In its first report on device application processing times since it completed most of its medical device reforms, Australia’s Therapeutic Goods Administration (TGA) met all the legislated time frames for processing medical device applications during the six-month period from July 31 to December 2021.
Japan’s Ministry of Health, Labour and Welfare announced 2022 drug price revisions that became effective on April 1. Across the board, the cuts averaged about 6.6%, which translates to more than ¥600 billion (US$4.73 billion), and the pace of cuts is expected to accelerate. Price cuts in 2021 were worth roughly ¥430 billion.
China’s Ministry of Science and Technology issued a draft rule on regulations governing sharing of human genetic resources that provides clarity on parts of the regulation that were previously ambiguous, Katherine Wang, partner at Ropes & Gray in Shanghai, told BioWorld.
Pfizer Australia Holdings Pty Ltd. has made an offer to acquire digital health company Resapp Health Ltd. in all cash offer worth AU$100 million (US$74.25 million). The two companies have entered into a binding scheme that is contingent upon shareholder agreement and regulatory clearances in Australia. Shareholders will vote on the proposed acquisition in June, and directors have unanimously recommended that shareholders vote in favor of the acquisition.
Medicine shortages have been of particular concern during the COVID-19 pandemic, and Australia’s Therapeutic Goods Administration said it would seek to amend regulations to allow imports of overseas substitute drugs if the Australian drug has been discontinued and canceled from the Australian Register of Therapeutic Goods.
Harbour Biomed Therapeutics Ltd. has out-licensed a preclinical bispecific antibody, HBM-7022, to Astrazeneca plc in a global licensing deal worth up to $350 million.
Telix Pharmaceuticals Ltd. has in-licensed Eli Lilly and Co.’s olaratumab antibody, agreeing to pay $5 million up front for exclusive worldwide rights to develop and commercialize radiolabeled forms of the antibody for the diagnosis and treatment of human cancers.
Truscreen Group Ltd. completed its largest clinical trial to date that showed its cervical cancer screening device surpassed liquid-based cytology (LBC) screening in 15,651 women across 64 hospitals in nine provinces in China over three years.
Harbour Biomed Therapeutics Ltd. has out-licensed a preclinical bispecific antibody, HBM-7022, to Astrazeneca plc in a global licensing deal worth up to $350 million.
Researchers in China have discovered that bacteria promote cancer metastasis by bolstering the strength of host cells against mechanical stress in the bloodstream, promoting cell survival during tumor progression.
