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Novartis day

FDA approval for Kisqali sets up showdown with Ibrance

Novartis breast cancer therapy drug has been predicted to reach blockbuster status

- PMLiVE

Trump nominates Gottlieb to head FDA

If confirmed he would take over from previous commissioner Robert Califf

Bristol-Myers Squibb (BMS) building

BMS replaces R&D head in wake of Opdivo setbacks

As Merck & Co’s Keytruda gains the lion’s share of the market

Sanofi reception

Sanofi adds to dupilumab evidence base as US approval nears

FDA to deliver verdict on atopic dermatitis drug

- PMLiVE

Merck & Co and Pfizer take aim at diabetes with trio of new drugs

File ertugliflozin-based products with EU and US regulators

- PMLiVE

Move on Immunomedics board puts Seattle Genetics deal in doubt

Four venBio candidates voted to the board which gives group a majority

- PMLiVE

NICE turns down first-line Keytruda for lung cancer

High cost of drug puts it above cost-effectiveness threshold

- PMLiVE

FDA sets August review date for Teva’s movement disorder drug

Could be first approved treatment for tardive dyskinesia

- PMLiVE

AZ gets US approval for diabetes combo Qtern

Wins licensing for Onglyza/Farxiga dual-therapy after rejection by the FDA in 2015

- PMLiVE

Novartis’ Zykadia nears first-line lung cancer label

Hopes to boost slow second-line sales to compete directly with Pfizer’s Xalkori and Roche’s Alecensa 

- PMLiVE

FDA verdict on Pfizer’s breakthrough leukaemia drug due in August

Phase III trials results saw complete remission in 81% of patients in the treatment group

- PMLiVE

FDA OKs Valeant’s psoriasis drug Siliq, with black box warning

Suicidal ideation labelling adds to challenge in rivalling Novartis’ Cosentyx and Lilly’s Taltz

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