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- PMLiVE

Pharmathen

- PMLiVE

Givlaari, Rybelsus lead crowded CHMP recommendations

EU regulator delivered 15 positive opinions and no rejections

Bristol Myers Squibb logo

Another blow for BMS in first-line NSCLC as it pulls EU filing

Opdivo/Yervoy combination is still under review with the FDA

- PMLiVE

It’s Brexit day – now comes the really hard stuff

Months of trade negotiations between UK and EU lie ahead

- PMLiVE

Takeda’s subcutaneous Entyvio formulation faces FDA rejection

Was seeking approval in moderate-to-severe ulcerative colitis

Roche Basel Switzerland

EMA backs adjuvant use of Roche’s breast cancer ADC Kadcyla

Could face tough competition soon from a number of rivals

- PMLiVE

Biogen defends aducanumab filing plan amid scepticism

A new look at pivotal trial data described as hard-to-interpret

- PMLiVE

Novartis’ Mayzent and Roche’s Polivy lead CHMP recommendations

Sanofi Genzyme’s Lemtrada and Pfizer's Xeljanz receive label restrictions

- PMLiVE

Takeda highlights 12 NMEs with $10bn-plus sales potential at R&D day

First wave of new molecular entities has potential to generate 14 approvals

- PMLiVE

Takeda divests over-the-counter and prescription drugs to Stada for $660m

Japanese pharma said it has plans to divest $10bn in non-core assests

- PMLiVE

Provention Bio wins PRIME designation for type 1 diabetes prevention drug

Meanwhile J&J partnered Crohn's drug flops in phase 2

- PMLiVE

Biogen and Eisai revive abandoned aducanumab in shock turnaround

Companies plan to file the deserted Alzheimer’s drug with FDA

- PMLiVE

CHMP says OK to UCB/Amgen’s Evenity for osteoporosis after appeal

Initially received a negative opinion of the drug

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