Pharminent · Daily Brief
October 20, 2026
Regulatory & Approvals
FDA grants Jemperli accelerated approval in locally advanced rectal cancer
The FDA granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab-gxly) in patients with MSI-H/dMMR locally advanced rectal cancer, a use that may allow some patients to avoid chemotherapy, radiation and surgery.
FDA →
FDA approves Roche’s Enspryng for thyroid eye disease
The FDA approved Roche’s Enspryng in thyroid eye disease, a second indication for the drug. Enspryng is the first drug suitable for at-home administration in TED.
Pharmaceutical Technology →$RHHBY
FDA finalizes guidance on biosimilar postapproval manufacturing changes
On October 13, 2026, the FDA announced a final guidance for industry titled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers,” finalizing a draft of the same title issued on July 23, 2024.
Big Molecule Watch →
Trump orders new NIH women’s health division and task force
President Trump signed an executive order creating a women’s health division at the NIH along with a task force, a research and policy initiative that Melania Trump said will set “a new standard for women’s health.”
STAT →
Clinical Data
Disc Medicine reports Phase 3 success for bitopertin in EPP
Disc Medicine said its APOLLO Phase 3 trial of bitopertin in erythropoietic protoporphyria succeeded, and the company plans to re-engage regulators after the FDA rejected the treatment.
BioPharma Dive →
Deals & Partnerships
Merck KGaA to acquire Silence Therapeutics for $1.3B
Merck KGaA agreed to acquire UK-based Silence Therapeutics in a deal valued at $1.3 billion, adding the siRNA therapy divesiran, which has passed a Phase 2 test in the blood disorder polycythemia vera.
BioPharma Dive →$MKKGY
Roche signs ADC deal with Hansoh worth up to $15B
Roche entered a collaboration and license agreement with Hansoh Pharma covering a broad portfolio of antibody-drug conjugates, paying $400 million up front in a deal that could be worth more than $15 billion.
BioPharma Dive →$RHHBY
Teva and Samsung Bioepis expand biosimilar partnership to six candidates
Teva and Samsung Bioepis announced on October 1, 2026 a new global license, development and commercialization agreement covering up to six potential biosimilar candidates, with Samsung Bioepis responsible for development, regulatory registration and manufacturing.
Big Molecule Watch →
AstraZeneca and Oracle launch AI platform for clinical trials
AstraZeneca launched a project with Oracle to use AI and real-world data to improve clinical research and patient care.
Pharmaphorum →$AZN
Business & Finance
China proposes restrictions on foreign biotech acquisitions
China is proposing new restrictions on foreign acquisitions of critical biopharmaceutical technologies as it seeks to retain control over its drug development industry.
STAT →
Analysis finds median net launch price of new medicines at $257,000
An analysis of 202 newly launched medicines found the median net price rose 35% to $257,000 last year from $173,000 in 2022.
STAT →
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