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BioWorld - Sunday, August 2, 2026
Breaking News: Science fiction realized: BCI tech is hereBreaking News: Science fiction realized: BCI tech is here
Home » Topics » BioWorld, Clinical

BioWorld, Clinical
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Tired mother holding newborn

Oral ‘roid void in PPD? Lipocine MINI bike may have wheels

April 2, 2026
By Randy Osborne
No Comments
Hopes in postpartum depression (PPD) with an oral version of brexanolone – a synthetic formulation of the endogenous neurosteroid allopregnanolone, approved by the U.S. FDA in 2019 when given intravenously for PPD – were dashed, at least near term, when Lipocine Inc. reported that the candidate failed in a phase III placebo-controlled trial.
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PET scans showing before and after treatment with VIPOR
ICKSH 2026

Five-drug VIPOR regimen shows promise in aggressive blood cancer

April 1, 2026
By Marian (YoonJee) Chu
No Comments
Deep molecular advances are enabling precision medicine for the field of hematology, Wyndham Wilson said during a plenary session at the 2026 Korean Society of Hematology International Conference March 26.
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Limb exam

Assay what? Eyes on Pepgen’s DM1 phase II

April 1, 2026
By Randy Osborne
No Comments
Phase II data disclosed March 31 by Pepgen Inc. in myotonic dystrophy type 1 (DM1) hobbled the stock but might have been much different if not for one outlier in the 5-mg/kg multiple ascending dose cohort of the ongoing phase II Freedom2-DM1 trial – and Wall Street is pondering what the hitch means for the Boston-based firm as well as the competitive space.
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Monoclonal antibody illustration

Simcere’s rademikibart meets phase III endpoints in atopic dermatitis

March 31, 2026
By Tamra Sami
No Comments
Simcere Pharmaceutical Group Ltd.’s monoclonal antibody, rademikibart (CBP-201), met the primary endpoint in a Chinese phase III study in adults and adolescents with moderate to severe atopic dermatitis.
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3D illustration of heart cross section

Braveheart finds phase II positive for cardiac myosin inhibitor

March 31, 2026
By Marian (YoonJee) Chu
No Comments
Braveheart Bio Inc. reported positive results from an open-label randomized phase II dose-ranging study of BHB-1893 (HRS-1893) in obstructive hypertrophic cardiomyopathy. Results presented at the American College of Cardiology’s Annual Scientific Session and Expo in New Orleans showed BHB-1893 treatment was associated with rapid and substantial reductions in left ventricular outflow tract gradient, the primary endpoint of the study.
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Handshake icon engraved on metal hexagonal background

Galapagos enters new era as Lakefront after reshaping Gilead alliance

March 31, 2026
By Nuala Moran
No Comments
Galapagos NV is about to bury its recent turbulent past and sail off for the future with its $3 billion cash pile and the new name of Lakefront Biotherapeutics NV. The foundation for the transition was laid earlier this month in an arrangement with Gilead Sciences Inc., holder of 25% of Galapagos’ equity, to “co-parent” the assets of Ouro Medicines LLC, which Gilead is acquiring for up to $2.17 billion.
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Oral medication

AAD 2026: Targeted oral therapies challenge injected biologics

March 30, 2026
By Nuala Moran
No Comments
Data presented at the 2026 American Academy of Dermatology (AAD) meeting have put the spotlight on the arrival of target-selective oral therapies that are set to challenge injected biologics in terms of efficacy, while offering greater convenience and improving access to treatment.
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Boston Scientific - Watchman FLX

Boston Sci boasts Champion-AF data but strokes signal a concern

March 30, 2026
By Shani Alexander
No Comments
Boston Scientific Corp. revealed much-anticipated data from the Champion-AF trial which showed that its Watchman FLX device provides superior protection from bleeding compared to non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF). The left atrial appendage closure device also proved noninferior to NOACs in reducing stroke, cardiovascular death, or systemic embolism.
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Tyvaso nebulizer

United’s Tyvaso nails endpoints in second phase III IPF trial

March 30, 2026
By Jennifer Boggs
No Comments
United Therapeutics Corp. is eyeing a possible priority review in its anticipated supplemental NDA for Tyvaso (treprostinil) in idiopathic pulmonary fibrosis (IPF) after the second phase III trial hit its endpoints, even besting the impressive findings from the first phase III study reported last year, and positioning United for a substantial commercial launch in 2027.
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Face with digital focus on eye

Elegrobart star in TED phase III but Viridian shares sacked

March 30, 2026
By Randy Osborne
No Comments
Analysts were sounding pleased and the company intends to go ahead with a regulatory filing, but investors seem to have wanted more from Viridian Therapeutics Inc.’s top-line data from the elegrobart (formerly VRDN-003) Reveal-1 phase III trial in active thyroid eye disease (TED). Viridian shares (NASDAQ:VRDN) closed March 30 at $18.53, down $8.86, or 32%.
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