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Gilead’s Livdelzi Receives Conditional EC Approval for Primary Biliary Cholangitis
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US-based Gilead Sciences Inc. (NASDAQ: GILD) announced that it has received conditional approval from the European Commission (EC) for its liver disease drug Livdelzi (seladelpar). The drug is approved for use in combination with ursodeoxycholic acid (UDCA) to treat primary biliary cholangitis (PBC) in adults who have an inadequate response…
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MHRA Approves Gilead’s Livdelzi for Primary Biliary Cholangitis
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The Medicines and Healthcare products Regulatory Agency (MHRA) last week signed off on US-based Gilead Sciences Inc.’s (NASDAQ: GILD) Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC), including pruritus. This approval marks a significant step forward in the treatment options available for patients suffering from this chronic liver…
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Gilead Buys Out Janssen’s Royalty Rights to Seladelpar for Primary Biliary Cholangitis Treatment
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Gilead (NASDAQ: GILD)’s financial report for the second quarter of 2024, followed by an earnings call, has disclosed a significant transaction: the company has paid Johnson & Johnson’s Janssen division USD 320 million to acquire full royalty rights to the PPAR-delta agonist, seladelpar, a drug for which Gilead obtained global…
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Gilead’s Seladelpar Shows Interim Benefits in PBC-Related Itch Clinical Trial
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Gilead Sciences (NASDAQ: GILD) has announced interim results from a long-term study assessing the safety and efficacy of seladelpar, a PPAR-delta agonist, in treating pruritus associated with primary biliary cholangitis (PBC). The trial involved patients who had an inadequate response or were intolerant to ursodeoxycholic acid (UDCA), with 70% of…
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Gilead Nears Completion of CymaBay Acquisition After Waiting Period Expires
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Gilead Sciences (NASDAQ: GILD) has moved one step closer to finalizing its cash tender offer for the acquisition of fellow US company CymaBay Therapeutics (NASDAQ: CBAY), following the expiration of a mandatory waiting period under local laws last week. The two companies had previously submitted regulatory filings for approval of…
