steve usdin
@steveusdin1
Followers
3K
Following
85
Media
415
Statuses
5K
Washington Editor, BioCentury. Author: Bureau of Spies & Engineering Communism.
Joined September 2011
An antibody-based assay from a Icahn School of Medicine at Mount Sinai could help determine how and where #COVID19 is spreading, and how many people have been infected. It could also find donors of convalescent sera to treat or prevent the infection.
6
161
437
Draft Exec Order wld halve FDA staffing, slash NIH, eliminate CDC. WH being warned of impact on public health, biopharma industry, science. OPM back to work starts at FDA March 17.
33
193
395
Three Biogen staff positive for #COVID19. Mgt sent email to all staff warning them not to seek testing "Hospital leaders have warned Biogen that they may need to have the Hospital Police Department intervene to prevent Biogen employees from entering the emergency room"
33
205
321
More turbulence w/FDA's vaccine office. Marks takes over FDA's vaccines office 1 month before Gruber departs. The move precipitated decisions by at least two reviewers to inform their colleagues that they will leave the agency, FDA sources said. Story ($)
4
75
200
Updated list of #COVID19 vaccines under development. Free (no paywall) at: More BioCentury coronavirus coverage at
8
100
184
FDA has lost two of its most experienced, respected oncology drug reviewers. Paul Kluetz and Marc Theoret, both deputy directors of the Oncology Center of Excellence, announced their resignations from the agency this week. BiocCentury will publish a story tomorrow.
15
51
153
Marion Gruber, Phil Krause, FDA's top vaccine regulators, are stepping down.
13
85
130
Even if the executive order is dialed back or shelved, former FDA staff expect rigid back to work order would lead to exodus, causing missed PDFUFA goals.
9
31
125
FDA’s aducanumab decision will erode public trust. The difference between science and science fiction is data. Asserting that a decision is based on science is credible only if data supporting the decision are made -- something FDA hasn't done.
1
29
114
Long knives at FDA. In addition to mass layoffs, some senior staff were told given choice of demotion or quitting. Peter Stein,longtime director of CDER’s Office of New Drugs was demoted & quit. BioCentury story coming later today.
2
23
91
Transformative meds since 2000: Gleevec effectively curing CML; VEGF treatments turning back blindness; eradication of Hep C in our lifetimes; vaccines preventing cervical cancer; millions saved from lymphatic filariasis and rotavirus; and more.
1
50
70
#COVID19 update: @GileadSciences. ramping up remdesivir production; @Codagenix. partners with vaccine giant @SerumInstIndia., WHO says big decisions must be made soon on vaccine development. No paywall. @V2019N.
6
35
66
A randomized, placebo-controlled trial in Argentina has found that convalescent plasma is not effective in severe COVID-19 patients, casting more doubt on the efficacy data FDA used to back the countermeasure’s emergency use authorization. @V2019N.
2
26
63
Gilead preparing a trial in China of remdesivir to treat 2019-nCoV: Meanwhile, at least 9 trials of #2019-nCoV therapies are underway. All BioCentury coverage of the outbreak is in front of the paywall at
1
49
71
Non-human primate data link higher neutralizing titers to stronger COVID-19 protection .@V2019N
2
14
58
FDA’s hands-off approach to serologic antibody tests is a huge mistake. It risks flooding the market with inaccurate tests that will lead people to make bad decisions. This cld have deadly consequences. . @V2019N
2
38
53
The IRA has fundamentally reset the economics of drug development, @LillyPad CEO Ricks told @BioCentury. Value of most small molecules halved. Some drugs won’t be developed, value of some biotechs crushed. More ($) at
4
18
58
FDA to reorganize new drug reviews. Creating a flatter organization, more engagement of FDA staff w patients, academia, drug developers. @SGottliebFDA.
7
39
62
Lauren Silvis, who served as chief of staff for FDA Commissioner @ScottGottliebMD, hired by Biden administration as #COVID19 vaccine consultant. She reports to David Kessler who replaced Moncef Slaoui as chief scientist on the COVID Response Team.
3
20
55
In drug plan Friday, Trump will not propose Medicare Part D negotiation. He'll accuse other countries of "free-riding" by using "socialist" systems to lower prices. Will focus on PBMs. No big hits to drug companies.
5
42
59
.@Regeneron announces good data on mAb cocktail -- but supply is v limited. @LillyPad has a deal to sell its mAb to the U.S. government. Emergency Use Authorizations pending for both could be issued this week. @V2019N .
