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Amgen scores Otezla patent win in court to keep competition at bay

Pharmaceutical Technology

This is one of several patent infringement cases Amgen has pursued in recent years to stave competition. Despite this legal win, Amgen still faces a competitive psoriasis market as other drugs enter the landscape. The FDA first approved Otezla in March 2014 for the treatment of psoriatic arthritis. Patent No.

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FDA grants access to new class of paediatric diabetes medicine

Pharmaceutical Technology

This is the first time the FDA has approved an oral diabetes drug for paediatric patients since its approval of metformin in 2000. The FDA first approved Jardiance to help control blood sugar in adults with T2D in 2014. The drugs are approved for use along with changes in diet and exercise.

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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

The agreement outlined that Par would keep its generic equivalent off the market for as many as two years, delaying the generic launch till September 30, 2014. In September, Novartis sent the FDA a petition, after a similar one was rejected in April 2021, asking for Entresto’s patent protection to be extended to February 2024.

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Illegal online pharmacies gain traction as regulators lag behind

Pharmaceutical Technology

The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. The US Food and Drug Administration (FDA commissioner Dr. Robert Califf says, “The illegal sale of prescription drug stimulants online puts Americans at risk and contributes to potential abuse, misuse, and overdose.”

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Pliant snags $287.5 million in oversubscribed public offering amid market uncertainty

Pharmaceutical Technology

The FDA approved both drugs in 2014. On February 2, the FDA cleared an Investigational New Drug Application for PLN-101095. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape.

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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. The company’s weight loss drug Saxenda (liraglutide) won an approval for chronic weight management in December 2014, and Wegovy (semaglude) got the same tag in 2021.

Medical 105
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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. The company’s weight loss drug Saxenda (liraglutide) won an approval for chronic weight management in December 2014, and Wegovy (semaglude) got the same tag in 2021.

Medical 98