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BioWorld - Tuesday, June 2, 2026
Breaking News: Ongoing coverage of the Ebola outbreakBreaking News: Ongoing coverage of the Ebola outbreak
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Myst it again: Milestone gets a CRL for its heart spray

March 28, 2025
By Lee Landenberger
Milestone Pharmaceuticals Inc.’s heart rhythm-restoring calcium channel blocker for paroxysmal supraventricular tachycardia (PSVT) has yet another obstacle in its way. 
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Alzheimer’s drug Kisunla rejected by European regulators

March 28, 2025
By Nuala Moran
The EMA has rejected the Alzheimer’s disease therapy Kisunla (donanemab) from Eli Lilly and Co., saying the benefits of the anti-amyloid antibody do not outweigh the risks of edema and hemorrhage in the brain, known as amyloid-related imaging abnormalities (ARIA).
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Vykat XR

First Prader-Willi treatment Vykat XR FDA-approved: Soleno soars

March 27, 2025
By Karen Carey
Becoming the first treatment for rare genetic disorder Prader-Willi syndrome, breakthrough therapy drug DCCR (diazoxide choline) gained U.S. FDA approval as Vykat XR the evening before its March 27 PDUFA date, sending shares of developer Soleno Therapeutics Inc. up 38%.
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US flag and HHS logo

HHS to cut staffing levels by 20,000 under efficiency initiative

March 27, 2025
By Mark McCarty
The U.S. Department of Health and Human Services HHS reported a plan to reduce staffing by 10,000 in an immediate reduction, which when paired with retirement initiatives will drop staffing by as many as 20,000.
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Regulatory actions for March 27, 2025

March 27, 2025
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Exelixis, GSK, Intellia, Kashiv, Kelun, Merck, Neurim, Plus, Sanofi, Theratechnologies, Vast.
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Other news to note for March 27, 2025

March 27, 2025
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aadi, GV20, Ionis, Kaken, Mitsubishi, Sobi, Turn, Vesigen, Whitehawk.
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In the clinic for March 27, 2025

March 27, 2025
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aligos, Calidi, IGC, Leap, Merakris , Merakris, Vaximm, Wave Life Sciences.
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Financings for March 27, 2025

March 27, 2025
Biopharmas raising money in public or private financings, including: Epicrispr, Hubble, Jaguar, Tribune.
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Appointments and advancements for March 27, 2025

March 27, 2025
New hires and promotions in the biopharma industry, including: Areteia, Asgard, Atyr, Auregen, Avalo, Biomea Fusion, Photocure, Psyence, Rezolute, Tevogen, Verrica.
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Illustration of green and yellow antibodies, DNA

Bifunction conjunction afoot; multiple players competing

March 27, 2025
By Randy Osborne
Bispecific antibodies have gotten plenty of press in recent years, but less prominent in headlines are bifunctional ones – i.e., those that boast one binding site for an antigen and another site for a non-antibody molecule such as a toxin or drug, taking aim at a single target and bringing a secondary function for extra oomph.
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