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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...

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...

ACG ACPL becomes first Asian company to receive EXCiPACT certification

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…

Pfizer to acquire AstraZeneca’s anti-infective business

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...

NICE says Bayer’s liver cancer drug is not cost-effective

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...

Teva’s severe eosinophilic asthma drug Cinqaero wins EU approval

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...

NICE says Novartis’ and Janssen’s cancer drugs are not cost effective

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. 

Gene activity linked to breast cancer survival

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...

NICE recommends Pfizer’s lung cancer drug after price drop

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…

Evgen Pharma receives UK approval for breast cancer trial

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...