Efficacy News and Research

RSS

GSK and Prosensa commence GSK2402968 Phase III study in DMD

GlaxoSmithKline and Prosensa today announced that the first patient has commenced treatment in the Phase III clinical study investigating GSK2402968, in ambulant boys with Duchenne Muscular Dystrophy (DMD), who have a dystrophin gene mutation amenable to an exon 51 skip (up to 13% of boys with DMD). Commencement of this study confirms previously announced plans to progress this asset into Phase III.

20 Jan 2011

Positive top-line results from TC-5619 Phase 2 trial in patients with schizophrenia

Targacept, Inc. today announced positive top-line results from a Phase 2 clinical proof of concept trial to assess TC-5619 as an augmentation therapy to improve cognition in patients with schizophrenia.

20 Jan 2011

Pluristem completes parallel scientific advisory process with EMA and FDA for PLX-PAD clinical development

Pluristem Therapeutics, Inc. today announced the successful completion of a parallel scientific advisory process with the European Medical Agencies (EMA) and the U.S. Food and Drug Administration (FDA) regarding the Company's planned clinical development program for PLX-PAD.

19 Jan 2011

New long-term survival data from OPUS, CRYSTAL studies demonstrate strong tumor shrinkage of Erbitux

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today highlighted a further analysis of the large randomized Phase II OPUS study demonstrating an association between early tumor shrinkage and long-term median overall survival (OS) of more than 2 years for patients with KRAS wild-type metastatic colorectal cancer (mCRC) treated with Erbitux® (cetuximab) plus FOLFOX standard chemotherapy.

19 Jan 2011

Convalescent plasma therapy may reduce mortality rate in patients with H1N1 infection: Study

A study published in the February 15 issue of Clinical Infectious Diseases suggests that convalescent plasma may reduce the death rate in patients severely ill with this type of influenza.

19 Jan 2011

Magnetic maneuverable capsule safe and well-tolerated in the stomach

A study from researchers in Germany showed that magnetic maneuvering of a modified capsule endoscope in the stomach of healthy volunteers under clinical conditions is safe, well-tolerated, and technically feasible. Maneuverability of the capsule within the stomach was excellent and visualization of the gastric mucosa, the inner lining of the stomach, was satisfactory in the majority of subjects.

19 Jan 2011

Antidepressant medication reduces frequency and severity of menopausal hot flashes

Women who were either in the transition to menopause or postmenopausal experienced a reduction in the frequency and severity of menopausal hot flashes with the use of the antidepressant medication escitalopram, compared to women who received placebo, according to a study in the January 19 issue of JAMA.

19 Jan 2011

PAM50 test is now available to classify breast cancer subtypes

ARUP Laboratories, a leading national clinical and anatomic pathology reference laboratory and a leader in innovative laboratory research and development, today announced the availability of a new laboratory developed test designed to classify breast cancer into clinically significant molecular subtypes that are important for the management of the disease.

18 Jan 2011

Forest Laboratories third quarter net sales increase 6.7% to $1,063.9 million

Forest Laboratories, Inc., an international pharmaceutical manufacturer and marketer, announced that reported earnings per share equaled $1.11 in the third quarter of fiscal 2011 after taking a charge for a new product licensing fee of $66.1 million or $0.23 per share, net of tax.

18 Jan 2011

Alexza completes FDA review for AZ-004 NDA

Alexza Pharmaceuticals, Inc. announced today that it completed an End-of-Review meeting with the U.S. Food and Drug Administration (FDA or Agency) for the AZ-004 New Drug Application (NDA), and has received the official FDA minutes from the meeting. In December 2010, Alexza held the End-of-Review meeting in response to a Complete Response Letter (CRL) received in October 2010.

18 Jan 2011

RTS,S offers 46 percent protection against malaria for at least 15 months after vaccination, Study finds

A Phase II trial published Friday in Lancet Infectious Diseases has shown that RTS,S, the "experimental malaria vaccine from GlaxoSmithKline provides African children with long-lasting protection" against malaria, Reuters reports.

18 Jan 2011

Regeneron, Bayer and SERI initiate new VEGF Trap-Eye Phase 3 clinical trial in myopic CNV

Regeneron and Bayer HealthCare announced initiation of a new Phase 3 clinical trial in collaboration with the Singapore Eye Research Institute investigating the efficacy and safety of VEGF Trap-Eye (aflibercept ophthalmic solution) in patients with choroidal neovascularisation (CNV) of the retina as a result of pathologic myopia.

