Expansion of Elevidys includes patients over the age of four years with Duchenne muscular dystrophy regardless of their ambulatory status.
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Phase III Trial Data Show Lenacapavir Demonstrated 100% Efficacy Preventing HIV in Cisgender Women
Results of the PURPOSE 1 trial indicated that a twice-yearly injection of lenacapavir outperformed the once-daily oral Truvada preventing HIV in cisgender women.
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Beyond the Numbers: Extrapolating Today’s Trends Forward
Q&A with Evaluate’s Paul Verdin digs deeper into the data-backed drivers likely to sway the future growth and jockeying of biopharma’s top players.
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FDA Approves Botanix Pharmaceuticals’ Sofdra for the Treatment of Primary Axillary Hyperhidrosis
Approval of Sofdra marks the first chemical entity to be approved by the FDA to treat primary axillary hyperhidrosis.
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FDA Approves AbbVie’s Skyrizi for the Treatment of Adults with Moderate to Severely Active Ulcerative Colitis
Approval of Skyrizi marks the first IL-23 specific inhibitor approved for both ulcerative colitis and Crohn disease of similar severity, according to AbbVie.
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FDA Approves Merck’s Keytruda in Combination with Carboplatin and Paclitaxel to Treat Advanced or Recurrent Endometrial Carcinoma
Approval of Keytruda combination for patients with primary advanced or recurrent endometrial carcinoma is based on results from the NRG-GY018/KEYNOTE-868 clinical trial, which was Phase III trial to evaluate an anti-PD-1 immunotherapy plus chemotherapy combination in patients with two distinct tumor types.
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FDA Approves AstraZeneca’s Imfinzi for Mismatch Repair Deficient Primary Advanced or Recurrent Endometrial Cancer
The approval of Imfinzi was based on the DUO-E Phase III trial, which indicated that in combination with chemotherapy, the drug reduced the risk of disease progression or death by 58% in mismatch repair deficient endometrial cancer.
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FDA Approves Amgen’s Blincyto to Treat CD19-Positive Philadelphia Chromosome-Negative B-Cell Precursor Acute Lymphoblastic Leukemia
The approval of Blincyto was based on results from the Phase III E1910 clinical trial, which found that the treatment significantly improved overall survival in CD19-positive, Ph-negative B-cell ALL compared to chemotherapy alone.
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Lamassu Pharma Bridges Scientific Knowledge and Patient Care
Gabi Hanna, MD, CEO and Co-Founder of Lamassu Pharma talks about a novel oncology platform and the link between science and patient care.
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2024 Pharm Exec Top 50 Companies
Highlighted by notable company and product maneuvering at the top and the continued dramatic growth of therapeutic settings such as GLP-1s, Pharm Exec’s latest listing of the top global biopharma sales producers is proof-positive of an industry in transition.