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Pharma industry news

cholesterol-repatha

Amgen receives positive CHMP opinion for use of Repatha for the treatment of high cholesterol

22 May 2015

The CHMP has adopted a positive opinion for the marketing authorisation of Amgen’s Repatha for use in certain patients with high cholesterol...

cristal-therapeutics

Cristal Therapeutics announces formation of Scientific Advisory Board

22 May 2015

Cristal Therapeutics has appointed Rob Liskamp, Twan Lammers, Alberto Gabizon, Maninder Hora and William Zamboni to its new Scientific Advisory Board...

nivolumab

Bristol-Myers Squibb receives positive CHMP Opinion for nivolumab for the treatment of advanced squamous NSCLC in previously-treated patients

22 May 2015

The CHMP has adopted a positive opinion recommending that nivolumab be granted approval for the treatment of NSCLC after prior chemotherapy in adults...

tris-pharma

FDA accepts for review New Drug Application for Dyanavel XR in ADHD

22 May 2015

Tris Pharma has announced that the FDA has accepted for review its New Drug Application for Dyanavel XR, an Extended-Release Oral Suspension...

everolimus

Afinitor (everolimus) extended progression-free survival in Phase III trial in advanced gastrointestinal or lung neuroendocrine tumours

22 May 2015

The Phase III study of everolimus in patients with advanced nonfunctional neuroendocrine tumours (NET) of GI or lung origin met its primary endpoint...

reneuron-retinitis-pigmentosa

FDA grants Fast Track designation to ReNeuron’s retinitis pigmentosa cell therapy candidate

22 May 2015

The FDA has granted Fast Track designation to ReNeuron’s human Retinal Progenitor Cell (hRPC) therapy candidate for retinitis pigmentosa...

lungs-QVA149

Novartis announces two positive US phase III programmes in COPD for QVA149 and NVA237

22 May 2015

Novartis has announced positive results from two pivotal Phase III clinical trial programmes for QVA149 and NVA237 in patients with moderate-to-severe COPD...

nabriva

Nabriva appoints Dr Elyse Seltzer as Chief Medical Officer

22 May 2015

Nabriva has announced the appointment of Elyse Seltzer, MD, as Chief Medical Officer. Dr Seltzer assumes the role from Dr William Prince...

cdi-1

DIFICLIR (fidaxomicin) significantly reduces recurrence and all-cause mortality when used first-line in all patients diagnosed with Clostridium difficile infection (CDI)

21 May 2015

Data presented from the Clostridium difficile Infection (CDI) Service Evaluation study shows that the adoption pattern of treatment impacts CDI outcomes...

revusiran

Alnylam receives Orphan Drug Designation for revusiran for the treatment of ATTR amyloidosis

21 May 2015

The FDA has granted Orphan Drug Designation to Alnylam’s revusiran for the treatment of transthyretin (TTR)-mediated amyloidosis (ATTR amyloidosis)...

sarilumab

Sanofi and Regeneron announce positive topline results from Phase 3 studies with sarilumab in patients with rheumatoid arthritis

21 May 2015

Phase 3 study of sarilumab met its co-primary efficacy endpoints of a greater improvement in signs and symptoms of rheumatoid arthritis...

dengue

Promising malaria and dengue vaccines alone will not defeat diseases, says GlobalData Analyst

21 May 2015

Despite optimism surrounding new dengue and a malaria vaccines, vaccination alone is not a long-term solution for combatting these diseases, says GlobalData...