Positive pivotal data for Libtayo® (cemiplimab) monotherapy in locally advanced basal cell carcinoma featured as a late-breaking presentation at ESMO
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Positive pivotal data for Libtayo® (cemiplimab) monotherapy in locally advanced basal cell carcinoma featured as a late-breaking presentation at...
Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra®/RoActemra® (tocilizumab) plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]). The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo arm. The EMPACTA study did not identify any new safety signals for Actemra/RoActemra. “The EMPACTA trial demonstrated that Actemra/RoActemra can reduce the need for mechanical ventilation in patients with COVID-19 associated pneumonia, an important outcome in this serious disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We plan to share this important data with the US Food and Drug Administration (FDA) and other health authorities around the world.” The study is the first global, phase III COVID-19 clinical trial to primarily enrol patient populations that are often underrepresented in clinical studies and have been disproportionately affected by the COVID-19 pandemic. Approximately 85% of the 389 patients were from minority racial and ethnic groups. The majority of patients were Hispanic, with significant representation of Native American and Black populations. The trial was conducted in the United States, South Africa, Kenya, Brazil, Mexico and Peru. “We have been striving to improve inclusion and diversity in our trials,” said Jamie Freedman, M.D., Ph.D., Head of U.S. Medical Affairs. “During the COVID-19 pandemic, we saw how high the stakes were for many communities of colour and made diversity the centerpiece of this trial.” The EMPACTA trial builds on Roche’s work in Advancing Inclusive Research, a cross-organisational US initiative to help address barriers in clinical research for underrepresented racial and ethnic groups.
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Roche’s phase III EMPACTA study showed Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalised patients with...
Dr. Jean-Christophe Rufin appointed President of the Sanofi Espoir Corporate Foundation
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Dr. Jean-Christophe Rufin appointed President of the Sanofi Espoir Corporate Foundation
NEW YORK, Sept. 17, 2020 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint” or the “Company”) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 7,142,857 shares of common stock of the Company, at a price to the public of $2.80 per share, less underwriting discounts and commissions. The closing of the offering is expected to occur on or about September 22, 2020, subject to satisfaction of customary closing conditions.
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Checkpoint Therapeutics Announces $20.0 Million Bought Deal Offering
CANTON, Mass., Sept. 17, 2020 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced that the date and time of its presentation at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit has been updated.
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Organogenesis Holdings Inc. Updates Date and Time of Presentation at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
- AUTO3 shows promise of a highly differentiated product profile
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Autolus Therapeutics presents additional data on AUTO3 in DLBCL during the ESMO Virtual Congress 2020
SYDNEY, Australia, Sept. 18, 2020 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) is pleased to report further interim data from its ongoing INSIGHT-004 Phase I clinical trial. The data were presented at the ESMO Virtual Congress 2020 on 17 September 2020, CEST (poster ID number 1032P) by trial investigator at Institute of Clinical Cancer Research, Krankenhaus Nordwest (IKF), PD Dr. Thorsten Götze.
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Immutep Reports Improving Results from INSIGHT-004 Trial
Dr. James Woody’s leadership qualities and experience leading innovative pharmaceutical ventures and raising funds will power Enosi’s development of second-generation anti-TNF therapeutics for inflammatory autoimmune diseases and cancer.
