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Latest From Sanwa Kagaku Kenkyusho Co., Ltd.
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Cerevel, which AbbVie is spending $8.7bn to acquire, unveiled topline results from the TEMPO-3 study of tavapadon, which an analyst said represents potentially a $1bn opportunity.
US FDA’s April Outlook: Decisions Pending For Rare Pediatric Diseases, New Antibiotics
User fee goal dates in April include four novel agents with breakthrough therapy designations, including Pfizer’s hemophilia B gene therapy and Immunity Bio’s IL-15 superagonist complex for bladder cancer.
Amneal Targets Limited US Ciprodex Pool With FDA Approval
The FDA has granted approval to Amneal’s ciprofloxacin/dexamethasone otic suspension ANDA product, referencing Ciprodex, adding a further drug to the company’s portfolio as the firm continues its strategic shift to complex generics.
FTC Sides With Amneal Over Inhaler Patent Dispute With Teva
After sending warning letters over more than 100 improper patent listings last year, the FTC has backed Amneal in its attempt to fight ProAir originator Teva over asthma inhalers.
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