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Amylyx's ALS drug gets a three-month PDUFA delay, setting up the pivotal decision for September
4 years ago
R&D
FDA+
Bristol Myers jumps into the M&A game with a $4B oncology buyout. And weary biotech analysts couldn't be any happier
4 years ago
Deals
Days after disclosing trial flop, stem cell therapy developer axes 70% of workforce while searching for cash
4 years ago
People
All in on early-stage, Qiming US bags $260M, recruits Atara founder Isaac Ciechanover for Fund III
4 years ago
Financing
Time Passages: Bruce Goldsmith out at Jim Wilson's gene therapy biotech; Flagship reveals Michael Severino’s CEO ...
4 years ago
Peer Review
Regeneron inks $1B+ deal for global rights to Sanofi-partnered PD-1 Libtayo
4 years ago
Deals
Pharma
Pfizer, like Moderna, fires back at Alnylam suit over Covid-19 vaccine patents
4 years ago
Pharma
Coronavirus
Novartis resumes remote business in Ukraine after safety protocol review
4 years ago
Pharma
Another refuse-to-file for a small biotech — is the FDA using RTFs to manage its workload?
4 years ago
FDA+
Organon debuts murals created by women around the world, plus ambitious ESG plan, on first anniversary
4 years ago
Pharma
Marketing
Gilead poaches new pharma development and manufacturing chief from cell therapy 2.0 player
4 years ago
R&D
Manufacturing
FDA compliance vet heads to India-based Lupin after long public career
4 years ago
People
FDA+
Manufacturing roundup: Lonza collaborates with a VC in Israel; Piramal updates one facility while opening a new one
4 years ago
Manufacturing
The target is the system: Condensates biotech aspires to ‘rewrite the rulebook’ on drug discovery
4 years ago
Financing
Biogen, Samsung Bioepis look to carve up a blockbuster Roche franchise with deep discount biosimilar
4 years ago
Marketing
Civica nabs trial partner as it forges ahead to create more affordable insulins
4 years ago
R&D
Manufacturing
Centessa axes lead program after a patient in kidney disease safety study is hospitalized
4 years ago
R&D
After filing for bankruptcy, rejected migraine drug developer Zosano’s value more than halved
4 years ago
People
Santhera renegotiates milestone payment, increases liquidity runway into 2023 pending NDA filing
4 years ago
Financing
R&D
Immatics imagines broader CAR-T pipeline with another Bristol Myers pact and addition to 2019 TCR deal
4 years ago
Deals
Cell/Gene Tx
Evonik to make a multimillion-dollar investment at their Indiana site
4 years ago
Manufacturing
Cambrex secures acquisition in Ireland, increasing their European footprint
4 years ago
Manufacturing
Sana banks on $100M savings as it shifts manufacturing plans to Washington state
4 years ago
Manufacturing
Precision drug + diagnostics biotech scores modest Series A, retrofitting existing drug for new indication
4 years ago
Financing
Diagnostics
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