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- PMLiVE

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- PMLiVE

GSK submits Votrient for ovarian cancer in Europe

Pharma company hopes for extra indication for oncology product

- PMLiVE

FDA panel turns down Otsuka’s drug for rare kidney disease

Unable to recommend expanded use of tolvaptan

EU flag

EC sets up expert group on rare diseases

Will revamp EUCERD to better handle development of orphan medicines

- PMLiVE

EMA’s head of human medicines development steps down

Patrick Le Courtois leaves regulator after 16 years

- PMLiVE

Boehringer: clinical trial set-up poses challenge in rare diseases

Says more support needed in regulatory process for orphan drugs

Actelion HQ Switzerland

Actelion to buy Ceptaris – if FDA backs its cancer treatment

Acquisition contingent on Valchlor approval in rare lymphoma

BTG extends orphan drug distribution partnership with Clinigen

Deal covers treatment for overexposure to chemotherapy

- PMLiVE

Boehringer’s first cancer drug leads EMA recommendations

Afatinib recommended for lung cancer under brand name Giotrif

- PMLiVE

Pfizer and Otsuka face drug rejections in Europe

EMA turns down Xeljanz for rheumatoid arthritis and delamanid for tuberculosis

- PMLiVE

EMA: no new safety concerns with GLP-1 diabetes drugs

CHMP takes issue with study that linked the treatments to serious side effects

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

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