FDA orphan drug designation: treatment of malignant glioma
All entries for: GSK
October 17, 2025
GSK
Orphan Drug Designation
London, UK
50,001+ employees
Disease Area: Rare Diseases
July 30, 2025
GSK
Negative Outlook
London, UK
50,001+ employees
While there is currently significant uncertainty regarding the implementation of some of these reforms or the scope of amended or additional reforms, the implementation of reforms could significantly reduce net sales resulting from the Medicare programs and limit our ability to increase the prices that we charge for our drugs. Reforms or other changes to these payment systems may change the availability, methods and rates of reimbursements from Medicare, private insurers and other third-party payors for our current and any future approved products. These reforms may affect future investments in our drug development, should the reforms affect our risk-benefit analysis of investing in a drug candidate. Some of these changes and proposed changes could result in reduced reimbursement rates or the elimination of dual sources of payment, which could reduce the price that we or any of our collaborators or licensees receive for any products in the future, and which would adversely affect our business strategy, operations and financial results.
Disease Area: Immune Diseases, Multiple, Oncology, Rare Diseases, Respiratory Diseases
Drug Type: Biologic, Small Molecule
July 21, 2025
GSK - Cambridge
Layoffs
Cambridge, MA
50,001+ employees
GSK is letting go of 150 employees in Cambridge, Massachusetts, according to a Worker Adjustment and Retraining Notification (WARN) Act notice. Endpoints News reported that the London-based company plans to move manufacturing of its pneumococcal vaccine asset that uses its multiple antigen presenting system (MAPS) technology from Cambridge to Marietta, Pennsylvania.
Disease Area: Antiviral, Immune Diseases, Multiple, Oncology, Respiratory Diseases
Drug Type: Biologic, Small Molecule
July 17, 2025
GSK
Layoffs
London, UK
50,001+ employees
London-based GSK is cutting its global research and development team by an unspecified number of people, Fierce Biotech reported July 15. A spokesperson told Fierce a “very limited number of positions will be impacted” across the company’s R&D workforce of more than 12,000 people.
Disease Area: Immune Diseases, Multiple, Oncology, Rare Diseases, Respiratory Diseases
Drug Type: Biologic, Small Molecule
April 30, 2025
GSK - Philadelphia
Negative Outlook
Philadelphia, PA
50,001+ employees
“HIV: HIV sales grew by 7% this quarter with the US growing at 9%. This was driven by a 9 percentage point increase in patient demand from Cabenuva, Apretude and Dovato reflecting strong market share growth. Growth in the quarter also benefited from customer ordering patterns, offset by unfavourable price impacts from channel mix adjustments and the impact of IRA Medicare Part D redesign. Nucala: Sales growth in the quarter was driven by strong performance across all regions, reflecting higher patient demand for treatments addressing eosinophilic-led disease. Growth in the quarter in the US was predominantly driven by the impacts of channel inventory reductions occurring in 2024, with further underlying double digit volume increases being largely offset by unfavourable price impacts, including the impact of IRA Medicare Part D redesign.
Trelegy: Trelegy sales continued to grow in the quarter, with strong volume growth continued across all regions reflecting patient demand, SITT class growth, and increased market share. Specifically in the US, continued strong volume growth is partially offset by price unfavourability resulting from channel mix and pricing pressures and the impact of IRA Medicare Part D redesign. US performance in the quarter reflected the introduction of the IRA Medicare Part D redesign, which adversely impacted a number of products across Specialty Medicines, Vaccines and General Medicines.”
Disease Area: Immune Diseases, Multiple, Oncology, Rare Diseases, Respiratory Diseases
Drug Type: Small Molecule