Theorem Clinical Research

Clinical Intelligence

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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Benitec initiates patient dosing of TT-034 in patients with hepatitis C

Friday, May 30, 2014 01:22 PM

RNAi-based therapeutics company Benitec Biopharma has dosed the first patient in its “first in man,” phase I/IIa clinical trial for TT-034, a ddRNAi-based therapeutic, designed to treat and potentially cure hepatitis C (HCV) with a single injection.

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FDA approves ALOXI for pediatric, chemotherapy-induced nausea

Thursday, May 29, 2014 01:50 PM

Eisai and Helsinn Group have announced the FDA approval of ALOXI (palonosetron HCl) injection for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy, in children aged one month to less than 17 years.

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AZTherapies to start enrolling for phase III study of ALZT-OP1 in early Alzheimer's

Friday, May 23, 2014 11:27 AM

AZTherapies, a company developing novel treatments for Alzheimer's disease based on technology licensed from Massachusetts General Hospital, has received notice from FDA that it may proceed with the phase III clinical study submitted in its IND application. This study is for its lead program, ALZT-OP1, a novel combination therapy for the prevention and treatment of early Alzheimer's disease (AD).

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Inhibikase Therapeutics receives Orphan Drug Designation for PML

Thursday, May 22, 2014 11:08 AM

Inhibikase Therapeutics, a developer of products to treat infectious diseases with little or no resistance, has received Orphan Drug Designation for imatinib to treat progressive multifocal leukoencephalopathy (PML) from the FDA.

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Pfizer receives kosher certification for Elelyso for injection

Monday, May 19, 2014 09:52 AM

Pfizer has announced that the Orthodox Union (OU) has granted kosher certification to ELELYSO (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of Type 1 Gaucher disease. ELELYSO is the first prescription medication to be certified kosher by the OU, a milestone for the brand which was approved by the FDA in May 2012. 

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Pernix to acquire Treximet migraine tablets from GlaxoSmithKline

Thursday, May 15, 2014 11:23 AM

Pernix Therapeutics, a specialty pharmaceutical company, has signed an agreement with GlaxoSmithKline to acquire the U.S. rights to Treximet (sumatriptan / naproxen sodium) for the acute treatment of migraine attacks with or without aura in adults.

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