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News

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...

Novartis’ phase III MS study successfully meets endpoints

25 August 2016 | By Novartis

The study included 1,651 people with SPMS randomised to receive either 2mg BAF312 or placebo in a 2:1 ratio respectively, the primary endpoint being an improvement in the time to three-month confirmed disability progression, as measured by the expanded disability status scale (EDSS), versus placebo...

NHS two cdf pills
NHS two cdf pills

NICE approves CDF drugs for routine NHS use

24 August 2016 | By National Institute for Health and Care Excellence (NICE)

The National Institute for Health and Care Excellence (NICE) issued final guidance recommending two drugs for routine use within the NHS: Bosutinib (Bosulif, Pfizer) for treating some patients with leukaemia and Pemetrexed (Alimta, Eli Lilly) for treating some patients with lung cancer...