AiCure

Clinical Intelligence

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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Abeona Therapeutics receives FDA Orphan Drug Designations for Sanfilippo

Wednesday, May 14, 2014 02:54 PM

Abeona Therapeutics, a start-up company created around intellectual property licensed from Nationwide Children's Hospital to develop treatments for Sanfilippo Syndrome Types A and B, has been granted Orphan Drug Designations for its lead investigational therapies by the FDA Office of Orphan Products Development. Following the successful close of seed financing in late 2013, Abeona is raising funds to advance its gene therapy-based clinical programs for both Sanfilippo Syndrome type A and B. Phase I/II clinical trials for both diseases are anticipated to begin in 2014.

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FDA approves Bayer's Kogenate FS Antihemophilic Factor VIII (recombinant)

Monday, May 12, 2014 12:35 PM

The FDA has approved a new indication for Bayer's Kogenate FS antihemophilic factor VIII (recombinant) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A. The approval is based on data from the SPINART study, in which 84 patients ages 15 to 50 were randomized to either prophylaxis (25IU/kg three times per week) or on-demand treatment.

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FDA approves Zontivity to reduce risk of heart attacks and stroke

Friday, May 9, 2014 12:50 PM

The FDA has approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.

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November 17

PPD, Medidata join their technologies for risk-based monitoring, adaptive trial design

ERT acquires eClinical Insights in "strategic combination" to gain cloud-based trial software platform, expertise

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November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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