‘Fast’ Progress: Ampligen Activist Ends Hunger Strike
Robert Miller, the patient advocating for Hemispherx Biopharma Inc.’s Ampligen (rintatolimod) for chronic fatigue syndrome by going on a hunger strike in protest of the FDA’s complete response letter, ended the hunger strike over the weekend. Progress was made, he said,…
On the ‘Gom-Boo,’ Ampligen, and Holding Out Hope
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.
Don’t Call Them Generics!
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.
Biosimilars are Changing the Global Game
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.
Patent Cliff Doom, Gloom Not Panning Out
A lot of ink has flowed describing the tough times that big pharma companies are experiencing as each, lemming-like, tumbles off the patent cliff.
DNA Donor Anonymity: for the Lucky Few?
Privacy concerns related to DNA sequencing got yet another airing today when a team from the Whitehead Institute reported in Science that using only publicly available information, they have been able to identify about 50 men who had anonymously donated…
Big Wins, a Cliff, a Race and a Red Face: A 2012 Recap
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…
BioWorld’s 6th Annual Holiday Gift Guide
It’s that time of year, when some thoughts turn to sugar plum fairies and others to the J.P. Morgan Healthcare Conference – or JPM#13 as it’s now widely known. Before you pop the cork on another New Year, however, it’s…
What’s 10 minus Four? Not Six, Apparently
Dec. 1 is World AIDS Day, and when I reflect on AIDS, I generally do it with a sense of amazement about how far we have come in the treatment of HIV since AIDS first came to the attention of…
FDA’s Confusing Action Against Burzynski – What Does it Really Mean?
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,…
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