Pharmaceuticals & Biopharmaceuticals

Jupiter – November 10, 2026 -- Myosin Therapeutics plans to move its MT-125 glioblastoma trial into Phase 2 in early 2027, with the Phase 1 dose-escalation stage running ahead of schedule, the company said ahead of the Society for Neuro-Oncology (SNO) meeting in Philadelphia.

CEO and CMO to meet investigators and prospective partners at SNO

CEO Courtney Miller and CMO Karen Smith will attend the 31st SNO Annual Meeting, running November 12-15, 2026. They will meet current clinical investigators and potential development partners to discuss the Phase 1/2 STAR-GBM trial and preparations for the Phase 2 transition.

Miller said the company's focus is on "solidifying the clinical and strategic relationships" needed for the next development stage.

THOUSAND OAKS, Calif. – November 10, 2026 -- Amgen reported that an independent health economic analysis of its PCSK9 inhibitor Repatha (evolocumab) found the drug cost-effective at approximately 36% below the ACC/AHA benchmark in high-risk patients with no prior heart attack or stroke. The company presented the data at the American Heart Association (AHA) Scientific Sessions 2026.

Duke-led analysis uses patient-level VESALIUS-CV data

The Duke Clinical Research Institute led the study with the TIMI Study Group at Mass General Brigham and Harvard. It is the first independent health economic analysis built on individual-participant data from the Phase 3 VESALIUS-CV trial, and it compared treatment costs with projected health benefits. A separate analysis found that adding Repatha to standard therapy was highly cost-effective versus standard therapy alone in adults with atherosclerotic cardiovascular disease (ASCVD).

Bloomington, Indiana – November 10, 2026 -- Simtra BioPharma Solutions has opened Building H, a more than $250 million expansion of its Bloomington manufacturing campus that adds prefilled syringe, vial and lyophilization capabilities for sterile injectable products.

153,000-square-foot facility adds three production capabilities

The contract development and manufacturing organization (CDMO), which focuses exclusively on sterile injectables, said Building H widens the range of injectable products it can support. Indiana Governor Mike Braun and Bloomington Mayor Kerry Thomson spoke at the ribbon-cutting. The expansion is expected to create hundreds of jobs in Bloomington.

FOSTER CITY – November 10, 2026 -- OrthoTrophix reported that femoral bone shape stabilized in knees treated with its osteoarthritis candidate TPX-100, while it kept changing in placebo-treated knees, according to two posters presented at ACR Convergence 2026 in Orlando (November 6-11).

MRI analysis links B-score to meniscal pathology

Poster #1581, presented November 9, is a retrospective MRI analysis of a one-year, double-blind Phase 2a study of intra-articular TPX-100 in knee osteoarthritis (KOA). Femoral bone shape, measured by B-score, was significantly associated with baseline meniscal pathology at 6 and 12 months.

In placebo-treated knees, the bone-meniscus link strengthened over time. In TPX-100-treated knees, bone shape stabilized and the link weakened. The company says this suggests TPX-100 may alter the structural course of KOA in patients with high meniscal disease burden.

BOSTON – November 10, 2026 -- Aisa Pharma, Inc. reported that its once-daily oral drug AISA-021 (cilnidipine) cut the mean frequency of Raynaud's attacks by 43% from baseline in the Part B crossover phase of the Phase 2 RECONNOITER-1 trial in systemic sclerosis-associated Raynaud's phenomenon (SSc RP). Placebo-treated patients saw a 26% reduction (p=0.028). The company has asked the U.S. Food and Drug Administration (FDA) for a Type C meeting on its development strategy and potential registration pathway, and is preparing a global Phase 3 pivotal study.

Attack-free days rise nearly fourfold from baseline in AISA-021 arm

AISA-021 delivered a placebo-adjusted improvement of more than 155% in the proportion of attack-free days, a nearly fourfold increase from baseline (p=0.013). The drug also significantly shortened attack duration (p=0.02) and improved skin temperature measured by thermography at the proximal interphalangeal joint (p=0.047).

Boston – November 10, 2026 -- HotSpot Therapeutics reported preclinical data showing that its oral IRF5 inhibitor HST-2011 suppressed three disease-driving pathways in systemic lupus erythematosus (SLE) across human cell systems, human whole blood and cynomolgus monkeys. The data were presented in a poster at ACR Convergence 2026.

HST-2011 reduces B cell, interferon and cytokine readouts in three models

In human cellular systems, HST-2011 inhibited plasmablast formation and IgG production. It also potently inhibited type I interferon and proinflammatory cytokine production, including TNF and IL-1β.

In human whole blood stimulated with a TLR agonist, the compound reduced plasmablast, B-cell activation and interferon gene signature scores. mRNA sequencing showed reduced expression of IFNB1, TNF and IL1B.

Castres – November 09, 2026 -- Laboratoires Pierre Fabre and XtalPi Holdings Limited (2228.HK) have signed a drug discovery agreement that includes an upfront payment, multiple milestone payments and downstream economic participation. Neither company disclosed the financial terms.

XtalPi to design small molecules de novo against undisclosed targets

XtalPi will apply its integrated AI capabilities and robotics platform to design and deliver novel small molecule therapeutics. The research programs cover oncology, potentially dermatology, and rare diseases. The targets were not named.

Pierre Fabre takes on compound selection and clinical and commercial development

Pierre Fabre will contribute expertise in disease biology, discovery, translational research and clinical development to select and advance the most promising compounds. It will also be responsible for subsequent clinical and commercial development.

Nanjing – November 09, 2026 -- PharmaBlock hosted a two-day CMC Lifecycle Strategy Forum in Nanjing on November 5 and 6, gathering experts with senior R&D experience at AstraZeneca, AbbVie, Bayer and Pfizer to debate how stage-appropriate chemistry, manufacturing and controls (CMC) decisions can improve development efficiency.

Professionals from Seda Pharmaceutical, Jacobio Pharma, Benemae and PharmaBlock also took part. The agenda covered candidate developability, solid-state science, model-informed drug development, clinical supply and commercial manufacturing.

New York and Stockholm – November 09, 2026 -- The Galien Foundation has named 45 nominees and products for the 2026 Prix Galien Bridges Awards and chosen HealthCap founder Björn Odlander as recipient of the Bengt I. Samuelsson "True North" Award. The ceremony takes place December 1, 2026, at the Medicinska Föreningen at Karolinska Institutet in Stockholm.

Awards span seven categories from drugs to public sector innovation

Nominees compete in seven categories: Best Pharmaceutical Agent, Best Biotechnology Product, Best Product for Rare/Orphan Diseases, Best Medical Technology / AI Advances in Human Health, Best Enabling Technology for Medical Innovation, Best Public Sector Innovation and Best Bridge-Builder Institution.

NEW TAIPEI CITY – November 08, 2026 -- GlycoNex (TPEx: 4168) has submitted a marketing authorization application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for SPD8, its denosumab biosimilar candidate, with approval possible as early as the end of 2027.

The timeline is subject to PMDA review. SPD8 was co-developed with Mitsubishi Gas Chemical (MGC). Preparations for a separate submission in Taiwan are also underway.

Phase 3 trial in 266 osteoporosis patients met its primary endpoint

The filing follows positive topline results from a randomized, double-blind, multicenter Phase 3 trial in Japan. The study enrolled 266 patients with osteoporosis. It demonstrated therapeutic equivalence to reference denosumab, measured by the percentage change from baseline in lumbar spine bone mineral density at Month 12.