Tag: pharmaceutical industry
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Kodiak Phase 3: Zenkuda Shows 24-Week Durability in Wet AMD
Kodiak’s Phase 3 DAYBREAK trial met its primary endpoint for both Zenkuda and KSI-501 in wet AMD. Zenkuda stood out as 54% of patients reached 24-week dosing, while KSI-501 met noninferiority without yet establishing a clear added benefit from IL-6 inhibition.
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AbbVie’s Juvmo Wins FDA Approval for Parkinson’s Disease
The FDA approved AbbVie’s Juvmo (tavapadon), a once-daily oral D1/D5 dopamine receptor partial agonist, for adults with Parkinson’s disease. Phase 3 TEMPO data support its efficacy, while pricing, coverage and real-world tolerability remain key commercial questions.
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Merck’s Remigromig Meets Phase 2b/3 Endpoint in Diabetic Macular Edema
Both remigromig doses were noninferior to ranibizumab at Week 52 in the Phase 2b/3 BRUNELLO trial, but safety imbalances and commercial differentiation require further data.
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GRAIL’s Galleri Wins FDA Panel Backing for Multi-Cancer Blood Test
FDA advisers backed GRAIL’s Galleri multi-cancer blood test, but a split effectiveness vote leaves key questions ahead of the final PMA decision.
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J&J’s CAPLYTA Meets Phase 3 Trial Goal in Bipolar Mania
Johnson & Johnson’s CAPLYTA met the primary endpoint in Phase 3 Study 451, producing a 4.8-point greater reduction in manic symptoms versus placebo and significant improvement from Day 3. Results from the second pivotal study remain under analysis.
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CAPLYTA Mechanism in Bipolar Mania: Dual D2 Modulation
CAPLYTA’s exact therapeutic mechanism remains unresolved, but its proposed pharmacology combines strong serotonin 5-HT2A antagonism with distinct presynaptic and postsynaptic dopamine D2 effects. This BP Science analysis examines how that profile may regulate dopamine signaling and differ from competing antipsychotics.
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Anthropic Opens Wet Lab to Test Claude in Biology Experiments
Anthropic has opened a Bay Area wet lab to test how Claude and the Model Hardware Standard can connect AI reasoning with physical biology experiments.
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Eli Lilly’s Inluriyo–Verzenio Combination Wins FDA Approval in ESR1-Mutated Breast Cancer
The FDA approved Eli Lilly’s Inluriyo plus Verzenio for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after endocrine therapy. In an exploratory EMBER-3 analysis, median progression-free survival was 11.1 months with the combination versus 5.5 months with Inluriyo alone.
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Ultragenyx’s Fayuvi Wins FDA Approval as the First Treatment for Sanfilippo Syndrome Type A
The FDA approved Ultragenyx’s Fayuvi as the first treatment for pediatric MPS IIIA, supported by a 23.5-point cognitive treatment effect.
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Skyhawk’s SKY-0515 Posts 1.59-Point cUHDRS Advantage at 15 Months
Skyhawk’s SKY-0515 showed a 1.59-point cUHDRS advantage over an external control at Month 15, alongside sustained reductions in mutant huntingtin and PMS1 messenger RNA.