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Transition Therapeutics begins TT-401 Phase 2 clinical study for treatment of type 2 diabetes

Transition Therapeutics Inc. today announced the dosing of the first patient in a Phase 2 clinical study of TT-401 (LY2944876), a drug candidate for the treatment of type 2 diabetes.

15 May 2014

Promedior to present interim data from PRM-151 Phase 2 trial at ASCO 2014 Annual Meeting

Promedior, Inc., a clinical stage biotechnology company developing novel therapeutics for the treatment of fibrosis, today announced that principal investigator, Srdan Verstovsek, MD, PhD, will present interim data from the Company's ongoing Phase 2 clinical trial of its lead product candidate, PRM-151, for the treatment of myelofibrosis, in a poster presentation on June 2, 2014 at the American Society for Clinical Oncology 2014 Annual Meeting.

15 May 2014

Kamada to present Phase 2/3 clinical trial results of AAT to treat alpha-1 antitrypsin deficiency

Kamada Ltd., a plasma-derived protein therapeutics company focused on orphan indications, will announce results from its Phase 2/3 clinical trial of its proprietary inhaled alpha-1 antitrypsin (AAT) to treat alpha-1 antitrypsin deficiency (AATD) in Europe and Canada on Friday, May 16, 2014, at approximately 7:30 a.m. Eastern time.

15 May 2014

Novel targeted drug shows promise in treating patients with advanced pigmented villonodular synovitis

A novel targeted drug shows promise in treating patients with advanced pigmented villonodular synovitis (PVNS), a rare neoplastic joint disorder, according to new phase I data from Memorial Sloan Kettering Cancer Center and other institutions highlighted to media today in advance of the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), which will take place from May 30 to June 3 in Chicago.

15 May 2014

Phase I study reveals abemaciclib drug shows evidence of single-agent activity in NSCLC patients

Abemaciclib, an oral drug administered twice daily, currently in development by Eli Lilly and Company (NYSE: LLY), has shown evidence of single-agent activity in patients with advanced non-small cell lung cancer in a Phase I study released ahead of the American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago, Ill.

15 May 2014

Astellas reports efficacy, safety data of isavuconazole invasive aspergillosis SECURE study at ECCMID

Astellas reported today that the efficacy and safety data of the isavuconazole invasive aspergillosis study (SECURE) were presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Barcelona, Spain.

15 May 2014

Isis Pharmaceuticals reports positive data from ISIS-GCGRRx Phase 2 study in patients with type 2 diabetes

Isis Pharmaceuticals, Inc. announced today positive data from a Phase 2 study of ISIS-GCGRRx in patients with type 2 diabetes uncontrolled on stable metformin therapy.

14 May 2014

MedImmune to present Phase IIb asthma data on benralizumab and tralokinumab at ATS conference

AstraZeneca today announced that MedImmune, its global biologics research and development arm, will present Phase IIb data on two novel investigational molecules – benralizumab and tralokinumab – at the upcoming American Thoracic Society 2014 International Conference being held in San Diego, California, 16-21 May.

14 May 2014

Intensive insulin treatment improves survival for diabetic heart attack patients

Long-term follow-up of the DIGAMI 1 trial – a landmark study of type 2 diabetes in Sweden – shows that intensive insulin treatment prolonged life by more than 2 years in patients with diabetes after a heart attack, compared with standard treatment for diabetes, reports Dr Viveca Ritsinger from the Unit of Cardiology of the Department of Medicine, Karolinska Institute, Stockholm, Sweden and colleagues in The Lancet Diabetes & Endocrinology.

14 May 2014

Ajinomoto announces Phase 2a results of oral alpha 4 integrin antagonist AJM300 in ulcerative colitis patients

Ajinomoto Pharmaceuticals Co., Ltd. (President, Takashi Nagamachi; Headquarters, Tokyo, Japan) announced on May 13 that the Phase 2a results of an oral alpha 4 integrin antagonist, AJM300, in patients with ulcerative colitis were presented in the Joint Presidential Plenary Session at Digestive Disease Week (DDW) 2014 held May 3 - 6 in Chicago, IL, USA.

13 May 2014

Amakem commences Phase 2 dose-ranging study of AMA0076 drug for treatment of glaucoma

Amakem Therapeutics, a clinical stage ophthalmology company, today announced that first patients have commenced treatment in a Phase 2 dose-ranging study of its lead drug candidate, AMA0076 for the treatment of glaucoma.

13 May 2014

Da Volterra presents promising results of DAV-132 compound for prevention of severe C. diff infections

Da Volterra, a leading biopharmaceutical company in the field of bacterial resistance, announces today very promising new results about DAV132 in the prevention of the side effects of antibiotics and the occurrence of severe Clostridium difficile infections.

13 May 2014

Verastem announces expansion of ongoing COMMAND study in Japan

Verastem, Inc., focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, today announced the expansion of its ongoing COMMAND study to include clinical trial sites in Japan.

