Registration & Regulatory Affairs News:

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Bayer submits NDA for treatment of gastrointestinal cancer

Mon 03 Sep 2012, 10:50AM

An application has been made to the US Food and Drug Administration...

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Pfizer targets Indonesian generics market

Tue 08 May 2012, 2:10PM

Pfizer is set to invest $3 million in generic drug manufacturing in Indonesia...

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Canada to change OTC approval rules

Thu 03 May 2012, 2:53PM

The Canadian government has unveiled reforms designed to improve access to over-the-counter drugs...

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Actelion welcomes positive clinical research results

Mon 30 Apr 2012, 12:11PM

Actelion's share price climbs after the announcement of positive results from the firm's clinical research trial of macitentan...

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FDA to re-label Merck drug

Fri 27 Apr 2012, 11:57AM

Victrelis could be made less effective when combined with HIV treatments...

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Lilly's Almita receives CHMP backing as continuation maintenance therapy

Tue 27 Sep 2011, 4:31PM

Regulatory affairs jobs provider Lilly has received CHMP backing for Alimta to be used as a continuation maintenance therapy for lung cancer...

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Allergan's Botox approved to treat urinary incontinence

Thu 25 Aug 2011, 3:10PM

Allergan's Botox product has been approved for the treatment of urinary incontinence by the US Food and Drug Administration...

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GSK to work with regulators to address Pandemrix risks

Fri 29 Jul 2011, 5:53PM

GSK's staff in regulatory affairs jobs will work in tandem with the European Medicines Agency to investigate links between Pandemrix and a heightened risk of narcolepsy...

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Roche's Tarceva receives positive CHMP opinion

Tue 26 Jul 2011, 11:10AM

Staff in regulatory affairs jobs at Roche will welcome news that the CHMP has recommended Tarceva as a first-line option for patients with a specific form of lung cancer...

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Healthcare sector to contribute to new value-based pricing system

Fri 22 Jul 2011, 1:24PM

Staff in pharmaceutical sector regulatory affairs jobs may be called upon to contribute to the development of the government's new value-based pricing system for the NHS...

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MSD receives EU approval for hepatitis C drug Victrelis

Wed 20 Jul 2011, 12:32PM

MSD's staff in regulatory affairs jobs have received European Commission marketing authorisation for the new hepatitis C drug Victrelis...

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Amgen's Xgeva approved by European Commission

Mon 18 Jul 2011, 1:12PM

Staff in regulatory affairs jobs at Amgen have secured EU approval for Xgeva, its treatment for skeletal-related events in adults with bone metastases from solid tumours...

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GSK and HGS secure regulatory clearance for Benlysta

Fri 15 Jul 2011, 4:14PM

GSK and HGS have won regulatory clearance for their new systemic lupus erythematosus treatment Benlysta...

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Regulatory compliance 'essential to pharma company success'

Thu 30 Jun 2011, 11:58AM

Staff in regulatory affairs jobs can play a vital role in pharmaceutical companies' success by improving compliance standards, according to Quintiles...

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Novartis receives CHMP backing for tuberous sclerosis drug

Wed 29 Jun 2011, 1:13PM

Novartis' staff in regulatory affairs jobs have received a CHMP recommendation for Votubia, its new treatment for astrocytoma caused by tuberous sclerosis...

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Regulatory processes 'becoming more difficult for drugmakers'

Wed 29 Jun 2011, 1:09PM

Pharmaceutical staff in regulatory affairs jobs are seeing fewer and fewer new drugs receive marketing approval, according to an industry expert...

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