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Remember that post-marketing trial? New study confirms many drugmakers don’t do them — half drag their feet
6 years ago
Bioregnum
Opinion
On track for first autoimmune drug approval, Bing Yao steers AstraZeneca spinoff to $150M IPO
6 years ago
Financing
Mylan wins tentative US approval for generic version of Lilly's Alimta — it could be years before it can be sold
6 years ago
Pharma
Novartis preps a 2020 launch in multiple sclerosis as 2 successful pivotal trials set stage for an assault on ...
6 years ago
R&D
Pharma
Academics and researchers raise concerns with FDA’s plan for ‘integrated reviews’
6 years ago
FDA+
Immunicum's dendritic cell therapy flunks co-primary endpoint in 'positive' PhII
6 years ago
R&D
Esperion releases positive PhII results; Safety warnings at India, China manufacturing sites spell trouble for global ...
6 years ago
News Briefing
AbbVie’s $10B Rova-T play ends in one last failure — R&D team shuts it all down
6 years ago
R&D
EMA follows FDA to approve Roche's Tecentriq combo for frontline use in triple negative breast cancer
6 years ago
Pharma
After disappointing investors, SillaJen gets into trouble with Korean prosecutors on suspected insider trading
6 years ago
R&D
FDA finalizes guidance on placebos and blinding for cancer trials
6 years ago
R&D
FDA+
In a battered field, AstraZeneca's lupus drug clears pivotal study — but can they get it approved now?
6 years ago
R&D
Amgen’s legendary lawyer corps loses a major court fight attempting to quash PCSK9 rival from Sanofi, Regeneron
6 years ago
Pharma
FDA fires off a warning on rare cases involving death, adverse liver events linked to misuse of 3 big hep C drugs
6 years ago
FDA+
Tears for FAERS: Another FAERS disaster rumor slams Vertex shares in a Wall Street melee — but this time the ...
6 years ago
Pharma
Kite partner HiFiBiO closes $67M round for preclinical antibody candidates churned out of single-cell analytics ...
6 years ago
Financing
Alexion's cash cow receives label expansion; Matthew Dallas tapped to CFO post at Zealand Pharma
6 years ago
News Briefing
Bristol-Myers, AbbVie's multiple myeloma drug wins second EU nod as part of triple regimen
6 years ago
Pharma
FDA+
The Woodford effect: Teetering on the edge, his co-investors are feeling the pain — and they want it to stop
6 years ago
R&D
AstraZeneca wins a round in their PhIII COPD bout with GSK — but can they catch up?
6 years ago
R&D
Purdue Pharma proposes $12B settlement to clean up opioid mess — report
6 years ago
Pharma
Decades in the making, Kyowa Hakko Kirin finally wins FDA approval for add-on Parkinson's therapy
6 years ago
Pharma
FDA+
Immatics scores $75M upfront in TCR deal with Celgene as interest in tech burgeons
6 years ago
Deals
Cell/Gene Tx
Top FDA exec Edward Cox jumps ship and joins Regeneron as new regulatory VP
6 years ago
People
Pharma
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