NEW DELHI – Bangalore-based Biocon Ltd. has received the Indian drug regulator's approval for restricted emergency use of its psoriasis biologic, itolizumab, to treat patients with severe cases of COVID-19 in need of ventilator support. Read More
HONG KONG – Takeda Pharmaceuticals Inc. is gaining access to the “library of libraries,” inking an agreement with Twist Bioscience Corp. in one of the Osaka, Japan-based firm’s recent efforts to build a sustained innovative R&D growth engine. Read More
LONDON – There were encouraging results from trials of three COVID-19 vaccines on July 20, with Astrazeneca plc, Biontech SE/Pfizer Inc. and Cansino Biologics Inc. all reporting T-cell responses in ongoing phase I/II studies of their respective products. Read More
HONG KONG – Incheon, South Korea-based Celltrion Inc. will start manufacturing its COVID-19 treatment for clinical trials and commercial distribution, even though it’s only reached phase I. The phase I trials testing the in-house antiviral antibody treatment CT-P59 began on July 17, the same day the company received approval from Korea’s Ministry of Food and Drug Safety (MFDS) for its investigational new drug application on the back of positive preclinical results. Read More
With the green light for a phase II trial to test a new drug to tackle some of the impacts of COVID-19, clinical-stage antibody developer Sorrento Therapeutics Inc. is going all in on the COVID-19 business. The company is now developing three therapeutic products, one diagnostic and a vaccine.
The two-year standstill provision in Assembly Biosciences Inc.’s potential $540 million pact with Beigene Ltd. to advance hepatitis B virus (HBV) therapies was “highly negotiated,” said Jason Okazaki, Assembly’s chief legal and business officer. Read More
HONG KONG – China and U.S.-based pharmaceutical company Antengene Corp. has closed a $97 million series C financing round, with proceeds mainly directed toward funding the continuing clinical development of its pipeline of hematology and oncology therapies. Read More
PERTH, Australia – With a series A investment in hand, Glyscend Therapeutics Inc. will take its polymer therapeutic that mimics the effect of gastric bypass surgery to Australia next year to begin clinical trials. Read More
The first bispecific antibody to win regulatory approval, Removab (catumaxomab) was voluntarily withdrawn due to commercial reasons. Now Chinese biotech Lintonpharm Co. Ltd., of Guangzhou, said it plans to move catumaxomab to a global phase III trial following an IND approval from China’s NMPA, investigating the trifunctional bispecific antibody in patients with peritoneal carcinomatosis, a form of advanced gastric cancer. Read More
HONG KONG – Shanghai-based I-Mab Biopharma Co. Ltd. expects to begin clinical trials for the world’s first and only claudin18.2 and 4-1BB bispecific program in a year. Read More
HONG KONG – Chinese eye disease specialist Arctic Vision (Shanghai) Biotechnology Co. Ltd. raised $32 million in a series A financing round to advance its lead program, ARVN-001 (triamcinolone acetonide suprachoroidal injectable suspension). Read More
BEIJING – U.S.-Taiwan biotech Acepodia Inc., of Burlingame, Calif., and Taipei, has licensed out two of its cell therapy candidates, ACE-1702 and ACE-1655, to Chinese CAR T therapy developer JW Therapeutics (Shanghai) Co. Ltd. Read More
PERTH, Australia – The University of Queensland’s Centre for Superbug Solutions has discovered a new class of antibiotics that has garnered an award from Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X).
HONG KONG – Osaka, Japan-based Shionogi & Co Ltd. continues to make global inroads with its influenza treatment, Xofluza (baloxavir marboxil), submitting supplemental new drug applications in Japan and Taiwan for a post-exposure prophylaxis indication on the back of positive results from its phase III trials. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: CDC, FDA, Health Canada, Ono Pharmaceuticals, U.S. Court of Appeals for the Federal Circuit, U.S. Department of Health and Human Services. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Astellas, Beigene, Deciphera, Generex, Immuron, IMV, Puma, Redhill, Shanghai Fosun, Sorrento, Specialised, Tetra. Read More
