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It's too early to know health effects of e-cigarettes

Cigarettes have been convicted of many crimes over the years. But the jury's still out on whether their younger, more fashionable cousins - electronic cigarettes, or e-cigarettes - will meet the same fate.

24 Dec 2014

PTC begins rolling NDA submission for Translarna to treat nmDMD

PTC Therapeutics, Inc. today announced that it has commenced a rolling submission of a New Drug Application to the United States Food and Drug Administration for Translarna™ for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).

23 Dec 2014

AMIC files de novo submission with FDA for Y-90 RadioGel device, seeks Class II reclassification

Advanced Medical Isotope Corporation, a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications, today announced that it has filed a de novo submission with the Food and Drug Administration for marketing clearance for its patented Y-90 RadioGel(TM) device pursuant to Section 513(f)(2) of the U.S. Food, Drug and Cosmetic Act.

23 Dec 2014

EMA validates Synageva's sebelipase alfa MAA for LAL Deficiency

Synageva BioPharma Corp., a biopharmaceutical company developing therapeutic products for rare disorders, today announced validation by the European Medicines Agency of the Marketing Authorization Application for sebelipase alfa for LAL Deficiency.

23 Dec 2014

Conference raises concerns regarding lack of scientific data on products containing botanicals

The challenges related to assessing the safety of botanicals in foods and food supplements and regulating their use were highlighted at a conference held in Denmark in November 2014.

23 Dec 2014

Shandong Taibang Biological Products earns GMP certification for new production facility

China Biologic Products, Inc., a leading fully integrated plasma-based biopharmaceutical company in China, today announced that its majority-owned subsidiary, Shandong Taibang Biological Products Co. Ltd., has received Good Manufacturing Practices ("GMP") certification from the China Food and Drug Administration (the "CFDA") for its new coagulation factor production facility.

23 Dec 2014

IGI Laboratories submits three additional ANDAs to FDA

IGI Laboratories, Inc., a New Jersey based specialty generic pharmaceutical company, today announced it has submitted three additional abbreviated new drug applications (ANDAs) to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions in 2014 to eleven, with twenty-two submissions now pending at the FDA.

23 Dec 2014

People urged to seek healthy eating information from registered dietitian nutritionists

For many people, the New Year is an opportunity for a fresh look at life - a time to resolve to return to or even begin a healthy lifestyle.

23 Dec 2014

Abbvie’s HOLKIRA PAK for chronic genotype 1 Hepatitis C treatment receives Health Canada approval

AbbVie receives Health Canada approval for HOLKIRA PAK (ombitasvir/paritaprevir/ritonavir film-coated tablets; dasabuvir film-coated tablets), an all-oral, short-course (12 weeks for the majority of patients), interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with cirrhosis.

23 Dec 2014

First successful vaccination of deer against chronic wasting disease

Researchers at NYU Langone Medical Center and elsewhere say that a vaccination they have developed to fight a brain-based, wasting syndrome among deer and other animals may hold promise on two additional fronts: Protecting U.S. livestock from contracting the disease, and preventing similar brain infections in humans.

23 Dec 2014

Three tips to maintain regular sleep schedule

Does your holiday wish list include getting more sleep? With an increase in parties and get-togethers, increased food and alcohol consumption and a general disruption of normal routines, the month of December can be exhausting.

23 Dec 2014

Research shows modern humans have less bone density than earlier human ancestors

New research shows that modern human skeletons evolved into their lightly built form only relatively recently — after the start of the Holocene about 12,000 years ago, and even more recently in some human populations.

23 Dec 2014

K2M completes first surgical case using innovative corpectomy cage system

K2M Group Holdings, Inc., a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced the completion of the first surgical case using the Company's CAPRI™ Corpectomy Cage System, an expandable vertebral body replacement device that provides structural stability following a corpectomy or vertebrectomy.

23 Dec 2014

Eating habits and brain chemistry: an interview with Dr Kevin Hall

Several times every day, we choose when, where, what, with whom, and how much to eat. Many of these eating decisions have become automatic and don’t require cognitive effort.

22 Dec 2014

Can-Fite BioPharma begins dosing in CF102 Phase II liver cancer trial

Can-Fite BioPharma Ltd., a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer and inflammatory diseases, today announced that it has dosed the first patient in a Phase II trial for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer.

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

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

Food News and Research

It's too early to know health effects of e-cigarettes

PTC begins rolling NDA submission for Translarna to treat nmDMD

AMIC files de novo submission with FDA for Y-90 RadioGel device, seeks Class II reclassification

EMA validates Synageva's sebelipase alfa MAA for LAL Deficiency

Conference raises concerns regarding lack of scientific data on products containing botanicals

Shandong Taibang Biological Products earns GMP certification for new production facility

IGI Laboratories submits three additional ANDAs to FDA

People urged to seek healthy eating information from registered dietitian nutritionists

Abbvie’s HOLKIRA PAK for chronic genotype 1 Hepatitis C treatment receives Health Canada approval

First successful vaccination of deer against chronic wasting disease

Three tips to maintain regular sleep schedule

Research shows modern humans have less bone density than earlier human ancestors

K2M completes first surgical case using innovative corpectomy cage system

Eating habits and brain chemistry: an interview with Dr Kevin Hall

Can-Fite BioPharma begins dosing in CF102 Phase II liver cancer trial

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

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

FDA approves intravenous administration of Erwinaze (asparaginase Erwinia chrysanthemi)

Enhancing confidence in chemical ionization spectrometry data eBook

Improving healthcare sustainability through carbon data

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

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