18 Jan 2011

Health Canada requests Osiris for additional information in support of Prochymal approval

Osiris Therapeutics, Inc. today announced that Health Canada has requested additional information in support of the Company's application for approval of Prochymal, a stem cell therapy, for the treatment of graft vs. host disease (GvHD).

14 Jan 2011

Unintended direct conflict between pharmaceutical marketing and public health

Drugs that pharmaceutical companies market most aggressively to physicians and patients tend to offer less benefit and more harm to most patients - a phenomenon described as the "inverse benefit law" in a paper from the University of Texas Medical Branch at Galveston.

14 Jan 2011

ICON announces acquisition of Oxford Outcomes

ICON plc,, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the expansion of its Late Phase and Outcomes Research services through the acquisition of Oxford Outcomes, a leading international health outcomes consultancy.

14 Jan 2011

BIOTRONIK announces FDA IDE approval and first patient enrollment for TOCCASTAR clinical trial

BIOTRONIK SE Co. & KG highlights two key milestones toward receiving premarket approval (PMA) of the TactiCath, a novel technology for treating atrial fibrillation (AF): FDA IDE (investigational device exemption) approval and the first patient enrollment of the TOCCASTAR (TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation) clinical trial.

14 Jan 2011

Merck announces changes in vorapaxar clinical studies

Merck today provided the following statement on the changes to the clinical studies for vorapaxar, one of the Company's investigational cardiovascular medicines, following an announcement from the two academic centers leading the studies of vorapaxar.

14 Jan 2011

Adjunctive lacosamide reduces seizures and improves responder rates

Comprehensive analyses of pooled data from three randomized, double-blind, placebo-controlled Phase II/III trials showing the efficacy and tolerability of Vimpat® (lacosamide) C-V for patients with partial-onset seizures, regardless of the type of concomitant AED used, have been published in the drug evaluation journal, CNS Drugs.

13 Jan 2011

BioCryst reports positive results from peramivir Phase 3 study in influenza

BioCryst Pharmaceuticals, Inc. today announced top-line results from one of its two Phase 3 studies of intravenous (i.v.) peramivir for the treatment of patients hospitalized with influenza, and provided an update regarding its peramivir program.

13 Jan 2011

Family physicians often uncomfortable in discussing IUDs with patients

Intrauterine devices (IUDs) for contraception are safe and effective, but only a small fraction of women in the United States use them.

13 Jan 2011

Efficacy News and Research

GSK and Prosensa commence GSK2402968 Phase III study in DMD

Positive top-line results from TC-5619 Phase 2 trial in patients with schizophrenia

Pluristem completes parallel scientific advisory process with EMA and FDA for PLX-PAD clinical development

New long-term survival data from OPUS, CRYSTAL studies demonstrate strong tumor shrinkage of Erbitux

Convalescent plasma therapy may reduce mortality rate in patients with H1N1 infection: Study

Magnetic maneuverable capsule safe and well-tolerated in the stomach

Antidepressant medication reduces frequency and severity of menopausal hot flashes

PAM50 test is now available to classify breast cancer subtypes

Forest Laboratories third quarter net sales increase 6.7% to $1,063.9 million

Alexza completes FDA review for AZ-004 NDA

RTS,S offers 46 percent protection against malaria for at least 15 months after vaccination, Study finds

Regeneron, Bayer and SERI initiate new VEGF Trap-Eye Phase 3 clinical trial in myopic CNV

Health Canada requests Osiris for additional information in support of Prochymal approval

Unintended direct conflict between pharmaceutical marketing and public health

ICON announces acquisition of Oxford Outcomes

BIOTRONIK announces FDA IDE approval and first patient enrollment for TOCCASTAR clinical trial

Merck announces changes in vorapaxar clinical studies

Adjunctive lacosamide reduces seizures and improves responder rates

BioCryst reports positive results from peramivir Phase 3 study in influenza

Family physicians often uncomfortable in discussing IUDs with patients

How can microdialysis benefit drug development

Global and Local Efforts to Take Action Against Hepatitis

Addressing Important Cardiac Biology Questions with Shotgun Top-Down Proteomics

Latest News