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FDA issues guidance on using pharmacology data for biosimilar products

BY Michael Johnsen

ROCKVILLE, Md. — The Food and Drug Administration moved one step closer to establishing a biosimilar pathway with a new guidance document explaining how to use clinical pharmacology data to show similarity to a reference product, according to a report published by Regulatory Focus on Tuesday. 

"These studies provide the data that describe the degree of similarity in drug exposure between the proposed biosimilar and the reference product," the FDA noted in its guidance. "In addition, clinical pharmacology studies often include [pharmacodynamic] endpoints (both therapeutic and toxic) and pharmacometric analysis to assess whether or not there are clinically meaningful differences between the proposed biosimilar and the reference product."

According to the report, the latest guidance follows the publication of five other biosimilar draft guidance documents.

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WellPet puts focus on finicky felines with latest offering

BY Ryan Chavis

TEWKSBURY, Mass. — WellPet — a premium pet food company whose portfolio of brands includes Wellness, Old Mother Hubbard, Eagle Pack and Holistic Select — announced the launch of Wellness Divin Duos, a dual-layered, natural wet cat food. The new addition offers felines a protein-rich meal in six grain-free recipes.

"Wellness Divine Duos are truly an innovation in the pet food aisle. To serve the recipe you peel the lid, flip the cup onto the cat’s plate and lift the cup off of the food to reveal the pate base topped with the layer of cuts and gravy. Divine Duos will appeal to even the pickiest of cats with texture, flavor and variety," said Chanda Leary-Coutu, senior marketing manager for Wellness Natural Pet Food. "This natural wet cat food has no wheat, corn or soy making it a smart, healthy option for cat owners."

Cat owners can choose from the following recipes: Chicken Pate & Diced Duck, Chicken Pate & Diced Turkey, Chicken Pate & Diced Salmon, Beef Pate & Diced Chicken Liver, Tilapia Pate & Diced Ahi Tuna and Tuna Pate & Diced Salmon.

 

 

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Yankee Candles expands popular Man Candles collection

BY Ryan Chavis

SOUTH DEERFIELD, Mass. — Yankee Candle Co. announced the debut of two new fragrances to its limited edition Man Candles collection. On Tap, which is reminiscent of freshly poured draft beer, and Camouflage, which gives off a woodsy blend of fresh air, golden leaves and oak tree bark.

The two new scents will join three popular scents from last year: MMM, Bacon!; Man Candles Man Town and Riding Mower. The Man Candles collection has proven a big hit with consumers since it first debuted in 2012, according to the company.

"We’ve found that our fans are drawn to Man Candles that authentically capture unique and intangible fragrances," said Hope Margala Klein, EVP brand, innovation and merchandising for the Yankee Candle Co. "What could be more intriguing than capturing the scent of the great outdoors in a candle?! It’s sure to be a fun, unexpected gift for Father’s Day and graduation season."

The collection can be purchased at Yankee Candle retail locations, at YankeeCandle.com and at select specialty retailers and gift shops. The company is also launching a series of social media contests that will give consumers a chance to win samples of the Man Candles collection.

 

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