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.
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.
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.
Pharmaceutical companies in China will cut the prices for more than five dozen drugs by an average of 61.7% to get them on the latest version of the country’s National Drug Reimbursement List. The National Healthcare Security Administration released the new list on Dec. 3, 2021. The new list includes 74 new drugs, the vast majority of which are branded products without generic versions in China. Only seven of the new drugs on the list have generic versions.
Although Pfizer Inc.’s COVID-19 oral antiviral candidate, Paxlovid (PF-07321332; ritonavir), has yet to be authorized anywhere, the push for compulsory licensing of the drug has begun.
The release of the FDA’s briefing document for a Dec. 8 meeting of its Cardiovascular and Renal Drugs Advisory Committee triggered heavy trading and a 38% drop in value in Reata Pharmaceuticals Inc., of Plano, Texas.
Pharmaceutical companies in China will cut the prices for more than five dozen drugs by an average of 61.7% to get them on the latest version of the country’s National Drug Reimbursement List. The National Healthcare Security Administration released the new list on Dec. 3, 2021. The new list includes 74 new drugs, the vast majority of which are branded products without generic versions in China. Only seven of the new drugs on the list have generic versions.
Longeveron Inc.’s share price (NASDAQ:LGVN) jumped 11.7% on Dec. 3 after the FDA awarded orphan designation to Lomecel-B, allogeneic bone marrow-derived mesenchymal stem cells, for treating hypoplastic left heart syndrome. The designation came two weeks after the FDA granted rare pediatric disease designation for Lomecel-B to treat the life-threatening congenital heart defect in infants.
CEO Michael Raab said that would-be partners for Ardelyx Inc.’s Ibsrela (tenapanor), cleared in September 2019 to treat irritable bowel syndrome with constipation, “don't understand and don't approach the market in the manner that we will,” which is why the company has chosen to launch the sodium/hydrogen exchanger 3 inhibitor on its own in 2022.
One of the biggest concerns at the Nov. 30 meeting of the FDA’s Antimicrobial Drugs Advisory Committee is that, if Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s antiviral drug, molnupiravir, is authorized for use in treating mild to moderate COVID-19 in patients at high risk of progressing to severe disease, it might be used too broadly, given its potential risks.
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