Clinical Intelligence

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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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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January 26

2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

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January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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