PHARMACY

BIO rolls out ‘Innovation Saves’ ad

BY David Salazar

WASHINGTON — The Biotechnology Innovation Organization on Tuesday launched a new television ad that’s focused on biopharmaceutical innovation and its ability to save lives and money. The new ad is part of BIO’s Value Campaign, which the company said is working to highlight the value of biopharmaceutical innovation, the importance of protecting the development ecosystem and the need to ensure patient access to these innovations. 
 
“We all know people whose lives were changed or saved thanks to biopharmaceutical innovation, but what many don’t know is the impact these breakthroughs have on society,” BIO president and CEO Jim Greenwood said. “BIO is committed to not only defending the value of these lifesaving medicines to patients, but also showcasing the value they bring to the broader healthcare system.”
 
The ads highlight the stories of patients and their loved ones and will run across the country for the next several weeks, the company said. 
 
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PHARMACY

Lupin gets tentative approval on Avelox generic

BY David Salazar
SILVER SPRING, Md. — The Food and Drug Administration has given Lupin’s U.S. arm, Gavia Pharmaceuticals, a tentative approval for its generic of Avelox (moxifloxacin HCl) tablets, the company announced Tuesday. 
 
The drug will be available from Lupin in 400-mg dosage strength, and the product had U.S. sales of $30.1 million for the 12 months ended June 2016, according to IMS Health data. 
 
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FDA approves expanded indication for Amgen’s Blincyto

BY David Salazar
SILVER SPRING, Md. — The Food and Drug Administration has approved Amgen’s supplemental Biologics License Application for an expanded indication for its Blincyto, the company said Thursday. 
 
The drug is now approved for treatment of pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The indication was granted under accelerated approval. 
 
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