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Second GSK intramuscular quadrivalent influenza vaccine approved by the FDA

GlaxoSmithKline plc [LSE/NYSE: GSK] announced that the U.S. Food and Drug Administration (FDA) has approved FLULAVAL® QUADRIVALENT (Influenza Virus Vaccine) for the active immunization of persons three years of age and older to help prevent disease caused by seasonal influenza (flu) virus subtypes A and B contained in the vaccine.

19 Aug 2013

FDA grants Orphan Drug Designation to ADXS-HPV for treatment of HPV-associated anal cancer

Advaxis, Inc., (OTCQB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that it has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for ADXS-HPV, its lead drug candidate, for the treatment of human papillomavirus (HPV)-associated anal cancer.

17 Aug 2013

Study: Type 2 diabetic patients treated with DPP-4 linagliptin experience reductions in blood glucose levels

Data published in The Lancet showed that elderly people with Type 2 Diabetes (T2D) treated for 24 weeks with the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin, marketed by Boehringer Ingelheim and Eli Lilly and Company, experienced significant reductions in blood glucose levels (HbA1c) compared with those receiving placebo.

17 Aug 2013

Phase II trial to investigate vaccine therapy combined with Avastin for patients with recurrent GBM

Northwestern Medicine- recently joined a landmark clinical trial to investigate if a vaccine made from a patient's own brain tumor is effective in slowing tumor progression and extending survival.

16 Aug 2013

Boehringer Ingelheim completes patient enrolment of two pivotal Phase III interferon-free hepatitis C clinical trials

Boehringer Ingelheim today announced that enrolment of over 950 treatment naïve genotype-1b patients in the pivotal Phase III interferon-free HCVerso™ 1 and 2 trials is complete.

15 Aug 2013

Cedars-Sinai launches Phase I clinical trial to study tolerability of immunization to treat Alzheimer's disease

Cedars-Sinai Medical Center has launched a Phase I clinical trial to study the safety and tolerability of an experimental immunization to treat Alzheimer's disease. The treatment is based on Copaxone (glatiramer acetate), a drug often prescribed to reduce the frequency of multiple sclerosis relapses.

13 Aug 2013

Patients with IBS-D treated with eluxadoline achieve better clinical response

Patients with diarrhea-predominant irritable bowel syndrome, or IBS-D, treated with eluxadoline achieved better clinical response and experienced more symptom improvement than those using placebo, according to a recent study in Gastroenterology, the official journal of the American Gastroenterological Association. Eluxadoline, which is currently in phase 3 trials, is under development as a potential treatment for IBS-D.

13 Aug 2013

NW Bio receives decision to continue Phase III clinical trial on brain cancer in Germany

Northwest Biotherapeutics (NASDAQ: NWBO)(NW Bio), a biotechnology company developing non-toxic DCVax® personalized immune therapies for solid tumor cancers, announced today that it has received a decision from the German regulatory agency (the Paul Ehrlich Institute, or PEI) under which the Company's Phase III clinical trial will be able to proceed in Germany after the Company makes three modifications, none of which affect the body of the trial or the bases for seeking product approval.

12 Aug 2013

Phase I clinical trial: Sanaria PfSPZ Vaccine provides complete protection against malaria

Results of a phase I clinical trial of the Sanaria PfSPZ Vaccine to combat malaria, published today in the online issue of Science magazine, show that the vaccine provided complete protection against malaria in subjects who were exposed to Plasmodium falciparum parasites. Plasmodium falciparum is the malaria parasite that causes more than 600,000 deaths annually.

9 Aug 2013

UAH invents smart pill bottle that notifies you to take your medications

Patented at The University of Alabama in Huntsville, (UAH), a smart pill bottle that notifies you to take your medications or reminds you if you missed a dose could be en route to medicine cabinets as soon as 2015.

8 Aug 2013

Teplizumab to block type 1 diabetes proves strikingly effective in phase 2 clinical trial

An experimental drug designed to block the advance of type 1 diabetes in its earliest stages has proven strikingly effective over two years in about half of the patients who participated in the phase 2 clinical trial.

8 Aug 2013

Regeneron, Bayer report positive results from Phase 3 VIVID-DME and VISTA-DME trials of EYLEA for DME

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare today announced that in the Phase 3 VIVID-DME and VISTA-DME trials of EYLEA (aflibercept) Injection for the treatment of diabetic macular edema, EYLEA 2 milligrams (mg) dosed monthly and EYLEA 2 mg dosed every two months (after 5 initial monthly injections) achieved the primary endpoint of a significantly greater improvement in best-corrected visual acuity from baseline compared to laser photocoagulation at 52 weeks.

