PERTH, Australia – Australian digital health company Resapp Health Ltd. received clearance from Australia’s Therapeutics Good Administration and CE mark certification in the EU for its stand-alone cough counter application that tracks cough frequency using a smartphone. The class I software as a medical device is the first regulatory approval for such an application, which uses Resapp’s machine learning algorithms to identify cough events from audio recorded using the smartphone’s in-built microphone.
India’s Department of Pharmaceuticals (DOD) released draft guidelines to boost research and development in its pharmaceutical and medical device industries. The document touched on the reasons for a dedicated R&D and innovation policy, which involved reducing import dependence, increasing the speed of biologic and biosimilar development cycles, and tackling infrastructural challenges.
Legochem Biosciences Inc. has licensed out its antibody-drug conjugate (ADC) LCB-14 to Iksuda Therapeutics Ltd. in the duo’s latest deal that is worth $1 billion. Daejeon, South Korea-based Legochem will receive $50 million in an up-front payment and near-term milestones, and up to $950 million in developments, regulatory and commercial milestones.
PERTH, Australia – Inventia Life Science Pty. Ltd. closed a A$35m (US$25 million) series B round that will see the company bring its Rastrum 3D cell culture platform to the U.S. market. The technology can “revolutionize the way drug discovery is done,” Inventia Founder and CEO Julio Ribeiro told BioWorld.
Nec Corp. has inked a global partnership agreement with Bostongene Corp. that will bring the latter’s Bostongene Tumor Portrait Tests to Japanese patients. Japan is the first market outside of the U.S. for the tests, according to the companies.
Obi Pharma Inc. has acquired global rights to BSI-04702, an anti-trophoblast antigen 2 (Trop2) humanized monoclonal antibody (MAb), from Biosion Inc. Obi is granted exclusive rights for further preclinical and clinical development, registration and commercialization of the candidate as an antibody-drug conjugate and other derivative products.
Everest Medicines Ltd. and Providence Therapeutics Holdings Inc.’s COVID-19 vaccine was cleared for inclusion in the World Health Organization’s (WHO) Solidarity Trial Vaccines clinical trial.
Qilu Pharmaceutical Co. Ltd. licensed rights to AB-729, an RNA interference (RNAi) therapeutic from Arbutus Biopharma Corp., in a deal worth up to $300 million. Qilu obtained rights to develop and commercialize the phase II asset for the treatment of hepatitis B (HBV) in mainland China, Hong Kong, Macau, and Taiwan. Under terms of the agreement, Qilu will pay Arbutus $40 million up front, as well as up to $245 million in development, regulatory and sales milestones. In addition, Qilu will make a $15 million equity investment in Arbutus at a price of $4.19 per share.
Everest Medicines Ltd. and Providence Therapeutics Holdings Inc.’s COVID-19 vaccine was cleared for inclusion in the World Health Organization’s (WHO) Solidarity Trial Vaccines clinical trial.
Avistone Biotechnology Co. Ltd. raised more than $200 million to support its oncology drug development and the acquisition Pearl Biotechnology Co. Ltd. with the aim of creating a “fully-integrated” targeted oncology platform. Vivo Capital LLC led the financing, with participation from Bain Capital LP. and Primavera Capital Group.
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