It appeared as though the controversy over the level of efficacy and benefit from the prostate cancer immunotherapy Provenge ended when the drug was approved by FDA at the end of April. The FDA approval may have just been the halfway point in the product's route through government agencies to the commercial market. Now Medicare is questioning whether the government should pay for the new therapy. The CMS decision is just as important to the biopharmaceutical industry as it is to Dendreon.
By Ramsey Baghdadi
Is $93,000 beyond the upper limit of what a drug company can charge for a non-curative cancer therapy when the...
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Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.
European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.
The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.
The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.
Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
