Less than a month after the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee handed down a unanimous vote in favor of Eli Lilly and Co.’s Alzheimer’s disease candidate (AD), donanemab, the agency approved the drug as a once-monthly injection for adults with early symptomatic disease. Branded Kisunla, the beta-amyloid antagonist marks the second approved AD drug that has demonstrated in clinical trials an ability to slow cognitive decline, going up against Leqembi (lecanemab) from Biogen Inc. and Eisai Co. Ltd., which won full approval in July 2023, only six months after nabbing an accelerated nod. Read More

Curevac AG is casting off the deadweight of its pandemic push to translate its mRNA technology into a marketed COVID-19 vaccine, in a new €1.45 billion (US$1.6 billion) deal in which GSK plc will acquire full rights to infectious disease vaccines the two were co-developing. Read More

Confidence in working with Chinese biopharma companies has dropped by 30% to 50% for U.S.-based life sciences companies, with Chinese contract development and manufacturing organizations the hardest hit, according to a recent LEK survey of global life sciences companies on the impact of the pending U.S. Biosecure Act. Read More

One year after arriving on the scene with a $120 million series A, ophthalmic gene therapy specialist Beacon Therapeutics Ltd. has raised $170 million in a series B. Read More

Lotte Biologics Co. Ltd. broke ground on its contract development and manufacturing organization (CDMO) plant at its Songdo Bio Campus in Incheon, South Korea, on July 3 to grow its production capacity and set “a new standard” for Korean CDMOs in the global market. Read More

BioWorld's offices will be closed in observance of Independence Day in the U.S. No issue will be published Thursday, July 4. Read More

New hires and promotions in the biopharma industry, including: Atossa, Cartesian, Inovio, Repair, Rondo, Skye. Read More

Biopharmas raising money in public or private financings, including: Anbogen, Aptevo, Checkpoint, Kanvas, Recce. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alvotech, Annovis, Biodexa, Cartesian, Irlab, Janssen, Legend. Read More

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biogen, Biosenic, Codexis, Crosswalk, Eli Lilly, Exelixis, Human Immunology, Ipsen, Medsenic, Phebra, Radionetics. Read More

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alteogen, Checkpoint, Heron, Inozyme, Serac, Sobi, Vertex. Read More