Lured by what Amgen Inc. CEO Bob Bradway called a "compelling opportunity" to strengthen the Thousand Oaks, Calif.-based company's oncology portfolio and support its international expansion strategy, Amgen on March 4 moved to buy South San Francisco-based Five Prime Therapeutics Inc. for $38 per share, or about $1.9 billion. Read More
Having rung the bell in phase II last summer, Ovid Therapeutics Inc. and Takeda Pharmaceutical Co. Ltd. signed a pact giving the latter global rights to develop and commercialize soticlestat, a first-in-class inhibitor of cholesterol 24-hydroxylase for the treatment of developmental and epileptic encephalopathies including Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). Read More
HONG KONG – Lianbio Co. Ltd. has inked a deal for the development and commercialization of Reviral Ltd.’s sisunatovir, picking up rights to the respiratory syncytial virus (RSV) candidate in mainland China, Hong Kong, Macau and Singapore in exchange for an up-front cash payment of $14 million and development and commercial milestone payments of up to $105 million. Read More
Four years after leaving the Nasdaq, Sciclone Pharmaceuticals Holdings Ltd. returned to the market March 3, issuing 116 million shares to raise HK$2.18 billion (US$281 million) on the Hong Kong Stock Exchange (HKEX). Shares were priced at HK$18.8 each. Read More
In an unusual move for a Chinese company, Bio-Thera Solutions Ltd. terminated the clinical development of its Trop2 antibody-drug conjugate (ADC), BAT-8003, and its PD-1 monoclonal antibody, BAT-1306, a month after it halted the phase III-stage HER2-ADC candidate BAT-8001. Read More
China’s most important annual government meetings, known as the “Two Sessions,” kicked off March 4 and biopharma executives that were also delegates to the National People's Congress (NPC) suggested that approval for trials should be stricter to avoid repetitive R&D and called for innovative drugs to get into the state insurance list – and to patients – faster. Read More
From the time it paused inspections of drug manufacturing sites a year ago due to the COVID-19 pandemic, the FDA conducted only three foreign “mission-critical” inspections in fiscal 2020. Those were in Canada, Germany and India, according to a new U.S. Government Accountability Office report. Read More
As the World Trade Organization (WTO) debate intensified this week over a demand to waive patent protections for COVID-19 vaccines and therapies, the group’s new director-general, Ngozi Okonjo-Iweala, urged members to “walk and chew gum” at the same time by working with “companies to open up and license more viable manufacturing sites now in emerging markets and developing countries. We must get them to work with us on know-how and technology transfer now.” Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Abcellera, Beigene, Betta, Cytodyn, Eisai, Eli Lilly, Exithera, Gtreebnt, Johnson & Johnson, Junshi, Kintor, Lee's, Moderna, Nicox, Oblato, Ocumension, RDIF, Shanghai Junshi, Sorrento, Turnsole, Wellmarker. Read More
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: Biontech, EMA, Health Canada, Minister of Health, Moderna, NIH, Pfizer, PhRMA, WHO. Read More
