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J&J’s Ebola vaccine approved in EU

J&J’s Ebola vaccine approved in EU

Pharmaforum

Bavarian Nordic

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Takeda takes a $200M hit after Novartis is forced to yank its marketing application for Xiidra

Takeda takes a $200M hit after Novartis is forced to yank its marketing application for Xiidra

Endpoints

dry eye disease

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Vertex : CHMP Grants Positive Opinion For KAFTRIO - KALYDECO In People Ages 12 And Older With CF

Vertex : CHMP Grants Positive Opinion For KAFTRIO - KALYDECO In People Ages 12 And Older With CF

Business Insider

Vertex Pharmaceuticals

cystic fibrosis

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Novartis strikes out with dry eye med Xiidra in Europe

Novartis strikes out with dry eye med Xiidra in Europe

Seeking Alpha

dry eye disease

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COVID-19 drug remdesivir recommended for EU approval

COVID-19 drug remdesivir recommended for EU approval

Pharmaforum

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BioGeneration Ventures €105M fund for early European biotechs

BioGeneration Ventures €105M fund for early European biotechs

Fierce Biotech

BioGeneration Ventures

venture capital

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Biopharma industry urges MRA to mitigate risk of no-deal Brexit

Biopharma industry urges MRA to mitigate risk of no-deal Brexit

RAPS.org

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Some Covid-19 trial sponsors never posted other study results in an EU database. Will they hide data again?

Some Covid-19 trial sponsors never posted other study results in an EU database. Will they hide data again?

Stat

clinical trials

clinical trial transparency

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AstraZeneca to supply Europe with up to 400 million doses of Oxford University’s vaccine at no profit

AstraZeneca to supply Europe with up to 400 million doses of Oxford University’s vaccine at no profit

Pharmaceutical Business Review

University of Oxford

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Surmodics' Regulatory Win Marks a Positive Shift in Paclitaxel Controversy

Surmodics' Regulatory Win Marks a Positive Shift in Paclitaxel Controversy

Medical Devices and Diagnostics Industry

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EU states back spending up to $2.7 billion upfront on COVID-19 vaccines

EU states back spending up to $2.7 billion upfront on COVID-19 vaccines

Reuters

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Gilead files remdesivir for EU approval, with a verdict possible “in weeks”

Gilead files remdesivir for EU approval, with a verdict possible “in weeks”

Pharmaforum

Gilead Sciences

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Europe mulls BARDA-style development contracts for COVID-19 vaccines: Bloomberg

Europe mulls BARDA-style development contracts for COVID-19 vaccines: Bloomberg

Fierce Pharma

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EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication

EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication

RAPS.org

clinical trial transparency

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EMA extends virtual-only meeting policy through August

EMA extends virtual-only meeting policy through August

Endpoints

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New Zolgensma 'inflection point' is here as Novartis snags EU nod for SMA gene therapy

New Zolgensma 'inflection point' is here as Novartis snags EU nod for SMA gene therapy

Fierce Pharma

spinal muscular atrophy

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World leaders pledge €7.4bn to research Covid-19 vaccine

World leaders pledge €7.4bn to research Covid-19 vaccine

The Guardian, UK

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EMA gives thumbs up to key drugs from Novartis, Alexion, Vertex and more

EMA gives thumbs up to key drugs from Novartis, Alexion, Vertex and more

Endpoints

Vertex Pharmaceuticals

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After NIH trial, EMA begins rolling review for remdesivir, setting up potential authorizations in US and Europe

After NIH trial, EMA begins rolling review for remdesivir, setting up potential authorizations in US and Europe

Endpoints

Gilead Sciences

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FDA, EU authorities update guidance on clinical trials during COVID-19

FDA, EU authorities update guidance on clinical trials during COVID-19

RAPS.org

clinical trials

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