Acceptance of the application was based on results from the Phase III STARGLO study, which found that Columvi demonstrated a statistically significant and clinically meaningful overall survival improvement in patients with relapsed or refractory diffuse large B-cell lymphoma.
Approval of Imfinzi was based on results from the ADRIATIC Phase III trial, marking the first systemic immunotherapy available for limited-stage small cell lung cancer.
The breakthrough designation is based on Phase II clinical trial data, which demonstrated that ATX101 provides sustained pain relief for up to four weeks following total knee arthroplasty.
Results from the SURMOUNT-5 Phase IIIb trial found that Zepbound achieved an average weight loss of 20.2%, surpassing Wegovy’s 13.7%.
The musician launched the Get Low #2 campaign.
The breakthrough designation is based on data from the expansion cohort of a Phase I/II study evaluating sacituzumab tirumotecan in patients with epidermal growth factor receptor-mutated non-small cell lung cancer.
Licensing deals are expected to enhance the oncology, neuroscience, and antibody drug conjugate pipelines of the three manufacturers.
The devices are being provided based on a variety of health-based features that they provide.
AIX exchanged key assets in exchange for ownership shares.
Acceptance of the Biologics License Application of Blenrep was based on promising results from the DREAMM-7 and DREAMM-8 Phase III trials in patients with relapsed or refractory multiple myeloma.
Under terms of the deal, Roche will gain access to Poseida’s pipeline, including P-BCMA-ALLO1, an allogeneic CAR T-cell therapy for multiple myeloma, and P-CD19CD20-ALLO1, a dual CAR T-cell therapy in early trials for B-cell malignancies and autoimmune diseases.
The two companies will work to develop treatments for SBMA.
Agreement grants Sarepta exclusive rights to several clinical-stage programs for muscular dystrophy, myotonic dystrophy type 1, and more.
Approval was based on the combined results from five studies of adults with supraventricular tachycardia.
The proposal aims to reduce out-of-pocket costs for a number of anti-obesity medications by 95%.
Results of the RESILIENT SMA study found that while taldefgrobep demonstrated clinically meaningful motor function improvements in patients with spinal muscular atrophy, the treatment arm did not achieve statistical significance at 48 weeks.
CelloType produces more accurate results when analyzing high content tissue images.
Pathway is now the first and only FDA-approved companion diagnostic for identifying HER2-positive biliary tract cancer patients eligible for treatment with Ziihera.
The educational platform is targeted at HCPs and their staff.
The actor is part of a campaign for early colon cancer screening.
Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA for a subcutaneous induction regimen of Tremfya for adults with moderately to severely active ulcerative colitis based on positive Phase III ASTRO trial results.
The results say that the industry still lacks talent and skills in this area.
The campaign also includes partnerships with other celebrities, including Lance Bass and Retta.
Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii) provides a chemotherapy-free treatment option for patients with HER2-positive biliary tract cancer, addressing a critical unmet need with promising efficacy and improved quality of life.
Dorman previously served as head of Gilead Sciences’ U.S. Oncology Unit.
The drug, developed by UCB, is approved to treat adults with the inflammatory skin disease.
Former Chief Oncology Officer and Executive Vice President, Chris Boshoff, MD, PhD, will assume the role and lead all R&D functions including oncology.
The latest news for pharma industry insiders.
Ron Lanton, Partner, Lanton Law, discusses ways that the recent FDA PD-1 inhibitor label restrictions could influence future drug development strategies.
Ron Lanton, Partner, Lanton Law, discusses potential challenges that will come as a result of the FDA’s recent move to tighten label restrictions on PD-1 inhibitors for gastric cancers.
