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Study compares effects of 2 intravenous fluids on survival for critically ill patients in ICU

Djillali Annane, M.D., Ph.D., of Raymond Poincare Hospital, Garches, France, and colleagues conducted a study to compare the effects of 2 types of intravenous fluids on survival for critically ill patients in an intensive care unit.

11 Oct 2013

Constellation Pharmaceuticals awarded grant to facilitate study of epigenetic control of inflammation

Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company in the field of epigenetics, today announced that it has been awarded a research grant in collaboration with the University of Pittsburgh School of Medicine from the Cystic Fibrosis Foundation to explore the potential use of BET bromodomain inhibitors for the control of inflammation in cystic fibrosis.

10 Oct 2013

Phase 3 study of idelalisibin reports positive results in CLL patients

Following a recommendation by an independent Data Monitoring Committee (DMC), Gilead Sciences, Inc. (Nasdaq:GILD) today announced that its Phase 3 study (Study 116) evaluating idelalisib in previously-treated chronic lymphocytic leukemia (CLL) patients who are not fit for chemotherapy will be stopped early.

10 Oct 2013

Pfizer reports positive results from two tofacitinib Phase 3 trials for chronic plaque psoriasis

Pfizer Inc. announced today top-line results from two Phase 3 clinical trials of tofacitinib, a novel, oral Janus kinase inhibitor that is being investigated for the treatment of adults with moderate-to-severe chronic plaque psoriasis: OPT Compare (A3921080) and OPT Retreatment (A3921111).

10 Oct 2013

Researchers find no serious adverse effects of HPV vaccine in girls

Researchers at Karolinska Institutet in Sweden and their Danish colleagues have monitored HPV-vaccinated girls via patient data registries in order to examine the incidence of a wide range of diseases and thus determine if there are any serious adverse effects of the vaccine. Their results show no significant increase of the examined diseases in the vaccinated girls relative to their unvaccinated peers.

10 Oct 2013

Study proposes novel treatment for narcolepsy

Lancet Neurology, a prestigious journal in its domain, publishes in its last issue, an article entitled "Pitolisant versus placebo and modafinil in patients with narcolepsy: a double-blind randomised trial" authored by Y. Dauvilliers and others from the HARMONY I study group which proposes a novel treatment for this orphan disease. It is accompanied by a Commentary entitled "A need for new treatments in narcolepsy".

10 Oct 2013

Allegro receives FDA IND approval to initiate Phase II clinical studies of ALG-1001 in AMD, VMT patients

Allegro Ophthalmics, LLC, a company dedicated to establishing Integrin Peptide Therapy as the next-generation pharmaceutical category for the treatment of vascular eye diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application to begin two Phase II clinical studies of ALG-1001.

10 Oct 2013

Promedior starts Phase 2 clinical trial to evaluate PRM-151 in patients with myelofibrosis

Promedior, Inc., a clinical stage biotechnology company developing novel biologic therapeutics for the treatment of fibrosis, announced today that it has initiated a Phase 2 clinical trial to evaluate PRM-151, its lead product candidate, in patients with myelofibrosis.

10 Oct 2013

CHD Bioscience's lead product can help mitigate increasing threat of HAIs

According to a recent report issued by the Centers for Disease Control, every year more than two million people develop infections that are resistant to antibiotics. Specific healthcare-associated infections are classified as urgent threats and affect approximately 1.7 million people annually across the United States, leading to death in nearly 99,000 patients.

9 Oct 2013

ARIAD announces changes in Iclusig product labeling to reflect updated safety information

ARIAD Pharmaceuticals, Inc. today announced results of its review of updated clinical data from the pivotal PACE trial of Iclusig® (ponatinib) and actions that it is taking following consultations with the U.S. Food and Drug Administration (FDA).

9 Oct 2013

WHO approves new Japanese encephalitis vaccine to protect children in developing countries

A newly accessible vaccine against Japanese encephalitis (JE) is going to make the protection of more children in developing countries easier. The vaccine, manufactured in China, only needs to be given in one dose, it can be used for infants, and it is less expensive than other Japanese encephalitis vaccines.

9 Oct 2013

Molecular Templates secures $8.5M series C financing plus $10.6M grant from CPRIT

Molecular Templates, Inc., a biopharmaceutical company focused on the discovery and development of a new class of biologic therapeutics, announced today that it recently secured an $8.5M series C financing led by Excel Venture Management. Santé Ventures, an existing investor, also participated in the round.

