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30 Mar 2017 07:38
Cold Chain Considerations for Cell Therapy Clinical Trials 
photoAmong the most important components to a successful cell therapy clinical trial is the necessity of controlling the environmental conditions to which the biological product is exposed. To understand how sponsors can reduce risk and position their product well for commercialization, I sat down with Kristen Franklin, Client Services Manager, Cell Therapy and Amy Hendricks, Project Manager, both from Fisher BioServices.

30 Mar 2017 06:51
Roche’s Multiple Sclerosis Drug is First Disease-Modifying Therapy Approved by FDA 
photoThe US Food and Drug Administration (FDA) has approved Roche’s Ocrevus (ocrelizumab) for the treatment of both relapsing and primary progressive multiple sclerosis (PPMS).

30 Mar 2017 06:50
Home-Based Smartphone Male Fertility Test Could Improve Access to Sperm Testing 
photoResearchers at Brigham and Women’s Hospital and Massachusetts General Hospital have developed a system that analyses the quantity and quality of sperm through an easy-to-use smartphone app.

29 Mar 2017 06:38
Study Finds Only Half of all UK Healthcare Professionals Report Pharma Perks 
photoAccording to a study conducted by research organization, RAND Europe, 55 percent of UK healthcare professionals who received payment or another perk from the pharmaceutical industry in 2015, disclosed that information to a publicly-accessible database.

29 Mar 2017 06:37
New PARP Inhibitor Drug Approved to Treat Women with Recurrent Ovarian Cancer 
photoThe US Food and Drug Administration (FDA) has approved Zejula (niraparib) as a maintenance treatment for women with certain types of recurrent cancers, including epithelial ovarian, fallopian tube, and primary peritoneal cancer.

28 Mar 2017 06:50
Nektar’s Opioid Analgesic Meets Endpoints in Phase III Clinical Trial 
photoNektar Therapeutics has announced that their opioid analgesic has met both its primary and secondary endpoint in a recent Phase III efficacy study.

28 Mar 2017 06:49
Small Molecule May Disrupt Biofilm Formation on Implantable Medical Devices 
photoResearchers at Trinity College Dublin in Ireland have identified a small molecule capable of preventing bacterial biofilms from growing on medical implants.

27 Mar 2017 08:51
FDA Approves PD-L1 Immunotherapy Developed by Pfizer and Merck KGaA 
photoPfizer and Merck KGaA’s PD-L1 inhibitor, Bavencio (avelumab), has become the first immunotherapy to be approved by the US Food and Drug Administration (FDA) to treat a rare form of skin cancer, known as metastatic Merkel cell carcinoma (MCC).

27 Mar 2017 08:50
New Approach Could Allow Red Blood Cells to be Manufactured 
photoUK researchers at the University of Bristol have developed an immortal line of early adult erythroblasts capable of continuously producing mature red blood cells.

24 Mar 2017 07:32
Lung Cancer Recurrence Could Be Better Detected Using Biomarker Blood Test 
photoThe results of a recent prospective clinical trial found that a biomarker blood test could detect lung cancer recurrence a full six months before imaging methods could spot the disease.

24 Mar 2017 07:31
Use of Testosterone Treatments Boosted by DTC Ad Campaigns 
photoThose with a stake in the pharmaceutical industry often question the effectiveness of direct-to-consumer (DTC) advertising, and whether it truly influences consumers to talk to their doctors about medical conditions and perhaps even ask for drugs by name.

23 Mar 2017 08:57
FDA Approves New Drug for Parkinson’s Disease 
photoNewron Pharmaceuticals’ Xadago (safinamide) has been approved by the US Food and Drug Administration (FDA) as an add-on medication for patients with Parkinson’s disease.

23 Mar 2017 08:56
Amgen Identifies Issue with Patient Access to PCSK9 Inhibitor 
photoMost US patients hoping to get their PCSK9 inhibitor medications covered by their prescription drug plan are being denied, according to two new studied conducted by Amgen.

22 Mar 2017 08:06
Will Pharmaceutical Serialization Solve All of Our Drug Counterfeiting Problems? 
In response to the growing threat posed by drug counterfeiting, international regulators have begun implementing guidelines aimed at increasing control over the pharmaceutical supply chain. Will these efforts be enough?

22 Mar 2017 07:01
Smartphone App Created Using Apple’s ResearchKit Used to Conduct Asthma Clinical Studies 
photoResearchers at the Icahn School of Medicine at Mount Sinai have conducted a large-scale, observational study of asthma patients using the Apple ResearchKit framework and the Asthma Health app on patients’ iPhones.

22 Mar 2017 07:00
IBS Patients Taking Viberzi May Be at Increased Risk of Pancreatitis 
photoAccording to a recent drug safety communication issued by the US Food and Drug Administration (FDA), patients with irritable bowel syndrome (IBS) with diarrhea should not be treated using Viberzi (eluxadoline), if they do not have a gallbladder.

