On March 21, Selecta Biosciences and Sobi announced positive pivotal results from two phase III studies (DISSOLVE I and DISSOLVE II). These two placebo-controlled, randomized clinical trials were designed to evaluate the safety and efficacy of two different dose levels of SEL-212 in adult patients with chronic refractory gout. Gout is an autoinflammatory disease in which patients experience severe pain and debilitating inflammatory arthritis due to deposits of pro-inflammatory sodium urate (MSU) crystals. Patients with chronic refractory gout often have a high tissue MSU burden, which can lead to frequent gout attacks and chronic arthritis. Gout is the most common inflammatory arthritic disease in the United States. SEL-212 has the potential to reduce serum uric acid and MSU deposition in patients with chronic refractory gout. Recombinant uricase is highly immunogenic in the human body. Through Selecta’s proprietary ImmTOR platform, SEL-212 has the potential to alleviate the formation of anti-drug antibodies, ...
India has cancelled the manufacturing licence of a firm whose cough syrups have been linked to 18 child deaths in Uzbekistan. The WHO in January had warned against the use of two cough syrups made by Marion Biotech, saying they were substandard. Marion Biotech denies the allegations. After the deaths were reported in Uzbekistan, India’s health ministry had suspended production at the company. On Wednesday, authorities in Uttar Pradesh state – where Marion Biotech is based – said they were now “permanently” cancelling the company’s licence. “The firm based in Noida city cannot carry out any manufacturing now,” drug inspector Vaibhav Babbar told the Hindustan Times newspaper. The BBC has reached out to state authorities for a statement. Marion Biotech has not responded to BBC’s request for comment. India is the world’s largest exporter of generic drugs, meeting much of the medical ...
Insulin resistance is becoming more prevalent, affecting 15.5% to 46.5% of the world’s population Novo Nordisk and Dewpoint Therapeutics have entered into a research and development partnership aimed at identifying drug candidates to treat insulin resistance and diabetic complications. A key driver of type 2 diabetes and metabolic syndrome, insulin resistance occurs when the body has an impaired response to insulin, resulting in elevated levels of glucose in the blood. The condition is rising in prevalence globally, affecting 15.5% to 46.5% of the world’s population. The collaboration will see the partners use Dewpoint’s discovery and AI technology platform to identify modulators of biomolecular condensates – membraneless organelles comprising proteins and RNA – that may be involved in insulin resistance and insulin sensitivity. The dysregulation of these condensates has been observed in many diseases, including diabetes, which is why Dewpoint believes that using its platform to develop ...
Stéphane Bancel argued a price increase was necessary because of waning demand and supply chain issues. Moderna CEO Stéphane Bancel defended the company’s plans to raise the price of its Covid vaccine at a Senate hearing Wednesday, saying the move was necessary because its government funding will soon end. “Until now, the U.S. government has purchased and distributed the vaccine. Now Moderna, a small company, must ensure that anyone who wants a vaccine can get one at a location convenient to them,” Bancel told members of the Senate Committee on Health, Education, Labor and Pensions at a hearing titled “Taxpayers Paid Billions For It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?” The company has said it plans to increase the cost of the vaccine to consumers to $130 a dose from the current price of about $26. The panel’s chair, Sen. Bernie ...
Roche Holding AG, a Swiss multinational healthcare company, has announced that the U.S. Food and Drug Administration (FDA) has granted approval for its new cancer treatment. The drug, known as Polivy, is designed to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), a type of non-Hodgkin’s lymphoma. This approval is significant for Roche, as DLBCL is one of the most common types of non-Hodgkin’s lymphoma and a highly aggressive form of cancer. Polivy is a first-in-class antibody-drug conjugate that targets CD79b, a protein that is highly expressed on the surface of B-cell lymphomas. The drug is designed to bind to the CD79b protein and deliver a toxic payload directly to cancer cells, without affecting healthy cells. This approach is known as targeted therapy and is considered to be a significant advancement in cancer treatment. The FDA’s decision was based on the results of a phase ...
