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NEWS

Bio Usawa Biotechnology and Bioeq AG Partner to Expand Access to Vision-Saving Treatments Across Sub-Saharan Africa 

Shots:  Bio Usawa Biotechnology and Bioeq AG entered into an agreement to make ranibizumab biosimilar for serious retinal diseases, accessible to millions in Sub-Saharan Africa   The partnership gives Bio Usawa exclusive rights to register and market Bioeq’s ranibizumab biosimilar, BioUcenta, advancing access to essential biologics in Sub-Saharan Africa   BioUcenta, an intravitreal injection, blocks abnormal retinal…
July 1, 2025

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Fresenius Kabi
NEWS

Fresenius Kabi Launches Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva) in the US 

Shots:  Fresenius Kabi launched Conexxence and Bomyntra, biosimilar of Prolia & Xgeva (denosumab) for all indications of the reference products across the US  Conexxence (denosumab-bnht) 60 mg/mL, available in PFS, is approved for adults at high risk of fractures, including those with osteoporosis, pts. on cancer treatments affecting bone density, or long-term glucocorticoids   Bomyntra (denosumab-bnht)…
July 1, 2025

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INSIGHTS+

New Drug Designations – May 2025  

Shots:      PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA    The May 2025 report covers designations granted to 44 drugs and 5 medical devices, spanning 15 small molecules, 7 biologics, 13 cell and gene therapies & 5 medical devices among others   …
June 24, 2025

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NEWS

Johnson & Johnson launches ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM Contact Lens in the US and Canada

Shots: Johnson & Johnson launched ACUVUE OASYS MAX 1‑DAY MULTIFOCAL for astigmatism daily disposable lens in the U.S. and Canada for people with both astigmatism and presbyopia A study showed 95% of people wearing ACUVUE OASYS MAX 1-DAY MULTIFOCAL for ASTIGMATISM contact lenses reported clear vision during daily activities, while 87% saw clearly while driving…
June 24, 2025

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NEWS

Purpose Pharma’s Attrogy Receives the CHMP’s Positive Opinion for the Treatment of Hereditary Transthyretin-mediated Amyloidosis  

Shots:  The CHMP has recommended Attrogy (diflunisal) to treat hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult pts. with stage 1 or stage 2 polyneuropathy  The EC will make decision within 67 days, and if approved, Attrogy will be authorized in all EU & EEA countries Iceland, Lichtenstein and Norway  Diflunisal has received EU ODD for…
April 25, 2025

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Avita Medical
NEWS

AVITA Medical Launches Cohealyx for Wound Healing in the US

Shots: AVITA Medical has launched Cohealyx, collagen-based dermal matrix in the US Cohealyx is currently being evaluated in the post-market Cohealyx I trial (enrolment ongoing) to further assess clinical outcomes, wound bed preparation for definitive closure, & patient recovery timelines Cohealyx, developed by AVITA & Regenity Biosciences, is designed to support cellular migration & revascularization, allowing…
April 4, 2025

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Biogen & Organon
NEWS

Organon Acquires Regulatory and Commercial Rights of Tofidence IV Infusion (Biosimilar, Actemra) from Biogen

Shots: Organon has acquired the US regulatory & commercial rights for Tofidence, a biosimilar version of Actemra (tocilizumab), from Biogen, which retains manufacturing rights in the US As per the deal, Biogen will receive upfront, while Organon will assume Biogen's obligation to pay Bio-Thera tiered annual net sales royalties & milestones Tofidence is a humanized…
April 2, 2025

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