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- PMLiVE

MEDI8897

- PMLiVE

Novartis files for approval of MS drug in EU, US

Siponimod could achieve blockbuster status if approved, says analysts

- PMLiVE

Insmed claims first FDA okay for limited population antibiotic

Arikayce is cleared to treat lung disease caused by MAC

- PMLiVE

Biotech leaders jump into US free speech debate

Senior biotech execs sign a letter in defence of free speech

- PMLiVE

MSD wins key EU approval for Keytruda, Alimta combo

Decision keeps Keytruda well ahead of rival Tecentriq

- PMLiVE

FDA rejects GSK’s Nucala for COPD

Says evidence that Nucala was effective in preventing COPD exacerbations was insufficient

AstraZeneca AZ

AZ, Amgen’s first-in-class asthma drug gets breakthrough status

Clinical data from the TSLP targeting antibody is due in 2020

- PMLiVE

FDA gives Loxo breakthrough tag for second cancer drug

US regulatory body to expect a NDA for LOXO-292 in late 2019

- PMLiVE

Novartis sells off part of Sandoz portfolio

Swiss pharma giant will retain biosimilars

Sanofi reception

Sanofi gets EU OK for Ablynx flagship drug Cablivi

EMA clears the drug to treat adults with aTTP

- PMLiVE

Alnylam gets EU nod for Onpattro amid pricing backlash

However the drug’s price could be lowered in the EU due to direct competition

AstraZeneca AZ

AstraZeneca’s Lupus treatment misses mark in trial

Anifrolumab failed to show statistically significant reduction in disease activity

- PMLiVE

Shire claims US okay for HAE blockbuster-in-waiting

FDA approves Takhzyro as a preventative measure for HAE attacks

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