Pfizer, the American pharmaceutical giant, has reported strong earnings for the fourth quarter of 2022, driven by the continued success of its COVID-19 vaccine. The vaccine has been a major growth driver for the company, with sales expected to reach $36 billion in 2023. Pfizer’s revenue for the quarter was $24.6 billion, up 17% from the same period the previous year. Net income was $5.2 billion, an increase of 6% compared to the same quarter in 2021. The strong results were driven by the success of the company’s COVID-19 vaccine, as well as several other key products, including Prevnar 13 and Ibrance. The COVID-19 vaccine, developed in partnership with German company BioNTech, has been a major contributor to Pfizer’s success in 2022. The vaccine has been authorized for emergency use in more than 200 countries and territories around the world, and Pfizer has shipped more than 2 billion ...
Sanofi, the French multinational pharmaceutical company, has reported strong quarterly earnings for the fourth quarter of 2022, driven by the success of several key products. The company’s performance beat analysts’ profit forecast, and shares rose in response to the news. Sanofi’s revenue for the quarter was €10.2 billion, up 6.7% from the same period the previous year. Net income was €1.3 billion, an increase of 28.6% compared to the same quarter in 2021. The strong results were driven by the success of several of the company’s products, including Dupixent, Aubagio, and Lantus. Dupixent, a treatment for atopic dermatitis and asthma, was a particular standout, with sales of €1.3 billion in the quarter, up 42.9% from the same period in 2021. The drug has been a major growth driver for Sanofi, with sales expected to reach €10 billion by 2025. Aubagio, a treatment for multiple sclerosis, also performed ...
The US Food and Drug Administration (FDA) has approved a new drug to treat Parkinson’s disease, providing hope for millions of patients who suffer from this debilitating condition. The drug, called Levodopa/Carbidopa Enteral Suspension (LCES), is the first new treatment for Parkinson’s disease to be approved by the FDA in over a decade. Parkinson’s disease is a progressive neurodegenerative disorder that affects movement and is caused by the degeneration of dopamine-producing neurons in the brain. The symptoms of Parkinson’s disease include tremors, stiffness, and difficulty with coordination and movement. LCES is a combination of two drugs, Levodopa and Carbidopa, that work together to increase the levels of dopamine in the brain. This can help to improve the symptoms of Parkinson’s disease and provide relief for patients. The approval of LCES is a significant development in the treatment of Parkinson’s disease, which has been largely treated with the ...
Two manufacturers of eyedrops have recalled products over fears about contamination and sterility. The FDA issued recall notices last week for eyedrops made by Pharmedica and Apotex after the companies said they were voluntarily recalling the products. “Use of contaminated eye drops can result in the risk of eye infections that could result in blindness,” Pharmedica said about some of its Purely Soothing 15% MSM Drops. The company urged consumers to stop using the drops and return them to the point of purchase. They are sold over the counter to treat eye irritation. The recall affects about 3,000 bottles of product made in Arizona. The FDA said there have been no reports of injury. Apotex is recalling some of its glaucoma drops distributed as Brimonidine Tartrate Ophthalmic Solution, 0.15% and sold from last April through February. The company said it found cracks in a few ...
A nationwide recall of organic frozen strawberry products is underway. The FDA is advising people who ate the products to get vaccinated against hepatitis A to prevent liver infection and symptoms like nausea and jaundice. The recalled products were sold at major retailers including Trader Joe’s, Costco, and ALDI, plus other regional retailers and suppliers. Five cases of hepatitis A in Washington state are linked to eating frozen strawberries, the FDA has warned. Two of the people were hospitalized. The illnesses started between Nov. 24, 2022, and Dec. 27, 2022, according to the CDC. The five people who were sickened all reported eating frozen strawberries and ranged in age from 38 to 61 years old. “Traceback and epidemiological investigations show that people with outbreak-associated cases in Washington purchased the same retail brand of frozen organic strawberries prior to becoming ill,” the CDC investigation report stated. The ...
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