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- PMLiVE

J&J gets CHMP backing for broader Darzalex use

Recommendation for earlier-stage approval could see multiple myeloma drug reach blockbuster sales

- PMLiVE

A rare talent

Shire’s Sebastian Stachowiak on dealing with change and working for a fit-for-purpose orphan drug environment

Shire Basingstoke

Shire pays record $350m to settle US kickback allegations

Charges centred around diabetic foot ulcer treatment Dermagraft, which it sold in 2014

- PMLiVE

Shire to focus rare disease R&D with new US facility

Cambridge, Massachusetts hub to drive firm’s push to become leading rare disease specialist

National Institute for Health and Care Excellence NICE logo

NICE backs Amicus Therapeutics’ Galafold

Recommends oral alternative for treating Fabry disease

- PMLiVE

Shire wins EU licence for pancreatic cancer drug Onivyde

Combination treatment is the first approved for this patient population

Shire Basingstoke

Shire gives up on Momenta-partnered Humira biosimilar

Will fund programme for another 12 months while divesting ongoing activities to Momenta

Shire Basingstoke

Shire launches dry eye drug Xiidra in US

Sparks rivalry with Allergan’s blockbuster Restasis as first new dry eye treatment in 13 years

- PMLiVE

Rare blood cancer therapy Oncaspar gets NICE green light

Baxalta’s acute lymphoblastic leukaemia treatment recommended for NHS use

- PMLiVE

HIV prevention pill heads July CHMP recommendations

Gilead’s Truvada given positive opinion alongside Ipsen Pharma’s Cabometyx and Eisai’s Kisplyx

Shire Basingstoke

FDA finally approves Shire’s potential blockbuster Xiidra

Dry eye disease treatment wins US licence

Shire Basingstoke

Shire receives FDA nod for self-infusion of Glassia

The company has also struck a deal with Pfizer to expand its GI portfolio

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