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EMA

Janssen seeks EMA nod for Imbruvica, rituximab combo in previously untreated CLL

Janssen seeks EMA nod for Imbruvica, rituximab combo in previously untreated CLL

Pharmaceutical Business Review

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With EMA review in progress, Novartis unveils more positive data on asthma therapy

With EMA review in progress, Novartis unveils more positive data on asthma therapy

Endpoints

clinical trials

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Pfizer's Xeljanz gets EMA blood clots warning following FDA's similar move

Pfizer's Xeljanz gets EMA blood clots warning following FDA's similar move

Fierce Pharma

ulcerative colitis

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Five drugs, including two Novartis therapies, win EMA endorsement

Five drugs, including two Novartis therapies, win EMA endorsement

Endpoints

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CHMP backs world’s first Ebola vaccine from Merck, NewLink

CHMP backs world’s first Ebola vaccine from Merck, NewLink

Pharmaforum

NewLink Genetics

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When Can RWE Translate Into Credible Evidence? EMA Officials Discuss

When Can RWE Translate Into Credible Evidence? EMA Officials Discuss

RAPS.org

real world evidence

real world data

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Study: How Dependable Are Surrogate Endpoints?

Study: How Dependable Are Surrogate Endpoints?

Xtalks

clinical trials

surrogate endpoints

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EMA and FDA Historically Agree on Just About Every New Drug Approval, but is That Slowly Changing?

EMA and FDA Historically Agree on Just About Every New Drug Approval, but is That Slowly Changing?

RAPS.org

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Following EMA, FDA restricts use of high-dose Xeljanz, warning of added risks for the blockbuster JAK

Following EMA, FDA restricts use of high-dose Xeljanz, warning of added risks for the blockbuster JAK

Endpoints

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Amgen/UCB hit another Evenity hurdle, as European regulators fail to back the osteoporosis drug

Amgen/UCB hit another Evenity hurdle, as European regulators fail to back the osteoporosis drug

Endpoints

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Celgene can breathe a sigh of relief as FDA accepts once-spurned ozanimod application — setting a target date on a blockbuster decision

Celgene can breathe a sigh of relief as FDA accepts once-spurned ozanimod application — setting a target date on a blockbuster decision

Endpoints

multiple sclerosis

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Bluebird Bio’s Gene Therapy for Blood Disease Wins European Approval

Bluebird Bio’s Gene Therapy for Blood Disease Wins European Approval

Xconomy

beta thalassemia

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EMA imposes formal limit on Xeljanz prescription as regulators continue to review safety concerns

EMA imposes formal limit on Xeljanz prescription as regulators continue to review safety concerns

Endpoints

post-marketing studies

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After falling short on prelim OS data, EMA tells Aveo it wants to see something better on its long suffering tivo this summer — or else

After falling short on prelim OS data, EMA tells Aveo it wants to see something better on its long suffering tivo this summer — or else

Endpoints

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Drug Sampling and Testing: EMA Releases 20 Year Report, Will Expand Program to Biosimilars

Drug Sampling and Testing: EMA Releases 20 Year Report, Will Expand Program to Biosimilars

RAPS.org

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Aimmune's peanut allergy immunotherapy clears European PhIII with flying colors, paving way for first US, EU therapeutic approval

Aimmune's peanut allergy immunotherapy clears European PhIII with flying colors, paving way for first US, EU therapeutic approval

Endpoints

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EMA sounds its own safety alarm for Pfizer blockbuster, but they’re also not forcing a limit on dosing — yet

EMA sounds its own safety alarm for Pfizer blockbuster, but they’re also not forcing a limit on dosing — yet

Endpoints

rheumatoid arthritis

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Merck Gets CHMP Nod for Six-Week Dosing Option of Keytruda

Merck Gets CHMP Nod for Six-Week Dosing Option of Keytruda

Yahoo/Zacks.com

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Sanofi's isatuximab meets survival endpoint for third-line multiple myeloma

Sanofi's isatuximab meets survival endpoint for third-line multiple myeloma

BioCentury

relapsed or refractory multiple myeloma

Multiple Myeloma

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AstraZeneca’s Forxiga recommended for marketing authorization in EU

AstraZeneca’s Forxiga recommended for marketing authorization in EU

Pharmaceutical Business Review

type 1 diabetes

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