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- PMLiVE

NePathe

- PMLiVE

Sarepta soars as FDA clears its muscular dystrophy drug

Analysts anticipate blockbuster status for DMD therapy despite efficacy concerns

EISAI

Eisai wins EU licence for kidney cancer drug Kisplyx

Approved as a second-line combination treatment for advanced RCC

Sanofi reception

Sanofi trumpets new IGlarLixi data after regulatory delay

Reports that the combination drug is more effective at controlling glucose than Lantus alone

- 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

Retrophin rockets away as rare disease trial hits targets

Sparsentan has potential to become a blockbuster FSG drug, according to analysts

- PMLiVE

Merck closes in on first-line NSCLC label for Keytruda in US

Accelerated FDA review could see PD-1 inhibitor approved by the end of the year

AstraZeneca AZ

AZ hopes dosing will differentiate its severe asthma therapy

Plans to file benralizumab in EU and US by the end of the year spurred by phase III data

Novartis day

Novartis claims first place for its biosimilar Enbrel in US

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

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

Takeda: No decision yet on shutdown of Cambridge, UK unit

Tells PMLiVE that consultation over proposed closure of R&D site still ongoing

- PMLiVE

FDA knocks back Amgen’s chronic kidney disease treatment

Parsabiv was hoped to equal or exceed solid earner Sensipar

Gilead Sciences

Gilead’s Truvada cleared for HIV prevention in EU

May help slow down recent uptick in new HIV diagnoses

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