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April 2023 PDUFA Calendar

April 2023 PDUFA Calendar

Research, Policy
Disrupted work schedules at FDA result in approval delays...
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Advisory Committee’s Split Decision on Biogen’s Tofersen

Advisory Committee’s Split Decision on Biogen’s Tofersen

Research, Policy
We expect the FDA to grant accelerated approval of Biogen's (BIIB) ALS treatment...
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Mitigation Expectations for Medicare Advantage Rate Notice

Mitigation Expectations for Medicare Advantage Rate Notice

Research, Policy
Size of Medicare Advantage mitigation may be less than earlier expectations...
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European Pharma: Top Picks as Growth Slows; New Launches and Core Products are Key

European Pharma: Top Picks as Growth Slows; New Launches and Core Products are Key

Research, Fundamental
How European Pharma fared versus consensus estimates...
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Glaukos (GKOS): Pipeline Policy Pathway

Glaukos (GKOS): Pipeline Policy Pathway

Research, Policy
Following Glaukos’ (GKOS) earnings report, attention now turns to the regulatory...
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Axonics (AXNX): Competition Coding Questions

Axonics (AXNX): Competition Coding Questions

Research, Policy
AXNX competitive pressures manageable following AMA disclosure...
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Shockwave (SWAV): Volatility Ahead?

Shockwave (SWAV): Volatility Ahead?

Research, Policy
No more than 50% odds to CMS forestalling an implied facility cut of 25%+ for SWAV's IVL procedures...
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Health Care: MedTech Companies Poised for Widening Operating Margins

Health Care: MedTech Companies Poised for Widening Operating Margins

Research, Fundamental
Recent earnings calls point to supply chain improvements...
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Johnson & Johnson (JNJ): Texas Two-Step Takes a Spill

Johnson & Johnson (JNJ): Texas Two-Step Takes a Spill

Research, Legal
Johnson & Johnson (JNJ: Talc Bankruptcy Opinion and Implications
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ENSG, BKD, OHI, SBRA: Two Key SNF Headwinds Amassing This Spring

ENSG, BKD, OHI, SBRA: Two Key SNF Headwinds Amassing This Spring

Research, Policy
Skilled nursing facilities face two key headwinds in ongoing recovery...
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