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- PMLiVE

Janet Woodcock

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

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

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

AstraZeneca AZ

AZ-Lilly start second pivotal trial of fast-tracked Alzheimer’s drug

AMARANTH could be first treatment to target underlying mechanism

Sanofi reception

Sanofi loses lead on diabetes combo IGlarLixi after FDA delay

FDA verdict on Novo Nordisk’s rival combo Xultophy due next month 

- PMLiVE

Portola rejection hands advantage to Boehringer’s Pradaxa

FDA’s ruling on reversal agent for NOACs unexpected

- PMLiVE

J&J therapy for suicidal depressives ‘a breakthrough’, says FDA

Status granted to esketamine after phase II PeRSERVERe trial

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