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Latest From Celera Group
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Proposed US BIOSECURE Act - Do Lonza, Other CDMOs Gain And How Soon?
Concerns over the impact of the proposed US BIOSECURE Act on the CRO and CDMO segments linger despite proponent Mike Gallagher’s plan to leave Congress soon. Which global manufacturers could gain, what determines a shift away from Chinese companies and how imminent is this? Scrip brings insights from industry feedback and other sources.
PTC’s Upstaza Takes Gene Therapy Straight To Brain (And US FDA); Translarna To Return Mid-Year
In a year full of regulatory milestones for the firm, PTC Therapeutics hopes to set some approval precedents – and basically hopes its candidates have an easier time of it than they have had before.
OKYO Hits Multiple Dry Eye Endpoints, Plans Move Into Phase III
OKYO’s eye drop OK-101 has hit endpoints for ocular pain, tear film breakup time and conjunctival staining in Phase II, while demonstrating a placebo-like tolerability profile.
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