Despite the regulatory approval of new antiepileptic drugs (AED) over the past decade and the expansion of indications deemed suitable for epilepsy surgery, individuals with intractable seizures – roughly one in three epilepsy patients – still face a dearth of…
Despite what the New York Times and its echoers have said, makers of innovative biologics have legitimate reason to sound alarms about automatic substitution of biosimilars that have not proven their interchangeability – and it’s not just because of the…
About a week ago, my obituary arrived by email. But something related, which you might think is weirder, happened Tuesday afternoon, and all of it involves chronic fatigue syndrome (CFS), and Hemispherx Biopharma Inc.’s drug candidate for it, Ampligen.
When the FDA’s Rachel Sherman said the biggest challenge the agency faces with biosimilars is educating the public, she wasn’t exaggerating. An article in the New York Times shows just how big of a challenge it’s going to be.
I recently took a few months off from daily deadlines to explore the evolving world of biosimilars for the newest BioWorld Data report, The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies. It was quite an eye-opening adventure.
Now that 2012 is drawing to a close, it’s once again time to take a look back at a year that saw some big hits and misses for the biotech industry – and there were plenty of both. The hits…
Last month the FDA’s Office of Prescription Drug Promotion (OPDP) issued a warning letter to the Burzynski Research Institute Inc. and the Burzynski Clinic regarding claims made for its antineoplastons A10 and AS2-1 injections that violate the Federal Food, Drug,…
A hunter walks into a bar and says, “Did you hear the one about the FDA?”
For BIO 2011, BioWorld published a list of overused BioCliches to shun, and I was pleased to observe that attendees and speakers must’ve taken notice and avoided using them at BIO 2012 this year. However, since the urge to use…
BOSTON ‑ After crisscrossing the exhibition hall and three Boston zip codes yesterday for my citywide BIO 2012 reception scavenger hunt and finding a belly full of German sausages, Chinese dim sum, French pastries, Japanese sake and Irish whiskey to…
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