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Profil Institute for Clinical Research forms strategic partnership with Gubra

Profil Institute for Clinical Research, an clinical research organization (CRO) focused on diabetes, obesity and NAFLD/NASH, announced today a strategic collaboration with Gubra ApS, a metabolic preclinical and drug discovery company, to combine expertise and resources to discover and translate into clinical research novel drug targets, compounds and biomarkers addressing metabolic disease.

4 Jun 2015

New study examines appropriate use of dietary supplementation in children with ASD

Children with Autism Spectrum Disorder (ASD) are often picky eaters, which can lead parents to suspect that their children might not be getting adequate amounts of vitamins and minerals. This sometimes leads parents of children with ASD to try nutritional supplements and dietary regimens such as gluten-free and casein-free (GFCF) diets without professional supervision.

4 Jun 2015

FDA grants exclusivity to Flublok influenza vaccine for 12 years

Protein Sciences Corporation announced that in a rare move, the FDA is granting exclusivity to Flublok for a period of 12 years. Flublok is the first vaccine awarded this very important status, demonstrating Flublok as a unique and game changing influenza vaccine.

3 Jun 2015

Study: Intravenous nutrition source may significantly reduce toxicity of platinum-based cancer drugs

A single dose of an FDA-approved intravenous nutrition source may be able to significantly reduce the toxicity and increase the bioavailability of platinum-based cancer drugs, according to a study by Carnegie Mellon University biologists published in Scientific Reports.

3 Jun 2015

RXi Pharmaceuticals receives Notice of Allowance from USPTO for novel, self-delivering RNAi platform

RXi Pharmaceuticals Corporation, a biotechnology company focused on discovering and developing innovative therapeutics, primarily in the areas of dermatology and ophthalmology, today announced that it received a Notice of Allowance from the United States Patent and Trademark Office on its novel, self-delivering RNAi platform (sd‑rxRNA).

3 Jun 2015

Ardelyx signs termination agreement with AstraZeneca, regains rights to portfolio of NHE3 inhibitors

Ardelyx, Inc., a clinical-stage biopharmaceutical company focused on cardio-renal, gastrointestinal and metabolic diseases, today announced that it has entered into a termination agreement with AstraZeneca, such that all the rights to Ardelyx's portfolio of NHE3 inhibitors, including Ardelyx's lead product candidate, tenapanor, are returned to Ardelyx.

3 Jun 2015

Baruch S. Blumberg Institute engaged to conduct study using ContraVir's new HBV therapeutic candidate

ContraVir Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that it has engaged the Baruch S. Blumberg Institute, the non-profit research sister organization of the Hepatitis B Foundation, to conduct a series of experiments using ContraVir's hepatitis B program, CMX157.

3 Jun 2015

Zapne offers better alternative to available acne treatments

After a decade of research, Zapne LLC has released its signature acne treatment, Zapne, an all-natural product to treat acne without the harsh side effects of many current regimens. Zapne offers four key advantages over most acne treatments: The treatment system is formulated from natural, non-synthetic ingredients, produces no material side effects, requires only a single 15-minute weekly application, and produces visible results quickly, in some cases after only one or a few applications.

3 Jun 2015

Genentech, Seragon, Regeneron and Avalanche receive Allicense 2015 Breakthrough Award for Deals of the Year

The Intellectual Property and Science business of Thomson Reuters, the world's leading provider of intelligent information for businesses and professionals, recently honored Genentech Partnering and Seragon, and Regeneron and Avalanche with the Allicense 2015 Breakthrough Award for Deals of the Year.

3 Jun 2015

Use of antidepressants in late pregnancy may be associated with increased risk of PPHN

An analysis of approximately 3.8 million pregnancies finds that use of antidepressants late in pregnancy may be associated with an increased risk of persistent pulmonary hypertension of the newborn (PPHN), according to a study in the June 2 issue of JAMA. However, the absolute risk was small and the risk increase appears more modest than suggested in previous studies.

3 Jun 2015

WHO accepts Elafibranor as generic name for GENFIT’s GFT505 drug candidate

GENFIT, a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announces that the World Health Organization (WHO) has accepted the international non-proprietary name (INN, or generic name) Elafibranor for its leading drug candidate previously referred to as GFT505.

3 Jun 2015

Researchers explore association between SSRI exposure in late pregnancy and risk of PPHN

Use of antidepressants late in pregnancy has been controversial since the FDA issued a Public Health Advisory in 2006 warning that the use of antidepressants in late pregnancy may increase risk of persistent pulmonary hypertension of the newborn (PPHN), a condition that typically occurs in term or near-term infants and presents within hours of birth with severe respiratory failure requiring intubation and mechanical ventilation.

