Search Results for “EU” – Page 45 – media

FT

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
- 519
- 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
- 146
- March 24, 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
- 298
- March 15, 2023
China’s Import and Export Market Report of Rheumatoid Arthritis Drugs

Rheumatoid arthritis (RA) is an autoimmune disease with complex pathogenesis and an extremely high morbidity rate, which seriously affects the quality of the life of patients and brings economic burden to society. Thus, effective treatments of RA has become a global concern of the pharmaceutical industry.
- Source: Ddu
- 3,945
- August 26, 2021
Ddu College Market Reports RA
Pfizer’s JAK inhibitor Xeljanz shows benefit in COVID-19 pneumonia

Pfizer’s JAK inhibitor Xeljanz reduced the risk of severe outcomes in hospitalised adult patients with COVID-19 pneumonia who were not on ventilation, according to new study data. The STOP-COVID trial was conduction by Pfizer and the ARO from the Hospital Israelita Albert Einstein in Sao Paolo, Brazil, which was also the trial coordinating centre. Patients were randomised to receive either Xeljanz (tofacitinib) 10mg twice daily plus standard of care (SoC) or placebo twice daily plus SoC for up to 14 days or until hospital discharge. The trial demonstrated a reduced cumulative incidence of death or respiratory failure through day 28 with Xeljanz (18.1%) compared to placebo (29.9%). In addition, death from any cause occurred in 2.8% of Xeljanz-treated patients compared to 5.5% in the placebo group. In the study, serious adverse groups occurred in 14.1% of patients in the Xeljanz group and 12% in the placebo group. Protocol-specified adverse events ...
- Source: drugdu
- 993
- August 25, 2021
Covid-19
Janssen inks inflammatory disease collaboration with Mestag Therapeutics

Janssen, the pharma division of Johnson & Johnson, has entered an agreement with Cambridge, UK-based Mestag Therapeutics to research and develop novel fibroblast targets for the treatment of inflammatory disease. The collaboration will utilise Mestag’s specialist fibroblast subpopulation biology platform, as well as the biotech’s ‘state-of-the-art’ data analytics in a bid to identify novel therapeutic targets. Under the terms of the agreement, Mestag will grant Janssen an option to an exclusive license to develop and commercialise therapeutics directed against up to two targets resulting from the collaboration. In exchange, Janssen will pay Mestag option fees, milestone payments and royalties – however, the detailed financial terms of the agreement were not disclosed by the companies. Also, as part of the collaboration, Janssen Research & Development’s global immunology therapeutic head David Lee will join Mestag’s scientific advisory committee. “Mestag’s vision is to leverage our unique fibroblast biology platform and state-of-the-art data analytics ...
- Source: drugdu
- 250
- May 19, 2021
Janssen
GW Pharma’s Epidyolex scores new EU indication

GW Pharmaceuticals’ Epidyolex has received approval from the European Commission (EC) for the treatment of seizures associated with tuberous sclerosis complex (TSC) – its third indication in Europe. Specifically, Epidyolex (cannabidiol) has been approved as an adjunctive treatment of seizures associated with TSC for patients aged two years and older. TSC is a rare genetic condition that causes mostly benign tumours to grow in vital organs including the brain, skin, heart, eyes, kidney and lungs. The condition is typically diagnosed in childhood and the most common neurological feature in TSC is epilepsy. It is also associated with an increased risk of autism and intellectual disability, although the severity of the condition can vary widely. The EC approval is based on data from a Phase III trial evaluating Epidyolex for the treatment of seizures associated with TSC. This study hit its primary endpoint of reduction in seizure frequency, with seizure reduction ...
- Source: drugdu
- 234
- April 21, 2021
Epidyolex
Novartis bags EU, UK licences for MS therapy Kesimpta

Novartis has received green lights from both the European Commission and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to market its multiple sclerosis (MS) therapy Kesimpta (ofatumumab). The drug is a fully human anti-CD20 monoclonal antibody (mAb) thought to work by binding to a distinct epitope on the CD20 molecule, inducing potent B-cell lysis and depletion. It enables faster repletion of B cells versus other anti-CD20 monoclonal antibodies and so may offer flexibility in the management of RMS, according to the drugmaker. As per its licence, Kesimpta can be used to treat adults with relapsing forms of multiple sclerosis (RMS) with active disease, defined by clinical or imaging features. Novartis says it has the potential to become a recognised treatment option for eligible UK patients that can be self-administered, with initial guidance from an appropriately trained healthcare professional, once monthly at home via the Sensoready autoinjector pen. Initial ...
- Source: drugdu
- 161
- April 8, 2021
MS therapy Kesimpta
Novo Nordisk’s Sogroya moves closer towards EU approval

Novo Nordisk’s Sogroya (somapacitan) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use – moving closer towards approval in the EU. The CHMP has recommended marketing authorisation for Sogroya for the treatment of adults with growth hormone deficiency (AGHD). The recommendation is based on results from the Phase III REAL 1 clinical trial programme, which investigated the efficacy and safety of Sogroya in AGHD. “We are very pleased with the positive opinion for once-weekly Sogroya as we are committed to continuously developing innovative and efficient medicines for people living with growth hormone deficiency,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. “We are confident that Sogroya will make management of this serious chronic disease easier and help improve the quality of life for more people living with growth hormone deficiency,” he added. Sogroya is a ...
- Source: drugdu
- 261
- February 5, 2021
Novo Nordisk’s Sogroya
EU approves Chiesi’s triple combination asthma therapy Trimbow

The European Commission (EC) has approved a marketing authorisation for Chiesi Group’s triple combination asthma therapy Trimbow (beclometasone/formoterol/glycopyrronium). The marketing authorisation indicates Trimbow for use as a maintenance treatment for adult asthma patients, whose condition is not adequately controlled with a combination of long-acting beta2-agonist (LABA) and medium dose of inhaled corticosteroid (ICS). Patients must have also experienced one or more asthma exacerbations in the previous year. Chiesi’s triple asthma therapy has been shown to reduce exacerbations and improve lung function in patients with uncontrolled asthma, compared to ICS/LABA. Both the CHMP’s recommendation and the EC’s approval are based on efficacy and safety data from four clinical studies, involving almost 3,000 patients. “This is the first step towards taking our triple therapy for moderate to severe COPD patients and providing the same treatment option for appropriate asthma patients,” said Alessandro Chiesi, chief commercial officer of Chiesi Group. “The European Commission’ ...
- Source: drugdu
- 216
- February 3, 2021
asthma therapy Trimbow

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