Efficacy News and Research

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One-third of PsA patients not receiving adalimumab doses to achieve optimal clinical benefit

Data presented today at the European League Against Rheumatism Annual Congress showed that a significant number of patients with psoriatic arthritis (PsA) were not receiving doses of the tumour necrosis factor-alpha (TNFα) inhibitor adalimumab necessary to achieve optimal clinical benefit.

12 Jun 2014

Exercise transiently suppresses inflammation in rheumatic disease

Research findings presented today at the European League Against Rheumatism Annual Congress suggest that exercise transiently suppresses local and systemic inflammation, reinforcing the beneficial effects of exercise and the need for this to be regular in order to achieve clinical efficacy in rheumatic disease.

12 Jun 2014

TxCell receives Certificate of GMP compliance for cell therapy manufacturing facility in France

TxCell SA, a biotechnology company developing innovative, personalized cell-based immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announces today that it has been granted Certificate of Good Manufacturing Practice (GMP) compliance for its cell therapy manufacturing facility in Besançon, France.

12 Jun 2014

Otsuka Pharmaceutical begins tolvaptan Phase 3b study in patients with ADPKD

Otsuka Pharmaceutical Development & Commercialization, Inc., announced today that patient enrollment has begun for a new Phase 3b study of tolvaptan for adult patients with autosomal dominant polycystic kidney disease (ADPKD), the most common, life-threatening, inherited genetic kidney disorder.

11 Jun 2014

Celgene: OTEZLA phase III study for psoriatic arthritis meets primary endpoint

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), today announced results of additional analyses from the phase III clinical trials of OTEZLA, the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4).

11 Jun 2014

BioLineRx gets Notice of Allowance for patent related to new treatment for celiac disease

BioLineRx Ltd., a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that a Notice of Allowance has been issued by the United States Patent and Trademark Office (USPTO) for a patent claiming the composition of BL-7010, a novel polymer for the treatment of celiac patients.

11 Jun 2014

ClarityMD effective in clearing acne without irritation

Envy Medical, Inc., a leader in professional skincare products and services, is excited to announce the publication of a new study in the June issue of the Journal of Drugs in Dermatology (JDD) proving the superior efficacy of its highly innovative acne system – ClarityMD.

11 Jun 2014

FDA grants orphan drug designation to EffRx Pharmaceuticals' EX404 for treatment of PCOS

EffRx Pharmaceuticals SA, a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration has granted orphan drug designation to its proprietary metformin-based product candidate, EX404, for the treatment of pediatric polycystic ovary syndrome (PCOS).

11 Jun 2014

Treato releases third version of flagship patient intelligence platform

Treato, the world's most comprehensive source of real-time patient voice insights, today announced the release of version 3 of its flagship patient intelligence platform.

10 Jun 2014

Alkermes initiates FORWARD-3 and FORWARD-4 efficacy studies in pivotal clinical program for ALKS 5461

Alkermes plc today announced the initiation of FORWARD-3 and FORWARD-4, two of the three planned phase 3 core efficacy studies in the pivotal clinical program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD).

10 Jun 2014

PaxVax partners with UC to develop combination vaccine to prevent genital HSV infections

PaxVax Inc., a specialty vaccine company with a commercial focus on travel and biodefense and a social mission to ensure global access to its vaccines, today announced that it has entered into a research and development collaboration with the University of California, San Diego to develop a combination vaccine to prevent genital herpes simplex virus (HSV) infections.

10 Jun 2014

electroCore's non-invasive vagus nerve stimulation therapy reduces cluster headache attacks

In a multi-center, randomized, trial across Europe, electroCore's non-invasive vagus nerve stimulation (nVNS) therapy was found to meet its primary endpoint of statistical significance in reducing the number of cluster headache attacks when compared with the standard of care.

10 Jun 2014

Inovio evaluates responses of immunotherapy product in treating HPV linked head and neck cancer

Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) today announced it has initiated a phase I/IIa clinical trial to evaluate safety, immunogenicity and clinical responses of its immunotherapy product, INO-3112, in treating human papillomavirus (HPV)- associated head and neck cancer.

