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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...
24 August 2016 | By Janssen-Cilag International NV
Phase 3 data supporting submission suggests potential clinical benefit of daratumumab as a backbone therapy in combination with either a proteasome inhibitor (PI) or an immunomodulatory agent for relapsed multiple myeloma patients...
24 August 2016 | By The National Institute for Health and Care Excellence (NICE)
NICE originally published guidance in 2010 which said that sorafenib was not cost effective but it was then made available through the CDF. NICE is reconsidering sorafenib as part of its programme to appraise drugs that are currently available...
23 August 2016 | By AstraZeneca
AstraZeneca and Eli Lilly and Company have received US FDA Fast Track designation for the development programme in Alzheimer’s disease for AZD3293, an oral beta secretase cleaving enzyme inhibitor currently in Phase III clinical trial.
23 August 2016 | By Amgen
Amgen will present data evaluating Repatha® (evolocumab) at the upcoming European Society of Cardiology (ESC) Congress 2016 in Rome...
PT Yusen Logistics Indonesia has become the first logistics business in Indonesia to acquire GDP certification, the industry standard of quality for the storage and transport of medical and pharmaceutical products.
18 August 2016 | By Caroline Richards, Editor, European Pharmaceutical Review & Drug Target Review
Cinqaero is a humanised interleukin-5 antagonist monoclonal antibody (IgG4 kappa) for add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment...
18 August 2016 | By The National Institute for Health and Care Excellence (NICE)
In new draft guidance, the National Institute for Health and Care Excellence (NICE) has advised that everolimus, for treating advanced breast cancer after endocrine therapy, and ibrutinib, for treating relapsed or refractory mantle cell lymphoma, two drugs on the Cancer Drugs Fund are not cost effective.
