Francesco de Rubertis, a co-founder of Medicixi Ventures, has unveiled the next generation of the venture-backed asset-centric biopharma model with the creation of Centessa Pharmaceuticals Ltd. The new company was created by acquiring, in all-share transactions, total control of 10 companies from the Medicxi portfolio. Read More
DUBLIN – The most solid conclusion that can be drawn from Immunic Inc.’s phase II trial of IMU-838 in hospitalized COVID-19 patients is that a reduction in the need for invasive ventilation is no longer a useful endpoint for studies of COVID-19 drugs. Read More
LONDON – The EU is taking concerted action to detect new variants of SARS-CoV-2, investing €225 million (US$270 million) to increase viral genome sequencing to 5% of positive cases across Europe, and to carry out research on their evolution and transmissibility. Read More
Excision Biotherapeutics Inc.’s CEO is specific when he talks about his company’s therapies and what they may achieve: a functional cure. “When you treat someone and they become cancer free, you can’t use the world ‘cured’ because the cancer may come back decades later,” Daniel Dornbusch told BioWorld. “But you can talk about a functional cure, meaning the cancer didn’t come back for a very long time. It’s functionally cured for maybe 10, 20 or 30 years." Read More
Aside from its place in the history books as a global pandemic that nearly locked down the world, COVID-19 could have a lasting, more positive legacy of finally opening U.S. biopharmaceutical clinical trials to greater diversity. Read More
In the opening panel of the BIO CEO & Investor digital conference BIO president and CEO Michelle McMurry-Heath explored some of the key issues that are currently impacting the sector with Adena Friedman, president and CEO of Nasdaq, which, this month, marks the 50th anniversary of its launch in 1971. Read More
Investing in biopharma has never been for the faint of heart. So headline figures unveiled from a clinical development success report during the BIO CEO & Investor Conference Feb. 17, putting the average likelihood of a drug entering phase I development ultimately achieving approval at 7.9% and the average drug development timeline at 10.5 years, appear largely unsurprising. But the addition of machine learning capabilities to the mix helped identify those factors that have the greatest impact on predictive outcome. Read More
PERTH, Australia – With the first COVID-19 vaccine ready to be launched in Australia, the Therapeutic Goods Administration has released guidance on its pharmacovigilance plan to track real-world safety data and adverse events following immunization. Read More
In a Feb. 17 update to its guidance on managing clinical trials during the COVID-19 pandemic, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) said all sponsors of ongoing clinical trials for indications other than treatment or prevention of COVID-19 are required to evaluate the impact a COVID-19 vaccine may have on the trial. Read More
New hires and promotions in the biopharma industry, including: Affinia, Antios, Avadel, Biocardia, Cue, Eli Lilly, Intercept, Maxwell, Scpharmaceuticals. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Algernon, Asklepios, Astrazeneca, Biophytis, Cidara, Eli Lilly, Evgen, Immunic, Inhibikase, Kintara, Mesoblast, Mind Medicine, Moebius, Pfizer, PTC, Redhill, Salarius, Scisparc, Selecta, Silence. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altimmune, Amgen, Beigene, Coherus, JCR, Johnson & Johnson, Novartis, RDIF, Ultragenyx, Verrica. Read More