16 Mar 2017 07:23
FDA Advisory Committees Find Benefits of Endo’s Opioid Drug Don’t Outweigh Risks 
photoAdvisory committees to the US Food and Drug Administration (FDA) have voted that the risk of abuse associated with Endo International’s opioid drug, Opana ER (oxymorphone hydrochloride extended release), outweighs its benefits.

16 Mar 2017 07:22
CRISPR Gene Editing Could Prevent Vision Loss Caused by Retinal Disease 
photoAccording to a new study published in the journal, Nature Communications, silencing a gene, known as Nrl, using CRISPR could preserve photoreceptors in the eye.

15 Mar 2017 07:17
Mylan, Genentech and Roche Reach Agreement on Biosimilar Cancer Drug 
photoMylan’s biosimilar version of the breast cancer drug, Herceptin, may soon be available, thanks to a settlement reached between the pharmaceutical company and the makers of the reference biologic, Genentech and Roche.

15 Mar 2017 07:16
Needle-Free Self-Administered Vaccines Could Be in Our Future 
photoA needle-free device developed by researchers at UC Berkeley, could be the next big thing in vaccine delivery technology.

14 Mar 2017 08:44
The Future of Real-World Evidence 
photoLife Sciences companies are performing advanced analytics, including cohort and predictive analytics, on top of these Real-World Evidence (RWE) data sources to understand the performance of their drugs and devices when used by actual, non-clinical trials patients.

14 Mar 2017 07:13
Trump Nominates Scott Gottlieb for FDA Commissioner Position 
photoFormer Deputy Commissioner for Medical and Scientific Affairs of the US Food and Drug Administration (FDA), Scott Gottlieb, has been nominated by President Donald Trump to be the next head of the agency.

14 Mar 2017 07:13
Allergan’s Dry Eye Ad Campaign Aims to Raise Disease Awareness 
photoUsing its new ad campaign titled, “Eyepowerment,” global pharmaceutical company Allergan hopes to inspire individuals experiencing these symptoms to talk to their doctor about treatment options for the eye condition.

13 Mar 2017 06:35
New Zika Virus Research Sheds Light on Tissues Infected with the Pathogen 
photoResearchers at Oregon Health and Science University (OHSU), have identified multiple tissue types infected by the mosquito-borne Zika virus.

13 Mar 2017 06:34
Researchers Work Towards Building a Fully-Synthetic Yeast Genome 
photoA global research team working on the Synthetic Yeast Project (Sc2.0), has assembled five new synthetic yeast chromosomes for the commonly-used Baker's yeast (Saccharomyces cerevisiae).

10 Mar 2017 08:00
European Pharmaceutical Associations Urge Physicians to Exercise Caution When Prescribing Biosimilars 
photoThree pharmaceutical industry groups in the EU have published a document aimed at helping physicians decide when it’s medically appropriate to switch a patient from a biologic to a biosimilar.

10 Mar 2017 07:59
First Drug for Frequent Nighttime Urination Approved By FDA 
photoSerenity Pharmaceuticals’ nasal spray, Noctiva, has been approved by the US Food and Drug Administration (FDA) to treat patients who experience frequent nighttime urination.

09 Mar 2017 07:48
Trial Finds Oral Drug Could Become Standard of Care for In Vitro Fertilization 
photoGlobal healthcare and research company, Abbott, has announced the results of their phase III clinical trial assessing the efficacy of oral dydrogesterone in women undergoing in vitro fertilization (IVF).

09 Mar 2017 07:47
General Mills Invests $500,000 in Wheat Alternative Grain 
photoCereal giant, General Mills, has contributed $500,000 in research funding for Kernza, a perennial grain related to wheat.

08 Mar 2017 07:23
Some Women with Breast Cancer May Benefit from Soy Compound 
photoFoods containing soy have long been considered off-limits to women being treated for breast cancer, due to their high content of estrogen-like compounds known as isoflavones.

08 Mar 2017 07:23
Preserving Fertility During Chemotherapy Using Available Cancer Drug 
photoEverolimus, a drug used to slow tumor growth, could prevent chemotherapy-induced infertility, according to researchers at NYU Langone Medical Center.

07 Mar 2017 09:48
Pharmaceutical Industry Cannibalization: The Launch of Authorized Generics After the Loss of Market Exclusivity 
photoOnce a drug begins to reach the end of its patent period, it’s vulnerable to being scooped up by generic drugmakers who seek to develop a copycat version of the medication. Authorized generics are identical to the company’s branded product in terms of both active and inactive excipient ingredients; the only thing missing is the brand name and packaging that comes along with it.

