Search Results for “EC” – Page 80 – media

Roche announces positive phase 3 results for Alecensa in early-stage lung cancer

Roche has shared new results from a late-stage study of its anaplastic lymphoma kinase (ALK) inhibitor Alecensa (alectinib) in early-stage lung cancer. The phase 3 ALINA study has been evaluating the targeted drug as an adjuvant therapy in patients with completely resected stage 1B to 3A ALK-positive non-small cell lung cancer (NSCLC). Alecensa was shown to reduce the risk of disease recurrence by 76% compared with platinum-based chemotherapy, Roche said. A clinically meaningful improvement of central nervous system disease-free survival was also observed in those receiving Alecensa, and the safety and tolerability of the therapy were consistent with previous trials in the metastatic setting. Overall survival data was immature at the time of this analysis and the company has outlined that follow-up is ongoing to “report a more mature estimate”. Levi Garraway, Roche’s chief medical officer and head of global product development, said: “By reducing the risk of recurrence or ...
- Source: https://www.pmlive.com/pharma_news/roches_alecensa_shows_promise_in_phase_3_early-stage_lung_cancer_trial_1502267
- 120
- October 30, 2023
Who is Tim Schmid, Johnson & Johnson MedTech’s new leader?

ohnson & Johnson MedTech Worldwide Chair Tim Schmid [Photo courtesy of Johnson & Johnson] Tim Schmid is the new worldwide chair of Johnson & Johnson MedTech and EVP of Johnson & Johnson (NYSE: JNJ)+ following Ashley McEvoy’s announcement today that she plans to resign from the world’s second-largest medical device manufacturer.“We are pleased to have the depth of talent at Johnson & Johnson that allows us to transition to Tim, a respected, results-driven and Credo-based leader,” J&J Chair and CEO Joaquin Duato said in a news release.McEvoy called Schmid “a trusted friend and partner” in a LinkedIn post announcing her resignation. Schmid has worked for New Brunswick, New Jersey-based J&J for three decades, most recently serving as group chair of J&J MedTech Asia Pacific (APAC).“During his tenure, the APAC region has delivered above-market growth and further strengthened our leadership position across multiple businesses,” J&J said. “Mr. Schmid has also been instrumental in elevating the role ...
- Source: drugdu
- 139
- October 27, 2023
Takeda announces EC approval for Adcetris combination in Hodgkin lymphoma

Roche announces positive phase 3 results for Alecensa in early-stage lung cancer Roche has shared new results from a late-stage study of its anaplastic lymphoma kinase (ALK) inhibitor Alecensa (alectinib) in early-stage lung cancer. The phase 3 ALINA study has been evaluating the targeted drug as an adjuvant therapy in patients with completely resected stage 1B to 3A ALK-positive non-small cell lung cancer (NSCLC). Alecensa was shown to reduce the risk of disease recurrence by 76% compared with platinum-based chemotherapy, Roche said. A clinically meaningful improvement of central nervous system disease-free survival was also observed in those receiving Alecensa, and the safety and tolerability of the therapy were consistent with previous trials in the metastatic setting. Overall survival data was immature at the time of this analysis and the company has outlined that follow-up is ongoing to “report a more mature estimate”. Levi Garraway, Roche’s chief medical officer and head ...
- Source: https://www.pmlive.com/pharma_news/takeda_announces_ec_approval_for_adcetris_combination_in_hodgkin_lymphoma_1502265
- 110
- October 21, 2023
AstraZeneca studies highlight burden of COVID-19 for immunocompromised

Two AstraZeneca studies have highlighted the continued significant and disproportionate burdens of COVID-19 on immunocompromised (IC) individuals.Covering almost 30 million individuals, the INFORM and EPOCH real-world studies showed that IC individuals have a higher rate of severe outcomes from COVID-19 compared to the general population. Including around 12 million participants aged 12 years and older in England, the INFORM study aimed to assess clinical outcomes and utilisation of healthcare resources in relation to COVID-19.The EPOCH study conducted an extensive insurance claims database of around 17 million people, providing real-world data on COVID-19 risks and outcomes in IC and non-IC populations within the US.The data revealed that 22% of all COVID-19 hospitalisations consisted of IC individuals, along with 28% of ICU admissions and 25% of deaths in England. People who are IC have a weakened immune system and are more susceptible to illness with COVID-19 or could be sick for a ...
- Source: drugdu
- 185
- October 20, 2023
After launch limitations, Johnson & Johnson exec touts manufacturing progress on CAR-T drug Carvykti

As Johnson & Johnson and Legend Biotech have sought to grow the reach of their multiple myeloma CAR-T drug Carvykti since winning FDA approval last year, they’ve occasionally run into manufacturing pitfalls. Now, with an eye on a big market expansion, J&J is laying out the state of its cell therapy production writ large. Over the past several months, J&J has been “progressively adding more and more capacity” to churn out Carvykti, John Reed, M.D., Ph.D., executive vice president of pharmaceuticals R&D, said on a Tuesday conference call. Aside from the company’s original launch site in New Jersey, Reed said J&J is close to having an additional Carvykti manufacturing site “up and rolling” in Belgium. The company also plans to boost output by leveraging excess capacity from Novartis under a relatively new partnership. Reed described the lentivirus portion of Carvykti as a “rate-limiting” component of the therapy. Lentiviral vectors are pricey delivery components used to ...
- Source: drugdu
- 108
- October 20, 2023
Surgery to straighten a crooked septum more effective than nasal sprays, trial suggests

