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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...
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...
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...
24 August 2016 | By ACG Worldwide
ACG Worldwide is pleased to announce that ACG Associated Capsules Pvt. Ltd. (ACG ACPL) has received EXCiPACT certification for its plant at Dahanu – Maharashtra, India. ACG ACPL is the first empty hard capsule manufacturing company in Asia to receive EXCiPACT certification. The certificate provides independent validation that ACG ACPL…
24 August 2016 | By Pfizer
The agreement includes the rights to the newly approved EU drug zavicefta (ceftazidime-avibactam), the marketed agents merrem/meronem (meropenem) and zinforo (ceftaroline fosamil), and the clinical development assets aztreonam-avibactam (ATM-AVI) and CXL...
