LONDON – Regeneron Pharmaceuticals Inc.’s antibody cocktail, Regen-Cov, has been shown to significantly reduce mortality in seriously ill hospitalized COVID-19 patients who have failed to mount their own immune response against the SARS-CoV-2 virus. Among these seronegative patients, the casirivimab/imdevimab monoclonal antibody mixture reduced deaths by 20% (p=0.001) in the U.K. Recovery trial. Read More
Zai Lab Ltd. and Macrogenics Inc. have announced a collaboration and license agreement involving up to four immuno-oncology molecules in a deal potentially worth upward of $1.5 billion. The deal makes sense as both are upcoming companies at around the same stage in development – making progress in oncology with first products recently approved by regulators. Read More
While phase I-III clinical trial data continue to rise above the same timeframe in 2020, the gap is closing and a smaller percentage of this year’s reports are focused on the COVID-19 pandemic. Read More
DUBLIN – Mnemo Therapeutics SAS emerged from stealth mode having raised €75 million (US$91 million) in a series A financing round to take forward a new chimeric antigen T-cell (CAR T) platform, which is focused on selectively targeting both solid and liquid tumors expressing a previously undescribed class of antigens and on improving the persistence and fitness of CAR T cells. Read More
LONDON – Newco Amyl Therapeutics Ltd. has raised €18.3 million (US$22.3 million) in a series A, to pick up the baton on a technology for neutralizing toxic protein aggregates by binding to their amyloid folds. Read More
Blueprint Medicines Corp. gained the FDA’s nod for Ayvakit (avapritinib) to treat systemic mastocytosis (SM), adding another indication to the KIT inhibitor’s label. For the first time, patients have available a targeted therapy designed to block D816V mutant KIT, the central driver of the disease. Read More
DUBLIN – Ochre Bio Ltd. has raised $9.6 million in seed financing to drug the liver like never before, by combining genetics, single-cell genomics, spatial sequencing, imaging and machine learning to build a high-resolution, in silico model of the organ, which can provide new insights into disease biology and open up new drug targets. Read More
Daiichi Sankyo Co. Ltd. has received conditional approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its oncolytic virus Delytact (teserpaturev) to treat malignant glioma. Read More
Multinational antibody specialist Hifibio Therapeutics Inc. closed an oversubscribed $75 million series D financing round to move its anti-TNFR2 antibody HFB-200301 and the anti-OX-40 antibody HFB-301001 to phase I trials by the end of this year. Read More
Inmagene Biopharmaceuticals Co. Ltd. has raised $100 million in a series C financing to move its IL-17 inhibitor to phase II trials in the U.S. and China. Read More
More than four months after its original PDUFA date of Feb. 2, 2021, Mallinckrodt plc’s Stratagraft gained FDA approval for use in deep partial-thickness thermal burns. Read More
Biopharmas raising money in public or private financings, including: Ena, Inhibikase, Janux, Kahr, Molecular Partners, Protagonist, Rapt, Veralox. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Clearside, Fibrogen, Fusion, Ironwood, KBP, Lundbeck, Novadip, Oncotelic, Organicell, Otonomy, Paratek, Regeneron, Reviral, Salarius, Springworks, Trevena. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ampio, Ascentage, Asieris, Autolus, Beigene, Cerevel, Eton, Immunitybio, Jounce, Oryzon, Pharmather, Verisim. Read More
