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News

Destiny’s SA trial shows fast acting antibiotic too quick for disease resistance

5 September 2016 | By Niamh Louise Marriott, Digital Content Producer

The two-stage clinical trial studied the safety, tolerability, and efficacy of intra-nasally applied exeporfinium chloride gels. Part 1 yielded safety data in eight volunteers and allowed progression to Part 2 in 48 healthy volunteers with colonised nasal Staphylococcus aureus (SA) bacteria. Part 2 was double-blinded, placebo controlled, and investigated two…

Roche’s cancer immunotherapy drug has longer OS vs. chemotherapy

1 September 2016 | By Niamh Louise Marriott, Digital Content Producer

Roche’s study for tecentriq (atezolizumab) met its co-primary endpoints and showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared with docetaxel chemotherapy in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed on or after treatment with platinum-based chemotherapy. Adverse events…

FDA approves Novartis’ biosimilar to treat multiple inflammatory diseases

1 September 2016 | By Niamh Louise Marriott, Digital Content Producer

The FDA approval is based on analytical, nonclinical, and clinical data confirming that Erelzi is highly similar to the US-licensed reference product. Clinical studies included four comparative pharmacokinetic (PK) studies in 216 healthy volunteers and a confirmatory efficacy and safety similarity study in 531 patients with chronic plaque psoriasis...

EU approval for Pfizer’s non-small cell lung cancer drug

1 September 2016 | By Niamh Louise Marriott, Digital Content Producer

The drug exhibited marked anti-tumour activity in patients with ROS1-positive advanced NSCLC and met its primary endpoint of ORR. Tumours were tested for ROS1 rearrangements by laboratory-developed break-apart fluorescence in situ hybridization (FISH) (96%) or real-time polymerase chain reaction (RT-PCR) (4%) assay...

FDA approves Genmab’s ofatumumab for relapsed CLL

31 August 2016 | By Niamh Louise Marriott, Digital Content Producer

Approval is supported by the Phase III complement study that evaluated ofatumumab in combination with FC versus FC alone in patients with relapsed CLL...

Abeona Therapeutics completes cohort in Sanfilippo syndrome trial

30 August 2016 | By Niamh Louise Marriott, Digital Content Producer

The first-in-man clinical trial utilises a single injection of AAV gene therapy for patients with MPS IIIA (Sanfilippo syndrome type A), a rare autosomal recessive disease that causes neurocognitive decline, speech loss, loss of mobility, and premature death...

RedHill Biopharma receives patent approval for MS drug

30 August 2016 | By Niamh Louise Marriott, Digital Content Producer

A first Phase III study with RHB-104 for the treatment of Crohn’s disease is currently ongoing, as well as a Phase IIa proof-of-concept study for the treatment of MS...