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BioWorld - Wednesday, December 31, 2025
Breaking News: BioWorld 2025 Year in ReviewBreaking News: BioWorld MedTech 2025 Year in ReviewBreaking News: Trump administration impacts continue to roil the life sciences sector
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U.S. Capitol building

US Congress avoids government shutdown, extends voucher program

Sep. 26, 2024
By Mari Serebrov
Both chambers of the U.S. Congress put aside their election year politicking Sept. 25 long enough to pass a continuing resolution that will keep the government running at its current funding level through Dec. 20. The spending bill is now awaiting President Joe Biden’s signature.
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Immune checkpoint inhibitors illustration of PD-1, CTLA-4 and PD-L1.

ODAC expresses itself on PD-L1, checkpoint inhibitors

Sep. 26, 2024
By Randy Osborne
The FDA’s Oncologic Drugs Advisory Committee (ODAC) met for what chairperson Christopher Lieu called, at the end, “an incredibly long day” to decide whether approval of immune checkpoint inhibitors should be restricted in accordance with expression levels of PD-L1.
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Pfizer pulls sickle cell drug after deaths and health complications

Sep. 26, 2024
By Lee Landenberger
The risk and benefit of Pfizer Inc.’s oral sickle cell disease drug Oxbryta (voxelotor) has flipped, prompted by what the company called new clinical data indicating “an imbalance in vaso-occlusive crises and fatal events” that need more study. Based on an EMA recommendation, Pfizer said it is voluntarily recalling all lots of Oxbryta from wherever it’s approved worldwide. Pfizer also is shuttering its Oxbryta clinical studies and expanded access programs.
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Brain illustrated with pills

Karxt for schizophrenia awaits US FDA decision; inventor opines

Sep. 26, 2024
By Nuala Moran
Nine years on from securing $3.84 million for a phase I clinical trial to test the formulation, with results showing it overcame side effects that had confounded its forerunner, the schizophrenia treatment Karxt met its PDUFA date Sept. 26 with no decision by midday. If approved, the fixed combination of xanomeline-trospium will be the first in a new drug class, and as a dual M1/M4 muscarinic agonist, the first new therapy to act via a novel mechanism for the serious psychiatric disorder in over 50 years.
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Transdermal patch on arm

China approves Sino Biopharm’s patch for Alzheimer’s disease

Sep. 26, 2024
By Tamra Sami
China’s National Medical Products Administration has approved Sino Biopharmaceutical Ltd.’s rivastigmine transdermal patch to treat mild to moderate Alzheimer’s disease. Developed by Sino Biopharm, the patch is the first domestically produced rivastigmine transdermal patch approved for marketing. Rivastigmine is a cholinesterase inhibitor used for the treatment of Alzheimer’s disease.
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New Japan drug approvals: cancer, insomnia, Alzheimer’s and more

Sep. 26, 2024
By Marian (YoonJee) Chu
Japan’s Ministry of Health, Labour and Welfare granted new drug approvals and expanded indications for conditions like cancer, insomnia and Alzheimer’s disease (AD) Sept. 24, including Eli Lilly and Co.’s Kisunla (donanemab) for early symptomatic AD.
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Other news to note for Sept. 26, 2024

Sep. 26, 2024
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acroimmune, Asklepios, Aitia, Bavarian Nordic, Bayer, Belief, Emergent, Mitem, Novartis, Oncoc4, Orion, Zetagen.
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In the clinic for Sept. 26, 2024

Sep. 26, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 2seventy Bio, Abbvie, Arcutis, Avadel, Biocon, Bristol Myers, Eli Lilly, Ferring, Galderma, Inflarx, Merck, UCB, Windtree.
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Regulatory actions for Sept. 26, 2024

Sep. 26, 2024
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarex, Amgen, Eli Lilly, Elixirgen, Heron, Junshi, Merck.
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Financings for Sept. 26, 2024

Sep. 26, 2024
Biopharmas raising money in public or private financings, including: Alpha Cognition, Bioage Labs.
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