11:27 AM

Shire has acquired Meritage Pharma, a global, privately held company, for $70 million upfront and additional contingent payments based on development and regulatory milestones.

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NIH expands tuberculosis research program, awards $105.3M

Thursday, February 19, 2015 02:40 PM

The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, is expanding its Tuberculosis Research Units (TBRU) program in an effort to drive innovation in tuberculosis (TB) research. NIAID is awarding up to $15.2 million in fiscal year 2015 and as much as $105.3 million over seven years to fund four institutions that will act as a collaborative TBRU network.

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Collegium Pharmaceutical files NDA with FDA for Xtampza ER

Thursday, February 19, 2015 01:15 PM

The FDA has accepted for filing Collegium Pharmaceutical’s NDA for Xtampza ER, its novel, abuse-deterrent, extended-release oxycodone formulation for the treatment of chronic pain. Collegium Pharmaceutical is a specialty pharmaceutical company focused on the development and commercialization of innovative abuse-deterrent treatments for chronic pain and other diseases

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FDA grants Genentech’s cobimetinib Priority Review for melanoma

Thursday, February 19, 2015 01:00 PM

The FDA has accepted and granted Priority Review for Genentech’s, a member of the Roche Group, NDA for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma. The FDA will make a decision on approval by Aug. 11.

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CWWeekly

March 2

Huntingdon Life Sciences-Harlan prepares for rebranding and U.S. expansion to compete with early phase CROs Covance, CRL

Patients' increased sharing of clinical trial experiences through social media can help sponsors improve outcomes, enrollment

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The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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