FDA

Roche skin cancer drug approval ‘imminent’

August 11, 2011
Sales and Marketing Roche, melanoma, vemurafenib

 Skin cancer treatment Zelboraf looks set to gain FDA approval months ahead of schedule. Roche and Daiichi Sankyo’s drug is …

Janssen reaches partial agreement over criminal investigation

August 10, 2011
Sales and Marketing Janssen, Risperdal, US, US Justice Department, illegal

Janssen Pharmaceuticals has reached a partial agreement with the US government over a criminal investigation into the marketing of Risperdal. …

TranslateMedia launches its new global translation platform, STREAM

August 10, 2011

Global translation agency TranslateMedia is releasing a new version of its award-winning translation platform. The latest version – TranslateMedia STREAM …

Nanoparticles to target Alzheimer’s disease

August 10, 2011
Research and Development Alzheimer's, nanoparticles

Researchers at Lancaster University funded by the European Union are hoping to develop a new treatment for Alzheimer’s disease. Nanoparticles …

New MS drug shows promise for Abbott

August 10, 2011
Research and Development, Sales and Marketing Abbott, Avonex, Biogen, MS, gilenya

Biogen and Abbott’s multiple sclerosis drug daclizumab has performed well in a mid-stage trial, but two deaths marred the overall …

NICE wants more RoActemra data for juvenile idiopathic arthritis

August 9, 2011
Medical Communications NICE, RoActemra, Roche

NICE has requested more evidence from Roche for RoActemra in childhood arthritis. RoActemra (tocilizumab) is being assessed for the treatment …

Shared API inspections project declared a success

August 9, 2011
Manufacturing and Production API, EMA, FDA, TGA, pharma manufacturing news, regulatory inspections

A two-year facility inspection programme carried out by regulators in the USA, Europe and Australia has been deemed a success …

Lord Howe

Taskforce to tackle £300m in wasted medicines

August 9, 2011
Sales and Marketing Lord Howe, NHS, medinces management

A task force has been set up to tackle medicine wastage in the NHS – a problem which, the government …

Pfizer teams up with University of California for drug discovery

August 9, 2011
Research and Development, Sales and Marketing Pfizer, academic research

Pfizer has signed a deal with the University of California to help expand its drug discovery and development programme. The …

Investment firm adds Roche facility to growing portfolio

August 9, 2011
Manufacturing and Production Colarado, International Chemical Investors, Roche, pharma manufacturing news

International Chemical Investors Group has snapped up another manufacturing facility, this time agreeing to buy a plant owned by Roche …

SkyePharma leases manufacturing business to CMO

August 9, 2011
Manufacturing and Production Aenova, Skyepharma, pharma manufacturing news

German contract manufacturer Aenova is to lease a manufacturing unit near Lyon, France, from UK drugmaker SkyePharma. Aenova has taken …

Lonza profits slide as exchange rates bite

August 9, 2011
Manufacturing and Production CMO, Lonza

A strong Swiss franc has pegged back first-half profits at fine chemical and contract manufacturer Lonza, although the company said …

Pradaxa approved for stroke prevention in Europe

August 9, 2011
Sales and Marketing Pradaxa, atrial fibrillation, direct thrombin inhibitor

Boehringer Ingelheim’s Pradaxa has become the first drug in 50 years to be approved in Europe for stroke prevention in …

Gilead buys manufacturing plant from Genentech

August 9, 2011
Manufacturing and Production Genentech, Gilead, biologics

Roche unit Genentech has agreed to sell a clinical manufacturing plant in California to Gilead Sciences. The 70,000 sq. ft. …

Takeda and Amylin stop obesity trial

August 8, 2011
Research and Development, Sales and Marketing Amylin, Takeda

Takeda and Amylin have decided to halt further studies of its combination treatment for obesity, due to ‘evolving dynamics’ within …

Pfizer building

Biotica becomes new victim of Pfizer’s R&D downsizing

August 8, 2011
Research and Development, Sales and Marketing

Pfizer has pulled out of a $195 million deal with UK firm Biotica, as it continues to downsize its global …

Meet Wainwright Associates at the TOPRA Symposium and CPhl worldwide

August 7, 2011
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Wainwright Associates

Wainwright Associates is an independent company offering consultancy services to the pharmaceutical, medical device and healthcare industry in Product Development, …

Dissent over patient involvement reforms

August 5, 2011
Medical Communications HealthWatch, NHS, patient involvement

The first 75 ‘pathfinders’ have been named in Local HealthWatch, the patient representative organisations due to replace the current local …

Gilenya

Gilenya rejected by NICE

August 5, 2011
Medical Communications, Sales and Marketing MS, NICE, Novartis, gilenya

NICE has not recommended Novartis’ multiple sclerosis drug Gilenya because of its cost and ‘uncertainties over its clinical effectiveness’. Gilenya …

First personalised asthma drug shows promise

August 4, 2011
Roche, asthma, personalised medicine

Roche’s personalised asthma drug lebrikizumab has met its primary end point in a phase II trial. Lebrikizumab increased the level …

The Gateway to Local Adoption Series

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