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Biogen Idec building

Biogen Idec’s long-acting beta interferon moves ahead in MS

US and EU accept filings for long-acting multiple sclerosis drug Plegridy

Enabling access for patients with rare diseases

When it comes to meeting patient needs, the well-known counsel to ‘think globally, act locally’ rings true

- PMLiVE

FDA approves intravenous Simponi for arthritis treatment

J&J says Simponi Aria will offer less frequent dosing schedule than subcutaneous version

EC consults on orphan drug application guidelines

Also seeks input on the transfer of designations from one sponsor to another

- PMLiVE

FDA fast-tracks Elan’s Alzheimer’s drug

Speeds up regulatory process for ELND005 for the treatment of neuropsychiatric symptoms

- PMLiVE

FDA clears first brain test to diagnose ADHD in children

NEBA system available as part of wider clinical assessment

- PMLiVE

Analysts question value of rumoured $20bn Roche bid for Alexion

Shares in orphan drug specialist slide back after earlier surge

- PMLiVE

Boehringer breaks into oncology with FDA approval

Agency backs company's first cancer drug afatinib in lung cancer

- PMLiVE

Court orders EC to approve rejected orphan medicine

Says CTRS should be allowed to market Orphacol for the treatment of rare bile condition

- PMLiVE

Revlimid faces NICE rejection for use in rare blood cancer

Watchdog's draft guidance does not recommend Celgene's drug for NHS use in England and Wales

Novartis sponsors rare disease patient community

Backs site for patients affected by pancreatic neuroendocrine tumours (PNET)

- PMLiVE

GSK files combination skin cancer drug in US

Seeks FDA approval for Tafinlar - Mekinist combination in melanoma

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