Copaxone 40mg Generic At-Risk Launch Anticipated As Soon As February
Teva is seeking injunction to block generic entry after court rules four patents on the three-times-a-week dosage are invalid; analysts expect launch soon after FDA approves an ANDA, with Sandoz/Momenta generic the likely leader.
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Teva awaits district court ruling on patents covering the three-times-a-week dosage and is appealing the Patent Trial & Appeal Board’s findings of unpatentability.
Seeking To Provide ‘The Best Clarity Possible,’ ACIP Votes For COVID Vaccine Booster In Children 5-11
CDC advisory committee recommends Pfizer/BioNTech vaccine booster, but one member votes ‘no,’ citing concern that only 29% of children ages 5 to 11 have received the primary two-dose series and arguing the focus should be on additional vaccinations, not additional doses.
House Energy & Commerce Committee adds Give Kids a Chance Act to user fee reauthorization package during markup. Bill was modified to exclude provision giving the FDA authority to require preclinical studies.