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SynAgile announces positive results from Phase 2a trial of continuous intraoral LD/CD therapy

SynAgile Corporation, a privately held pharmaceutical company that develops and commercializes drug delivery systems using its proprietary OraFuse intraoral technology platform, today announced positive results from a proof-of-concept, Phase 2a, open-label clinical trial of continuous intraoral administration of levodopa-carbidopa (LD/CD).

8 Oct 2015

FDA grants Breakthrough Therapy Designation to Lilly's abemaciclib for treatment of metastatic breast cancer

Eli Lilly and Company today announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer.

8 Oct 2015

Phase II psoriasis study shows efficacy of Boehringer Ingelheim's BI 655066 over ustekinumab

New results from a Phase II head-to-head psoriasis study showed superior efficacy of Boehringer Ingelheim's investigational biologic compound BI 655066, over ustekinumab. After nine months, 69 percent of patients with moderate-to-severe plaque psoriasis maintained clear or almost clear skin (PASI 90) with BI 655066 in the higher dose group compared to 30 percent of patients on ustekinumab.

8 Oct 2015

Allergan's anti-infective portfolio to be highlighted at IDWeek 2015

Allergan plc today announced that its infectious disease portfolio will be featured in 13 abstracts highlighting data at IDWeek 2015, which takes place from October 7-11, 2015, in San Diego.

8 Oct 2015

Clinical study data on Mallinckrodt's H.P. Acthar Gel to be presented at ACR 2015

Mallinckrodt plc, a leading specialty biopharmaceutical company, today announced that data from a pilot study for its H.P. Acthar Gel (repository corticotropin injection) will be presented at the American College of Rheumatology 2015 Annual Meeting to be held November 7-11 in San Francisco.

8 Oct 2015

Neurocrine Biosciences announces positive data from NBI-98854 Phase III trial in tardive dyskinesia

Neurocrine Biosciences, Inc. announced today that NBI-98854, a highly selective small molecule VMAT2 inhibitor, showed a statistically significant reduction in tardive dyskinesia during the six weeks of placebo-controlled treatment in the Kinect 3 clinical trial. This Phase III trial included moderate to severe tardive dyskinesia patients with underlying schizophrenia, schizoaffective disorder, bipolar or major depressive disorder.

8 Oct 2015

Smoking cessation medication 46% effective in women

The most effective prescription drug used to quit smoking initially helps women more than men, according to a Yale School of Medicine study. The study, published Oct. 7 by the journal Nicotine and Tobacco Research, found that varenicline, marketed as Chantix, was more effective earlier in women, and equally effective in women and men after one year.

8 Oct 2015

Genocea announces positive data in Phase 2 trial evaluating GEN-003 for the treatment of genital herpes

Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, has announced positive results from a planned interim analysis of data collected six months after dosing from its ongoing Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. At its best performing dose of 60 µg per protein / 75 µg of Matrix-M2TM adjuvant, GEN-003 demonstrated a statistically significant 58 percent reduction from baseline in the viral shedding rate (p < 0.0001), the primary endpoint of the study.

7 Oct 2015

Interim data from long-term extension Tecfidera® (dimethyl fumarate) study

Biogen (NASDAQ: BIIB) will, this week, present data at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain, demonstrating the efficacy and safety of TECFIDERA® (dimethyl fumarate) across a broad range of people with relapsing-remitting multiple sclerosis (RRMS).

7 Oct 2015

Everolimus, 177Lu-dotatate extend neuroendocrine tumour PFS

Positive progression-free survival results from the RADIANT-4 and NETTER-1 trials extend the armamentarium for physicians treating patients with neuroendocrine tumours.

7 Oct 2015

Brain metastases evolve ‘clinically actionable’ mutations

Brain metastatic disease shows branched evolution from the primary tumour, suggest preliminary findings from the largest massively parallel sequencing study of paired samples performed so far.

7 Oct 2015

Sorin Group initiates PERSIST-AVR trial to evaluate Perceval sutureless aortic valve against standard sutured bioprostheses

Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, today announced the initiation of PERSIST-AVR, the first international, prospective, post-market randomized multi-center trial evaluating the Perceval sutureless aortic valve compared to standard sutured bioprostheses in patients with aortic valve disease.

