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.
“Aging is not only slow, but it is irreversible, and that is what most people have been suspecting,” Gero Pte Ltd.’s CEO Peter Fedichev recently told BioWorld. “[But] aging is not an inevitable part of human existence.” By setting limits to what science can do – and not do – for aging, the Palo Alto, Calif.- and Singapore-based generative artificial intelligence (AI) biotech Gero is trying to figure out and, at the same time help the industry, “see what is actionable, reversible and what may not be” to help people avoid “hitting their heads against the wall” when tackling aging and aging-related diseases.
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.
Shanghai-based Henlius Biotech Inc. and India’s Intas Pharmaceuticals Ltd. agreed upon a potential €185 million (US$195.38 million) licensing deal for Intas to develop and sell Henlius’ China NMPA-approved lung cancer drug, serplulimab, across Europe and India. Serplulimab (HLX-02) is a recombinant humanized PD-1 monoclonal antibody (MAb) injection that first gained approval as Hansizhuang in March 2022.
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.
Danish obesity and diabetes drugmaker Novo Nordisk A/S is set to acquire the Singapore-based KBP Biosciences Co. Ltd.’s hypertension drug, ocedurenone (KBP-5074), for potentially $1.3 billion, creating a platform to increase its reach in the cardiovascular (CV) landscape beyond a crowding obesity market.
Drug discovery in Japan has been steadily declining, and it has reached a crisis point where swift action is needed or pharma companies will leave Japan or stop listing products here, said speakers at the BioJapan 2023 meeting held Oct. 10 to 13 in Yokohama, Japan.
Precision cancer biotech Abion Inc. announced a positive interim phase II readout for ABN-401, its novel c-mesenchymal-epithelial transition (c-MET)-targeting tyrosine kinase inhibitor (TKI) for advanced non-small-cell lung cancer (NSCLC), lighting a runway to its next trial as a combination regimen.
RSS
