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Pharma channel feed
EMA committee recommends Alnylam's early-stage ATTR amyloidosis drug for orphan status
8 years ago
Pfizer hits stumbling block on Herceptin rival, but wins 'breakthrough' status on MenB vaccine
8 years ago
R&D
Sage files for an approval for its ‘breakthrough’ therapy for postpartum depression
8 years ago
Penny stock biotech Synthetic Biologics sees its 'breakthrough' status pulled as FDA ponders safety issues
8 years ago
Dicerna shares rocket up on a $15M-plus-stock deal to settle Alnylam claims — will deals follow?
8 years ago
Arcturus takes another legal stab at former CEO as public battle turns serious for the company
8 years ago
People
Novartis CEO Vas Narasimhan is raising the bar on second-gen cancer drug studies
8 years ago
R&D
CHMP scolds AB Science (again) for masitinib shortcomings, triggering a new rout on stock price
8 years ago
UCB snags an NDA-ready epilepsy drug from Proximagen in $370M deal
8 years ago
Biogen pays $1B cash to enlist Ionis on a new drug discovery campaign — but can it deliver fast enough for analysts?
8 years ago
R&D
GW Pharma walks away from adcomm with unanimous support for anti-seizure med. An OK shouldn’t take long now
8 years ago
FDA’s insider review raises serious safety issues as Eli Lilly’s quick comeback shot for baricitinib heads for expert showdown
8 years ago
Badrul Chowdhury jumps ship at the FDA and moves to AstraZeneca, joining an exodus of agency officials
8 years ago
People
AstraZeneca wins expanded OK to use Tagrisso in frontline lung cancer niche, spurring hope of hitting $3B sales goal
8 years ago
Sangamo probes for fresh breaches of its digital security system after top exec’s email was hacked -- exposing secrets
8 years ago
FDA chief Scott Gottlieb promises to streamline drug development pathway for biopharma
8 years ago
In FDA double header, regulators also offer a green light to Rigel's fostamatinib
8 years ago
Ultragenyx wins a blockbuster OK for its leading rare disease drug burosumab -- priced at $200,000
8 years ago
GW Pharma's cannabis-based drug appears poised for a groundbreaking FDA approval as internal review offers a clear thumbs up
8 years ago
Unencumbered by safety concerns, Roche's Hemlibra gets breakthrough status for new patient group
8 years ago
Bristol-Myers invites J&J into an alliance of giants on cardio drug development/commercialization program
8 years ago
R&D
Servier buys Shire's oncology unit for $2.4B in the run-up to Takeda's final buyout offer — if it makes one
8 years ago
In a stunning about face, the FDA is now welcoming the new drug application from Alkermes it rejected 2 weeks ago
8 years ago
Next-generation sequencing: FDA offers guidance to streamline path to market
8 years ago
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