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Top Industry News
- MHRA Guidance on the licensing of biosimilar products
- FDA drafts guidance on ‘sameness’ evaluations for generic drugs
- PMDA Guidance-required/over-the-counter drugs Updated "Regarding insufficient application documents" and "Deadline for replacement instructions"
- SFDA Guidance for the Preparation of a Site Master File (SMF)
- ANVISA publishes notice on biosimilar products
- EMA shares guidance on anonymization of protected personal data in risk-management plans
- ANVISA publishes guidelines for the regulation of biologicals, biosimilars and radiopharmaceuticals
- ANVISA advises on new procedure for post-registration of pesticides of biological origin
- SFDA Guideline on Blood Products (Plasma Derived Medicinal Products)
- FDA Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents
Mergers & Acquisitions
- Bruker announces agreement to acquire Neurescence Inc., Bolstering Neuroscience Research Portfolio
- Oyster Point Pharma, a leading Ophthalmology-Focused Biopharmaceutical Company, to be acquired by Viatris
- Avenue Therapeutics Completes the acquisition of Baergic Bio and its Selective GABA-A α2/3 Receptor Positive Allosteric Modulator for the Treatment of Central Nervous System Disorders