The ever-contentious issue of drug pricing creates a tug-of-war between biopharma’s innovation machine and the general population’s need for accessible and affordable drugs. BioWorld has covered the issue of drug pricing from insulin caps and the early days of the IRA to failed legal challenges and the recent rollout of the Centers for Medicare & Medicaid Services’ negotiated prices. Read our collection of 2024 stories.
The National Medical Products Administration (NMPA) has approved Innovent Biologics Inc.’s Dupert (fulzerasib) as the first KRAS G12C inhibitor in China to treat select patients with non-small-cell lung cancer (NSCLC).
Drug and device sponsors conducting clinical trials in China to support U.S. FDA approval may want to reconsider their choice of trial sites, as trials conducted at hospitals and clinics affiliated with China’s military or in the Xinjiang Uyghur Autonomous Region could be in for increased scrutiny.
Adcendo ApS has inked a deal with Multitude Therapeutics Inc. and is licensing Multitude’s phase I-ready antibody-drug conjugate (ADC), ADCE-T02, which targets tissue factor. Under the deal, Copenhagen, Denmark-based Adcendo gains exclusive development and commercialization rights for the ADC globally, excluding greater China (mainland China, Hong Kong, Macao and Taiwan) where Multitude retains all rights.
The U.S. FDA approved Janssen Biotech Inc.’s Rybrevant (amivantamab-vmjw) plus a new oral tyrosine kinase inhibitor called Lazcluze (lazertinib) as a first-line combination treatment to treat select non-small-cell lung cancers.
Skin biopsies could be a thing of the past thanks to the development of a new non-invasive microneedle patch to pre-screen for skin cancer. Dermr Health Solutions Pty Ltd. founder and CEO Stefan Mazy told BioWorld that the fledgling genomics startup company is pushing the boundaries of science with its Dermr patch that quickly and painlessly extracts live skin cells in 15 seconds, drastically cutting the time and discomfort associated with traditional biopsy procedures.
China’s National Medical Products Administration cleared Ascentage Pharma Group Corp. Ltd. to begin a registrational phase III trial of its BCL-2 selective inhibitor lisaftoclax (APG-2575) in combination with azacitidine for first-line treatment of newly diagnosed patients with higher-risk myelodysplastic syndrome.
Pfizer Inc. is calling on the Australian government to establish priorities for the life sciences sector to attract more investment into research, clinical trials and manufacturing in Australia. The new report recommends that the government issue a life sciences vision akin to the one issued by the U.K. in 2021 to make the country more competitive to attract investment.
In the wake of shortages for Novo Nordisk A/S’ Ozempic (semaglutide), Australia’s Therapeutic Goods Administration has announced that Wegovy, which has the same active ingredient, is now available in Australia and is advising prescribers to stop prescribing Ozempic off-label for weight loss.
Imbiologics Inc. scored a potential ₩430 billion (US$315.5 million) deal with China’s Hangzhou Zhongmei Huadong Pharmaceutical Co. Ltd. for Oxtima, an autoimmune disease program with two assets co-developed by Seoul, South Korea-based HK Inno.N Corp.
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