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Latest From Bayer AG

Scrap Citizen Petition Proposal For 505(b)(2), Off-Patent Industry Urges FDA

Several stakeholders across the off-patent industry, including trade groups and manufacturers, have encouraged the FDA to scrap its proposal to require companies to submit citizen petitions for requesting therapeutic equivalence evaluations for 505(b)(2) applications.

FDA Drug Approval Standards

China Drug Price Negotiations: Another Race To The Bottom?

With the fourth quarter just around the corner, China's closely-watched annual drug reimbursement and prices negotiations are entering a key final stage. But will applicants need to be more strategic than expedient?

China Reimbursement

October Outlook For US FDA Approvals: Goal Dates Are Sparse, But Backlog Looms

Upcoming user fee goal dates include AstraZeneca’s tremelimumab, Amicus’ AT-GAA, and drug delivery technology-driven NDAs from Supernus/US Worldmeds and scPharmaceuticals

US FDA Performance Tracker Drug Review

Torrent’s $245m Curatio Deal Gives Pole Position In Fast-Growing Cosmetic Dermatology

Torrent’s $245m acquisition of Curatio Healthcare has moved it up a rank to No.7 in the overall Indian pharmaceutical market apart from making it the market leader in cosmetic dermatology. While it’s a pricey deal, factors like growing prevalence of skin diseases and shift towards e-commerce bode well for future revenue growth in a nascent market

Commercial Deals
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    • Actus Therapeutics, Inc.
    • AskBio
    • Asklepios BioPharmaceutical, Inc.
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    • Conceptus Inc.
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