Theorem Clinical Research

Clinical Intelligence

FDA approves new sleep drug Belsomra

Friday, August 15, 2014 09:17 AM

The FDA has approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).

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Quest Diagnostics

FDA approves Orbactiv to treat skin infections

Friday, August 8, 2014 12:44 PM

The FDA has approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.

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BioSpecifics Technologies initiates phase II study of CCH for Lipoma

Friday, August 8, 2014 12:33 PM

BioSpecifics Technologies, a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX (collagenase clostridium histolyticum or CCH) in the U.S. and XIAPEX in the E.U., has injected the first patient in its placebo-controlled phase II clinical trial of CCH for the treatment of lipoma. The company expects to complete patient enrollment in this trial during the first quarter of 2015.

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FDA expands approval of Lumizyme to treat Pompe disease

Monday, August 4, 2014 03:27 PM

The FDA has approved Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than eight years of age. In addition, the risk evaluation and mitigation strategy (REMS) known as the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program is being eliminated.

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The CenterWatch Monthly, August 2014

Friday, August 1, 2014 01:46 PM

Reality of costs and impact rain on Sunshine Act

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FDA approves Jardiance to treat type 2 diabetes

Friday, August 1, 2014 01:33 PM

The FDA has approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes.

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FDA expands approved use of Imbruvica for CLL

Thursday, July 31, 2014 01:55 PM

The FDA has expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received a Breakthrough Therapy Designation for this use.

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Noxxon initiates study of Anti-Hepcidin Spiegelmer Lexaptepid Pegol

Thursday, July 31, 2014 01:52 PM

Noxxon Pharma, a biopharmaceutical company developing proprietary therapeutics called Spiegelmers, has treated the first patient with its anti-hepcidin Spiegelmer lexaptepid pegol (NOX-H94) in a phase IIa proof-of-concept clinical trial to treat erythropoietin (EPO) hyporesponsive anemia in dialysis patients.

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Butrans Transdermal System CIII receives new dosage strength approval

Wednesday, July 23, 2014 08:00 AM

Purdue Pharma has announced that the FDA approved a new 7.5mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII. Five strengths of Butrans now will be available: 5mcg/hour, 7.5mcg/hour, 10mcg/hour, 15mcg/hour and 20mcg/hour. The Butrans Transdermal System also is approved to allow the use of two patches to facilitate dose adjustments during titration. The total dose from both patches should not exceed 20mcg/hour. Purdue expects to launch Butrans 7.5mcg/hour commercially in the U.S. in October 2014.

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Ruthigen treats first human subjects in clinical trial for RUT58-60

Tuesday, July 22, 2014 08:00 AM

Ruthigen, a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications, has treated the first human subjects with its drug candidate RUT58-60 in a 30 patient, 21-day skin irritation trial, which is expected to be completed in August.

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AiCure
CWWeekly

March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

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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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