steve usdin retweeted
IMO… it is a mistake to “try to increase U.S. competitiveness through protectionism.” The new rule “may make it easier for non-U.S. companies to succeed through manufacturing in China. This wouldn’t help our global competitiveness.”
IMO… let’s instead kick ass with American ingenuity!
biocentury.com/article/66129…
A proposed outbound investment rule released by the U.S. Treasury Department Thursday would leave U.S. drugmakers free to license molecules from Chinese companies but could have a chilling effect on a broad range of collaborations between U.S. and Chinese companies.
The proposed rule would, however, bar U.S. companies and investors, absent a national interest exemption, from acquiring stakes in or forming many kinds of joint ventures with a broad range of Chinese companies.
The prohibition in the proposed rule covers companies engaged in “the development, engineering, or use of a biological system—or component of a biological system” to produce or modify pharmaceutical compounds, including small-molecule drugs. It would also bar U.S. companies from building or expanding their own operations in China to engage in those activities.
More: biocentury.com/article/66129…
steve usdin retweeted
New rules for China's IIT dramatically reduced the number of trials approved during the first months after Order 818 was enacted, but the tradeoffs could protect patients and raise the profile of China's data on the global stage buff.ly/qoA0JVD
steve usdin retweeted
Tigermed’s take on running trials in the U.S. and China: Britney Winterberger on parallel U.S.-China development strategies, IITs, and easing friction in clinical development buff.ly/rUDt4p9
steve usdin retweeted
In BioCentury's Deals Report: An agreement with Roche around ADCs could allow Hansoh to opt into global development, expanding its reach around the world; plus Gilead/Vir, Merck KGaA/Silence and more buff.ly/EabQ9JE
Treasury could release draft COINS rule, including controls on outbound biotech investments, this week. Its fate may be determined by reaction to the Roche-Hansoh deal announced today. Story: biocentury.com/article/66123…
The Roche-Hansoh collaboration announced Monday is part of the Chinese pharma’s strategy to move beyond asset licensing to co-development arrangements that allow it to assume more clinical development risk in exchange for a greater share of future profits, Hansoh’s CBO, Weiyong Sun, told BioCentury. Sun detailed Hansoh's future trajectory in an interview with BioCentury: biocentury.com/article/66123…
steve usdin retweeted
On the latest #BioCenturyShow @StephenPHansen speaks with @ArrowheadPharma CEO Chris Anzalone about solving the challenge of delivering #siRNA to extra-hepatic tissues, and how breakthroughs here can enable future growth opportunities for Arrowhead $ARWR buff.ly/DThToy4
steve usdin retweeted
First human tau-lowering data from @ArrowheadPharma mark a milestone for brain shuttle–siRNA delivery. But how much tau knockdown delivers benefit without compromising normal neuronal functions remains an open question. $ARWR buff.ly/Gy5YGoj
Will Heidi Overton be confirmed as FDA Commissioner this year? She’s caught between the congressional clock, Republican divisions over abortion (some demanding reinstatement of mifepristone in-person dispensing requirements, some opposing changes), and the Trump administration’s vaccine policies. Could be tough to get the nomination through the HELP Committee this year – and it could be even more difficult next year. biocentury.com/article/66113…
steve usdin retweeted
Nobel prize for optogenetics arrives as first drug nears FDA decision. Nanoscope leads direct therapeutic applications, while MapLight uses the technology to guide psychiatric drug discovery buff.ly/aRBZBRM
steve usdin retweeted
Small GLOBE, big precedent. In a Perspective, Washington Editor @SteveUsdin1 writes that the mandatory Medicare Part B MFN model has shrunk, laying bare the real issues buff.ly/rzLh0s7
steve usdin retweeted
Hidden in plain sight: Canaan’s Grant on company building in white spaces. Julie Grant joins The #BioCenturyShow to discuss company building toward M&A, what talent looks like early on, and filling gaps where others aren’t. buff.ly/74xeXaK
YolTech has evidence that rebuts Beam’s accusations that it misappropriated trade secrets, Emma Wang, the scientist who is the focal point for Beam’s lawsuit, told BioCentury. Her comments, and a review of YolTech’s scientific publications, suggest that the litigation will be complex and may hinge on a jury’s evaluation of technical questions, as well as its confidence in the trustworthiness of the opposing sides.
Much more, including an assessment of the arguments YolTech is likely to make if the case goes to trial, at biocentury.com/article/66097…
steve usdin retweeted
Radiopharma financing continues to grow as U.S. and China drive equity growth, while Telix debt lifts Australia buff.ly/GFaYy0B
steve usdin retweeted
New PDUFA agreement aims at clearing CMC obstacles, prioritizing pivotal reviews. America First provisions are symbolic. buff.ly/sHlr2xq
steve usdin retweeted
How @US_FDA is signaling tighter scrutiny of early-stage data from China -- but stopping short of an outright ban. buff.ly/KAn4WAw
steve usdin retweeted
Biopharmas look to academics for innovation: a BioCentury Data Byte buff.ly/NBvGeKZ
steve usdin retweeted
.@US_FDA could approve psychedelics before redosing is resolved. Agency officials say 12-week efficacy and preliminary follow-up could support initial approval while durability and maintenance regimens continue to mature buff.ly/nQdkdXt
steve usdin retweeted
ARPA-H envisions faster rare disease diagnosis with AI. Agency invests in four projects to develop early detection tools in Rare Disease AI/ML for Precision Integrated Diagnostics (RAPID) program. buff.ly/pk1V3pQ


