Biopharmaceuticals

Yantai – September 09, 2026 -- CelluPro has become the first Chinese cell culture media supplier to receive EXCiPACTTM GMP Certification for Pharmaceutical Auxiliary Materials, adding an internationally recognized quality benchmark to its biomanufacturing supply chain.

EXCiPACT Certification Validates Manufacturing Controls and Traceability

The EXCiPACTTM scheme sets GMP requirements for materials used in biopharmaceutical manufacturing, assessing quality management, manufacturing controls, traceability, and supply chain practices. CelluPro's certification adds to an existing compliance portfolio that includes ISO 9001, ISO 13485, ISO 14001, ISO 45001, and ISO 22301, covering quality management, environmental management, occupational health and safety, and business continuity.

Nottingham – September 09, 2026 -- Isomab Ltd has published a systematic review showing no increased cancer or retinopathy risk from pro-angiogenic therapies for coronary artery disease, removing a two-decade safety barrier that has constrained development across the field.

Review of 636 patients finds malignancy rates below population norms

The analysis covered 11 clinical studies conducted between 2002 and 2024, spanning 636 patients with angina or peripheral artery disease -- 441 receiving pro-angiogenic therapy and 195 on placebo -- with follow-up periods ranging from two to 12 years. Mean malignancy incidence was 0.84 per 100 patient-years for the treatment group versus 0.72 for placebo, both figures falling below the age-matched population rate of 1.0 per 100 patient-years. Retinal events were rare in both cohorts and also below population benchmarks.

Hamilton, Ontario – September 09, 2026 -- AtomVie Global Radiopharma has opened a new $160 million manufacturing facility in Hamilton, Ontario, that the company calls the largest single-site radiopharmaceutical CDMO plant in North America.

New 72,300-square-foot plant multiplies manufacturing capacity tenfold

The purpose-built facility at 10 Aeropark Boulevard spans 72,300 square feet and increases AtomVie's manufacturing capacity by more than ten times its previous output. The site is designed to handle low- to high-volume production runs and supports a continuous path from early-stage clinical development through commercial-scale manufacturing.

San Diego – September 09, 2026 -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) will webcast primary endpoint results from the randomized, controlled Phase 2 portion of its HexAgon study on Tuesday, September 8, 2026 at 5:00 a.m. Pacific Time.

Phase 2 data will compare INBRX-106 combination therapy against pembrolizumab alone

The study evaluates INBRX-106, a hexavalent OX40 agonist, combined with pembrolizumab against pembrolizumab monotherapy as a control arm. The trial enrolled first-line, treatment-naïve patients with PD-L1 positive (CPS ≥ 20) metastatic or unresectable recurrent Head and Neck Squamous Cell Carcinoma (HNSCC).

Leesburg, Va. – September 09, 2026 -- Resonant Clinical Solutions has acquired France-based Creapharm Bioservices from Myonex, expanding its cryogenic storage and biobanking capabilities across Europe to support increasingly complex cell and gene therapy trials.

Deal adds specialized cryogenic infrastructure in France

Creapharm Bioservices, headquartered in Bailly-Romainvilliers, France, provides biobanking and cryogenic storage services for biotherapeutics, advanced therapy medicinal products (ATMPs) and biological samples. Its capabilities include liquid nitrogen storage down to -196°C, mechanical freezing, cold storage, GMP-compliant sample storage and GDP-compliant custody for quality control. Financial terms of the transaction were not disclosed.

Delray Beach, Fla. – September 08, 2026 -- The global clinical trial services market will grow from $66.20 billion in 2026 to $97.41 billion by 2031, expanding at a compound annual growth rate of 8.0%, according to MarketsandMarkets.

North America commands 45% of the market as CRO density drives outsourcing demand

North America held the largest regional share in 2025, roughly 45%, anchored by a dense concentration of contract research organizations and established pharmaceutical R&D spending. Phase III trials accounted for the largest service share in 2025 at approximately 39.5%, reflecting the higher volume of outsourced work their complexity demands. Small molecules led by modality with a 50.5% share in 2025, supported by a large installed pipeline of drug candidates.

Hamilton, ON – September 08, 2026 -- AtomVie Global Radiopharma has opened a 72,300-square-foot manufacturing facility at 10 Aeropark Boulevard in Hamilton, Ontario, representing an investment exceeding $160 million and marking the largest single-site CDMO facility in North America for radiopharmaceutical development.

New site delivers more than tenfold increase in manufacturing capacity

The purpose-built facility supports low-to-high throughput production, enabling AtomVie to scale operations from early clinical development through commercial manufacturing for its partners. The company is targeting a workforce of more than 200 employees by the end of 2026 as the site ramps toward full operational capacity.

Shanghai – September 08, 2026 -- Mabwell (688062.SH, 02493.HK) reported that its anti-ST2 monoclonal antibody 9MW1911 reduced the annualized rate of severe COPD exacerbations by 100% in the 900 mg dose group compared with placebo, according to Phase Ib/IIa data presented as a poster at the European Respiratory Society International Congress 2026 (ERS 2026).

Trial enrolled 80 COPD patients across four dose arms

The randomized, double-blind, placebo-controlled study (9MW1911-C03) enrolled 80 former smokers with moderate-to-severe COPD, randomizing participants to intravenous 9MW1911 at 100 mg, 300 mg, 600 mg, or 900 mg, or placebo, every four weeks. Most participants had blood eosinophil counts of 300 cells/μL or below.

Carlsbad – September 08, 2026 -- Tyra Biosciences, Inc. (Nasdaq: TYRA) will disclose initial clinical results from its SURF302 Phase 2 study of oral dabogratinib in intermediate risk non-muscle invasive bladder cancer (IR NMIBC) during a conference call scheduled for September 9, 2026, at 8:00 am ET.

Tyra sets September 9 call to unveil first SURF302 data

The clinical-stage biotech confirmed the call and webcast will present initial efficacy and safety data from the ongoing SURF302 trial, marking the first public disclosure of results for dabogratinib in this bladder cancer indication.

Dabogratinib targets FGFR3-driven tumors as lead pipeline asset

Dabogratinib is Tyra's lead precision medicine candidate, developed as a potential first-in-class selective FGFR3 inhibitor. Beyond IR NMIBC, the company is advancing the drug for low-grade upper tract urothelial cancer (LG-UTUC) and achondroplasia (ACH).

Melbourne – September 08, 2026 -- Dimerix Limited (ASX: DXB) has secured non-dilutive loan facility agreements worth up to A$34 million with a syndicate of Australian and U.S. lenders, expanding on its previously announced A$10 million SKIPTAN facility.

Dimerix locks in A$34 million loan facility from Australian, U.S. lenders

The new terms are substantially consistent with the earlier SKIPTAN agreement, with minor amendments made to standardise conditions across all lenders. The structure gives Dimerix the option to expand total commitments to A$50 million on or before March 31, 2027, though the company currently has no plans to draw on that additional capacity.