Pharminent · Daily Brief
October 8, 2026
Regulatory & Approvals
FDA approves Pfizer’s Tukysa combination for metastatic breast cancer
The FDA approved Pfizer’s Tukysa (tucatinib) in combination with pertuzumab and trastuzumab as a maintenance therapy for metastatic breast cancer.
Pharmaceutical Technology →$PFE
Biocon’s pertuzumab biosimilar Pebrilzo wins positive CHMP opinion
Biocon Biologics announced on September 22, 2026 that the EMA’s CHMP issued a positive opinion recommending marketing authorization for PEBRILZO (pertuzumab), its biosimilar to Genentech’s PERJETA. According to Biocon, PEBRILZO is the first monoclonal antibody biosimilar to be recommended under the EMA’s tailored clinical approach.
Big Molecule Watch →$RHHBY
FDA details expedited IND pilot under Operation TrialBlazer
The FDA’s expedited IND pilot program, part of Operation TrialBlazer, aims to speed early research and bring clinical trials back to the US from overseas.
PharmaVoice →
Cleveland Clinic and Piramidal build EEG-based AI seizure detection
Cleveland Clinic and startup Piramidal are developing an AI model to detect brain seizures from EEG data, which is pending clearance from the FDA.
Forbes →
Clinical Data
Optogenetics restores some vision in small retinitis pigmentosa trial
In a small study of patients with retinitis pigmentosa, about half regained photosensitivity in their vision following optogenetic treatment.
STAT →
Cerevance plans FDA meeting after Phase 3 solengepras data
Cerevance, a Takeda spinout, has Phase 3 data in hand for its Parkinson’s disease drug solengepras and plans to meet with the FDA to determine next steps.
BioPharma Dive →$TAK
Deals & Partnerships
10x Genomics and Fred Hutch sign multi-project cancer research agreement
10x Genomics entered a multi-project research agreement with Fred Hutch to advance single cell and spatial platforms in solid tumors and blood cancers.
Pharmaceutical Technology →
Business & Finance
Dutch court halts Merck’s subcutaneous Keytruda in parts of Europe
A Dutch court ordered a halt to the manufacturing and marketing of a subcutaneous formulation of Merck’s Keytruda in several European countries, in a patent dispute with Halozyme.
STAT →$MRK
PhRMA sues Trump administration over Medicare international pricing pilot
PhRMA, the brand drug industry’s main trade group, is suing the Trump administration over a pilot program that ties Medicare drug prices to those in peer countries.
STAT →
Caribou halts CAR-T programs, cuts staff, weighs strategic alternatives
Caribou Biosciences is stopping work on its two remaining allogeneic cancer cell therapies and laying off staff after failing to secure funding for its clinical trial plans, including a late-stage-ready candidate in lymphoma, and will pursue “strategic alternatives.”
BioPharma Dive →
Biohub raises $1.8B for AI-powered virtual biology initiative
Biohub has raised $1.8 billion in backing for its AI-powered ‘virtual biology’ initiative, months after launching an open-source platform for the effort.
Pharmaphorum →
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