Noah AI Industry News

Delivers real-time biopharma news and signals — powered by AI, curated for professionals.

Sarepta's Elevidys Faces New Challenges and Opportunities

Sarepta's Elevidys Faces New Challenges and Opportunities

Sarepta Therapeutics has received FDA approval to study an enhanced immunosuppressive regimen for its gene therapy Elevidys, aimed at addressing safety concerns that led to recent label restrictions. This development comes in the wake of significant setbacks for the Duchenne muscular dystrophy (DMD) treatment.

NoahAI News11/26/2025
Johnson & Johnson's Tecvayli/Darzalex Combo Shows Remarkable Results in Multiple Myeloma Treatment

Johnson & Johnson's Tecvayli/Darzalex Combo Shows Remarkable Results in Multiple Myeloma Treatment

Johnson & Johnson's combination therapy of Tecvayli and Darzalex has demonstrated exceptional efficacy in treating relapsed or refractory multiple myeloma (RRMM), potentially revolutionizing the standard of care for this challenging condition. The results from the Phase III MajesTEC-3 study, set to be presented at the upcoming American Society of Hematology (ASH) meeting, have been hailed as "remarkable" by industry analysts.

NoahAI News11/25/2025
Former DARPA Official Alicia Jackson Appointed as ARPA-H Director Amid Budget Challenges

Former DARPA Official Alicia Jackson Appointed as ARPA-H Director Amid Budget Challenges

The Department of Health and Human Services (HHS) has officially announced the appointment of Alicia Jackson as the new director of the Advanced Research Projects Agency for Health (ARPA-H). This significant leadership change comes at a time when the agency faces substantial budget cuts and programmatic challenges.

NoahAI News11/25/2025
J&J's Alzheimer's Antibody Fails in Phase II Trial, Dealing Another Blow to Tau-Targeting Approach

J&J's Alzheimer's Antibody Fails in Phase II Trial, Dealing Another Blow to Tau-Targeting Approach

Johnson & Johnson has announced the discontinuation of its Phase II Au𝜏onomy study evaluating posdinemab, an anti-tau antibody, in patients with early Alzheimer's disease. The decision comes after a scheduled review revealed the drug's failure to significantly slow clinical decline, marking another setback in the pursuit of effective Alzheimer's treatments.

NoahAI News11/25/2025
Abbott Issues Urgent Correction for Millions of Glucose Sensors Amid Safety Concerns

Abbott Issues Urgent Correction for Millions of Glucose Sensors Amid Safety Concerns

Abbott Laboratories has launched a significant medical device correction for approximately 3 million FreeStyle Libre 3 and Libre 3 Plus continuous glucose monitoring (CGM) sensors in the United States. The company's action comes in response to reports of incorrect low glucose readings, which have been associated with severe adverse events and deaths.

NoahAI News11/25/2025
Okami Medical Raises $45M for Vascular Embolization Device Commercialization

Okami Medical Raises $45M for Vascular Embolization Device Commercialization

Okami Medical, a company specializing in vascular embolization devices, has successfully raised $45 million in a recent financing round. The funding will be used to expand the company's commercial footprint and support clinical programs for its innovative Lobo system. In conjunction with this financial milestone, Okami has appointed Drew Hykes, former CEO of Inari Medical, as its new chief executive officer.

NoahAI News11/25/2025
Biogen's Leqembi Gains Ground as Novo Nordisk's GLP-1 Fails in Alzheimer's Trials

Biogen's Leqembi Gains Ground as Novo Nordisk's GLP-1 Fails in Alzheimer's Trials

Biogen's Alzheimer's drug Leqembi (lecanemab) is poised for increased uptake following the failure of Novo Nordisk's semaglutide in two pivotal Phase III trials for Alzheimer's disease progression. This development removes a perceived competitive threat and solidifies the position of anti-amyloid antibodies as the primary disease-modifying treatment option in the Alzheimer's market.

NoahAI News11/25/2025
Novo Nordisk's GLP-1 Drug Fails in Alzheimer's Trials, Shaking Industry Expectations

Novo Nordisk's GLP-1 Drug Fails in Alzheimer's Trials, Shaking Industry Expectations

Novo Nordisk's highly anticipated phase III trials exploring the potential of its GLP-1 drug semaglutide in Alzheimer's disease have failed to meet their primary endpoints, dealing a significant blow to hopes that this class of medications could offer a new avenue for treating neurodegenerative diseases.

NoahAI News11/25/2025
NervGen's NVG-291 Shows Promise in Phase II Spinal Cord Injury Study

NervGen's NVG-291 Shows Promise in Phase II Spinal Cord Injury Study

NervGen Pharma Corp. has announced positive results from its Phase II CONNECT SCI study, evaluating the investigational peptide therapeutic NVG-291 in patients with chronic spinal cord injury (SCI). The drug demonstrated significant improvements in functional performance and quality of life, positioning it for potential late-stage development.

NoahAI News11/25/2025
FDA Leadership Turmoil Continues Amid White House Intervention

FDA Leadership Turmoil Continues Amid White House Intervention

The Food and Drug Administration (FDA) faces ongoing leadership challenges as the White House intervenes in personnel decisions. In a recent development, Sanjula Jain-Nagpal, associate director of Policy & Research Strategy at the FDA, was denied a promotion to deputy chief of staff for Commissioner Marty Makary. The decision came after Jain-Nagpal prematurely announced her new role to FDA stakeholders before receiving official approval.

NoahAI News11/25/2025
Bayer's Asundexian Achieves Phase 3 Success in Stroke Prevention, Revitalizing Factor XIa Inhibitor Class

Bayer's Asundexian Achieves Phase 3 Success in Stroke Prevention, Revitalizing Factor XIa Inhibitor Class

Bayer's experimental blood thinner asundexian has met its primary endpoint in a closely watched Phase 3 stroke prevention trial, potentially paving the way for a new class of cardiovascular drugs. The success comes as a welcome development for the Factor XIa inhibitor class, which has faced recent setbacks in clinical trials.

NoahAI News11/25/2025
Gilead Sciences Acquires TREX1 Cancer Program from Sprint Bioscience in $400M Deal

Gilead Sciences Acquires TREX1 Cancer Program from Sprint Bioscience in $400M Deal

Gilead Sciences has made a significant move in the oncology space, acquiring an early-stage TREX1 cancer program from Swedish biotech Sprint Bioscience. The deal, announced on November 24, 2025, involves an upfront payment of $14 million to Sprint Bioscience, with the potential for up to $400 million in additional milestone payments.

NoahAI News11/25/2025
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