SHERIDAN, WYOMING – July 25, 2025 – The U.S. Food and Drug Administration (FDA) has cast doubt over GSK’s attempt to return its antibody-drug conjugate Blenrep to the U.S. market for relapsed or refractory multiple myeloma, citing persistent safety concerns and limited evidence of efficacy across key patient populations.
SHERIDAN, WYOMING – July 25, 2025 – The U.S. Food and Drug Administration has delayed its decision on GSK’s antibody-drug conjugate Blenrep, postponing the company's market reentry plans for the treatment of relapsed or refractory multiple myeloma. The updated Prescription Drug User Fee Act (PDUFA) target date is now set for October 23, 2025, following the agency's request for additional information.
SHERIDAN, WYOMING – July 25, 2025 – A recent string of awkward and, at times, insensitive employee layoff notifications in the biopharma industry is sparking serious concerns around internal communications, HR protocol, and employer branding amid rising workforce reductions.
SHERIDAN, WYOMING – July 25, 2025 – Maryland continues to assert itself as a national leader in life sciences, driven by a dynamic workforce, strong academic institutions, and expanding industry infrastructure. With the Washington, D.C.–Baltimore area ranking among the top six U.S. regions for R&D and manufacturing talent, the state is attracting significant investment and fostering sustainable growth across biotech and pharmaceutical sectors.
Talent-Driven Advantage for Life Sciences Expansion
SHERIDAN, WYOMING – July 25, 2025 – Roche has officially discontinued development of CT-173, an investigational PYY analog once positioned as a novel obesity treatment, citing a lack of competitiveness and development potential in its latest strategic assessment.
SHERIDAN, WYOMING – July 25, 2025 – Roche has reported strong momentum in the first half of 2025, achieving 7% sales growth at constant exchange rates (CER) and a 23% increase in IFRS net income, driven by high demand for innovative pharmaceutical treatments and effective cost control measures.
Strong Performance in Pharmaceuticals Drives Growth
SHERIDAN, WYOMING – July 25, 2025 – Roche has received CE Mark certification for its Elecsys® pTau181 blood test, marking a pivotal advancement in Alzheimer’s diagnostics by introducing the first IVDR-certified in-vitro diagnostic test to help rule out Alzheimer’s-associated amyloid pathology.
SHERIDAN, WYOMING – July 25, 2025 – Roche has received European Commission (EC) approval for Itovebi™ (inavolisib), a targeted therapy for adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer. The approval marks a significant milestone in the treatment of a subtype associated with poor prognosis and limited therapeutic options.
Regulatory milestone based on robust clinical evidence
SHERIDAN, WYOMING – July 25, 2025 – Roche has announced a significant step in the modernization of its capital structure, as its Board of Directors proposes to exchange the company's non-voting equity securities ("Genussscheine") for newly issued participation certificates. The proposal, which will be submitted to shareholders for approval at the 2026 Annual General Meeting (AGM), aims to align Roche’s capital instruments with current Swiss corporate law and modern market practices.
SHERIDAN, WYOMING – July 25, 2025 – Roche has announced topline results from two pivotal clinical trials evaluating astegolimab for chronic obstructive pulmonary disease (COPD), highlighting a complex development path for the investigational monoclonal antibody. The phase IIb ALIENTO trial met its primary endpoint, while the phase III ARNASA trial did not, despite both showing numerical reductions in exacerbation rates.
Phase IIb ALIENTO Achieves Statistically Significant Reduction in Exacerbations