12 May 2014

Pfizer reports positive results from rLP2086 Phase 2 study for invasive meningococcal disease

Pfizer Inc. announced today the results from two Phase 2 studies of bivalent rLP2086, Pfizer's recombinant vaccine candidate, currently under development for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 to 25 year olds.

12 May 2014

Neurovance reports positive results from EB-1020 SR phase 2a pilot study in adult ADHD patients

Neurovance, Inc. today announced complete results from its phase 2a pilot study of EB-1020 SR, a non-stimulant, in adult male patients with all subtypes of ADHD (attention deficit hyperactivity disorder).

8 May 2014

Janssen submits sNDA to FDA for simeprevir in combination with sofosbuvir for treatment of HCV genotype 1 infection

Janssen Research & Development, LLC (Janssen) today announced it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for simeprevir, an NS3/4A protease inhibitor marketed as OLYSIO™ in the United States, in combination with the nucleotide analog NS5B polymerase inhibitor sofosbuvir developed by Gilead Sciences, Inc.

8 May 2014

WHI: Combined hormone therapy clinical trial yields massive economic return

Economic findings were released today on the Women's Health Initiative (WHI), estrogen plus progestin (E+P) trial.

8 May 2014

Controlling low-density lipoprotein-cholesterol levels: an interview with Jay Edelberg, M.D., Sanofi and Bill Sasiela, Ph.D., Regeneron

Lipids, primarily cholesterol and triglycerides, come from two sources: what is naturally manufactured in the liver and what comes from the intestines through the diet.

From Sanofi 7 May 2014

New data presented at EADO on investigational MEK inhibitor in combination with BRAF inhibitor for metastatic melanoma

New data have been presented for the first time at the European Association of Dermato Oncology (EADO) Congress today on the investigational MEK inhibitor cobimetinib (GDC-0973) in combination with BRAFV600 inhibitor Zelboraf® (vemurafenib) for metastatic melanoma, the most aggressive form of skin cancer. The findings illustrate that cobimetinib and vemurafenib can be safely co-administered and that the combination shows promising anti-tumour activity, with a median progression-free survival (mPFS) of 13.7 months for BRAF inhibitor-naive patients.1

7 May 2014

Exelixis presents final Phase 1b data on investigational MEK-BRAF inhibitor combination therapy for metastatic melanoma

Exelixis, Inc. today announced final results from BRIM7, an ongoing phase 1b clinical trial conducted by Roche and Genentech, Exelixis' collaborator and a member of the Roche Group, of the BRAF inhibitor (BRAFi) vemurafenib in combination with the MEK inhibitor cobimetinib in patients with locally advanced/unresectable or metastatic melanoma carrying a BRAFV600 mutation.

7 May 2014

Drug Trial News

Transition Therapeutics begins TT-401 Phase 2 clinical study for treatment of type 2 diabetes

Promedior to present interim data from PRM-151 Phase 2 trial at ASCO 2014 Annual Meeting

Kamada to present Phase 2/3 clinical trial results of AAT to treat alpha-1 antitrypsin deficiency

Novel targeted drug shows promise in treating patients with advanced pigmented villonodular synovitis

Phase I study reveals abemaciclib drug shows evidence of single-agent activity in NSCLC patients

Astellas reports efficacy, safety data of isavuconazole invasive aspergillosis SECURE study at ECCMID

Isis Pharmaceuticals reports positive data from ISIS-GCGRRx Phase 2 study in patients with type 2 diabetes

MedImmune to present Phase IIb asthma data on benralizumab and tralokinumab at ATS conference

Intensive insulin treatment improves survival for diabetic heart attack patients

Ajinomoto announces Phase 2a results of oral alpha 4 integrin antagonist AJM300 in ulcerative colitis patients

Amakem commences Phase 2 dose-ranging study of AMA0076 drug for treatment of glaucoma

Da Volterra presents promising results of DAV-132 compound for prevention of severe C. diff infections

Verastem announces expansion of ongoing COMMAND study in Japan

Pfizer reports positive results from rLP2086 Phase 2 study for invasive meningococcal disease

Neurovance reports positive results from EB-1020 SR phase 2a pilot study in adult ADHD patients

Janssen submits sNDA to FDA for simeprevir in combination with sofosbuvir for treatment of HCV genotype 1 infection

WHI: Combined hormone therapy clinical trial yields massive economic return

Controlling low-density lipoprotein-cholesterol levels: an interview with Jay Edelberg, M.D., Sanofi and Bill Sasiela, Ph.D., Regeneron

New data presented at EADO on investigational MEK inhibitor in combination with BRAF inhibitor for metastatic melanoma

Exelixis presents final Phase 1b data on investigational MEK-BRAF inhibitor combination therapy for metastatic melanoma

Transforming Lab Workflows with Cell Culture Automation

Building Bridges to Scalable Allogeneic Cell Therapy

Edoardo Fabini

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