PHARMACY

PharmaJet, Invectys enter Phase 2 cancer vaccine trial

BY David Salazar

Needle-free injection technology company PharmaJet, based in Golden, Colo., will be working with French biopharma company Invectys to test Invectys’ therapeutic cancer vaccine. The Phase 2 trial is for INVAC-1, which uses PharmaJet’s needle-free injection system and is an immunotherapeutic DNA vaccine meant to treat cancer, the companies said.

“We believe the PharmaJet Needle-free device offers many advantages to patients and providers including less pain and stress, elimination of needles and provides a more precise and consistent method for vaccine delivery,” Invectys CEO Pierre Langlade Demoyen said.

PharmaJet said that it has previously tested its Tropis needle-free injection system in huyman and animal clinical trials without evidence of safety concerns.

“We are pleased that the PharmaJet Tropis Intradermal device has been chosen as the method of administration for this important cancer immunotherapy vaccine development.” PharmaJet CEO and chairman Ron Lowy said. “The Needle-free device is safe, fast and easy to administer, and has already been used successfully in numerous clinical studies for nucleic acid (DNA or RNA) vaccine delivery.”

 

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Dr. Reddy’s reaches settlement regarding Consumer Product Safety Act compliance

BY Gisselle Gaitan

It has been announced by the United States subsidiary of Dr. Reddy’s Laboratories, that the company has reached a settlement with the U.S. Government in a case involving packaging for five blister-packed prescription products.

In a joint filing, both parties have agreed to a settlement of the action without any adjudication or issue of fact or law. The matter has been settled for $5 million dollars, and the product in question has not been distributed in the packaging at issue since June 2012, the company said.

The company also said that it is not aware of any reports that a child gained access to the products as a result of the packaging, or that the products have caused harm to a child as a result of the packaging. Dr. Reddy’s said that it is committed to complying with all applicable requirements of the Consumer Product Safety Act, which includes applicable packaging and reporting requirements.

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Amneal names Allergan vet president

BY David Salazar

Amneal Pharmaceuticals and Impax Labs have new leadership. The Bridgewater, N.J.-based Amneal has named Robert Stewart president, effective Jan. 25, 2018. Stewart was most recently COO at Allergan.

Once Amneal’s acquisition of Impax closes, Stewart will become president and CEO of the combined Amneal Pharmaceuticals, the company said. Also after the close, Impax president and CEO Paul Bisaro will be named executive chairman, with current Amneal co-CEOs and co-founders Chirag Patel and Chintu Patel assuming the titles of co-chairmen of the combined company’s board of directors.

“We are excited that Rob will be joining Amneal. He is a great leader to inspire our team as we prepare for the expected combination with Impax and next phase of our growth in becoming a leading, affordable, healthcare company” Chirag Patel said.

Stewart will work with Chirag and Chintu Patel to lead the company’s current business, as well as play a key role in overseeing pre-integration planning for the planned Impax combination, expected to closein the first half of 2018.

“I am honored and excited to work with the Amneal and Impax teams,” Stewart said. “The combination creates a dynamic leader in generics and specialty pharmaceuticals, with a deep and rich pipeline of products and integrated global manufacturing platform for strong continued profitable growth. I look forward to leading the teams and helping the organization achieve its long-term goals.”

Stewart joined Allergan, which was then Watson, as vice president of global operations in 2009. He held various titles, including president of generics and global operations and president of global operations. Before Allergan, he held various positions at Abbott Labs and Hoffman La-Roche.

“Rob is a highly respected leader with a wealth of pharmaceutical expertise which will further enhance our team of world-class leaders focused on creating value for patients, customers, employees and shareholders,” Chintu Patel said.

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