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“Clinical data to date indicate this investigational approach provides benefits in multiple tissues evaluated, including the eyes, skin, gastrointestinal mucosa and the neurocognitive system,” the company said. Read More
In a win for Amyndas Pharmaceuticals, the U.S. District Court in Massachusetts has overturned a lower court ruling that had dismissed the company’s complaint of misappropriation of trade secret agreements by Zealand US, allowing Amyndas to continue its legal battle. Read More
At least 88 additional lawsuits have been filed in Delaware against GSK and former Zantac (ranitidine) owners Pfizer, Boehringer Ingelheim and Sanofi, alleging the heartburn drug increases users’ risk of cancer. Read More
In addition to being interchangeable with their reference products, biosimilars approved in the EU are interchangeable with an equivalent biosimilar, the European Medicines Agency (EMA) and the EU’s Heads of Medicines Agencies (HMA) said in a joint statement. Read More
Resolving allegations that it violated the False Claims Act, generic drugmaker Akorn has entered into a settlement to pay $7.9 million for causing Medicare to be billed for three over-the-counter (OTC) drugs that were no longer eligible for Medicare coverage. Read More
Vanda Pharmaceuticals is suing the FDA for the third time in 2022 — this time over what the company claims is FDA’s “unlawful” delay in granting a public hearing to Vanda regarding expanding the approval of the company’s sleep disorder drug Hetlioz (tasimelteon) to also include the treatment of jet lag disorder. Read More
The panel concluded that the absence of in vitro neutralization activity strongly suggests absence of clinical effectiveness of these monoclonal antibodies. Read More
There are only twelve days until Sept. 30, the end of the fiscal year — the point at which the FDA faces potentially laying off thousands of employees if user fee legislation isn’t reauthorized by Congress — and yet Congress still has not completed the vital legislation. Read More