7 Oct 2015

OLFUS study supports safety, efficacy of DBV's Viaskin Peanut patch in children with peanut allergy

DBV Technologies, a clinical-stage specialty biopharmaceutical company, today announced that topline findings from the first 12 months of the OLFUS-VIPES study, or OLFUS, support the long-term safety and efficacy of Viaskin Peanut for the treatment of peanut allergy.

7 Oct 2015

Tarix Orphan's TXA127 granted FDA Fast Track Designation for treatment of DMD patients

Tarix Orphan LLC, a privately held biopharmaceutical company focused on the treatment of rare neuromuscular disorders and connective tissue diseases, today announced that the U.S. Food and Drug Administration has granted Fast Track Designation to TXA127 (angiotensin 1-7) to reduce skeletal muscle damage and fibrosis and thereby improve muscle strength in Duchenne Muscular Dystrophy (DMD) patients.

6 Oct 2015

First patients screened in Axovant's phase 3 study of RVT-101

Axovant Sciences Ltd., a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, today announced the first patients screened in MINDSET, a confirmatory global phase 3 study of Axovant's lead product candidate, RVT-101. Axovant also announced that the company and the U.S. Food and Drug Administration have agreed to a Special Protocol Assessment (SPA) supporting this phase 3 program.

6 Oct 2015

AcelRx Pharmaceuticals initiates ARX-04 Phase 3 study in emergency room patients with acute pain

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute and breakthrough pain, today announced the initiation of an open-label Phase 3 study (SAP302) of ARX-04 for the treatment of adult patients who present in the emergency room with moderate-to-severe acute pain associated with trauma or injury.

6 Oct 2015

Envisia's ENV515 (travoprost XR) meets primary efficacy endpoint in phase 2a glaucoma trial

Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today reported results from its first clinical trial of the Company's lead product candidate, ENV515 (travoprost XR).

6 Oct 2015

Mycobacterium could be more effective in treating superficial bladder cancer, study finds

Universitat Autònoma de Barcelona researchers have found a mycobacterium that is more effective in treating superficial bladder cancer and does not cause infections, unlike those used up to now.

6 Oct 2015

Oncolytics completes Phase II trial enrollment for REOLYSIN in prostate cancer

Oncolytics Biotech Inc. today announced that enrollment has been completed in a randomized Phase II study of REOLYSIN in patients with recurrent or metastatic castration resistant prostate cancer (IND 209). The trial is being sponsored and conducted by the NCIC Clinical Trials Group (NCIC CTG) at Queen's University in Kingston, Ontario.

6 Oct 2015

FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept

Sandoz, a Novartis company and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s US-licensed Enbrel (etanercept) - a tumor necrosis factor alpha (TNF-α) inhibitor

5 Oct 2015

Efficacy News and Research

SynAgile announces positive results from Phase 2a trial of continuous intraoral LD/CD therapy

FDA grants Breakthrough Therapy Designation to Lilly's abemaciclib for treatment of metastatic breast cancer

Phase II psoriasis study shows efficacy of Boehringer Ingelheim's BI 655066 over ustekinumab

Allergan's anti-infective portfolio to be highlighted at IDWeek 2015

Clinical study data on Mallinckrodt's H.P. Acthar Gel to be presented at ACR 2015

Neurocrine Biosciences announces positive data from NBI-98854 Phase III trial in tardive dyskinesia

Smoking cessation medication 46% effective in women

Genocea announces positive data in Phase 2 trial evaluating GEN-003 for the treatment of genital herpes

Interim data from long-term extension Tecfidera® (dimethyl fumarate) study

Everolimus, 177Lu-dotatate extend neuroendocrine tumour PFS

Brain metastases evolve ‘clinically actionable’ mutations

Sorin Group initiates PERSIST-AVR trial to evaluate Perceval sutureless aortic valve against standard sutured bioprostheses

OLFUS study supports safety, efficacy of DBV's Viaskin Peanut patch in children with peanut allergy

Tarix Orphan's TXA127 granted FDA Fast Track Designation for treatment of DMD patients

First patients screened in Axovant's phase 3 study of RVT-101

AcelRx Pharmaceuticals initiates ARX-04 Phase 3 study in emergency room patients with acute pain

Envisia's ENV515 (travoprost XR) meets primary efficacy endpoint in phase 2a glaucoma trial

Mycobacterium could be more effective in treating superficial bladder cancer, study finds

Oncolytics completes Phase II trial enrollment for REOLYSIN in prostate cancer

FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept

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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