Drug Developers “Facing Complex Global Regulatory Requirements”

Experts have warned that as pharmaceutical and biopharmaceutical companies increase the number of clinical trials they conduct in emerging global markets, growing regulatory complexity is forcing them to change the way they operate. “What a company does in one region can very likely affect how regulators treat it elsewhere,” according to Christopher-Paul Milne, associate director of

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Diabetes is pharma’s fastest-growing market

Diabetes is the pharmaceutical industry’s fastest-growing market, and the costs of preventing and treating the condition worldwide are forecast to rise from $376 billion in 2010 to $490 billion by 2030, according to new research.  285 million people, or 6.4% of the world’s adult population, are currently estimated to be living with diabetes, and this

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MS drug hits Phase II targets

Biogen Idec and Abbott Laboratories have reported promising results in a Phase IIb trial of daclizumab, their once-monthly injectable treatment for multiple sclerosis. Top-line results from the dose-ranging SELECT trial in patients with the relapsing-remitting form of MS indicate that treatment with daclizumab at a dose of 150mg given by subcutaneous injection once every four

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Allergan’s Botox gets EU approval for Incontinence

Allergan has been boosted by the news that Botox has received a positive agreement for approval in 14 European Union countries for treating certain patients with urinary incontinence. The recommendation from the Irish Medicines Board is for Botox (botulinum toxin type A) to be approved for the management of urinary incontinence in adults with neurogenic

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GSK signs ‘bubble boy disease’ agreement with MolMed

GlaxoSmithKline’s efforts to tackle a rare and often deadly immune deficiency are making progress following the announcement that they have signed a deal with Italy’s MolMed. In October last year, GSK linked up with San Raffaele Telethon Institute, gaining an exclusive licence to an investigational gene therapy for ADA-SCID (adenosine deaminase deficiency – severe combined

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Novartis MS pill rejected by NICE

The decision by the UK’s cost watchdog to reject Novartis’ Gilenya, the first pill to treat multiple sclerosis, has been greeted with dismay by the company and patient groups. In provisional draft guidance published this morning, the National Institute for Health and Clinical Excellence has decided against recommending payment by the National Health Service for

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Roche gains RoActemra European Approval for children with RA

Roche has gained approval in Europe for its biologic RoActemra for systemic juvenile idiopathic arthritis. The European Commission has approved the use of RoActemra (tocilizumab) for the treatment of active sJIA in patients two years of age and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs and systemic corticosteroids (used to

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AZ’s Nexium/aspirin combination gets EU thumbs-up

AstraZeneca have announced that Axanum, a fixed dose combination of 81 mg low-dose ASA (acetylsalicylic acid) and 20 mg esomeprazole, has received positive agreement for approval in 23 European Union member countries and in Norway. The combination is indicated for prevention of cardiovascular events such as heart attack or stroke, in high-risk patients in need of

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Quintiles takes commercial operations to Russia

US-based biopharmaceutical services company Quintiles is expanding its remit in Russia by launching its first commercial project in the market. The project involves a 40-strong sales team and comes after Quintiles set up a local legal entity to deliver commercial operations in the country and appointed Sergey Smirnov as head of business development & operations,

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Bristol-Myers Squibb to acquire Amira

Bristol-Myers Squibb has hit the acquisition trail again and is buying privately held Amira Pharmaceuticals in a deal that could be worth $475 million to the inflammatory and fibrotic diseases specialist. Under the terms of the agreement, B-MS is shelling out $325 million in an upfront fee and may make additional milestone payments totalling $150

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