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NICE approves funding for Novartis gene therapy

Funding is for onasemnogene abeparvovec and concerns babies with spinal muscular atrophy NICE has published final draft guidance regarding the recommendation of routine NHS funding for onasemnogene abeparvovec. The treatment is a potentially curative one-off gene therapy for treating a rare genetic condition, spinal muscular atrophy (SMA). It will be used specifically among babies aged up to 12 months, before they develop symptoms. The drug – also known as Zolgensma – is produced by Novartis Gene Therapies. The recommendation has emerged after NICE reviewed the evidence to determine whether it should be available for routine NHS funding in England and Wales. Onasemnogene abeparvovec is designed to address the genetic cause of SMA and its effects are thought to be life-long. Under NICE’s original guidance, released in 2021, it was recommended for babies before they develop symptoms of SMA as part of a managed access agreement (MAA). The agreement ensured that ...
- Source: drugdu
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- March 17, 2023
Brazil’s ANVISA approves Takeda’s dengue vaccine Qdenga

Qdenga’s approval is supported by the data obtained from 19 clinical trials, and follows similar decisions in other countries. The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda’s tetravalent dengue virus vaccine, Qdenga. The vaccine, previously known as TAK-003, has received approval for preventing dengue disease in people aged four years to 60 years. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes and is designed to provide protection against any of these. Qdenga is purported to be the only dengue vaccine approved in Brazil for use in people without the need for pre-vaccination testing and regardless of previous exposure. ANVISA’s approval follows similar decisions by the European Commission in December, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) last month. The company continues to advance regulatory filings in other dengue-endemic countries in Asia and Latin America. In ...
- Source: drugdu
- 145
- March 17, 2023
Healthcare companies may turn to big banks after SVB’s fall

Healthcare startups may turn to traditional large banks and prioritize conserving cash after the collapse of regional lenders Silicon Valley Bank and Signature Bank last week. The fall of SVB created a hole in the life sciences startup sector, locking out funds temporarily for some companies and cutting off a source of short-term cash for healthcare startups. A major bank and lender for healthcare companies, SVB last year had clients in nearly half of U.S. venture-backed technology and life sciences companies. “At this very moment, I think most of the companies are flying to safety, to the big banks,” said Ian Chiang, partner at healthcare investing company Flare Capital, “Perhaps it’s a little bit of a knee-jerk reaction to see what would happen.” However, companies may still deposit with regional banks, depending on size. Healthcare unicorns, meaning companies with valuations exceeding $1 billion, are likely not going to be able to have ...
- Source: drugdu
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- March 17, 2023
China’s NMPA accepts GSK’s drug application review for Nucala to treat SEA

China National Medical Products Administration has accepted the review of GSK’s drug application for Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma (SEA). If given approval, Nucala will become the first targeted anti-Interleukin-5 (IL-5) treatment in the country for adult and adolescent patients with SEA. A first-in-class monoclonal antibody to target IL-5, Nucala was first approved in 2015 for SEA in the US. It prevents IL-5 from binding to its receptor on the surface of eosinophils, lowering blood eosinophils and maintains them under normal levels. The application to China National Medical Products Administration has been submitted based on positive data from Phase III trial undertaken on patients in China and the global SEA development programme, which included three important clinical trials – DREAM 2, MENSA3 and SIRIUS4. These trials established the efficacy and safety profile of mepolizumab for SEA patients. The Phase III trial for 52 weeks studied the ...
- Source: drugdu
- 132
- March 16, 2023
PBD Biotech reveals vital update to TB test

By John Pinching Lyophilized PCR reaction bead reduces the cost of transport and extends shelf life for the test. PBD Biotech has developed a lyophilized PCR reaction bead for its Actiphage blood test which identifies active tuberculosis (TB). The new function enables transportation without the need for a cold chain, which reduces the cost associated with shipment and also extends the shelf life for test components. TB treatment and testing must occur close to the point of infection and the update meets these criteria. Typically, products that contain enzymes are temperature-sensitive and require cold chain transport to ensure their functional integrity. Lyophilization, however, is a water removal system that can be used to extend the life of a product. PBD Biotech has also established PCR primers and probes that allow specific detection of DNA from mycobacteria TB isolated from a whole blood sample. By enabling early detection of TB disease ...
- Source: drugdu
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- March 16, 2023
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
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- 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
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- 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
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- 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

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