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Newron, Zambon announce re-submission of safinamide NDA to FDA

Newron Pharmaceuticals S.p.A., a research and development company focused on novel CNS and pain therapies, and its commercial and development partner Zambon S.p.A., an international pharmaceutical company, announced today that the NDA for safinamide has been re-submitted to the US FDA.

29 Dec 2014

Protein Sciences earns Frost & Sullivan 2013 Global New Product Innovation Award

Based on its recent analysis of the influenza vaccines market, Frost & Sullivan recognises Protein Sciences with the 2013 Global New Product Innovation Award. Flublok is the world's first recombinant protein vaccine for the prevention of seasonal influenza disease to gain U.S. FDA approval.

29 Dec 2014

United Therapeutics submits pre-market approval application for use of Remodulin with implantable drug infusion system

United Therapeutics Corporation (NASDAQ: UTHR) announced today that Medtronic, Inc. (NYSE: MDT) has submitted a pre-market approval application to the U.S. Food and Drug Administration (FDA) for the use of Medtronic's SynchroMed® II implantable drug infusion system (including a newly developed catheter) for use with United Therapeutics' Remodulin® (treprostinil) Injection delivered intravenously to patients with pulmonary arterial hypertension.

25 Dec 2014

FDA approves Novo Nordisk’s weight loss injection, Saxenda

Novo Nordisk today announced that the Food and Drug Administration (FDA) has approved the new drug application (NDA) for Saxenda® (liraglutide [rDNA origin] injection), the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management.

25 Dec 2014

FDA approves Namzaric drug for treatment of moderate to severe Alzheimer's disease

Actavis plc and Adamas Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Namzaric, a fixed-dose combination (FDC) of memantine hydrochloride extended-release, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor.

25 Dec 2014

Cancer could be broken down by its evolving defense mechanism

Turning the tables, Katherine Borden at the University of Montreal's Institute for Research in Immunology and Cancer (IRIC) has evoked Star Trek's Borg in her fight against the disease.

24 Dec 2014

CorMedix signs Neutrolin sales/distribution agreement with Arabian Trade House

CorMedix Inc., a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious disease, announced today the first signed Middle East sales/distribution agreement for lead product Neutrolin with distributor Arabian Trade House in the Kingdom of Saudi Arabia.

23 Dec 2014

EB Pharma licenses tipifarnib from Janssen to study potential new therapy for HDV

EB Pharma, LLC., a subsidiary of Eiger BioPharmaceuticals, Inc., announced that it has executed an agreement with Janssen Pharmaceutica NV, for an exclusive license, to tipifarnib in the field of virology and a related, clinical stage back-up compound.

23 Dec 2014

Different antidepressants may affect pregnant women differently

About 15 percent of women in the United States suffer from anxiety disorders and depression during their pregnancies, and many are prescribed antidepressants. However little is known about how early exposure to these medications might affect their offspring as they mature into adults.

23 Dec 2014

Higher doses of vancomycin linked to increased risk of kidney damage in children, shows study

Results of a small Johns Hopkins Children’s Center study show that hospitalized children given high-dose IV infusions of the antibiotic vancomycin to treat drug-resistant bacterial infections face an increased risk for kidney damage — an often reversible but sometimes serious complication.

23 Dec 2014

Infectious disease specialist underscores the importance of flu vaccines

Flu season is in full swing, but it's not too late to get a flu vaccine. In fact, it's never been easier and more convenient.

23 Dec 2014

Injection technique provides pain relief following knee replacement surgery

It's estimated that more than half of adults in the United States diagnosed with knee osteoarthritis will undergo knee replacement surgery.

22 Dec 2014

Study emphasizes the importance of transparency in health communication for routine vaccination

A new study by Dr. Anat Gesser-Edelsburg, Dr. Yaffa Shir-Raz and Prof. Manfred S. Green from University of Haifa, School of Public Health, published in the Journal of Risk Research suggests that even parents who are not "vaccine refusers" and who usually comply with the routine vaccination programs may hesitate or refuse to vaccinate their children based on poor communication from the relevant healthcare provider, as well as concerns about the safety of the vaccine.

22 Dec 2014

Keryx Biopharmaceuticals supplies AURYXIA tablets to wholesalers in US

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) (the "Company") today announced it has begun shipping AURYXIA™ (ferric citrate) tablets to wholesalers in the U.S. Auryxia is approved for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.

22 Dec 2014

Ganciclovir drug resistance may occur more frequently in cystic fibrosis patients

A drug called ganciclovir is given to lung transplant patients to protect against a life-threatening virus that is common after transplantation.

22 Dec 2014

FDA approves Myriad’s BRACAnalysis CDx for use with ovarian cancer drug

Myriad Genetics, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for BRACAnalysis CDx to be used as the only companion diagnostic in conjunction with AstraZeneca’s drug Lynparza™ (olaparib).

22 Dec 2014

Novo Nordisk gets positive CHMP opinion for expanded use of Tresiba in children with diabetes

Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for expanded use of Tresiba® (insulin degludec) in children and adolescents aged one to 17 years with diabetes.

From Novo Nordisk 22 Dec 2014

Prostaglandin analogue eye drops reduce risk of vision loss in OAG patients

Prostaglandin analogue eye drops, the most commonly prescribed treatment for glaucoma, can greatly reduce risk of vision loss in people with open angle glaucoma (OAG), one of the leading causes of blindness, according to the first placebo-controlled trial to assess their vision-preserving effect published in The Lancet.

22 Dec 2014

FDA approves AbbVie's VIEKIRA PAK for treatment of patients with GT1 HCV infection

The U.S. Food and Drug Administration has approved AbbVie's VIEKIRA PAK, an all-oral, interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis.

21 Dec 2014

FDA approves intravenous administration of Erwinaze (asparaginase Erwinia chrysanthemi)

Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration approved the intravenous administration of Erwinaze (asparaginase Erwinia chrysanthemi). Erwinaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.

19 Dec 2014

Pharmaceutical News

Newron, Zambon announce re-submission of safinamide NDA to FDA

Protein Sciences earns Frost & Sullivan 2013 Global New Product Innovation Award

United Therapeutics submits pre-market approval application for use of Remodulin with implantable drug infusion system

FDA approves Novo Nordisk’s weight loss injection, Saxenda

FDA approves Namzaric drug for treatment of moderate to severe Alzheimer's disease

Cancer could be broken down by its evolving defense mechanism

CorMedix signs Neutrolin sales/distribution agreement with Arabian Trade House

EB Pharma licenses tipifarnib from Janssen to study potential new therapy for HDV

Different antidepressants may affect pregnant women differently

Higher doses of vancomycin linked to increased risk of kidney damage in children, shows study

Infectious disease specialist underscores the importance of flu vaccines

Injection technique provides pain relief following knee replacement surgery

Study emphasizes the importance of transparency in health communication for routine vaccination

Keryx Biopharmaceuticals supplies AURYXIA tablets to wholesalers in US

Ganciclovir drug resistance may occur more frequently in cystic fibrosis patients

FDA approves Myriad’s BRACAnalysis CDx for use with ovarian cancer drug

Novo Nordisk gets positive CHMP opinion for expanded use of Tresiba in children with diabetes

Prostaglandin analogue eye drops reduce risk of vision loss in OAG patients

FDA approves AbbVie's VIEKIRA PAK for treatment of patients with GT1 HCV infection

FDA approves intravenous administration of Erwinaze (asparaginase Erwinia chrysanthemi)

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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