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BioLineRx's BL-9020 antibody holds promise in treating Type 1 diabetes

Type 1 diabetes, which usually appears in children and adolescents, affects over 30 million people worldwide. Resulting from an auto-immune reaction that destroys the pancreatic beta cells that produce insulin, the disease leads to pathologically high levels of sugar in the blood and urine, resulting in high rates of morbidity and mortality. The current treatment for Type 1 diabetes is lifetime administration of insulin by injection.

8 Jun 2015

St. Michael's Hospital researchers find novel method to combat flu virus

The flu kills hundreds of thousands of people around the world every year, yet there is essentially only one class of drugs to fight the ever-changing virus. Cases of flu resistant to this class of drugs have already been reported and researchers worry a completely new strain of flu could evolve, leading to a pandemic like the one in 1918 that killed approximately 50 million people.

8 Jun 2015

Janssen begins rolling submission of daratumumab BLA to FDA for treatment of patients with multiple myeloma

Janssen Research & Development, LLC has initiated the rolling submission of its Biologic License Application (BLA) for daratumumab to the U.S. Food and Drug Administration (FDA) for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and an IMiD.

7 Jun 2015

AWMSG recommends Daklinza (daclatasvir) for treatment of adult patients with chronic HCV infection

The All Wales Medicines Strategy Group has recommended Daklinza (daclatasvir) for the treatment of adult patients with chronic hepatitis C virus (HCV) infection. The recommendation is specifically for patients with advanced liver disease, for whom treatment options can be limited.

5 Jun 2015

Withholding ARBs for longer than two days after surgery significantly increases risk of postoperative death

Withholding angiotensin receptor blockers (ARBs) for longer than two days after surgery is associated with a significantly increased risk of postoperative death, according to a study of more than 30,000 patients in the VA health care system by researchers at UC San Francisco and the San Francisco VA Medical Center.

5 Jun 2015

Tentative FDA approval of lopinavir/ritonavir oral pellet formulation closes treatment gap for children with HIV

Infants and young children living with HIV will finally have access to an improved formulation of an antiretroviral (ARV) treatment, following the U.S. Food and Drug Administration's tentative approval last week of lopinavir/ritonavir (LPV/r) oral pellets developed by the Indian generic company Cipla.

5 Jun 2015

First phase of Amway's new $81 million nutrition manufacturing facility opens in Ada, Michigan

Amway today announced the opening of the first phase of its new $81 million USD nutrition manufacturing facility in Ada, Michigan, USA, near its world headquarters. The 317,000-square-foot facility will house select manufacturing operations for the company's Nutrilite brand of vitamins, minerals and dietary supplements, sold exclusively by Amway Business Owners.

4 Jun 2015

Updated SOGC guidelines include FIBRISTAL as only approved medical treatment for uterine fibroids

The Society for Obstetrics and Gynecology of Canada has issued updated guidelines for the management of uterine fibroids (uterine leiomyomas), which now include the first and only approved medical treatment for uterine fibroids: FIBRISTAL (ulipristal acetate).

4 Jun 2015

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

Pharmaceutical News

BioLineRx's BL-9020 antibody holds promise in treating Type 1 diabetes

St. Michael's Hospital researchers find novel method to combat flu virus

Janssen begins rolling submission of daratumumab BLA to FDA for treatment of patients with multiple myeloma

AWMSG recommends Daklinza (daclatasvir) for treatment of adult patients with chronic HCV infection

Withholding ARBs for longer than two days after surgery significantly increases risk of postoperative death

Tentative FDA approval of lopinavir/ritonavir oral pellet formulation closes treatment gap for children with HIV

First phase of Amway's new $81 million nutrition manufacturing facility opens in Ada, Michigan

Updated SOGC guidelines include FIBRISTAL as only approved medical treatment for uterine fibroids

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

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