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2 September 2016 | By Niamh Louise Marriott, Digital Content Producer
NICE has today issued draft final guidance recommending radium-223 dichloride (Xofigo, Bayer) as an option for treating prostate cancer...
2 September 2016 | By PerkinElmer Inc
ChemDraw software moves to the cloud for enhanced collaboration among chemists and biologists...
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…
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...
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...
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...
Market leaders in temperature controlled microscopy, Linkam Scientific Instruments, in response to user input have released new system control and imaging processing software - LINK...
30 August 2016 | By Niamh Louise Marriott, Digital Content Producer
The study (n=76) showed that 18% of patients receiving fostamatinib achieved a stable platelet response compared to none receiving a placebo control (p=0.0261)...
30 August 2016 | By Niamh Louise Marriott, Digital Content Producer
The trial showed adding praluent to existing therapy reduced LDL cholesterol by approximately 50% from baseline, compared to 2% increase for placebo...
30 August 2016 | By Niamh Louise Marriott, Digital Content Producer
The FDA have granted Santhera an award of $246,000 in support of its ongoing Phase I trial with omigapil (callisto) incongenital muscular dystrophy (CMD)...
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...
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...
26 August 2016 | By Niamh Louise Marriott, Digital Content Producer
For the treatment of Duchenne muscular dystrophy (DMD), Synacthen Depot is a synthetic 24 amino acid melanocortin receptor agonist. Outside the US, it...
25 August 2016 | By Niamh Louise Marriott, Digital Content Producer
Mylan and Biocon, who co-developed this proposed biosimilar, anticipate that this may be the first MAA for a trastuzumab biosimilar accepted by the EMA...
25 August 2016 | By Intercept Pharmaceuticals
The trial evaluated safety and efficacy of ocaliva in PBC patients with an inadequate therapeutic response to, lack of tolerance to, ursodeoxycholic acid...
