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HONG KONG – Rapt Therapeutics Inc., of San Francisco, and Seoul, South Korea-based Hanmi Pharmaceutical Co. Ltd. entered a license agreement for Rapt’s FLX-475 in Asia. FLX-475 is an oral, small-molecule CCR4 antagonist for cancer treatment.
PERTH, Australia – Industry was supportive of most of the changes proposed by Australia’s Therapeutic Goods Administration (TGA) for custom-made and 3D-printed devices. However, the comments also indicated that the current regulatory requirements for custom-made devices are not well understood. The agency stressed that increasing use of 3D printing for medical applications is raising questions about the adequacy of the current medical device regulatory framework to mitigate risks to patients.
HONG KONG – Rapt Therapeutics Inc., of San Francisco, and Seoul, South Korea-based Hanmi Pharmaceutical Co. Ltd. entered a license agreement for Rapt’s FLX-475 in Asia. FLX-475 is an oral, small-molecule CCR4 antagonist for cancer treatment.
BEIJING – Infection diagnostics specialist Genskey Technologies Co. Ltd., of Beijing, closed a series B financing round to secure ¥100 million (US$14 million) to advance pathogen testing using next generation sequencing. The series B round was joined by SB China Capital, Shanghai Lin Chong Investment Management, and Juyuan Capital.
HONG KONG – Celltrion Healthcare Co. Ltd., a South Korean biopharmaceutical corporation, won European Union (EU) marketing approval for Remsima SC for the treatment of rheumatoid arthritis (RA), as a subcutaneous version of Celltrion’s infliximab biosimilar, CT-P13.
NEW DELHI, India – While India is still an attractive prospect for investment in biotechnology, the country needs to learn from the successful examples of other countries, including its Asian biotech competitors, according to a new report.
HYDERABAD – India, home to a quarter of the global tuberculosis (TB) cases, plans to enhance its capacity to fight TB drug resistance and bolster susceptibility testing under a new initiative launched by the Geneva-based nonprofit Foundation for Innovative New Diagnostics (FIND).
The U.S. FDA has cleared Cochlear Ltd.’s newest cochlear implant, the Osia 2 system, an active implantable bone conduction hearing system. Unlike Cochlear’s traditional implant, the Osia implant bypasses damaged parts of the ear and sends sound vibrations directly to the cochlea.
HYDERABAD, India – India, home to a quarter of the global tuberculosis (TB) cases, plans to enhance its capacity to fight TB drug resistance and bolster susceptibility testing under a new initiative launched by the Geneva-based nonprofit Foundation for Innovative New Diagnostics (FIND).
NEW DELHI, India - While India is still an attractive prospect for investment in biotechnology, with plenty of potential waiting to be tapped by investors, the country needs to learn from the successful examples of other countries, including its Asian biotech competitors, according to a new report.
LONDON – It’s no secret that American citizens pay the most for drugs, but the extent of the disparity is laid bare in a new index of the prices of 13 medicines...
The U.S. FDA has cleared Cochlear Ltd.’s newest cochlear implant, the Osia 2 system, an active implantable bone conduction hearing system. Unlike Cochlear’s...
Commissioner of the FDA for five years starting in 1984, Frank Young relished his position “at the vortex of controversy” as he sought to deal with the AIDS...
After being in the doldrums for the majority of the year, public biopharmaceutical companies, it appears, have turned the corner and are now on a major upswing.
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