Tracing FDA announced a draft guidance giving sponsors recommendations for early-phase IND protocols for solid tumor drugs and biologics, with comments due January 11, 2027.×Refreshed just now
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In the News
One card per story, every outlet that covered it71h agoYahooBill Cassidy says Trump’s FDA pick faces uncertain committee voteSenate HELP Chair Bill Cassidy says he still has questions about FDA commissioner nominee Heidi Overton, leaving the outcome of Wednesday's committee vote uncertain.1 outlet9 linked 2d agoNewsweekTrump Pushes $350B Military Bill, Says Democrats Will ‘Block and Resist’Trump seeks $350 billion for defense via reconciliation before Democrats take Congress in January, within a $1.5 trillion fiscal 2027 defense request.1 outletDefenseCongress weighs defense reconciliation bill and Dec. 11 funding deadline in lame duck23 linked 4d agoSTATSTAT+: Cassidy sets key vote on Overton, even as he remains undecided on nominee to lead FDASenate HELP Committee schedules a Nov. 18 vote on FDA commissioner nominee Heidi Overton, with Chair Bill Cassidy still undecided.1 outletBiotech2 linked 4d agoLos Angeles TimesFor peptide enthusiasts, a new HHS policy means party timeHHS's enforcement discretion policy lets pharmacies compound six unapproved peptides ahead of a final FDA rule, which critics say expands access without adequate safety or efficacy evidence.1 outletBiotech5 linked 6d agoPolitico‘Russ Vought’s gonna meet his match’: What Murkowski’s potential promotion means for the White HousePolitico reports Sen. Lisa Murkowski is set to become the top Republican on the Senate Appropriations Committee in January, positioning her to check Russ Vought's grant and spending-power moves.1 outlet6 linked 7d agoPoliticoSanders warns Democrats about spending too much time investigating TrumpSanders urges incoming Democrats to prioritize affordability over investigating Trump and says he will summon RFK Jr. before the HELP committee.1 outlet12 linked 11d agoAxiosDemocrats will face a health care stress testAxios analysis says Democrats' post-election health care agenda, including Medicare for All votes and Medicaid cut rollbacks, will be constrained by limits and internal divisions.1 outlet5 linked
On the Hill
Congress, the White House and agencies4Ahead
Wednesday, Nov 18
9:45 AMCongressSenate Health, Education, Labor, and PensionsThe Senate HELP Committee has scheduled a business meeting to consider five executive nominees, including Heidi Overton for FDA Commissioner and James O'Neill for NSF Director.BiotechDetails6 linked
Monday, Jan 11
Recent
Friday, Oct 25
Wednesday, Nov 11
3d agoAgencyHealth and Human Services DepartmentFDA announced a draft guidance giving sponsors recommendations for early-phase IND protocols for solid tumor drugs and biologics, with comments due January 11, 2027.BiotechDetails5 linked
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Contracts
Solicitations, SBIR topics, grants and awards12AwardNational Institutes of HealthApr 30NIH awarded EMERGENT, LLC contract HHSN276201700089U valued at roughly $41.08 million.$41.1M obligatedHHSN276201700089UEMERGENT, LLCBiotechLifecycle12 linked AwardNational Institutes of HealthAug 30NIH awards Thomas Jefferson University contract HHSN272201700082C for advanced development of multivalent filovirus and Lassa fever vaccine candidates.$26M obligatedHHSN272201700082CThomas Jefferson UniversityBiotechLifecycle12 linked AwardNational Institutes of HealthSep 22NIH awarded Baylor College of Medicine a $16.68M task order for TOPMed Centralized Omics Resource task areas 2, 3, and 4.$16.7M obligated75N92024F00001Baylor College of MedicineBiotechLifecycle15 linked GrantNational Institutes of Health11d agoNIH seeks applications for a U19 systems biology program on infection, inflammation and chronic disease, with a $26 million ceiling.$26M ceilingCloses in 95 daysRFA-AI-28-014BiotechLifecycle12 linked GrantNational Institutes of Health12d agoNIH seeks applications for translational genome editing and biologic therapy development for Alzheimer's-related dementias, with a $6 million ceiling.$6M ceilingCloses in 694 daysRFA-NS-28-012BiotechLifecycle12 linked GrantNational Institutes of HealthOct 29NIH seeks applications for Genomic Data Generation Center(s) for the Gabriella Miller Kids First Pediatric Research Program, with a $6 million ceiling and responses due January 8, 2027.$6M ceilingCloses in 54 daysRFA-RM-27-008BiotechLifecycle11 linked GrantNational Institutes of HealthOct 20NIH seeks applications to continue the Immune Tolerance Network for tolerogenic therapy clinical trials, with a $27 million ceiling.$27M ceilingCloses in 75 daysRFA-AI-28-005BiotechLifecycle11 linked GrantNational Institutes of HealthOct 20NIH seeks applications for consortium Translational Centers using Microphysiological Systems for Infectious Diseases (RFA-AI-28-012), with a $7M ceiling.$7M ceilingCloses in 75 daysRFA-AI-28-012BiotechLifecycle14 linked GrantNational Institutes of HealthOct 16NIH National Library of Medicine seeks applications for T15 institutional training programs in biomedical informatics, data science, and AI/ML, with a $17.1M ceiling.$17.1M ceilingCloses in 88 daysRFA-LM-28-001BiotechLifecycle14 linked GrantNational Institutes of HealthOct 13NIH seeks applications for research and preclinical development of next-generation malaria vaccines under RFA-AI-28-024, with a $4 million ceiling.$4M ceilingCloses in 88 daysRFA-AI-28-024 (R61/R33 Clinical Trial Not Allowed)BiotechLifecycle12 linked RFPADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH (ARPA-H)2d agoARPA-H seeks proposals for SURPASS, a simulation-augmented real-time adaptive seamless trial platform, under solicitation ARPA-H-SOL-26-164.Closes in 15 daysARPA-H-SOL-26-164BiotechLifecycle10 linked AwardNational Institutes of HealthSep 20NIH awarded Blacksmith Medicines contract 75N93022C00060 for development of FG-2101, an LpxC inhibitor for MDR gram-negative urinary tract infections.$14.6M obligated75N93022C00060Blacksmith Medicines, Inc.BiotechLifecycle17 linked