Although biopharma investors pulled back in 2022 – largely a response to freely flowing funds the previous two years during COVID-19 surges – they are cautiously returning to the sector, as the industry has raised $32.8 billion in the first half of 2023, a 23.6% jump over the same period last year. Read More
The U.S. FDA has removed the partial clinical hold it placed in April 2022, prompted by a patient’s death, on Curis Inc.’s phase I/IIa study of emavusertib in treating leukemia. The company also said it just raised $15 million to keep everything going. Read More
In a move to address both prevention and treatment of hepatitis B virus (HBV), Brii Biosciences Ltd. has acquired from VBI Vaccines Inc. a global exclusive license to HBV therapeutic vaccine BRII-179 (VBI-2601) and an exclusive license for HBV prophylactic vaccine Prehevbri in the Asia Pacific region, excluding Japan. Read More
Moderna Inc. may have risen to prominence during the pandemic with its messenger RNA (mRNA)-based COVID-19 vaccine, but it’s now casting a net far larger and wider. The company said on July 5 that it is readying international approval for its second mRNA vaccine called mRNA-1345 for respiratory syncytial virus (RSV)-associated acute respiratory disease based on positive interim data from the ongoing Conquer RSV study in individuals 60 and older. Read More
Tolerogenixx GmbH raised €7 million (US$7.6 million) in an extension to its series A round, which will enable it to continue phase IIb development of a cell therapy that induces donor-specific immune tolerance in kidney transplant recipients. At the same time, the company disclosed five-year follow-up data from a phase Ib trial of the therapy, which demonstrated that recipients continue to have stable graft function and to avoid acute rejection and severe opportunistic infections while on a reduced regimen of immunosuppressive drugs. Read More
The British Museum in London, steeped in history and tradition, sits alongside world class biomedical and clinical research centers, where numerous technological advances and scientific breakthroughs have originated. “This unique combination of tradition and innovation […] also defines our industry today,” said Rivki Stern, co-founder and CEO of Shortwave Pharma Inc., which is working to develop psychedelic drugs as approved medicines that meet unmet medical needs of patients with treatment-resistant depression, addictions and eating disorders. Read More
The Association for Accessible Medicines fired off a constitutional challenge in U.S. federal court July 5 to provisions included in Minnesota’s new budget law that would restrict price increases for generic and off-patent drugs. Read More
Biopharmas raising money in public or private financings, including: Adocia, Allarity, Altamira, Caribou, Curis, Genecode, IGC, Intensity, VBI. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aelis, Biogen, Boehringer, Cassava, Galderma, Innocare, Janssen, Kashiv, Oryzon, Oxford, Palisade, Sensorion, Small, Sorrento, Teva. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: ABVC, Adocia, Aicuris, Arvinas, Carrick, Hillstream, Histogen, Pfizer, Sanofi, Shorla, Tempus and Tscan. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acasti, Amneal, Ayala, Biocardia, C4, Clarity, Impact, Incyte, Infant, Jacobio, Moderna, Poseida, Rarestone, Taiho, Tiumbio, Vertex. Read More
