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US FDA approves Pfizer’s migraine nasal spray Zavzpret

Zavzpret’s approval expands Pfizer’s migraine portfolio that includes an oral therapy for acute and preventive treatment. The US Food and Drug Administration (FDA) has granted approval for Pfizer’s Zavzpret (zavegepant) for the acute treatment of migraine in adult patients with or without aura. Zavzpret is claimed to be the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray approved to treat migraine. It is a third-generation, selective and structurally unique, small molecule CGRP receptor antagonist and is currently under clinical development with oral and intranasal formulations. The company stated that the regulatory approval expands its migraine portfolio, which includes oral therapy for acute and preventive treatment. Pfizer Global Biopharmaceuticals Business president and chief commercial officer Angela Hwang said: “The FDA approval of Zavzpret marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications. “Zavzpret underscores Pfizer’s commitment to delivering an additional treatment ...
- Source: drugdu
- 118
- March 16, 2023
Novo Nordisk to reduce US list prices of insulin products

Novo Nordisk will reduce the list price of four legacy insulin brands, including NovoLog and NovoLog Mix 70/30, by 75%. Novo Nordisk has announced plans to reduce the US wholesale acquisition cost (WAC), also known as the list price, of several pre-filled insulin pens and vials by up to 75% for people living with type 1 and type 2 diabetes. Set to come into effect from 1 January 2024, these changes will be applicable for products including pre-filled pens and vials of basal (long-acting), bolus (short-acting) and pre-mix insulins, Levemir, Novolin, NovoLog and NovoLog Mix 70/30 in specific. Novo Nordisk Market Access & Public Affairs senior vice-president Steve Albers said: “We have been working to develop a sustainable path forward that balances patient affordability, market dynamics, and evolving policy changes. “Novo Nordisk remains committed to ensuring patients living with diabetes can afford our insulins, a responsibility we take seriously.” The company will reduce the ...
- Source: drugdu
- 127
- March 16, 2023
Chasing Pfizer, GSK’s 5-in-1 meningococcal vaccine delivers phase 3 trial win

Nearly three years after dosing the first patient in a phase 3 trial, GSK has now reported positive results from the trial of its much-anticipated combination meningitis vaccine. The shot, a combination of GSK’s approved vaccines Bexsero and Menveo, targets meningitis and blood poisoning caused by the A, B, C, W, and Y groups of meningococcal bacteria. The serogroups A, B, C, W and Y cause nearly all invasive meningococcal disease (IMD) cases globally, GSK said in a statement. As it stands now in the U.S., protection from all five groups requires four injections from two separate vaccines. But GSK is looking to change that with its two-dose shot, which is administered six months apart. GSK said that the vaccine candidate met endpoints in the trial, which enrolled healthy people between 10 and 25 years of age. The vaccine matched up to Bexsero and Menveo, eliciting a “clinically meaningful immune response.” https://www.fiercepharma.com/pharma/gsks-combination-menabcwy-vaccine-holds-its-own-against-gsks-approved-meningitis-jabs
- Source: drugdu
- 129
- March 16, 2023
Opzelura, Dermavant’s Vtama cream hits goal in eczema phase 3 study

Incyte’s Opzelura cream may be looking at a new competitive rival in the lucrative atopic dermatitis field. Wednesday, Dermavant Sciences said its topical drug Vtama has come out successful in the first of two phase 3 studies the company is running in atopic dermatitis. As William Blair analysts see it, Vtama’s results put it “in reach of Opzelura on efficacy,” although one important data point remains unknown. In a phase 3 trial called ADORING 2, 46.4% of eczema patients who received the Vtama cream enjoyed clear or almost clear skin at week 8 while demonstrating at least a two-grade improvement from baseline. Vtama’s skin clearance rate was higher than the 18% observed in control patients who got a dummy therapy. Vtama also aced other secondary endpoints. The topical AHR agonist helped 59.1% of patients experience a 75% reduction from baseline in the Eczema Area and Severity Index (EASI), versus 21.2% in the ...
- Source: drugdu
- 245
- March 16, 2023
LG Chem locks in $200M vaccine supply deal with UNICEF

Korea’s LG Chem is stepping up to the plate with a deal to manufacture essential vaccines for millions of infants and children. The company has locked up a $200 million deal with the United Nation’s Children’s Fund (UNICEF) to supply both its polio shot Eupolio and its pentavalent vaccine Eupenta, which protects against diphtheria, pertussis, tetanus, hepatitis B and meningitis. The contract is evenly split between supplies of both shots. The $100 million Eupolio contract provides supplies of the shot for the two years from 2024 to 2025, while LG Chem agreed to provide Eupenta for the five-year stretch from 2023 to 2027. The deal is expected to cover vaccines for roughly 80 million kids and infants around the world. LG Chem credited the deal to its investment in a factory in Osong, Korea. The site can produce more than 60 million dodses of Eupolio per year, according to the ...
- Source: drugdu
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- March 16, 2023
Molecular component of caffeine may play a role in gut health

