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- PMLiVE

Sobi’s Gamifant receives final rejection from CHMP for primary HLH

Committee reiterated previous negative opinion

- PMLiVE

Novartis scores CHMP backing for cholesterol drug Leqvio

Potential first-in-class treatment moves closer to EU approval

- PMLiVE

Pfizer and BioNTech’s COVID-19 vaccine begins EMA evaluation

Vaccine is the second to undergo EMA's 'rolling review' process after AstraZeneca/Oxford Uni's candidate

- PMLiVE

EMA begins rolling review of AZ’s COVID-19 vaccine candidate

Agency has started evaluating data from non-clinical laboratory studies

- PMLiVE

EMA accepts application for bluebird bio’s Lenti-D in CALD

Gene therapy could become a potentially transformative treatment for cerebral adrenoleukodystrophy

AstraZeneca AZ

AZ’s Farxiga cuts risk of death in chronic kidney disease

Detailed results revealed at the European Society of Cardiology virtual congress

- PMLiVE

Gut instincts lead Takeda to GI pipeline success

Takeda’s Asit Parikh talks about a game changer for IBD patients and the company’s long-term strategy for gene and cell therapy

- PMLiVE

Boehringer/Lilly’s Jardiance hits the mark in pivotal heart failure trial

Drug reduced risk of death/hospitalisation in patients with and without diabetes

- PMLiVE

GSK’s anti-BCMA drug leads crowded CHMP recommendations

Ten new drugs receive positive recommendations for approval

- PMLiVE

EMA to support real-world monitoring of COVID-19 treatments/vaccines

New infrastructure will support real-world studies

- PMLiVE

In virtual meeting, CHMP backs Sanofi’s myeloma drug Sarclisa

Monthly meeting held remotely for the first time due to COVID-19 pandemic

- PMLiVE

FDA says no to Lilly, Boehringer’s Jardiance in type 1 diabetes

Formally rejects extended use of SGLT2 inhibitor

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