David Bianculli
๐ค SpeakerAppearances Over Time
Podcast Appearances
No, I mean, there's certainly costs associated with developing the drug. And, you know, Celgene should be given credit for developing this drug. It's not easy to get FDA approval for a drug, and running clinical trials is hard business. You know, that being said, the company estimated about $800 million was spent to develop Revlimid.
No, I mean, there's certainly costs associated with developing the drug. And, you know, Celgene should be given credit for developing this drug. It's not easy to get FDA approval for a drug, and running clinical trials is hard business. You know, that being said, the company estimated about $800 million was spent to develop Revlimid.
a few hundred million more to test it in clinical trials for other cancers. You know, when you consider the revenue in excess of $100 billion, you know, it's a fairly small amount in terms of the research and development costs for this particular drug.
a few hundred million more to test it in clinical trials for other cancers. You know, when you consider the revenue in excess of $100 billion, you know, it's a fairly small amount in terms of the research and development costs for this particular drug.
a few hundred million more to test it in clinical trials for other cancers. You know, when you consider the revenue in excess of $100 billion, you know, it's a fairly small amount in terms of the research and development costs for this particular drug.
They did it by turning the most dangerous aspect of this drug, the fact that it potentially causes birth defects into an asset. They controlled distribution because the FDA, in approving the drug, mandated a safety program. They wanted to make sure that only the patients who needed it got the drug. They didn't want to see somebody accidentally take it and get pregnant and develop a birth defect.
They did it by turning the most dangerous aspect of this drug, the fact that it potentially causes birth defects into an asset. They controlled distribution because the FDA, in approving the drug, mandated a safety program. They wanted to make sure that only the patients who needed it got the drug. They didn't want to see somebody accidentally take it and get pregnant and develop a birth defect.
They did it by turning the most dangerous aspect of this drug, the fact that it potentially causes birth defects into an asset. They controlled distribution because the FDA, in approving the drug, mandated a safety program. They wanted to make sure that only the patients who needed it got the drug. They didn't want to see somebody accidentally take it and get pregnant and develop a birth defect.
They were extremely concerned about that. So they controlled the distribution, and that meant that generic companies who wanted to develop a competing product had to acquire Revlimid from Celgene because you have to test your generic product against the brand name to prove to the FDA that they're essentially the same thing. and safe. They couldn't get the drug from Celgene.
They were extremely concerned about that. So they controlled the distribution, and that meant that generic companies who wanted to develop a competing product had to acquire Revlimid from Celgene because you have to test your generic product against the brand name to prove to the FDA that they're essentially the same thing. and safe. They couldn't get the drug from Celgene.
They were extremely concerned about that. So they controlled the distribution, and that meant that generic companies who wanted to develop a competing product had to acquire Revlimid from Celgene because you have to test your generic product against the brand name to prove to the FDA that they're essentially the same thing. and safe. They couldn't get the drug from Celgene.
Celgene simply refused to sell it to them, and they controlled the distribution. So that enabled them to really maintain a grip on the market for a number of years beyond the exclusivity period that the FDA granted them.
Celgene simply refused to sell it to them, and they controlled the distribution. So that enabled them to really maintain a grip on the market for a number of years beyond the exclusivity period that the FDA granted them.
Celgene simply refused to sell it to them, and they controlled the distribution. So that enabled them to really maintain a grip on the market for a number of years beyond the exclusivity period that the FDA granted them.
They became aware of it. The FDA at one point ordered or directed Celgene to sell to a generic competitor. The FDA didn't have any enforcement ability, however. The Federal Trade Commission did do a lengthy investigation, and the staff proposed taking legal action against Celgene, but that didn't happen. The company promised that they would sell the drug
They became aware of it. The FDA at one point ordered or directed Celgene to sell to a generic competitor. The FDA didn't have any enforcement ability, however. The Federal Trade Commission did do a lengthy investigation, and the staff proposed taking legal action against Celgene, but that didn't happen. The company promised that they would sell the drug
They became aware of it. The FDA at one point ordered or directed Celgene to sell to a generic competitor. The FDA didn't have any enforcement ability, however. The Federal Trade Commission did do a lengthy investigation, and the staff proposed taking legal action against Celgene, but that didn't happen. The company promised that they would sell the drug
The commissioners that are needed to approve litigation thought that they were going to sell the drug and were not interested in pursuing litigation at that time. And that enabled them for several more years, again, to have this market all to themselves without any competition. So what did that mean for Celgene in the end?
The commissioners that are needed to approve litigation thought that they were going to sell the drug and were not interested in pursuing litigation at that time. And that enabled them for several more years, again, to have this market all to themselves without any competition. So what did that mean for Celgene in the end?
The commissioners that are needed to approve litigation thought that they were going to sell the drug and were not interested in pursuing litigation at that time. And that enabled them for several more years, again, to have this market all to themselves without any competition. So what did that mean for Celgene in the end?