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Post by peppy on Sept 4, 2018 23:35:15 GMT -5
good times
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Post by lakers on Sept 4, 2018 23:46:39 GMT -5
5/1/2018 Spark Therapeutics has sold a priority review voucher, entitling the holder to a faster six-month FDA drug review, to Ireland’s Jazz Pharmaceuticals for $110m, a fraction of the price these documents once commanded. Under FDA rules, companies that develop a drug or biologic for a rare paediatric disease may qualify for a voucher, which can be redeemed for a priority review of a drug filing. Priority reviews are usually reserved for badly-needed drugs for serious diseases, but the vouchers shave four months off the FDA review period for any drug, which could be worth millions of dollars in extra sales. As the priority review vouchers (PRVs) can also be sold on to other companies, a second market for the vouchers has emerged. Spark got its priority review voucher for getting its eye disease gene therapy Luxturna approved late last year, and the FDA had issued 19 such vouchers for paediatric rare diseases, under a separate tropical disease scheme. But the $110m price indicates that the market for these vouchers is in decline. The highest price paid for a priority review is $350 million in August 2015, when United Therapeutics sold its voucher to AbbVie.And in May 2015 Retrophin sold a PRV, originally transferred from Asklepion Pharma, to Sanofi for $245 million. But since then the prices paid for vouchers have fallen – Sarepta sold a voucher to Gilead for $125 million in February 2017, according to a round-up published by the US Regulatory Affairs Professionals Society. In December last year Ultragenyx sold a voucher to Novartis for $130m, although the lowest price ever paid was $67 million by Sanofi and Regeneron in 2014, for a voucher awarded to Biomarin, the first transaction of this kind. Joseph La Barge, chief legal officer, Spark Therapeutics, said: “The sale of our PRV will provide an influx of capital to reinvest back into the research and development of our robust pipeline of investigational gene therapies that may provide benefits for people with limited treatment options.” There was no immediate word from Jazz about how it planned to use the voucher, although the company may opt to use them for fast review of one of its phase 3 pipeline products, such as its treatments for hepatic veno-occlusive disease and narcolepsy with catalepsy in phase 3. The FDA is also implementing a priority review voucher scheme for “material threat countermeasures” – which are drugs or therapies that could help stave off a public health emergency in the event of a terrorist attack, or naturally occurring disease. With the vouchers becoming more common, the prices could slip further. pharmaphorum.com/news/spark-sells-priority-review-voucher-to-jazz/ |
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Post by patten1962 on Sept 21, 2018 2:19:47 GMT -5
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Post by patten1962 on Nov 2, 2018 10:37:51 GMT -5
I go back and forth between Epinephrine and PDE5 as the next drug on TS.
The more I think about it, PDE5 makes the most sense for UTHR.
It's on page 2 on website under pipeline.
Personally, an inhaled drug for ED!
So many patients have told me how they hate taking an ED drug then striking out with a young lady.
These pills are about $50 a pop.
Some of you may make fun of my statement but to patients it is a real problem.
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Post by peppy on Nov 2, 2018 10:48:00 GMT -5
I go back and forth between Epinephrine and PDE5 as the next drug on TS. The more I think about it, PDE5 makes the most sense for UTHR. It's on page 2 on website under pipeline. Personally, an inhaled drug for ED! So many patients have told me how they hate taking an ED drug then striking out with a young lady. These pills are about $50 a pop. Some of you may make fun of my statement but to patients it is a real problem. epinephrine, is available for license from MNKD. viagra is generic now selling for 2 dollars for 20 mg. The tablets were at times dosed 100 milligrams when prescribed. It is a math problem. now put it in an inhaler, patent good? |
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Post by uvula on Nov 2, 2018 10:48:02 GMT -5
$50. Wow. Does that include the young lady?
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Post by peppy on Nov 2, 2018 10:48:47 GMT -5
$50. Wow. Does that include the young lady? no. With Viagra off patent there is a pick up in old men interest for old women. I swear. |
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Post by markado on Nov 2, 2018 11:37:14 GMT -5
I just like the fact that UTHR's size of market on their two products was $600M+, back in 2013. A 10% royalty on same sales with TS version would fund more than 6mos of MNKD operations at current cost.
This, without calculating royalties on the creative OTC options that might be derived for other purposes! 😉
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Post by sportsrancho on Nov 2, 2018 12:47:11 GMT -5
$50. Wow. Does that include the young lady? no. With Viagra off patent there is a pick up in old men interest for old women. I swear. Lol! Yeah ditch those pills guys where you have to schedule your time, We’ll buy you the Dreamboat. Fast on-set short-tail control. |
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Post by mytakeonit on Nov 2, 2018 14:03:10 GMT -5
How do you inhale pills with the Dreamboat?
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Post by otherottawaguy on Nov 2, 2018 14:17:54 GMT -5
Inhale really deeply, try not to cough...
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Post by helmut8056 on Nov 2, 2018 16:23:28 GMT -5
no. With Viagra off patent there is a pick up in old men interest for old women. I swear. Lol! Yeah ditch those pills guys where you have to schedule your time, We’ll buy you the Dreamboat. Fast on-set short-tail control. You girls are jesting with the primal jender so I must bring this to your attention: "Boys will be boys, and even that wouldn't matter, if only we could prevent girls form being girls." From the diary of Anne Frank. What a mind this 14 yr old must have had. |
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Post by mytakeonit on Nov 2, 2018 17:29:03 GMT -5
Why is a short-tail good? Hmmm ... now I'm confused ...
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Post by sportsrancho on Nov 2, 2018 17:30:37 GMT -5
Why is a short-tail good? Hmmm ... now I'm confused ... I knew you would be:-))) Just put that sentence in there to see if I could get a rise out of somebody🤣 |
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Post by mytakeonit on Nov 2, 2018 17:32:06 GMT -5
Let me inhale a pill now ... where is my Dreamboat?
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