Pharminent · Daily Brief
October 21, 2026
Regulatory & Approvals
FDA approves GSK’s Hibsago for chronic hepatitis B
The FDA approved Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, to treat chronic hepatitis B virus infection in certain adults without cirrhosis. The agency described the antisense-based drug as a first-of-its-kind treatment for chronic hepatitis B.
FDA →$GSK
MHRA revokes approval for Valneva’s chikungunya vaccine Ixchiq
The UK’s MHRA revoked the approval of Valneva’s chikungunya vaccine Ixchiq over safety concerns, resulting in the vaccine’s withdrawal from the market.
Pharmaceutical Technology →
FDA approves Cosette’s Evoxac oral solution for Sjogren’s disease
The FDA approved Cosette’s Evoxac oral solution to treat symptoms of dry mouth in adults diagnosed with Sjögren’s disease.
Pharmaceutical Technology →
FDA approves first generic of Climara Pro hormone therapy patch
The FDA approved the first generic of Climara Pro (estradiol and levonorgestrel transdermal system, 0.045 mg per day/0.015 mg), a once-weekly transdermal hormone therapy patch for women with an intact uterus.
FDA →
Clinical Data
Novo’s CagriSema shows 25% weight loss in women in late-stage analysis
Novo released a new late-stage analysis showing its experimental CagriSema injection produced 25% weight loss in women. The company said the data show CagriSema can improve on the weight loss achieved with its GLP-1 obesity injection Wegovy.
CNBC →$NVO
Rapport’s RAP-219 meets main goal in mid-stage bipolar mania trial
Rapport’s epilepsy drug RAP-219 narrowly met the primary endpoint of a mid-stage trial in bipolar mania. Some analysts had described expectations for the study as low.
BioPharma Dive →
Deals & Partnerships
Genentech and Biocon settle pertuzumab biosimilar patent litigation
On October 14, 2026, the U.S. District Court for the District of New Jersey dismissed without prejudice all claims in Genentech and Hoffmann-La Roche’s BPCIA litigation against Biocon Biologics over its proposed pertuzumab biosimilar. Biocon announced a settlement the same day.
Big Molecule Watch →$RHHBY
Business & Finance
Mark Cuban’s Cost Plus Drugs targets rare disease manufacturing costs
Mark Cuban’s Cost Plus Drugs says it can reduce manufacturing costs for custom rare disease drugs and n-of-1 gene therapies.
STAT →
AbbVie signs Formula 1 sponsorship deal
AbbVie has entered Formula 1 through a sponsorship deal, one of several such agreements signed by pharmaceutical companies in sport.
Pharmaceutical Technology →$ABBV
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