6 Aug 2013

Isis Pharmaceuticals announces results of ISIS-CRPRx Phase 2 study in RA patients

Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced that patients treated with ISIS-CRPRx achieved rapid, dose-dependent mean reductions of up to 67 percent in C-reactive protein (CRP) in a Phase 2 study in patients with rheumatoid arthritis (RA).

6 Aug 2013

BioLineRx reports positive results from pre-clinical trials with RHB-104 for treatment of thrombocytopenia

BioLineRx, a biopharmaceutical development company, announced today that BL-8040 has been shown in pre-clinical trials to be effective for the treatment of thrombocytopenia, or reduced platelet production.

5 Aug 2013

Jersey Shore hospital participates in clinical study of investigational vaccine for prevention of CDI

Mark Martens, M.D., chief of Obstetrics and Gynecology at Jersey Shore University Medical Center, announces that the hospital is participating in a clinical study to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of primary symptomatic Clostridium difficile infection (CDI).

3 Aug 2013

Boehringer Ingelheim, Lilly initiate linagliptin clinical trial in adults with Type 2 Diabetes

Boehringer Ingelheim and Eli Lilly and Company today announced enrollment of the first patient into a cardiovascular and renal outcomes trial for linagliptin (Trajenta).

1 Aug 2013

Using the immune system to control cancer: an interview with Dr. Jedd Wolchok, MD, PhD, Ludwig Center at MSKCC

Cancer immunotherapy aims to recruit a patient’s immune system to recognize cancer as foreign and dangerous and to remove it from the body, as it would an infection.

1 Aug 2013

Intrinsic Therapeutics enrolls 400th patient in randomized clinical trial to evaluate effectiveness of Barricaid prosthesis

Intrinsic Therapeutics today announced the enrollment of the 400th patient in a level 1, prospective, randomized, multi-center clinical trial evaluating the effectiveness of its Barricaid Prosthesis in improving outcomes for lumbar discectomy patients suffering from sciatica.

1 Aug 2013

Pharmanest announces positive results from SHACT Phase II study

Karolinska Development: Pharmanest AB announced today positive results from a Phase II-study investigating the efficacy and tolerability of SHACT. The data show that SHACT is effective in reducing pain in connection with intrauterine device insertion. Karolinska Development owns 63% of Pharmanest.

1 Aug 2013

Phase III trial shows afatinib offers clinical benefit to patients with EGFR mutation positive NSCLC

Afatinib has a novel mode of action and data has shown that it offers a clinical benefit to patients with a specific type of lung cancer, which we are further investigating in the extensive LUX-Lung clinical trial programme.

1 Aug 2013

Drug Trial News

Second GSK intramuscular quadrivalent influenza vaccine approved by the FDA

FDA grants Orphan Drug Designation to ADXS-HPV for treatment of HPV-associated anal cancer

Study: Type 2 diabetic patients treated with DPP-4 linagliptin experience reductions in blood glucose levels

Phase II trial to investigate vaccine therapy combined with Avastin for patients with recurrent GBM

Boehringer Ingelheim completes patient enrolment of two pivotal Phase III interferon-free hepatitis C clinical trials

Cedars-Sinai launches Phase I clinical trial to study tolerability of immunization to treat Alzheimer's disease

Patients with IBS-D treated with eluxadoline achieve better clinical response

NW Bio receives decision to continue Phase III clinical trial on brain cancer in Germany

Phase I clinical trial: Sanaria PfSPZ Vaccine provides complete protection against malaria

UAH invents smart pill bottle that notifies you to take your medications

Teplizumab to block type 1 diabetes proves strikingly effective in phase 2 clinical trial

Regeneron, Bayer report positive results from Phase 3 VIVID-DME and VISTA-DME trials of EYLEA for DME

Isis Pharmaceuticals announces results of ISIS-CRPRx Phase 2 study in RA patients

BioLineRx reports positive results from pre-clinical trials with RHB-104 for treatment of thrombocytopenia

Jersey Shore hospital participates in clinical study of investigational vaccine for prevention of CDI

Boehringer Ingelheim, Lilly initiate linagliptin clinical trial in adults with Type 2 Diabetes

Using the immune system to control cancer: an interview with Dr. Jedd Wolchok, MD, PhD, Ludwig Center at MSKCC

Intrinsic Therapeutics enrolls 400th patient in randomized clinical trial to evaluate effectiveness of Barricaid prosthesis

Pharmanest announces positive results from SHACT Phase II study

Phase III trial shows afatinib offers clinical benefit to patients with EGFR mutation positive NSCLC

Fourier 80: bringing benchtop NMR systems to the laboratory

How industrial hygiene flow calibration supports defensible exposure data

How electrical engineering ensures accurate calibration and patient safety

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