07 Mar 2017 08:45
Research First: Mouse Embryo Grown From Stem Cells in Culture 
photoIn a world first, researchers at the University of Cambridge have grown an artificial mouse embryo using a stem cell mix in cell culture.

07 Mar 2017 08:44
Drug Therapy versus Psychotherapy for Mental Health Disorders: Which is More Accepted by Patients? 
photoA review study recently published in the American Psychological Association’s journal, Psychotherapy, has found that patients are less likely to complete a treatment program for mental disorders if it involves taking psychotropic drugs.

06 Mar 2017 08:03
Study: Physicians Over-Order Patient Liver Blood Tests 
photoAccording to a study conducted at the University of Michigan, doctors may be increasing costs and patient worry when they order multiple blood tests at once.

06 Mar 2017 08:03
Canadian Meat Producers Can Now Irradiate Beef to Improve Food Safety 
photoHealth Canada has announced that meat producers will soon be permitted to sell fresh and frozen ground beef that’s been irradiated.

03 Mar 2017 08:05
Gene Therapy Could Be Effective Cure for Sickle Cell Disease 
photoA patient in France with sickle cell disease has been successfully treated for the condition using gene therapy.

03 Mar 2017 08:02
Drug for Dust Mite Allergy Approved by FDA 
Allergy, FDA, Drug DeliveryGood news for house dust mite allergy sufferers: the FDA has approved Merck, Sharp & Dohme Corp.’s Odactra to treat allergic rhinitis and conjunctivitis in patients between the ages of 18 and 65.

02 Mar 2017 09:15
Five Ways to Optimize Capsule Filling Production 
photoIf your product’s ideal formulation is a capsule, there a few things you should consider before manufacturing.

02 Mar 2017 07:58
Metered-Dose Inhalers May Be Less Accurately Used Than Previously Thought 
photoResearchers at Rice University and Baylor College of Medicine have found that many metered-dose inhalers used in the maintenance of chronic lung diseases, may be dispensing just half of the active ingredient in each puff.

02 Mar 2017 07:57
FDA Approves Nanocoated Cardiac Stent as Alternative Device for Heart Disease Patients 
Despite the debate surrounding the procedure, medical device company CeloNova Biosciences believe their nanocoated stent may be a good alternative to traditional drug-eluting stents for some patients.

01 Mar 2017 07:43
Experimental Therapy for Midgut Neuroendocrine Tumors Investigated in Clinical Trial 
photoA new drug has been shown to improve progression-free survival in patients with rare midgut neuroendocrine tumors, according to researchers from Northwestern Medicine.

01 Mar 2017 07:42
Coca-Cola backs WHO’s Guidelines for Daily Sugar Intake 
photoAccording to the new CEO of Coca-Cola Co., James Quincey, the company will support the World Health Organization’s (WHO) guidelines for recommended daily sugar consumption limits.

28 Feb 2017 08:21
Genomic Diagnostic Could Use Nasal Swab to Detect Lung Cancer 
photoA non-invasive nasal swab could improve lung cancer diagnosis, according to genomic diagnostics company, Veracyte.

28 Feb 2017 08:21
Merck’s Antiviral Drug Meets Primary Endpoint in Phase III Clinical Trial 
Merck’s investigational antiviral medicine, letermovir, has met its primary endpoint of reducing the incidence of cytomegalovirus (CMV) infection in adults following a bone marrow transplant.

27 Feb 2017 08:20
Pfizer and Celltrion Seek Biosimilar Interchangeability for Crohn’s Disease Drug 
photoPfizer recently reported that its biosimilar version of Johnson and Johnson’s Remicade, showed similar efficacy compared to the reference biologic in patients with moderate-to-severe Crohn’s disease.

27 Feb 2017 08:20
Lack of Research Reproducibility Calls Scientific Integrity Into Question 
photoThe journal, Nature conducted a survey last year which found that over 70 percent of researchers have, at one time or another, been unable to reproduce another’s results by conducting the same experiments.

24 Feb 2017 08:18
ImmusanT Releases Phase I Clinical Trial Results for Celiac Therapeutic 
photoMassachusetts-based biotech company ImmusanT, has completed a Phase Ib clinical trial for its celiac disease vaccine, Nexvax2.

24 Feb 2017 08:17
Antimicrobials Present on Healthy Skin Could Treat Atopic Dermatitis 
photoIn studying the differences in microbial makeup of healthy and non-healthy skin, researchers from the University of California San Diego School of Medicine found that some beneficial bacterial naturally produce antimicrobial peptides, which could be used to treat patients with atopic dermatitis.

23 Feb 2017 07:56
CDC: Interim Results Suggest Flu Vaccine 48 Percent Effective This Season 
photoThis year’s influenza vaccine has reduced the risk of contracting the virus by approximately 50 percent, according to an interim report released by the Centers for Disease Control and Prevention (CDC).
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