North China Pharmaceutical Group New Drug Research & Development Co. Ltd. has received approval from China’s NMPA to market ormutivimab as post-exposure treatment for the prevention of rabies.
PERTH, Australia – After raising AU$7.5 million (US$5.4 million) in a private placement, biopharma company Servatus Ltd. is advancing its microbial biotherapeutics clinical programs targeting serious autoimmune conditions. The Coolum, Queensland-based private company is focused on identifying and developing live microbial biotherapeutics and engineered proteins to treat chronic and autoimmune diseases, as well as non-antibiotic treatments for bacterial infections.
Cansino Biologics Inc. has received marketing approval from the NMPA for its ACYW-135 meningococcal conjugate vaccine, Menhycia, making it the first of its kind to be authorized in China. The approval marks “an important step in accelerating the development of China’s meningococcal vaccine immunization strategy,” the company said.
Following an FDA priority review, Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, has won U.S. approval as the first drug in the country to treat resistant cytomegalovirus (CMV) infection and disease in adult and pediatric transplant recipients. The drug will be marketed as Livtencity.
Fosun Pharmaceutical Group Co. Ltd. has acquired a 73% stake of Antejin Biotech Co. Ltd. in a merger and acquisition deal worth up to ¥4.006 billion (US$626.2 million) to expand its pipeline in the field of bacterial vaccines. To kick off, Shanghai-based Fosun purchased about 32.52% equity interest in Antejin from nine shareholders for about ¥1.108 billion in cash.
If the FDA follows the advice of its Antimicrobial Drugs Advisory Committee, Takeda Pharmaceutical Co. Ltd.’s antiviral drug, maribavir, will become the first drug approved in the U.S. to treat resistant or refractory cytomegalovirus infection and disease in both solid organ and hematopoietic stem cell transplant recipients. The committee voted 17-0 that the overall benefit-risk assessment favors the use of maribavir for transplant patients with refractory CMV infections both with and without genotypic resistance to the four antivirals currently used off-label to treat the infections – ganciclovir, valganciclovir, foscarnet and cidofovir.
Minhai Biotechnology Co. Ltd. has won approval from the NMPA for its 13-valent pneumococcal conjugate vaccine, which makes it the third company with such a vaccine to be greenlighted in China.
LONDON – Conflicting data from around the world on the extent to which the Delta variant of SARS-CoV-2 is reducing the effectiveness of vaccines is generating uncertainty over the need, or not, for booster programs.
China’s NMPA gave conditional approval to Henan Sincere Biotech Co. Ltd.’s dual-targeting, oral HIV drug, azvudine, to treat HIV-1-infected adult patients with high viral loads. Azvudine could challenge lamivudine, a drug extensively used for treating HIV infection.
Medigen Vaccine Biologics Corp. released results from a phase III trial of its enterovirus 71 (EV71) vaccine that showed efficacy of 100% against a virus that causes hand, foot and mouth disease and continues to emerge on a regular basis across Asia.
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