Surgery to straighten a crooked septum (the thin wall of bone and cartilage dividing the space between the two nostrils) is more effective than nasal sprays, and should be offered to adults with at least moderate symptoms such as breathing disruption, suggests a UK trial published by The BMJ today.A crooked (deviated) septum often means that one nasal passage is narrower than the other, making it feel blocked, which can affect breathing, sleep or exercising. Surgery to correct this (septoplasty) is a common operation. In 2019-20, 16,700 septoplasties were carried out in England, but there’s a lack of high quality evidence evaluating septoplasty and therefore no clear guidelines for its use.To address this, a team of UK researchers designed the Nasal Airways Obstruction Study (NAIROS) to provide definitive evidence and recommendations for use of septoplasty. Their aim was to inform guidance on which patients may benefit from this treatment, and ...
- Source: drugdu
- 142
- October 20, 2023
CHMP recommends European authorisation for seven new drugs

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended seven new drugs for authorisation. The drugs include Pfizer’s Elrexfio for the treatment of multiple myeloma and Astellas Pharma’s Veozah for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Elrexfio (elranatamab) is a subcutaneously administered bispecific B-cell maturation antigen-directed CD3 T-cell engager. The US Food and Drug Administration (FDA) granted accelerated approval for Elrexfio in August for patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. According to GlobalData, sales for Elrexfio are expected to reach $536m by 2029. One of its competitors in the market is Talvey (talquetamab-tgvs), marketed by Janssen, which was approved as a fifth-line treatment for relapsed/refractory multiple myeloma in August. Talvey is forecasted to generate $1.9bn in sales by 2029. Astellas Pharma’s Veozah ...
- Source: drugdu
- 108
- October 19, 2023
Q&A With Harpreet Gill, Head of Decentralized Clinical Trials at Icon

Mike Hollan Gill discusses her continuing work to transform clinical trials and improve the patient experience through DCTs. Harpreet Gill Head of decentralized clinical trials Icon Harpreet Gill, head of decentralized clinical trials (DCTs) at Icon, is working to make DCTs more easily implemented and more commonly used throughout the industry. She recently spoke with Pharmaceutical Executive about her work. Pharmaceutical Executive: Can you explain the importance of decentralized trials? Harpreet Gill: As the time has gone on over the last few years (and we know the pandemic accelerated this) there’s been a greater need to think about the different ways to engage patients in clinical trials. There’s an element of efficiency there in terms of how data is collected. One of the things that we are seeing is that there are more clinical trials, but there aren’t as many patients there are interested in being involved because it can ...
- Source: drugdu
- 194
- October 19, 2023
New contrastive learning method could improve voice pathology detection

Voice pathology refers to a problem arising from abnormal conditions, such as dysphonia, paralysis, cysts, and even cancer, that cause abnormal vibrations in the vocal cords (or vocal folds). In this context, voice pathology detection (VPD) has received much attention as a non-invasive way to automatically detect voice problems. It consists of two processing modules: a feature extraction module to characterize normal voices and a voice detection module to detect abnormal ones. Machine learning methods like support vector machines (SVM) and convolutional neural networks (CNN) have been successfully utilized as pathological voice detection modules to achieve good VPD performance. Also, a self-supervised, pretrained model can learn generic and rich speech feature representation, instead of explicit speech features, which further improves its VPD abilities. However, fine-tuning these models for VPD leads to an overfitting problem, due to a domain shift from conversation speech to the VPD task. As a result, the ...
- Source: drugdu
- 210
- October 18, 2023
Merck’s Keytruda receives approval greenlight from EU CHMP

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirmed a positive recommendation for Merck’s Keytruda (pembrolizumab) as part of a first-line treatment for advanced gastric and gastroesophageal junction cancer (GEJ). Keytruda, an anti-programmed death receptor-1 (PD-1) therapy, would be used in conjunction with fluoropyrimidine- and platinum-containing chemotherapy in adults whose tumours express PD-L1 with a combined positive score (CPS) ≥1. The intravenously administered drug is designed to improve the immune system’s anti-tumour response by inhibiting the binding of PD-1 to its ligands PD-L1 and PD-L2, thereby activating tumor-fighting T-cells. Keytruda is also being studied as a treatment for hepatobiliary, oesophageal, pancreatic, and colorectal cancers. The EU CHMP’s positive recommendation was based on results from the Phase III KEYNOTE-859 (NCT03675737) study, a randomised, double-blind clinical trial evaluating the efficacy of Keytruda plus chemotherapy as a first-line treatment for human epidermal growth factor receptor-2 (HER2) negative, unresectable or ...
- Source: drugdu
- 171
- October 18, 2023

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