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Pfizer and European Commission officials have waded through months of pushback over a large, controversial COVID-19 vaccine supply deal in Europe. They’ve now reportedly hashed out a new supply agreement—but there’s a catch. Under the terms of a revised deal, Pfizer agreed to extend the European supply contract from 2023 out to 2026, the Financial Times reports based on two people with knowledge of the talks. Given the drop in vaccine use, Pfizer also agreed to cut the total number of doses to be supplied by 40%, but the company is also pushing for payment for the doses that will never be manufactured, according to the publication. Pfizer and the European Commission (EC) inked their large vaccine supply deal in May 2021. The agreement covered 900 million vaccine doses for delivery split between 2022 and 2023, with the option for the EC to order another 900 million doses in the future. In December 2021, European officials exercised part of ...
- Source: drugdu
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- March 24, 2023
England’s NICE signs off on PTC Therapeutics’ $3.7M gene therapy for ultra-rare disease

The National Institute for Health and Care Excellence (NICE) has recommended the therapy to treat patients with aromatic L-amino acid decarboxylase (AADC) deficiency who are 18 months and older. PTC has inked a confidential discount access scheme to make Upstaza available to the National Health Service (NHS), NICE says. The drug carries a list price of 3 million pounds sterling (around $3.71 million) per 0.5-mL infusion solution before the confidential discount. AADC deficiency is so rare that it affects an estimated 10 children in the U.K., only a few of whom could be eligible for the treatment. The disease causes a wide range of severe symptoms, but around 80% of patients have a severe form that leaves them fully dependent on caregivers and unable to meet normal developmental milestones. Due to the rarity of this condition, there isn’t much research on the expected life span of a person with AADC deficiency. It’s estimated that most ...
- Source: drugdu
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- March 24, 2023
Selecta, Sobi rout gout in pair of phase 3 trials that could challenge Horizon

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, ...
- Source: drugdu
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- March 24, 2023
India cancels licence of drug maker linked to child deaths in Uzbekistan

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 ...
- Source: drugdu
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- March 24, 2023
Novo Nordisk and Dewpoint partner on insulin resistance drug candidates

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 ...
- Source: drugdu
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- March 24, 2023
Moderna CEO grilled over plan to raise Covid vaccine price at Senate hearing

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 ...
- Source: drugdu
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- March 24, 2023
Roche Holding AG Receives FDA Approval for New Cancer Treatment

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 ...
- Source: drugdu
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- March 24, 2023
Pfizer Reports Strong Earnings, Driven by Continued Success of COVID-19 Vaccine

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 ...
- Source: drugdu
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- March 24, 2023
Sanofi Reports Strong Quarterly Earnings, Driven by Success of Key Products

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 ...
- Source: drugdu
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- March 24, 2023
FDA Approves New Drug to Treat Parkinson’s Disease, Providing Hope for Millions of Patients

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 ...
- Source: drugdu
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- March 24, 2023

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