A cocktail of monoclonal neutralizing antibodies developed by Brii Biosciences Ltd. has become “the first locally-discovered and approved SARS-CoV-2 target-specific treatment in China, through a randomized, double-blind and placebo-controlled trial,” Rogers Luo, president and general manager of greater China at the company, told BioWorld. The NMPA approved a combination of Brii’s amubarvimab and romlusevimab as a treatment for both adults and pediatric patients, ages 12 to 17, with mild and “normal type” COVID-19 at high risk for progression to severe disease, including hospitalization or death. Read More
LONDON – New figures underline the devastating effect the pandemic is having on cancer clinical research, with recruitment to U.K. studies falling by 60%. A total of 27,734 patients were recruited in 2020/21, compared to an average of 67,057 in the three years previously. Over those three years, recruitment had been on the rise, going from 61,810 in 2017/18 to 71,709 in 2019/20, according to figures compiled by the Institute of Cancer Research in London. Read More
While financings have reached record levels, the stocks of BioWorld’s Neurological Diseases Index are now underground by 12.5%, a trajectory shadowed by the Nasdaq Biotechnology Index, down by 3.45%. The Dow Jones Industrial Average representing the broader markets, however, is up by nearly 13%. Read More
As Omicron spreads throughout Europe there’s a pressing need for new therapies that could reduce the burden on hospitals by preventing COVID-19 symptoms from escalating to a critical point. Apogenix GmbH, of Heidelberg, Germany, is pushing a potential new therapy into phase III that could be added to the armamentarium against COVID-19 with €20.7 million (US$23.4 million) government funding. Read More
In 2021, no drug approval garnered as much attention and debate as Biogen Inc.’s Aduhelm (aducanumab). The FDA’s surprise, accelerated approval of Aduhelm for Alzheimer’s disease flew in the face of the recommendation by an advisory committee, causing a stir that included the resignation of three adcom members, along with publicly made claims that the company’s relationship with regulators had become too cozy. Read More
Cansino Biologics Inc. has entered a development and commercial supply partnership with Aerogen Ltd. for an inhalable version of its COVID-19 vaccine, Convidecia, also known as Ad5-nCoV. Cansino will combine Convidecia with Aerogen’s vibrating mesh aerosol drug delivery technology to produce a consistent droplet size for optimal lung deposition. The technology delivers up to six times more medication to the lungs compared to jet nebulizers. It also enables consistency and drug denaturing to improve efficacy. Cansino and Aerogen did not disclose the deal’s commercial terms. Read More
The Russian Federation is making progress in building its drug supply system and increasing access to medicines and medical devices. In a Dec. 7 update on the progress being made, Minister of Health Mikhail Murashko highlighted the work of the Circle of Kindness fund, efforts to ensure the availability of vaccines and other drugs throughout the federation, and the launch of a labeling system to promote the timely identification of uncertified and counterfeit drugs. Read More
U.S. President Joe Biden has yet to nominate a new director to helm the National Institutes of Health (NIH) when Francis Collins steps down next week, but in the interim, Lawrence Tabak, the principal deputy director at the agency, will serve as the acting director beginning Dec. 20. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abpro, Ascentage, Betterlife, Canbridge, Clover, Prestige, Redx and Smart Immune. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aytu, Bioinvent, Biontech, Cybin, Cytodyn, Daré, Moderna, Neurop, Nuvation, Pfizer, Saol, Supernus. Read More
