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US approvals double year-on-year
Posted 29 May 2017
The FDA is approving drugs at twice the rate it did last year suggesting 2016's marked slowdown was an aberration rather than a sign of flagging R&D, according to Reuters.
It said the FDA had already approved 21 drugs this year compared to 22 for the whole of 2016. Only nine at been approved at the end of May last year.
Meanwhile the EMA's approval progress has also picked up though less rapidly with 42 approvals to date this year against a 2016 total of 81. There were 31 EMA approvals in the first five months of 2016.
It noted pharmacos were "getting smarter" in their drug development by shifting R&D resources to more specialised and costly drugs and way from "mass-market products".
But, while that was leading to more approvals there was still the omnipresent problem of pricing, with some new cancer treatments costs more than US $10,000 per month facing off against healthcare providers trying to push down spending.
It quoted former Pfizer research head, John LaMattina, now a board member at PureTech Health, as saying he was unsurprised by the approvals rebound and believed concerns expressed at the end of last year about deteriorating drug pipelines were "far too dire".
"A lot of biopharmaceutical companies are filling their pipelines with programs that seek treatments for diseases that can be approved with an accelerated review such as rare diseases, different cancers and anti-infectives," LaMattina told the news agency.
"These types of programs benefit from requiring modest-sized clinical trials and have the potential for generous pricing".
"We're seeing fewer R&D resources devoted to programs that require rigorous differentiation in phase III trials," he said.
But the article noted that there was also a shift in R&D with more products coming from new biotech companies which meant "big pharma companies are not necessarily out of the woods when it comes to getting a decent return on the billions of dollars they spend each year on R&D".
A compilation of consensus analyst forecasts compiled by Thomson Reuters included "several highly promising products from large multinationals that are tipped to generate billions of dollars in sales," it said.
These included;
- Sanofi and Regeneron's Dupixent (dupilumab) for severe eczema (projected US $5 billion to 2023)
- Roche's multiple sclerosis drug Ocrevus (ocrelizumab) (US $4 billion+)
- AstraZeneca's cancer drug durvalumab (forecast US $3 billion)
- Novo Nordisk's diabetes drug semaglutide
- Novartis' as yet unnamed novel cell therapy for leukaemia
- GSK's new shingles vaccine
It quoted QuintilesIMS as saying the robust state of the industry's late-phase R&D pipeline means it was well placed to yield an average of 40 to 45 new launches annually through to 2021.
David Rowley
david.rowley@lushmedia.com.au
Posted 29 May 2017
The FDA is approving drugs at twice the rate it did last year suggesting 2016's marked slowdown was an aberration rather than a sign of flagging R&D, according to Reuters.
It said the FDA had already approved 21 drugs this year compared to 22 for the whole of 2016. Only nine at been approved at the end of May last year.
Meanwhile the EMA's approval progress has also picked up though less rapidly with 42 approvals to date this year against a 2016 total of 81. There were 31 EMA approvals in the first five months of 2016.
It noted pharmacos were "getting smarter" in their drug development by shifting R&D resources to more specialised and costly drugs and way from "mass-market products".
But, while that was leading to more approvals there was still the omnipresent problem of pricing, with some new cancer treatments costs more than US $10,000 per month facing off against healthcare providers trying to push down spending.
It quoted former Pfizer research head, John LaMattina, now a board member at PureTech Health, as saying he was unsurprised by the approvals rebound and believed concerns expressed at the end of last year about deteriorating drug pipelines were "far too dire".
"A lot of biopharmaceutical companies are filling their pipelines with programs that seek treatments for diseases that can be approved with an accelerated review such as rare diseases, different cancers and anti-infectives," LaMattina told the news agency.
"These types of programs benefit from requiring modest-sized clinical trials and have the potential for generous pricing".
"We're seeing fewer R&D resources devoted to programs that require rigorous differentiation in phase III trials," he said.
But the article noted that there was also a shift in R&D with more products coming from new biotech companies which meant "big pharma companies are not necessarily out of the woods when it comes to getting a decent return on the billions of dollars they spend each year on R&D".
A compilation of consensus analyst forecasts compiled by Thomson Reuters included "several highly promising products from large multinationals that are tipped to generate billions of dollars in sales," it said.
These included;
- Sanofi and Regeneron's Dupixent (dupilumab) for severe eczema (projected US $5 billion to 2023)
- Roche's multiple sclerosis drug Ocrevus (ocrelizumab) (US $4 billion+)
- AstraZeneca's cancer drug durvalumab (forecast US $3 billion)
- Novo Nordisk's diabetes drug semaglutide
- Novartis' as yet unnamed novel cell therapy for leukaemia
- GSK's new shingles vaccine
It quoted QuintilesIMS as saying the robust state of the industry's late-phase R&D pipeline means it was well placed to yield an average of 40 to 45 new launches annually through to 2021.
David Rowley
david.rowley@lushmedia.com.au
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