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Latest From Cubist Pharmaceuticals, Inc.
Axogen, Dario Health, Biobeat, Immunexpress All Weigh In On 2022 And What Will Succeed In 2023
Medtech Insight was invited to ask questions at a roundtable event organized by Russo Partners to review the major medtech industry trends of 2022 and what to expect in 2023.
Pfizer In Pole Position To Benefit From Novartis Sickle Cell Drug Setback
Pfizer joined Novartis as the market leader in sickle cell disease when it acquired Global Blood Therapeutics last year. The US giant's Oxbryta may now move ahead following a clinical and regulatory setback for the Swiss major's Adakveo.
Orphan Drug Exclusivity: In Narrow Application Of Catalyst Ruling, FDA Retains Its Existing Regs
US FDA will continue to tie orphan exclusivity to uses or indications for which the drug was approved. Attorneys say this buys agency time to sort out complex policy and legal questions and continue to seek legislative fix. Additional litigation is also possible, as happened in Depomed case.
New Drug Exclusivity Not Impacted By Impurities In Compound, Court Finds In Loss For Sandoz
DC Circuit Court upholds FDA’s grant of new chemical entity exclusivity to Sanofi’s multiple sclerosis drug Aubagio (teriflunomide) even though the agency had previously approved teriflunomide as an impurity in Sanofi’s Arava (leflunomide). FDA reviews known impurities in drugs only to assess their impact on safety and efficacy, not to approve them, court says.
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