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- PMLiVE

AAR

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AZ withdraws EU filing for ovarian cancer drug cediranib

Maintains cediranib’s value as a combination therapy despite EMA information request

- PMLiVE

EMA’s head of international affairs steps down

Emer Cooke will take up new post at the WHO in November

- PMLiVE

Lilly closes on first approval for sarcoma drug Lartruvo

Orphan drug improved patient survival time by almost 12 months in phase II trial

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Combatting EU drug shortages

New guidelines to be issued after EMA report

- PMLiVE

Newron back on track for Xadago approval in US

Italian firm is not required to conduct additional trials for its Parkinson’s disease drug

- PMLiVE

Merck decision to drop odanacatib lifts UCB/Amgen

Pulls plug on osteoporosis candidate after studies show high risk of stroke

- PMLiVE

Amgen agrees to take Cytokinetics’ heart failure drug into phase III

Phase II results showed significant cardiac function benefit and no adverse safety signals

Novartis day

Novartis claims first place for its biosimilar Enbrel in US

However, Amgen’s patent infringement lawsuit could delay the launch of Erelzi

- PMLiVE

FDA knocks back Amgen’s chronic kidney disease treatment

Parsabiv was hoped to equal or exceed solid earner Sensipar

- PMLiVE

Patient reporting rises after EU pharmacovigilance reforms

Safety issues detected more quickly with increased patient participation

- PMLiVE

Germany’s IQWIG ‘perplexed’ by EMA’s adaptive pathways plan

Reliance on real-world evidence questioned

- PMLiVE

NICE swayed by extra data on Amgen’s Imlygic

Cost effectiveness watchdog backs immunotherapy in final draft guidance

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