Brigham researchers studying how and why certain cell types proliferate in the gut found that xanthine, which is found in coffee, tea and chocolate, may play a role in Th17 differentiation. Insights may help investigators better understand gut health and the development of conditions such as inflammatory bowel disease. The gut is home to a cast of microbes that influence health and disease. Some types of microorganisms are thought to contribute to the development of inflammatory conditions, such as inflammatory bowel disease (IBD), but the exact cascade of events that leads from microbes to immune cells to disease remains mysterious. A new study by investigators from Brigham and Women’s Hospital explores exactly what leads to the generation of Th17 cells—an important subtype of cells in the intestine—and uncovers some of the underappreciated molecular players and events that lead to cell differentiation in the gut. One of those players is the purine metabolite xanthine, which is found ...
- Source: drugdu
- 263
- March 15, 2023
Study finds COVID-19 pandemic has long-lasting effects on adolescent mental health and substance use

The COVID-19 pandemic has had a long-lasting impact on adolescent mental health and substance use, according to a new population-based study based on survey responses from a nationwide sample of over 64,000 13–18-year-old North American and Icelandic adolescents assessed prior to and up to two years into the pandemic. The study was conducted by faculty at Columbia University Teachers College and Mailman School of Public Health and a team of Icelandic and other North American clinical, behavioral and social scientists. The findings are published in published in The Lancet Child & Adolescent Health. This same research team published a population-based study in The Lancet Psychiatry in 2021 showing an increase in depressive symptoms and decrease in mental well-being among 13–18-year-old adolescents within one year of the global spread of the COVID-19 pandemic. A decline in substance use, in particular cigarette smoking, e-cigarette use and alcohol intoxication, was also observed. Expanding on these findings, this new study shows ...
- Source: drugdu
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- March 15, 2023
An overview of COVID-19-associated neurological complications in children

In a recent study posted to the Research Square* preprint server, an international team of researchers review current literature to understand the association between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, abnormal neuroimaging manifestations, and neurological symptoms among individuals under the age of 18. Background The clinical presentation of the coronavirus disease 2019 (COVID-19) varies widely across individuals, ranging from asymptomatic or mild to severe cases involving acute respiratory distress syndrome (ARDS), pneumonia, and multi-organ complications. Emerging evidence suggests that the thrombogenic reactions and cytokine storm that develop during acute COVID-19 contribute to psychiatric and neurological complications, with a high incidence of intracerebral hemorrhage and ischemic stroke. While many studies have investigated the neurological complications associated with acute SARS-CoV-2 infections among adults, COVID-19 manifestations among children have largely been asymptomatic or mildly symptomatic and not require hospitalization. However, emerging evidence indicates that systemic symptoms such as secondary inflammatory responses, which are collectively known ...
- Source: drugdu
- 299
- March 15, 2023
Siemens and Sysmex Sign Global Hemostasis Supply Agreement

Image: Sysmex and Siemens have established global agreement to supply hemostasis instruments and reagents as OEMs (Photo courtesy of Sysmex) Sysmex Corporation (Kobe, Japan) and Siemens Healthcare Diagnostics Inc. (Siemens Healthineers, Erlangen, Germany) have signed a global OEM agreement on hemostasis products under which each company will supply the other with their products in the diagnostic field of hemostasis on an OEM basis. Both Siemens and Sysmex provide hemostasis products used in testing for blood clotting disorders, preoperative bleeding risk management, and the monitoring of patients receiving anticoagulant therapy medications. Following their global agreement on distribution, sales, and services for hemostasis products signed in 1995, the two companies have since then developed a strong partnership and gone on to become one of the leading solution providers in the global hemostasis space. Over this period, the companies have further expanded their capabilities and gained strength by introducing new innovations in ...
- Source: drugdu
- 233
- March 15, 2023
Websites and Tools You Need to Know!

The pharmaceutical foreign trade industry is fiercely competitive, demanding a constant grasp of the latest market information and tech tools to successfully expand business. Today, we're showcasing must-have websites and practical tools for pharmaceutical foreign trade professionals, empowering you to operate more efficiently.
- Source: drugdu
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- March 3, 2023
pharmaceutical foreign trade practical tools

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