For European biotechnology, 2022 was a year of contraction. Disclosed equity investments in European firms engaged in the discovery and development of therapeutics totaled $6.782 billion, down 55% on the previous year’s record-breaking tally of $15.193 billion. Last year’s tally is the worst performance since 2017 and is well below the totals achieved during the two years immediately preceding the onset of the COVID-19 pandemic, which triggered a boom in biotech investing. Read More
As expected, the U.S. FDA gave its go-ahead to lecanemab, an amyloid-beta binder for mild cognitive impairment caused by Alzheimer’s disease (AD) and mild AD – together known as early AD – from Biogen Inc. and Eisai Co. Ltd, which have assigned to the compound the brand name Leqembi. Read More
Fate Therapeutics Inc. is making big changes. The company told Janssen Biotech Inc. it was not interested in continuing the collaboration and option agreement cut in 2020 that could have brought Fate up to $3 billion. Fate also is halting four solid tumor natural killer (NK) cell programs to concentrate on two of its NK cell programs and two T-cell programs, all while reducing headcount to 220 employees in the first quarter of 2023. Read More
Hightide Therapeutics Inc. closed a $107 million series C round that will advance multiple global development programs for lead candidate HTD-1801, including a phase III trial in type 2 diabetes. Read More
The EMA will require all new clinical trial applications to be submitted via its clinical trials information system after Jan. 31, 2023, despite pharma companies and other users raising concerns about functionality and technical failures they are experiencing with the system. Read More
Raynovent Biotech Co. Ltd. has raised ¥370 million (US$54 million) in a series C round to further develop candidates in the field of respiratory and metabolic diseases. Funds will be used to accelerate clinical trials of lead candidates in its pipeline, as well as to prepare for the commercialization of oral pills to treat COVID-19 and influenza A virus. Read More
Biontech SE is piggybacking on the U.K.’s lead in implementing cancer genomics in routine health care to set up a national clinical trial of personalized mRNA cancer vaccines that are based on the mutational landscape of individual tumors. Read More
The serious adverse event in the first phase I/II patient dosed with nulabeglogene autogedtemcel (nula-cel) – a gene editing, autologous hematopoietic stem cell therapy for sickle cell disease (SCD) – may have involved the quality of the stem cells and not the conditioning regimen or characteristics of the patient at baseline. But researchers won’t know until more work is done. Read More
New hires and promotions in the biopharma industry, including: Alnylam, Annexon, Annovis, Athersys, Blueprint Medicines, Lyndra, Pneumagen, Provention. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Acorda, Bluebird, BMS, Catalent, Crown, Cytomx, Dragonfly, Emergent Biosolutions, Harbor, Helix, Immunome, JSR, Moderna, Qiagen. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Astrazeneca, Azafaros, Fabre-Kramer, Innovent, Jubilant, Lantern, Orchard, Revive, Sosei, Vaxcyte. Read More
