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Latest From Sanofi

Sanofi Clarifies Xyzal-Zyrtec Size Comparison, Outweighs J&J Calculation

National Advertising Division recommends Sanofi add "nearly" to claim that Xyzal Allergy 24HR is "as effective at half the size" of J&J's Zyrtec in a TV ad because 3D modeling comparing the products showed Xyzal tablet has 73-mm volume and a Zyrtec tablet's is 145.2 mm. Sanofi's evidence also supported referring to Xyzal's size would not mislead consumers to expect its drug has half the pharmaceutical dosage of Zyrtec.

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Insulin Maker Lilly Seeks US FDA Assurances On ‘Authorized Biologics’

Sponsor of an NDA-approved protein product subject to March 2020 ‘transition provisions’ should be able to seek biosimilar licensure of that same product without surrendering its ‘deemed’ 351(a) approval, company says, also requesting that FDA clarify parameters for ‘branded biosimilars.’

Biologics Biosimilars

Rx Spending Growth To Be Driven By New Drug Entries, CMS Says

Advances in cancer, diabetes, and Alzheimer's could lead to expensive new treatments, contributing to spending increases in next decade, according to CMS projections.
Reimbursement Pricing Debate

Evotec Extends Anti-Infectives Footprint With Helmholtz Collaboration

Building on a leading position in anti-infectives research, Evotec aims to develop a new class of antibacterials based on cystobactamids, which are found in slime bacteria and have potent activity against serious bacterial pathogens.

 

Infectious Diseases Research and Development Strategies
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