Singapore’s Health Science Authority is rolling out new drug substance evidence requirements following consultations with stakeholders, and drugmakers will have one year to comply with the new regulations.
American pharma giant Bristol Myers Squibb Co. (BMS) will pick up the rights to Lianbio Co. Ltd.’s FDA-approved drug for obstructive hypertrophic cardiomyopath, Camzyos (mavacamten), in six Asian countries by paying $350 million up front and waiving some outstanding payments.
Korean bioventure GI Innovation Inc. inched closer to achieving its goal of “five tech transfer deals in five years” with another licensing deal for its allergy drug, GI-301, with Japan-based Maruho Co. Ltd. for ₩298 billion (US$220.7 million), although share prices still dropped on the news.
Elevar Therapeutics Inc. and Hengrui Pharmaceuticals Co. Ltd.’s licensing deal for camrelizumab (SHR-1210; Airuika in China) will add the PD-1 antibody to Elevar’s liver cancer armory for pairing with rivoceranib, its tyrosine kinase inhibitor on the brink of U.S. FDA review.
Biologics innovators typically take a lifecycle approach to developing new indications and formulations of their prescription drugs, especially when biosimilar competition is on the horizon.
Burning Rock Biotech Ltd. wants to significantly change the way cancers are detected and the biotech is sailing ahead with the latest breakthrough device designation received from China’s NMPA for its multi-cancer detection blood test (MCDBT), Overc.
Medical Microinstruments Inc. (MMI) is expanding its Symani surgical system into the Asia Pacific – a region with “clear demand for the technology” – through two local partners, Device Technologies Australia Pty Ltd. and Seoul-based TRM Korea Corp.
Elevar Therapeutics Inc. and Hengrui Pharmaceuticals Co. Ltd.’s licensing deal for camrelizumab (SHR-1210; Airuika in China) will add the PD-1 antibody to Elevar’s liver cancer armory for pairing with rivoceranib, its tyrosine kinase inhibitor on the brink of U.S. FDA review.
The mRNA technology used in vaccines against viral infections could also be developed for cancer therapies. A group of scientists has designed a circular RNA (circRNA) encapsulated in lipid nanoparticles (LNPs) that acts in the mitochondria of tumor cells through the protein gasdermin-D (GSDMD) and reduces adenocarcinoma. The work was published on Oct. 16, 2023, in Nature Cancer.
Korean bioventure GI Innovation Inc. inched closer to achieving its goal of “five tech transfer deals in five years” with another licensing deal for its allergy drug, GI-301, with Japan-based Maruho Co. Ltd. for ₩298 billion (US$220.7 million), although share prices still dropped on the news.