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Trump is rounding out his health cabinet with another controversial figure: one of the authors of the Great Barrington Declaration, which advocated for herd immunity through infection during the COVID-19 pandemic.
FEATURED STORIES
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
At one point in merger negotiations with Novartis, Avidity CEO Sarah Boyce and her team walked, cutting off access to a data room and moving on to a capital raise.
Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them just a few years in.
Job Trends
Eisai Co., Ltd. and Biogen Inc. announced that the results from Eisai’s large global Phase 3 confirmatory Clarity AD clinical study of lecanemab, an investigational anti-amyloid beta protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer’s disease and mild AD with confirmed presence of amyloid pathology in the brain, were presented at the 2022 Clinical Trials on Alzheimer’s Disease conference, in San Francisco, California and virtually.
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Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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FDA
The FDA is facing four big target action dates in the final week of June, including one label expansion for a bispecific antibody and another for an investigational gene therapy.
BioSpace’s ⁠Lori Ellis⁠ and ⁠Chantal Dresner⁠ bring live updates from ⁠the first day of #DIA2024⁠ in San Diego.
The hold on BioNTech and MediLink’s antibody-drug conjugate candidate BNT326/YL202 has halted enrollment in a Phase I U.S. trial in patients with non-small cell lung cancer or breast cancer, following multiple deaths.
FDA
AstraZeneca on Monday secured FDA approval for its blockbuster Imfinzi, in combination with chemotherapy, to treat adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient.
Takeda’s soticlestat, licensed from Ovid Therapeutics, did not significantly reduce seizures in patients with Dravet syndrome and Lennox-Gastaut syndrome, respectively, according to two late-stage readouts on Monday.
Novo Nordisk CEO Lars Jørgensen has agreed to appear before the Senate health committee in a hearing on the prices of its blockbuster drugs Ozempic and Wegovy.
Johnson & Johnson’s FcRn inhibitor nipocalimab in a mid-stage study significantly improved disease activity across various organ systems in patients with the chronic autoimmune Sjögren’s disease.
A final analysis of Gilead Sciences’ now-discontinued Phase III ENHANCE study showed a worrying trend of increased death risk in myelodysplastic syndromes patients treated with magrolimab.
While GLP-1 drugs remain wildly popular and are a highly lucrative sector, data analytics firm GlobalData contends manufacturing and cost will remain overhangs on the obesity market.
Accurately diagnosing Alzheimer’s disease pathologies is becoming increasingly important, but the U.S. is facing imaging resource constraints.