6
23
49
Avian flu has jumped from birds to cows to humans. The U.S. is flying blind @RickABright warns. It is either the start of a serious outbreak or a fire drill. Either way, the U.S. needs to do much better. Watch at or listen at
2
13
47
RFK Jr cited pseudo-science to justify holding up of Novavax COVID vaccine. He said single-antigen vaccines don’t protect against respiratory diseases. There are 2 FDA-approved sgl antigen vaccines for RSV. And data on Novavax solid, FDA reviewers said.
2
18
50
FDA ended 2018 with a record 59 new molecular entity approvals, up from 46 in 2017. The agency's previous approval record was 53 in 1996, the all-time high in FDA's published data.
1
23
40
WHO panel recommends shutting down hydroxychloroquine #COVID19 prevention trials. Amazing: Despite evidence of no efficacy “more than 80 trials planning to enroll at least 100k participants are registered or ongoing.".
5
19
34
4
17
39
Novavax has proposed that FDA accept a Phase 3 U.K. and Phase 2b S Africa trial to support EUA of its #COVID19 vaccine. FDA may wait until mid-April for interim data from a U.S./Mexico Phase 3. This, and thoughts about variants, from $NVAX pres for R&D.
2
10
37
U.S. not part of global #COVID19 vaccine, drug, dx group. @wellcometrust Farrar: “The only true exit strategy is through science. and the equitable distribution to the world to make sure everybody receives it independent of their ability to pay.” @V2019N
3
29
30
At least 20 European countries have temporarily suspended the use of AstraZeneca’s #COVID19 vaccine due to concerns around thromboembolic events, but side effect rates are about the same as other two COVID-19 vaccines & may be same as background levels.
2
16
32
1
27
32
Serum Institute of India, world's largest vaccine maker, to make 100s of millions of doses of #COVID19 vaccines for developing world. Will make only pennies per dose. Company head tells BioCentury IP is OK for computers or Viagra, but not for vaccines.
1
11
35
Biopharma execs were shocked by Jan 6 attack, paused giving to members of Congress who voted against certification of the 2020 election. At least 9 biopharmas and trade assoc BIO have since given to 42 of them. List & statements from co’s, BIO, no paywall:
0
17
32
Widespread antibody testing is critical to understanding spread of #COVID19 & establishing possible immunity. But getting the tests right isn’t easy.
1
15
28
John Crowley, CEO of @IAmBiotech meeting with Trump, advisers at Mar-a-Lago this weekend to discuss formation of advisory body on FDA reform. Crowley will serve on the board, along with academic scientists, biotech executives.
0
12
32
Co's routinely fib about interactions with FDA, John Jenkins, Dir Office of New Drugs, says in exit interview.
1
28
31
0
15
29
Biotech CEOs, investors support Ukraine.More than 150 industry leaders vow to disengage with Russia until it stops war, respects Ukraine’s sovereignty. @PeterKolchinsky @jmaxlevin.
1
14
22
CEOs of Genentech, Novartis say IRA will cause them to delay launches of cancer drugs for smaller indications like mesothelioma & ovarian cancer to prioritize lung or prostate cancer. Tragic. Patients will be harmed.
2
14
30
#COVID19 testing delays are an unnecessary tragedy caused by incompetence at CDC and poor decisions at FDA. Competence, clarity and courage are needed -- qualities that have been in short supply during the COVID-19 outbreak. Free at
2
7
26
Jefferies is leading an initiative to raise as much as $1 billion to support HHS’s newly launched public-private partnership to build U.S.-based manufacturing capacity to rapidly produce hundreds of millions of prefilled medical-grade syringes. @V2019N .
0
9
28
FDA details hiring challenges. FDA medical officers earn 46% below salaries they could earn in the private sector. Among other positions, mathematical statisticians earn 41% less, pharmacists 35%, chemists 33%, and toxicologists 26%.
5
26
30
At least 8 #2019-nCoV vaccines under development using a variety of technologies. List below. In addition at least three groups are working on mAbs: Regeneron, Vir, and NIH’s NIAID. mAbs might be ready faster and provide both prophylaxis and treatment.
3
19
24
Two companies developing antibody therapies for #COVID19, @Regeneron and @Vir_Biotech are taking different scientific approaches. @V2019N
0
11
29
Efficacy in older populations is critical for #COVID19 vaccines. Data released to date shows large variation among vaccine candidates in neutralizing titers across age groups – this could signal differences in efficacy by age.
3
16
28
Updated list of new therapies under development for #COVID19 (not including repurposed drugs), includes RNAi from @Alnylam, antibodies from @AbCelleraBio, @Regeneron, @Vir_Biotech, WuXi Biotech, and more at @V2019N
0
12
26
Data from several vaccines makes it possible to start correlating antibody data with efficacy. This could be the start of defining correlates of protection.
