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- PMLiVE

simvastatin

- PMLiVE

Merck & Co to buy IO specialists Immune Design for $300m

US giant looks to next generation technology

- PMLiVE

More good news, and some bad, for Merck’s Keytruda

A rare setback in phase 3 liver cancer trial

- PMLiVE

Intercept NASH drug closes in on FDA approval

Although the drug failed to meet secondary endpoint

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CMS proposes coverage scheme for CAR-T therapies

Proposal says it would improve access to CAR-Ts

- PMLiVE

Merck puts prostate cancer firmly in Keytruda’s sights

Lynparza combination could open up huge new market

Roche Basel Switzerland

Roche submits Kadcyla for FDA Real-Time review

Aims to extend use in breast cancer patients

- PMLiVE

Analysts look beyond Keytruda in Merck’s future

CEO Frazier made to defend pipeline prospects

- PMLiVE

Immunomedics craters after FDA rejects breast cancer ADC

Regulator wants to see more data on manufacturing

Sanofi reception

FDA adcomm split on Sanofi’s type 1 diabetes drug

Concerns rose after Zynquista-treated patients showed an eight-fold increase in DKA

- PMLiVE

Evenity back on track with FDA panel blessing in osteoporosis

US drugs regulator first rejected the drug due to cardiovascular concerns

- PMLiVE

FDA expecting boom in cell and gene therapies

Pledges clampdown on developers working outside regulations

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FDA moves into crisis mode as shutdown drags on

New drug appraisals already being affected

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