Priority Review was based on data from the ECHO Phase III trial, which demonstrated that a combination of Calquence, bendamustine, and rituximab reduced the risk of disease progression or death by 27% in patients with previously untreated mantle cell lymphoma.
A Q&A with Dr. Ken Dychtwald, Recipient of the McKinsey Award for his Harvard Business Review article, “It’s Time to Retire Retirement.”
The ROGUE device is being developed thanks to a $34.9 million grant from ARPA-H.
Marketed as a biosimilar to Stelara, approval of Otulfi was based on clinical data demonstrating comparable efficacy in treating inflammatory conditions such as Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis.
New facilities are expected to focus on manufacturing next-generation medicines and biologic medicines.
Laura Johnson, senior director, sales, life sciences, Loftware, discusses issues faced by the pharmaceutical industry when it comes to proper drug labeling.
CN201 is currently being evaluated in Phase I and Phase Ib/II clinical trials for relapsed or refractory non-Hodgkin lymphoma and B-cell acute lymphocytic leukemia.
Partnership is expected to leverage Amneal’s global manufacturing and product development experience and Metsera’s portfolio of ultra-long acting injectables and oral nutrient-stimulated hormone analogs.
The application for Priority Review of Enhertu was supported by positive results from the DESTINY-Breast06 Phase III trial, which demonstrated that Enhertu reduced the risk of disease progression or death by 37% in patients with HER2-low or HER2-ultralow metastatic breast cancer.
Joseph Panetta, President and CEO of Biocom California, shares his insights on biotech industry trends, policy challenges, and educational initiatives, drawing from over 25 years of leadership in California’s thriving life sciences sector.
CSL and Artcurus announced the results of a study on the self-amplifying RNA vaccine.
Flyrcado is the first positron emission tomography myocardial perfusion imaging agent of its kind designed for the detection of coronary artery disease.
Designed for cataract patients, the TECNIS Odyssey aims to reduce the need for glasses by offering a full range of precise vision at all distances.
Dupixent was found to significantly reduce the rate of moderate to severe exacerbations of chronic obstructive pulmonary disease, according to data from the Phase III BOREAS and NOTUS trials.
Landmark FDA approval of Cobenfy represents the first new class of drugs indicated to treat schizophrenia in decades.
A Harvard Business School Healthcare Alumni Association Q&A with Martin Gonzalez, Principal of Org and Leadership Development at Google.
Murphy previously worked at the Biotechnology Innovation Organization as its chief policy officer.
The program, Rx-Performance, will be available starting in January of next year.
A new JAMA study indicates that semaglutide produced up to a 68% lower risk of opioid overdose for patients with type 2 diabetes compared to other antidiabetic medications.
Tagrisso was approved under a Priority Review based on the pivotal LAURA Phase III trial in adults with unresectable stage III epidermal growth factor receptor-mutated non-small cell lung cancer.
The legal challenges surrounding Biogen’s Aduhelm and Cassava Sciences’ simufilam underscore the ongoing difficulties in Alzheimer's drug development, leading to securities litigation over allegedly misleading statements about trial results and commercialization efforts.
Max Colao, CEO of OncoVerity, discusses his extensive experience in the biotech industry and shares how his company is harnessing computational biology and machine learning to develop personalized cancer treatments that aim to reshape the future of oncology care.
The drug is approved for newly diagnosed patients not eligible for transplant and is to be used in combination with standard-of-care treatment.
Bimzelx is the first approved medication for active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis that selectively inhibits IL-17A and IL-17F, both of which are key cytokines that drive inflammatory processes.
Rybrevant is the first targeted second-line regimen to significantly reduce the risk of disease progression by more than 50% in patients with locally advanced or metastatic EGFR mutated non-small cell lung cancer, according to Johnson & Johnson.
Results of the Phase III HERTHENA-Lung02 trial demonstrated the superiority of patritumab deruxtecan over platinum plus pemetrexed induction chemotherapy in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer.
The service will provide compounding pharmacy services to healthcare providers.
Approval was based on results from the MANDARA Phase III trial, which demonstrated the superiority of Fansenra over Nucala in patients with eosinophilic granulomatosis with polyangiitis.
Approval was based on data from the IND.227/KEYNOTE-483 trial, which demonstrated a 21% reduction in the risk of death when Keytruda was added to chemotherapy in patients with unresectable advanced or metastatic malignant pleural mesothelioma.
Ten-year data from the Phase III KEYNOTE-006 trial found that Keytruda produced a 34% ten-year overall survival rate compared to 23.6% for ipilimumab in patients with advanced melanoma.
