Rachel King, interim CEO of , says trade group's priorities are the Inflation Reduction Act, accelerated approval, capital formation and DEI.
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steve usdin
@steveusdin1
Washington Editor, BioCentury. Author: Bureau of Spies & Engineering Communism.
Joined September 2011
steve usdin’s Tweets
. to continue granting orphan exclusivity to sub-populations, despite loss in court in Catalyst case, failure to convince Congress
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We agree . "Opportunity is hard to come by in DC this year, but there are signs that the quest for better medicines can breach the partisan divide." #OneRareVoice #ODAat40
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@RareCoalition members stand ready to work with stakeholders & policymakers in the #raredisease community to protect and strengthen #ODA. Thanks @SteveUsdin for this article in @BioCentury and opportunity to contribute our #OneRareVoice. biocentury.com/article/646529
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The Orphan Drug Act at year 40: successes, controversy and calls for ODA 2.0
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Biotech and biomanufacturing can transform our lives, create new jobs, and help achieve our climate goals. Provide your input about the new National Biotech and Biomfg Initiative by tomorrow to this RFI. We want to hear from you!
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Deals and stormy sentiments at biopharma's annual #JPM22 kickoff, plus hot takes from CERSI, neuroscience meetings. Tune into 's latest podcast to get the scuttlebutt from San Francisco with
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Thank you #BIAmembers for your support in our SME R&D tax relief campaign . We have received a positive response from the Chancellor, recognising the challenge the rate cut poses for the life sciences sector⭐
Learn more in 's recent podcast
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In the 8 years since the discovery that Celgene’s #IMiDs degrade oncogenic transcription factors by “gluing” them to E3 ubiquitin #ligases, over a dozen #biotechs have developed molecular glue degraders. See where this field is headed > (FREE with reg) ow.ly/X4l250Mkkoy
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Congress's recommendations on how to avoid another Aduhelm debacle are lame. Here's what it should have recommended. A BioCentury Editor's Commentary by Washington Editor #Alzheimers $BIIB
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A bumper podcast to kick off the year- UK R&D tax credits, latest in Aduhelm saga, drug approvals, 2023 what we’ll be watching. & me, w superhost .
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What were they thinking? 's board in the spotlight as documents released by two House committees shed light on critical questions associated with the Aduhelm debacle. via Washington Editor :
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U.K. appears to avert blow to biotechs from new R&D tax policy. It's welcome news for hundreds of small British biotechs that faced the prospect of losing millions of pounds because of the new policy, writes 's biocentury.com/article/646312
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Delighted to share our latest publication out today in JAMA Health Forum!
Eight-factor regulatory framework proposed to ensure robust #compassionateuse regulations at a country level that would facilitate speedy, ethical, responsi…lnkd.in/eZX4PE-b
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Our CSO, Tony Wood, joined Editor in Chief for a discussion on our approach to R&D, including our focus on areas like #infectiousddiseases.
Register for free access: gsk.to/3FVGlg0
#pharma #oncology #researchanddevelopment #thebiocenturyshow
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On January 10, at the 11th annual #WuXiGlobalForum during #JPMWeek: Join , , , , and to discuss new approaches to redefine “druggability.”
Register now: bit.ly/3zw1BoT
#JPM23
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MUST READ from
#ASH22 could be IL-18’s watershed moment
[Details/analysis via subscription or free trial access]:
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If you work in blood cancer and are interested in new targets, then this is the article for you. and the team have identified new targets at ASH 2022 - and about half of them are in AML.
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FDA/EMA holding meeting Dec. 15 on next-generation COVID monoclonals. Important bc there are no mABs effective vs current variants. fda.gov/drugs/news-eve
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Steve Usdin of reports on new language in medical diagnostics bill (VALID Act) now before Congress that would provide exemption for tests developed, used by academic medical centers biocentury.com/article/646100 I wrote about VALID here twitter.com/scottgottliebm
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My commentary on @statnews with Mark McClellan on why @US_FDA reform measures that address agency oversight of cosmetics and diagnostics - now before Congress - are key for advancing patient protections and fostering innovation in these dynamic industries statnews.com/2022/12/05/con
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A striking 100% ORR in a small NHL CAR T cell trial at #ASH22 could be an inflection point for the relatively uncrowded IL-18 space.
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Congressional staff racing to shore up support for the VALID Act have agreed to give academic medical centers an exemption from FDA regulation of lab-developed tests. Exemption wld cover tests prescribed & performed in an academic medical center. ($)
BioCentury – FDA, NCI study will serve as prototype for streamlined pragmatic trials
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The white paper is available free (no-cost online registration required) at
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The Charles Forum, a group that brings together the regulatory heads of 14 global biopharmas has written a white paper, Navigating the Gray Zone, about challenges and opportunities in the transition to a post-pandemic “new normal.” Story:
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Maintaining momentum on the path to the post-pandemic world: Regulatory heads of global biopharmas at The Charles Forum point to opportunities, threats in transition to new normal. Read more from 's
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Always great to talk to James Sabry from - hear his advice to biotechs seeking to partner with pharmas, on The BioCentury Show ( ).
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., tussle over Keytruda patents, with JHU seeking hundreds of millions of dollars from Merck via 's
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Allogene's latest data cut strengthens the case that long-term responses to allogeneic CAR T cell therapies are possible $ALLO
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#BioFuture2022 Interviews! Check out this great interview from the conference - from interviews
with >> bit.ly/3VeZf6a
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The National Institute of Health RADx diagnostic team just announced a national mechanism to self-report results of COVID home tests. I am grateful on Thanksgiving weekend for this step forward in our ability to track COVID, and f…lnkd.in/gBvRCYHR
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Another sign China's biotech ecosystem is maturing -- over half of the therapies Chinese companies out-licensed to Western companies in 2021-22 employ new modalities or unapproved targets
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A new term sheet template 4 early-stage life science startups spun from academic research labs is now avail after >2 yrs of work by individuals from university tech transfer offices, VCs, & law firms. Could slash time & cost of licensing IP 80%
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Biopharma is preparing for a productive lame duck session of Congress, followed by a year of noisy gridlock.
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Great conversation with of about what to expect from Congress for biopharma in the lame duck and in 2023. Video is open access (free w/online registration)
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November 16th is World Sanfilippo Syndrome Awareness Day. Meet Eliza, lovingly painted by Ian Mohon.
Because of its neurodegenerative nature and multi-system impact, Sanfilippo Syndrome is often called “childhood Alzheimer’s” or “childhood dementia.”
#sanfilippo #RareDiseases
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