0
13
26
PhRMA to accept inflation caps. PhRMA is prepared to accept a cap on drug price increases, biopharma executives involved in drafting the trade association’s response to the Trump administration’s drug pricing blueprint told BioCentury. More at:
2
21
23
At least 232 clinical trials of therapeutics and vaccines for COVID-19 end or yield interim results by Aug. 31, according to BioCentury’s COVID-19 Clinical Trials Dashboard (. Graphic showing trial readouts at and below. @V2019N
3
14
23
$50 million a year for pediatric cancer? That's all? Really? It should be much more. This is an area where industry won't invest and government should step up to the plate.
Trump announces HIV, children’s cancer initiatives
5
6
23
The leaked Trump administration 2026 HHS budget is sickening. If enacted, it will destroy American science. NIH budget slashed by 40%. The 15% overhead for universities baked into law. Ill-conceived reorganization of NIH institutes.
5
8
25
@Dereklowe FDR’s private intelligence service informed him in the months before and after Pearl Harbor that Japanese on the west coast and in Hawaii posed no threat to the U.S. DR was advised to protect, not persecute, them. I wrote about this in Bureau of Spies
0
10
19
NIH 2025 summer internships cancelled. This really sucks. NIH internships have launched many scientific careers. At a time when the U.S. is discouraging foreign students, how can it make sense to kill a program that costs pennies and is critical to building homegrown scientists?.
0
9
25
Oxford and SinoVac #COVID19 preclinical vaccine candidate data is Apples to Oranges. Here’s a side-by-side look at the data. @BioCentury’s story about why the data are difficult to compare is at @V2019N
1
17
23
.@ScottGottliebMD on the need to ensure equitable access to the coming wave of curative therapies: "We need to make sure that access to a curative drug doesn’t become a yardstick by which poverty is eventually measured.".
0
6
23
.@BioCentury’s exit interview w SGottliebFDA. His approach to promoting medical innovation, strategic communications, creating lasting change – and more.
2
14
23
Biotech CEOs, investors urge colleagues to shun states w/voter suppression laws. Georgia biotech pushes back, calls effort “counterproductive.” If all else is = @PeterKolchinsky says he won’t invest in states that suppress votes.
0
5
21
A COVID-19 vaccine from @Novavax has produced the highest reported levels of neutralizing titers in non-human primate studies. Study designs make direct comparison impossible, but the results look good. 1st step down a long path. Phase I results in July.
0
6
22
Treating #COVID19 may require a two-step approach: anti-virals in the first stage, then anti-inflammatories.
0
7
22
CMS proposes payment models for accelerated approval, gene & cell therapies.
8
8
22
Former FDA Commissioners Hamburg, Califf, McClellan endorse @ScottGottliebMD for Commissioner.
0
25
21
FDA is reorganizing the Office of New Drugs to stay ahead of drug development
0
10
21
Is immuno-oncology a bubble? "The science is real; the results are potentially transformational. The question is whether the current level of investment is justified."
1
9
21
The biopharmaceutical industry, and the patients who rely on it, have a stake in the outcome of challenges to FDA preemption that will be triggered by the Supreme Court's decision to overturn Roe v Wade. ($)
0
9
21
Janet Woodcock to serve as Acting FDA Commissioner after 1/20, Josh Sharfstein a contender for top FDA job. David Kessler will advise Biden at WH on COVID-19, will not return to FDA. Story:
2
17
22
Maybe politicians who got their graduate degrees from the University of Twitter should not make public comments about science or medicine?.
0
4
22
FDA opens doors for digital tools to facilitate siteless trials, find new endpoints @SGottliebFDA says in remarks to Bipartisan Policy Center:
1
7
20
Upcoming FTC workshop could be a jumping off point for more aggressive regulation of biopharma M&A, including more oversight over large pharma acquisitions of small biotechs.
8
11
21
FDA investing $500M on innovation, patient-focused drug development, regulatory science, better trials.
0
27
19
Amid signs that monkeypox may have spread too widely for the current outbreak to be contained and extinguished, WHO is convening a meeting this week to develop a research roadmap for diagnostics, treatments and vaccines.
2
7
17
FDA releases real-world evidence framework. Important note: RWE will be only for adding an indication to an approved drug -- not for first time approvals of new drugs.
2
10
20
FDA/NIH postpone Rare Disease Day w/no explanation. Last week the agencies told advocates the event would be held as planned. Hundreds of families have made plans to travel to DC for a week of activities, the FDA/NIH event wld have been a highlight.
3
22
20