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Latest From Baxter International Inc.
Immunogenicity Data Drove Monkeypox Dose-Sparring Decision…It Also Drove Initial Approval
Comfort with the initial approval based on inferred effectiveness may have made the current EUA process more palatable to US FDA officials but means there is a bigger gap in what’s known about the vaccine’s effectiveness overall.
Prestige Consumer Opens Its FY2023 With Revenue Thirst Quenched By Hydralyte International Sales
Hydralyte line has 90% share in Australia’s hydration market and accounted for a large share of firm’s overall sales growth in its latest quarter as 28.9% international sales growth to $34.5m offset flat North American results at $242.4m.
Monkeypox Vaccine: US FDA Eyes Dose-Sparing Strategy For Jynneos
Switching method of administration from subcutaneous to intradermal would increase by five-fold the number of doses of Bavarian Nordic’s vaccine available to combat the outbreak; an EUA declaration would be needed to make this change, FDA commissioner Robert Califf said.
Cimerli Interchangeable Biosimilar Approved Without Switching Data
Citing low risk of a clinically impactful immunogenic response from systemic anti-drug antibodies and intraocular inflammation when alternating between Coherus’ Cimerli and Genentech’s reference product ranibizumab, US FDA says a switching study would not be informative.
Company Information
- Industry
- Contract Research, Toxicology Testing-CRO
- Medical Devices
- Pharmaceuticals
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Pharmaceuticals
- Drug Delivery
- Nutraceuticals
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Medical Devices
- Infusion Therapy Equipment and Supplies
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Surgical Equipment & Devices
- Surgical Sealants
- Other Names / Subsidiaries
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- AesRX LLC
- Althin Medical A.B.
- Chatham Therapeutics
- Cheetah Medical
- Claris Injectables Limited
- Fusion Medical Technologies, Inc.
- Gambro AB
- Immuno-US
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- Renal Therapy Services
- SIGMA International Geneeral Medical Apparatus
- SuppreMol GmbH
- Synovis Life Technologies, Inc.
- Wound Care Technologies, Inc.
- Baxter Healthcare Corporation