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Regeneron’s R&D approach scores dual wins against Alexion’s Ultomiris and in lymphoma

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Regeneron left the American Society for Hematology meeting in San Diego this week with a pair of trial aces, notching a head-to-head win against a rare disease blockbuster and a potential best-in-class performance in the crowded lymphoma market.

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Pharma Voice

AstraZeneca’s rare disease unit overcomes FDA snub to expand Ultomiris in NMOSD

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Nearly five years after an FDA approval for Soliris in neuromyelitis optica spectrum disorder (NMOSD), AstraZeneca’s follow-on C5 drug Ultomiris has entered the rare neurological disease, as well.

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Fierce Pharma

EHA 2023 – Astrazeneca keeps up its complement defense

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Astrazeneca has the dominant complement inhibitor franchise via the acquisition of Alexion and its intravenous therapies Soliris and Ultomiris. But that position could soon come under fire from Novartis’s oral contender iptacopan.

Astra has oral projects of its own, although these are either way behind or focused on relatively small niches in paroxysmal nocturnal haemoglobinuria (PNH), their first indication. But Anita Hill, vice-president of global medical affairs at the Alexion division, believes that there is a good reason not to write off Soliris and Ultomiris just yet.

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EP Vantage

AstraZeneca's Alexion hopes to extend dominance in PNH as Big Pharma competitors close in

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For years, Alexion has been the only name in the game for a blood disease called paroxysmal nocturnal hemoglobinuria (PNH). Now, a number of Big Pharmas want in, vying to show their candidates can go head-to-head with the AstraZeneca unit's market-leading therapies Ultomiris and Soliris.

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Fierce Biotech

Novartis, eyeing $3B market, beats AstraZeneca blood disorder blockbusters in phase 3

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Novartis is coming for the jewels of AstraZeneca’s $39 billion takeover of Alexion. In a phase 3 trial, the Swiss drugmaker’s iptacopan beat the incumbent rare disease drugs Soliris and Ultomiris, advancing its plan (PDF) to turn the oral challenger into a $3 billion-a-year blockbuster.

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Fierce Biotech

AstraZeneca wins two recommendations, one priority review

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AstraZeneca PLC on Monday said it won two recommendations for approval in the EU and one priority review in the US.

AstraZeneca's and Daiichi Sankyo Co Ltd's breast cancer drug Enhertu won strategic priority review in the US for patients with some forms of breast cancer. "Enhertu is a specifically engineered HER2-directed antibody drug conjugate," AstraZeneca, a Cambridge-based pharmaceutical company, explained. HER2 stands for human epidermal growth factor receptor 2, a protein that promotes the growth of cancer cells.

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Morningstar

AstraZeneca's Ultomiris scores its 3rd FDA approval, setting up market clash with argenx

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Thursday, Ultomiris continued its rapid ascent with an FDA approval to treat generalized myasthenia gravis (gMG), an autoimmune neuromuscular disorder that causes severe weakness and loss of muscle function.

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Fierce Pharma

After Alexion buyout, AstraZeneca pays Roche $775M to settle Ultomiris patent brawl

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AstraZeneca and Roche recently decided to end a patent infringement fight around Ultomiris. Now, we know the price of the deal.

AstraZeneca’s Alexion will pay $775 million to Roche’s Chugai Pharmaceutical to resolve all patent disputes related to the C5 inhibitor, the two companies said Thursday.

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Fierce Pharma