Policy
In this episode of Denatured, you’ll be hearing from Edoardo Negroni, co-founder & managing partner at AurorA-TT and Naveed Siddiqi, senior partner, Venture Investments at Novo Holdings. We debate whether Europe’s world-class science can be matched by a truly integrated venture ecosystem—and what it would take, in practice, to get there.
Despite exceptional regional hubs and research strength, investors say Europe still needs more integrated incubators, smarter regulation and broader pools of patient capital to keep breakthrough companies growing at home.
In this whitepaper, BioSpace reviews the major trends impacting the CDMO sector and the evolving relationship between sponsors and providers. We examine the key qualities pharma and biotech should consider in CDMO selection, and how the macroeconomic and macrodevelopment factors affecting the space play a role in this selection.
BioSpace looks back at 2025 and where the FDA is going in 2026.
During the pharma earnings season, which begins on Tuesday, Novo Nordisk will report the first revenue numbers from an oral GLP-1 medicine, while other companies are expected to address the FDA, drug pricing and Trump’s new tariffs.
Some 30% of clinical trials that are mandated to report their findings have not posted results to clinicaltrials.gov, the federal government’s public repository for studies, according to internal data from the FDA.
A Louisiana court on April 7 asked the FDA to complete its internal review of mifepristone’s safety and gave the agency six months to provide the court with an update on the investigation.
Industry leader Steve Ubl has served as PhRMA’s CEO for more than a decade, the longest tenure of any head of the trade group.
Biotech, in particular companies that are pre-commercial with a longer-duration risk profile, could be great investments as Operation Epic Fury rolls on, according to a Truist Securities analysis.
Sarepta Therapeutics says the FDA has agreed to review a regulatory package for Amondys 45 and Vyondys 53 after they failed a confirmatory trial, but whether the agency will agree to approve them is still unknown.
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