Market Access News | pharmaphorum

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uniQure says it has reached agreement with the FDA on a pathway to accelerated approval for its much-anticipated Huntington's disease gene therapy.

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A non-invasive device that could help millions of women in the US with a condition known as pelvic organ prolapse (POP) has launched in the US.

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EU says Novo Holdings’ $16.5 billion takeover of US contract development and manufacturing organisation Catalent does not pose antitrust issues.

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US legislation that could have a big impact on the businesses of five biotechs with links to China now looks unlikely to be passed this year.

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Lilly will spend $3 billion on a recently acquired Wisconsin plant for injectable medicines, including diabetes and obesity drugs.

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AstraZeneca's Imfinzi becomes the first cancer immunotherapy to be FDA-approved for limited-stage small cell lung cancer (LS-SCLC).