9 Oct 2013

New method for improving cord blood transplant success

Starting with a discovery in zebrafish in 2007, Harvard Stem Cell Institute researchers have published initial results of a Phase Ib human clinical trial of a therapeutic that has the potential to improve the success of blood stem cell transplantation.

9 Oct 2013

Bayer HealthCare receives FDA approval for Adempas tablets

Bayer HealthCare announced today that the United States Food and Drug Administration has approved Adempas (riociguat) tablets for: (i) the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class; and (ii) the treatment of adults with pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity, improve WHO functional class and delay clinical worsening.

9 Oct 2013

Edimer doses first XLHED-affected neonate in Phase 2 trial of EDI200

Edimer Pharmaceuticals, a biotechnology company focused on developing an innovative therapy for the rare genetic disorder X-linked Hypohidrotic Ectodermal Dysplasia (XLHED), today announced the enrollment and completed dosing of the first XLHED-affected neonate in a Phase 2 trial of EDI200, the company's novel, proprietary, recombinant protein.

9 Oct 2013

Alkermes completes patient enrollment in phase 3 study of aripiprazole lauroxil in schizophrenia patients

Alkermes plc (NASDAQ: ALKS) today announced completion of patient enrollment in the pivotal, multinational phase 3 study evaluating aripiprazole lauroxil in patients with schizophrenia.

9 Oct 2013

Alnylam advances Development Candidate for ALN-AS1 for treatment of hepatic porphyrias

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it is advancing its Development Candidate for ALN-AS1, an RNAi therapeutic targeting aminolevulinate synthase-1 (ALAS-1) for the treatment of hepatic porphyrias including acute intermittent porphyria (AIP).

9 Oct 2013

Arrowhead initiates Phase 1 study of ARC-520 for treatment against chronic HBV infection

Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that it completed enrollment in a Phase 1 clinical trial of ARC-520, its RNAi-based candidate against chronic hepatitis B virus infection.

9 Oct 2013

Acorda Therapeutics initiates second clinical trial of Glial Growth Factor 2 in heart failure patients

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the first patient has been enrolled in the second clinical trial of Glial Growth Factor 2 (GGF2). This Phase 1b single-infusion trial in people with heart failure will assess tolerability of three dose levels of GGF2, and also includes several explorative measures of efficacy.

9 Oct 2013

MNK-795 for acute pain management: an interview with Dr Lynn Webster

MNK-795 is a product in development that is intended to be used for acute pain. It has some unique properties. First, it is an extended release formulation, meaning that it’s going to last more than three to four hours. It was studied to be dosed once every 12 hours, and that is unique for an acute pain formulation.

8 Oct 2013

Efficacy News and Research

Study compares effects of 2 intravenous fluids on survival for critically ill patients in ICU

Constellation Pharmaceuticals awarded grant to facilitate study of epigenetic control of inflammation

Phase 3 study of idelalisibin reports positive results in CLL patients

Pfizer reports positive results from two tofacitinib Phase 3 trials for chronic plaque psoriasis

Researchers find no serious adverse effects of HPV vaccine in girls

Study proposes novel treatment for narcolepsy

Allegro receives FDA IND approval to initiate Phase II clinical studies of ALG-1001 in AMD, VMT patients

Promedior starts Phase 2 clinical trial to evaluate PRM-151 in patients with myelofibrosis

CHD Bioscience's lead product can help mitigate increasing threat of HAIs

ARIAD announces changes in Iclusig product labeling to reflect updated safety information

WHO approves new Japanese encephalitis vaccine to protect children in developing countries

Molecular Templates secures $8.5M series C financing plus $10.6M grant from CPRIT

New method for improving cord blood transplant success

Bayer HealthCare receives FDA approval for Adempas tablets

Edimer doses first XLHED-affected neonate in Phase 2 trial of EDI200

Alkermes completes patient enrollment in phase 3 study of aripiprazole lauroxil in schizophrenia patients

Alnylam advances Development Candidate for ALN-AS1 for treatment of hepatic porphyrias

Arrowhead initiates Phase 1 study of ARC-520 for treatment against chronic HBV infection

Acorda Therapeutics initiates second clinical trial of Glial Growth Factor 2 in heart failure patients

MNK-795 for acute pain management: an interview with Dr Lynn Webster

Industry Focus eBook - Analytical Chemistry (2nd Edition) eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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