2016 Documentation Drug Development 
Pharmaceutical Technology
JULY 18, 2025
Comstock said it is not yet clear if the report will be turned into an official agency guidance document, but it will be made publicly available. Moreover, other threats to the early-stage drug development for rare diseases are also a concern.
FDA Law Blog: Biosimilars
OCTOBER 13, 2024
We have heard over and over again how the potential for a priority review voucher has allowed small companies with limited resources to invest in the development of drugs for rare pediatric diseases. Notably, it was reauthorized in 2016 (until 2020) and in 2020 (until 2024). After all, this is what incentives are for.
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pharmaphorum
AUGUST 6, 2025
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Syner-G
SEPTEMBER 15, 2023
Nonetheless, their rising popularity – eight of the top 10 best-selling drugs internationally in 2016 were biologics – underscores their increasing importance. 5 Key Steps in Large Molecule (Biologics) Development Target Identification Drug discovery involves identifying biological targets relevant to diseases.
pharmaphorum
APRIL 27, 2021
Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies. In 2016, the agency was criticised by the US Government Accountability Office (GAO) for not gathering enough post-marketing data on drugs granted expedited approvals.
pharmaphorum
OCTOBER 29, 2020
Figure 2: NICE OMA safe harbour meetings, 2016/17 to 2019/20. For PRIMA, the agency quotes Peter Wheatley-Price, market access and pricing director at Takeda UK, who said : “The Takeda team highly regarded the quality of the PRIMA reports and model review documentation. Source: Data from NICE FOI responses. Great job!”.
European Pharmaceutical Review
JULY 4, 2024
The second was crofelemer, Mytesi , an indicator drug for HIV-associated diarrhoea extracted from the blood-red latex of the South American croton tree. 2 It was first approved as Fulyzaq in December 2012 and in October 2016, Napo Pharmaceuticals launched the new brand, Mytesi. 3 Is two too few? BMB Reports. 2017;50(3):111–6.
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