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Calliditas Therapeutics AB

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Latest From Calliditas Therapeutics AB

Travere Set For Big Expansion As Filspari Wins Full Approval In IgAN

The drug maker could end up doubling the addressable patient population for Filspari thanks to the new label removing the proteinuria threshold, plus a draft treatment guideline from a kidney disease group.

Approvals Market Access

US FDA September User Fee Calendar Slims Down, Still Boasts More Than Five Novel Agents

New therapies in the wings include two candidates for Niemman-Pick disease type C, a first-in-class antipsychotic, a targeted oncology therapy under Real-Time Oncology Review, and a new drug for gastroparesis.

US FDA Performance Tracker Drug Review

Fabhalta IgAN Nod Plays Into Novartis’s Long-Term Nephrology Development Plan

US FDA approval in IgAN is just the first step in a much larger renal disease strategy for the company, which includes additional kidney indications for Fabhalta.

Approvals Launches

M&A Activity During Q2 Declined In Volume And Valuation

Following a pair of $10bn+ deals in Q4 2023 and a $16.5bn takeout in Q1, the second quarter saw no acquisition priced as high as $5bn, Evaluate notes. Aggregate deal volume and values dropped from Q1.

Evaluate Data M & A
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    • Pharmalink AB
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