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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In new draft guidance, the National Institute for Health and Care Excellence (NICE) has advised that everolimus, for treating advanced breast cancer after endocrine therapy, and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.
18 August 2016 | By The Institute of Cancer Research, London
In a study of nearly 2000 patients, researchers found that women whose tumours had high F12 activity and low STC2 activity had a 32% chance of dying within 10 years, whereas those with low F12 activity and high STC2 activity had only a 10% chance of dying...
18 August 2016 | By The National Institute for Health and Care Excellence (NICE)
When initially reviewed, the committee concluded that the drug was too expensive compared to the current standard of care. Pfizer submitted further evidence, including a new patient access scheme that provided the drug at a lower price alongside revised analyses, which the committee then concluded could now be considered value…
17 August 2016 | By Evgen Pharma
The primary objectives of the STEM (SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer) trial are to use tumour imaging to evaluate safety and efficacy in patients starting to become resistant to mainstream hormone therapy...
16 August 2016 | By Janssen
Following succesful phase II trials, the FDA have granted a Breakthrough Therapy Designation for esketamine, an investigational antidepressant medication...
16 August 2016 | By ViiV Healthcare
ViiV Healthcare is undertaking two identical studies as part of a global phase III programme comparing a two-drug regimen of dolutegravir plus lamivudine, with a three-drug regimen of dolutegravir (Tivicay), plus the fixed-dose tablet tenofovir/emtricitabine (Truvada), to support regulatory filings as a treatment for HIV, for adults who have had…
16 August 2016 | By University of Florida
Scientists have found that using magnetic resonance imaging reveals areas where Parkinson’s disease causes progressive decline in brain activity, a biomarker discovery which will help to evaluate new experimental treatments to slow or stop the disease’s progression...
