Merck & Co. Inc. telegraphed the future focus of Organon & Co., which will spin off from the pharmaceutical giant as a public company in the first half of 2021, with an announcement of an agreement to acquire Alydia Health Inc. Alydia makes the Jada system, which treats postpartum hemorrhage.
HONG KONG – Eisai Co. Ltd. has received not one, but two approvals from Japan’s Ministry of Health, Labour and Welfare (MHLW), for its anticancer agent Remitoro (denileukin diftitox) and multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib mesylate). Both approvals, each for a rare disease indication, were granted based on phase II trial results, instead after the usual phase III trials.
Merck & Co. Inc. is bringing in Amathus Therapeutics Inc. to collaborate on developing small molecules to treat neurodegenerative disease. The deal is one of several in the past 18 months that has expanded Merck’s presence in the space.
Oncology drugs that have racked up a number of indications through accelerated approvals are losing some of those indications as the result of an FDA industrywide evaluation of confirmatory trials that didn’t back up the approvals.
Months of talks between Johnson & Johnson (J&J) and Merck & Co. Inc. about a COVID-19 vaccine manufacturing partnership came to fruition March 2 with the Biden administration hailing the deal as an “unprecedented historic” agreement between two long-time rivals.
During a panel discussion at Biocom California's Global Life Sciences Partnering Conference, business development executives at various pharmaceutical companies advised biotech companies on everything from funding to manufacturing to deal structure.
Merck & Co. Inc. is paying $1.85 billion, or $60 per share, to acquire Pandion Therapeutics Inc. on the back of early stage data in human volunteers for its lead program, PT-101, an engineered interleukin-2 mutein fused to an Fc backbone, which is designed to stimulate targeted expansion of regulatory T cells for use in autoimmune disease indications.
The latest global regulatory news, changes and updates affecting biopharma, including: CBO model touts savings of H.R. 3; FDA to ODAC: Are data ripe for 2nd TNBC Keytruda approval?; Fifth Circuit reiterates no liability remedy for generics; Consultant faces insider trading charges.
