Enthusiasm stayed high but abated somewhat throughout the day as Wall Street took in the positive interim phase III results from Biontech SE and Pfizer Inc. with the COVID-19 vaccine candidate BNT-162b2. Read More
LONDON – A new study has delivered evidence that people who survive COVID-19 infection are at increased risk of being diagnosed with a psychiatric disorder. Read More
DUBLIN – Vifor Pharma Group is paying $60 million, including $30 million up front and $30 million in equity investment, to secure rights to Angion Biomedica Corp.’s hepatocyte growth factor mimetic, ANG-3777, in all nephrology indications. Read More
Yantai, China-based biologics developer Remegen Ltd. launched the biggest pre-revenue biotech IPO in Hong Kong this year by raising HK$3.99 billion ($514.5 million) on Nov 9. With this IPO, Remegen’s CEO Jianmin Fang told BioWorld in an exclusive interview, the company aims to take its assets abroad. Read More
Calliditas Therapeutics AB, filled with confidence by positive top-line results from a phase III trial of its oral budesonide, Nefecon, in patients with primary immunoglobulin A nephropathy (IgAN), said it plans to seek accelerated approval for the drug from the FDA in the first quarter of 2021. Read More
Wellcome Leap has launched its first program, dedicating $50 million to help develop human tissues, organoids and full organs. The Human Organs, Physiology and Engineering (HOPE) program is looking to bring biologists and engineers together to develop both therapeutic organs as well as organs that can be used in vitro to help discover and develop new medications. Read More
Preparing for a Biden presidency in which COVID-19 will be a top priority, the Joe Biden-Kamala Harris transition team named a board of scientists and public health experts Nov. 9 to advise the team on how to respond to the surging pandemic in the U.S. Read More
HONG KONG – Incheon, South Korea-based Celltrion Inc. has gleaned positive results in a small early stage trial for its anti-COVID-19 monoclonal antibody CT-P59. The results were presented at the Korean Society of Infectious Diseases’ 2020 fall conference, which took place on Nov. 5. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Final analysis: hydroxychloroquine offers no benefit; FDA finalizes PDUFA VI fee guidance. Read More
New and updated preclinical and clinical data presented by biopharma firms at the Society for Immunotherapy of Cancer’s annual meeting Nov. 9-14, including: 4D, Acepodia, Advaxis, Affimed, Agenus, Alkermes, Alx, Amgen, Beam, Bioinvent, Checkpoint, Codiak, Genocea, Huya, Kleo, Oncolytics, Oncosec, Rubius, Transgene, Vigeo, Windmil. Read More
Biopharmas raising money in public or private financings, including: Ambrx, Compass, Decibel, Inmagene, Moberg, Patrys, Prometheus, Summit, Vaxil. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amo, Astrazeneca, Axovant, Bayer, Beigene, Eusa, Impel, Liminal, Novavax, Orphazyme, Sorrento. Read More