2 Jun 2015

Celltrion receives approval for infliximab biosimilar antibody from Brazil's ANVISA

Hospira, Inc., a global leader in biosimilars, today announced that its partner, Celltrion – a global biopharmaceutical company – has received approval from ANVISA – the National Health Surveillance Agency in Brazil – for Remsima (infliximab), the first biosimilar monoclonal antibody approved for use in Brazil.

2 Jun 2015

Elusys’ Anthim BLA to treat inhalational anthrax accepted for review by the FDA

Elusys Therapeutics, Inc. today announced the U.S. Food and Drug Administration has accepted for filing and review its Biologics License Application for Anthim® (obiltoxaximab) for the treatment and prevention of inhalational anthrax, a top bioterror threat which was submitted on March 20, 2015. Anthim is a candidate for future acquisition into the Strategic National Stockpile, the U.S. government's repository of critical medical supplies for biowarfare preparedness.

2 Jun 2015

Intermountain Precision Genomics: Precision medicine can benefit advanced cancer patients without increasing costs

Two new studies conducted by Intermountain Healthcare’s Intermountain Precision Genomics reveal that precision medicine can improve survival in advanced cancer patients – and do so without increasing costs.

2 Jun 2015

Stable IV formulation to treat systemic susceptible and resistant Gram-positive hospital-acquired infections

MGB Biopharma, a biopharmaceutical company developing a truly novel class of anti-infectives, to address the major global problem of antibiotic resistance - announces that it has developed a stable intravenous (IV) formulation of MGB-BP-3, designed for the treatment of systemic susceptible and resistant Gram-positive hospital-acquired infections.

2 Jun 2015

Helsinn's Akynzeo for CINV prevention receives EC approval

Helsinn, the Swiss Group focused on building quality cancer care, announces today that on 27th May 2015, the European Commission (EC) approved Akynzeo® (netupitant-palonosetron) for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy in the European Union.

2 Jun 2015

FDA approves Actavis ANDA for guaifenesin/pseudoephedrine tablets to relieve chest congestion

Actavis plc and its partner Perrigo Company plc announced today that Actavis has received U.S. Food and Drug Administration approval for its Abbreviated New Drug Application for guaifenesin/pseudoephedrine tablets and that Perrigo will begin shipments in time for the cough/cold season to its retail and wholesale customers in the U.S. The product will be packaged and marketed under store and proprietary brands and will be a high quality, value alternative to Mucinex® D tablets.

2 Jun 2015

Green Cross Biotherapeutics starts construction on new biopharmaceutical facility in Montreal

This is with great pride that Green Cross Biotherapeutics Inc. kicked off construction today on its biopharmaceutical facility that will be located on the Montreal Technoparc's Saint-Laurent Campus. The CA$315 million project represents one of the largest green field investment projects in Canada in the biopharmaceutical industry, giving place to the construction of the first intravenous immunoglobulin (IVIG) and albumin manufacturing plant in Canada.

2 Jun 2015

Telbivudine drug prevents perinatal transmission of HBV

The antiviral drug telbivudine prevents perinatal transmission of hepatitis B virus (HBV), according to a study in the June issue of Clinical Gastroenterology and Hepatology, the official clinical practice journal of the American Gastroenterological Association.

2 Jun 2015

Pharmaceutical News

Profil Institute for Clinical Research forms strategic partnership with Gubra

New study examines appropriate use of dietary supplementation in children with ASD

FDA grants exclusivity to Flublok influenza vaccine for 12 years

Study: Intravenous nutrition source may significantly reduce toxicity of platinum-based cancer drugs

RXi Pharmaceuticals receives Notice of Allowance from USPTO for novel, self-delivering RNAi platform

Ardelyx signs termination agreement with AstraZeneca, regains rights to portfolio of NHE3 inhibitors

Baruch S. Blumberg Institute engaged to conduct study using ContraVir's new HBV therapeutic candidate

Zapne offers better alternative to available acne treatments

Genentech, Seragon, Regeneron and Avalanche receive Allicense 2015 Breakthrough Award for Deals of the Year

Use of antidepressants in late pregnancy may be associated with increased risk of PPHN

WHO accepts Elafibranor as generic name for GENFIT’s GFT505 drug candidate

Researchers explore association between SSRI exposure in late pregnancy and risk of PPHN

Celltrion receives approval for infliximab biosimilar antibody from Brazil's ANVISA

Elusys’ Anthim BLA to treat inhalational anthrax accepted for review by the FDA

Intermountain Precision Genomics: Precision medicine can benefit advanced cancer patients without increasing costs

Stable IV formulation to treat systemic susceptible and resistant Gram-positive hospital-acquired infections

Helsinn's Akynzeo for CINV prevention receives EC approval

FDA approves Actavis ANDA for guaifenesin/pseudoephedrine tablets to relieve chest congestion

Green Cross Biotherapeutics starts construction on new biopharmaceutical facility in Montreal

Telbivudine drug prevents perinatal transmission of HBV

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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