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The Federal Trade Commission broke new ground last year in its opposition to M&A transactions and challenge of Orange Book patent listings. The biopharma community is waiting to see if deals will face similar hurdles in 2024 and whether there will be legal battles if manufacturers of drug-device combination products decline to delist their patents. Researchers advocate that the FTC extend its inquiry to device patents on GLP-1 receptor agonists, including Wegovy and Ozempic.
In this second instalment on key trends playing out in India, Scrip talks to industry leaders on the marked shift in GMP norms that could potentially resize Indian manufacturing, large player interest in the CDMO space and M&A activity, where PE firms may be the “most aggressive” buyers.
In 2024, Viatris will initiate the second phase of its long-term business plan, which will see it step away from the perceived volatility of the generics space and begin to move toward innovative and high-growth products. The past year has seen it lay the groundwork for this pivot, shedding surplus business units and making significant hires from the branded space.
In a blow to several generics firms – albeit one telegraphed by a decision handed down nine months ago – the European Commission has ordered the removal of marketing authorizations for generic versions of Biogen’s MS brand, Tecfidera.
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