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- PMLiVE

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- PMLiVE

NICE blocks second Alexion rare disease drug in a week

Says high cost and “considerable uncertainties” over long-term benefits prohibit routine NHS use

- PMLiVE

FDA approves first steroid for Duchenne muscular dystrophy

Marathon Pharma’s Emflaza is first approved to treat all genetic forms of the condition

- PMLiVE

Amgen’s chronic kidney disease drug Parsabiv cleared in US

Sensipar follow-up is the first therapy to be approved for treatment of sHPT in 12 years

- PMLiVE

Cellectis gets FDA nod for ‘off-the-shelf’ CAR-T trial

Investigational New Drug gets go-ahead for trials in patients with two haematological cancers

- PMLiVE

Keytruda filed for first- and second-line bladder cancer

Merck & Co hopes to gain advantage over Opdivo and Tecentriq with first-line setting

- PMLiVE

Trump talks pricing and manufacturing with pharma

Heads of Celgene, Lilly, Merck & Co, Novartis and trade body PhRMA met at the White House

ABPI London offices

UK pharma slams new drug evaluation plans

ABPI and BIA oppose "arbitrary" proposal to impose £100,000 QALY limit on rare disease therapies

ABPI London offices

UK pharma slams new drug evaluation plans

ABPI and BIA oppose "arbitrary" proposal to impose £100,000 QALY limit on rare disease therapies

- PMLiVE

A rare talent

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

- PMLiVE

FDA approves Synergy’s constipation drug Trulance

Set to launch by March this year, analysts say the CIC therapy could see sales of $450m by 2020

- PMLiVE

Merck & Co’s Keytruda muscles further ahead of rivals in lung cancer

Granted accelerated review by FDA for use in combination with chemotherapy

FDA: Cybersecurity is an ever-present risk for medical devices

US regulator issues new guidance for manufacturers

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