Tag Archives: Biosimilar

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Alpine Immune Sciences Lands AbbVie as R&D Partner for Lupus Drug

Alpine Immune Sciences’ lupus drug candidate now has AbbVie lined up to continue the compound’s development. The drug, ALPN-101, is ready for Phase 2 testing, which will be conducted by Seattle-based Alpine. The deal announced Thursday grants AbbVie (NYSE: ABBV) an exclusive option to license the drug after that study. The North Chicago, IL-based pharmaceutical […]

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Bio Roundup: Cholesterol Check, J&J’s Opioid Hit, AbbVie’s Flop & More

You might be camping, barbecuing, or sleeping on Monday. It’s Labor Day, after all. But in Paris, this cardiologist will be in a conference center, walking an audience through a slide deck packed with Phase 3 data for a new cholesterol-lowering drug, inclisiran. Inclisiran’s owner, the Medicines Co., jumped the presentation by a week, promising […]

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Bio Roundup: Zolgensma Fallout, Duchenne Redux, Ebola Boost & More

We learned last week that the FDA was investigating Novartis for manipulating animal data related to its $2 million-a-dose gene therapy Zolgensma. The activity took place at AveXis, the firm Novartis bought for $8.7 billion in 2018, and Novartis reportedly knew but failed to report it to the FDA before the agency approved Zolgensma in […]

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Bio Roundup: Gottlieb Exits, Bristol Defends, Biogen Buys & More

In early 2017, Scott Gottlieb was considered the most moderate of the potential candidates to head the Food and Drug Administration, which is the most powerful regulator of medical products in the world. It wasn’t a high bar to clear. Libertarians who had questioned some of the basic premises of the FDA were in the […]

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Two Years and Done: FDA Commissioner Gottlieb To Resign

Two months after insisting on Twitter that he wasn’t going anywhere, Food and Drug Administration Commissioner Scott Gottlieb announced his resignation today. He leaves a record of health and medical regulation that was more active than critics who spoke out against his nomination in early 2017 might have expected. Gottlieb’s remit extended beyond drugs, of […]

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Pharma CEOs to Senate: We Will Lower Drug Prices if Rebates Go Away

Seven top pharmaceutical executives gathered today in Washington, DC, for a Senate hearing on drug prices, bringing face-to-face two groups held in the lowest esteem possible by the American public. Top executives from seven companies—AbbVie, AstraZeneca, Bristol-Myers Squibb, Merck, Johnson & Johnson, Pfizer, and Sanofi, which represent a combined $1.1 trillion in market value—stuck to […]

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Bio Roundup: 2019 Trials, Pilgrim Price Chat, Pre-Xmas Sales & More

It’s beginning to look a lot like, well, the last roundup of the year, with plenty of news to pack in before our holiday breather. Whew. Before you fly off, or drive, or simply unplug, check out our preview of what could be next year’s top clinical studies; the tumult in big pharma’s on again-off […]

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Bio Roundup: Midterm Fallout, Alzheimer’s Search, Postpartum Panel

There was plenty at stake in this week’s midterm elections, and not just in terms of political wins and losses. With congress now divided—Democrats took back control of the House and Republicans extended their majority in the Senate—the implications are significant for U.S. healthcare. Just a day after the results, for instance, Senate Majority Leader […]

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Bio Roundup: Trump Health, Cholesterol Wars, 23andMe OK & More

Trump administration health officials were out on the stump this week, talking tough about drug prices and healthcare value, encouraging the private sector to take the lead but letting everyone know the federal government is willing to push. In the debate over high drug prices, arguably no class of drug has been punished more by […]

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Bio Roundup: Phase 3 Fails, Shkreli Jailed, Moderna Flip-Flops & More

It was a week of realignments. President Trump, who used to be known as “The Donald” but now goes by “Amnesty Don,” kept up the parlay-voo with his new friends Chuck and Nancy. Martin Shkreli, who was once known—and still is!—as the “pharma bro,” will have a new perspective for a while, through the bars […]

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