A lot of development dollars are shed when the FDA withdraws approval or requests that a drug be withdrawn from the market because new potential risks have come to light. And it’s not just the brand company that feels the loss.
What with the lawsuits, declining prescriptions and approval hurdles that seem to be the U.S. answer to a nationwide opioid epidemic, drug companies have to think long and hard before spending the resources to develop yet another opioid drug. And patients are paying the price.
Eisai Co. Ltd. is removing Belviq (lorcaserin) from the U.S. market due to the FDA’s concerns about an increased occurrence of cancer in a long-term trial evaluating the cardiovascular effects associated with the weight-loss drug.
The Association for Accessible Medicines (AAM) is garnering support in its Ninth Circuit challenge to a new California law that seemingly thumbs its nose at a 2013 U.S. Supreme Court ruling on so-called pay-for-delay patent settlements.
Touting the efforts his administration already has taken to lower U.S. prescription drug prices through increased competition, President Donald Trump placed the burden for further action squarely on Congress during his State of the Union address Tuesday, Feb. 4.
Now that U.S. Health and Human Services (HHS) Secretary Alex Azar has declared a nationwide public health emergency due to the 2019 novel coronavirus (2019-nCoV), HHS is saying it may need more money to help it be as proactive and aggressive as possible in detecting the virus and containing an outbreak.
Despite pressure from several lawmakers to declare the new coronavirus a U.S. public health emergency, Health and Human Services (HHS) Secretary Alex Azar said such a declaration isn’t needed, at least not yet.
Combination products with digital interfaces. Antibody-drug conjugates. Complex drugs. Synthetic biologics. They’re all examples of how technology is expanding the ambit of what’s considered a drug beyond the current U.S. binary regulatory system of small molecules and biologics.
With four gene therapies already approved and more than 900 in development, the FDA has finalized six guidances and issued a draft guidance to clarify the rules of the road for developing and manufacturing the treatments.