10 Jun 2014

Antiviral therapy may prevent hepatitis B virus from developing into hepatocellular carcinoma

Researchers have found that antiviral therapy may be successful in preventing hepatitis B virus from developing into the most common form of liver cancer, hepatocellular carcinoma (HCC).

9 Jun 2014

BioDelivery Sciences receives approval of NDA for BUNAVAIL from FDA

BioDelivery Sciences International, Inc. received approval of the New Drug Application (NDA) for BUNAVAIL™ (buprenorphine and naloxone) buccal film (CIII) from the U.S. Food and Drug Administration (FDA).

9 Jun 2014

Cubist Pharmaceuticals publishes positive results from Phase 3 clinical trial of SIVEXTRO

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that The Lancet Infectious Diseases published online the positive results from ESTABLISH-2, a pivotal Phase 3 clinical trial of the investigational antibiotic SIVEXTRO™ (tedizolid phosphate), which is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and complicated skin and soft tissue infections (cSSTI).

9 Jun 2014

Valeant Pharmaceuticals receives approval from FDA for treatment of onychomycosis

Valeant Pharmaceuticals International, Inc. today announced that that its wholly owned subsidiary, Valeant Pharmaceuticals North America LLC, received notice that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Jublia® (efinaconazole 10% topical solution), the first topical triazole approved for the treatment of onychomycosis of the toenails.

9 Jun 2014

Actinium's Chairman to discuss role of alpha-particle radiopharmaceuticals at SNMMI Annual Meeting

Actinium Pharmaceuticals, Inc. ("Actinium" or "the Company"), a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, today announced that Actinium's Clinical Advisory Board Chairman Joseph Jurcic, MD will participate in an upcoming panel discussion highlighting the role of Actinium's alpha-particle radiopharmaceuticals in the treatment of leukemia patients.

9 Jun 2014

Batu Biologics reports FDA development plans for cancer immunotherapeutic vaccine ValloVax

Batu Biologics announced today FDA development plans for its patent-pending lead product, ValloVax, a cancer immunotherapeutic "vaccine" that specifically targets the tumor blood vessels (endothelium).

9 Jun 2014

European Commission approves Boehringer Ingelheim's Pradaxa for prevention of DVT and PE

Boehringer Ingelheim today announces that Pradaxa (dabigatran etexilate) has been approved by the European Commission for the treatment and prevention of recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE).

6 Jun 2014

Efficacy News and Research

One-third of PsA patients not receiving adalimumab doses to achieve optimal clinical benefit

Exercise transiently suppresses inflammation in rheumatic disease

TxCell receives Certificate of GMP compliance for cell therapy manufacturing facility in France

Otsuka Pharmaceutical begins tolvaptan Phase 3b study in patients with ADPKD

Celgene: OTEZLA phase III study for psoriatic arthritis meets primary endpoint

BioLineRx gets Notice of Allowance for patent related to new treatment for celiac disease

ClarityMD effective in clearing acne without irritation

FDA grants orphan drug designation to EffRx Pharmaceuticals' EX404 for treatment of PCOS

Treato releases third version of flagship patient intelligence platform

Alkermes initiates FORWARD-3 and FORWARD-4 efficacy studies in pivotal clinical program for ALKS 5461

PaxVax partners with UC to develop combination vaccine to prevent genital HSV infections

electroCore's non-invasive vagus nerve stimulation therapy reduces cluster headache attacks

Inovio evaluates responses of immunotherapy product in treating HPV linked head and neck cancer

Antiviral therapy may prevent hepatitis B virus from developing into hepatocellular carcinoma

BioDelivery Sciences receives approval of NDA for BUNAVAIL from FDA

Cubist Pharmaceuticals publishes positive results from Phase 3 clinical trial of SIVEXTRO

Valeant Pharmaceuticals receives approval from FDA for treatment of onychomycosis

Actinium's Chairman to discuss role of alpha-particle radiopharmaceuticals at SNMMI Annual Meeting

Batu Biologics reports FDA development plans for cancer immunotherapeutic vaccine ValloVax

European Commission approves Boehringer Ingelheim's Pradaxa for prevention of DVT and PE

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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