Theorem Clinical Research

Clinical Intelligence

Debiopharm Group initiates phase I study of Debio 1450 for staphylococcal infections

Thursday, June 19, 2014 02:16 PM

Debiopharm Group, a Swiss-based global biopharmaceutical company developing prescription drugs that target unmet medical needs as well as companion diagnostics, has launched a phase I dose-escalation study of Debio 1450 (previously known as AFN-1720), a highly potent anti-infective agent that is selectively active against a large number of Staphylococcus species, including all known resistant strains such as methicillin-resistant S. aureus (MRSA) and vancomycin-intermediate S. aureus (VISA).

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Amgen joins NCI to accelerate development of personalized cancer treatments

Tuesday, June 17, 2014 10:26 AM

Amgen will collaborate with the National Cancer Institute (NCI), part of the NIH, and other public and private sector partners, on the Lung Master Protocol (Lung-MAP), a new clinical trial program that will use biomarker-driven research and genomic profiling to match squamous cell lung cancer patients to investigational treatments based on their individual cancer profiles. Lung-MAP is the first trial of its kind to study a large number of rare lung cancer subsets under one trial protocol.

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FDA approves Bayer's Gadavist Injection for breast cancer

Thursday, June 12, 2014 12:41 PM

The FDA has approved a new indication for Bayer Healthcare’s Gadavist (gadobutrol) injection for intravenous use with MRI of the breast to assess the presence and extent of malignant breast disease. The approval is based on priority review of two, multi-center, phase III studies (GEMMA-1 and GEMMA-2) conducted in 13 countries.

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FDA approves antihemophilic factor, Fc fusion protein hemophilia A

Thursday, June 12, 2014 11:33 AM

The FDA has approved Eloctate, Antihemophilic Factor (Recombinant), Fc fusion protein, for use in adults and children who have hemophilia A. Eloctate is the first hemophilia A treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.

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BioDelivery Sciences receives FDA approval for BUNAVAIL for opioid dependence

Monday, June 9, 2014 10:24 AM

BioDelivery Sciences International has received approval of the NDA for BUNAVAIL (buprenorphine and naloxone) buccal film (CIII) from the FDA. BUNAVAIL is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. BDSI expects to launch BUNAVAIL late in the third quarter of 2014.

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Caris Life Sciences shows positive results for comprehensive tumor profiling

Friday, June 6, 2014 02:06 PM

Data from more than 30 clinical has reinforce comprehensive tumor profiling as a “game changer” for oncologists, enabling them to personalize cancer treatments more precisely than ever before. The studies, conducted by Caris Life Sciences in cooperation with academic and clinical institutions, focused on treatment-resistant, rare or aggressive cancers where patients have limited treatment options.

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Merck globally enrolling treatment-naïve adults with HIV-1

Friday, June 6, 2014 01:57 PM

Merck has announced that the first patient has been enrolled in the company’s global phase III clinical trial, ONCEMRK. ONCEMRK is assessing a once-daily investigational formulation of ISENTRESS (raltegravir), known as reformulated raltegravir, as part of combination HIV therapy for treatment-naïve HIV-1-infected adults. ISENTRESS film-coated tablets currently are administered twice daily in accordance with the approved prescribing Information.

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Lilly's CYRAMZA (ramucirumab) produces positive phase III results

Friday, June 6, 2014 01:46 PM

Eli Lilly has announced detailed results from REVEL, a global phase III study of CYRAMZA (ramucirumab) in combination with chemotherapy in patients with second-line non-small cell lung cancer (NSCLC). REVEL is the first positive phase III study of a biologic in combination with chemotherapy to demonstrate improved overall survival compared to chemotherapy alone in second-line NSCLC.

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The CenterWatch Monthly, June 2014

Monday, June 2, 2014 07:59 AM

CRO market poised for growth and consolidation

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Trimel receives FDA approval for Natesto Nasal Gel male low testosterone

Friday, May 30, 2014 01:33 PM

The FDA has approved Trimel Pharmaceuticals’ Natesto (testosterone), formerly CompleoTRT, a testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Natesto is self-administered via a nasal applicator, thereby minimizing the risk of secondary exposure to testosterone of women or children.

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