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Published on Nov 15, 2024

European Medicines Agency Reverses Opinion on Lecanemab for Alzheimer Disease But Limits Eligible Population

In an usual regulatory shift, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on Thursday that it will recommend approval of lecanemab (Leqembi; Eisai) as a treatment for symptoms associated with …

Source: Patient Care - Label Pending
Published on 11:44 GMT

8 most dangerous antiobiotic resistant bacteria in the world

Millions of people die as a direct result of bacterial infections — especially when the bacteria have developed a resistance to the antibiotics we use to treat them. It's this drug-resistance that makes them particularly deadly. And the latest data is …

Source: Deutsche Welle - Public Broadcaster
Published on Nov 15, 2024

Eleventh Industry Standing Group (ISG) meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 21 ...

EMA is holding its eleventh quarterly meeting of the Industry Standing Group (ISG). This forum for interaction has been established as part of the EMA's continuous improvement for engagement with industry stakeholders supply chain of human, veterinary …

Source: European Medicines Agency - Label Pending
Published on 16:21 GMT

Ratio Enters License and Collaboration Agreement with Novartis for SSTR2-targeting Radiotherapeutic Candidate

Breast cancer is the most commonly diagnosed cancer in Europe 7 . HR+/HER2- is the most common subtype, accounting for approximately 70% of all breast cancers, and more than 40% of these are diagnosed in stage II or III 8-10 . The positive CHMP …

Source: Investing News Network - Neutral
Published on 10:09 GMT

Bristol Myers Squibb gets positive CHMP opinion for Opdivo plus Yervoy to treat adult with MSI─H or dMMR metastatic ...

Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with …

Source: Pharmabiz.com - Neutral
Published on 12:59 GMT

‘Right of every Filipino’: Generic brand advocates for affordable healthcare

Healthcare products provider RHEA Generics is committed to promoting affordable healthcare by offering generic medications that provide Filipinos with high-quality and cost-effective options. Neogin Evangelista, the president of PHILUSA Corporation, which …

Source: Interaksyon - Pro-Government
Published on 12:00 GMT

Samsung Bioepis and Biogen Receive European Commission (EC) Approval for Aflibercept Biosimilar, OPUVIZ™

OPUVIZ™ is one of the first wave aflibercept biosimilars in Europe OPUVIZ is the second European Commission (EC)-approved ophthalmology biosimilar under Samsung Bioepis and Biogen’s partnership EC approval based on robust totality of evidence confirming …

Distribution channels: Healthcare & Pharmaceuticals Industry ...
Published on 10:29 GMT

EMA’s CHMP to approve BMS’ Opdivo for colorectal cancer

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a combination therapy consisting of Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) and Yervoy (ipilimumab) for the first-line …

Source: Pharmaceutical Technology - Neutral
Published on 11:40 GMT

How decentralisation can fill the gaps in Alzheimer’s research

In a new era of Alzheimer’s disease research, the emergence of blockbuster therapies like Eli Lilly’s Kisunla (donanemab) and Eisai and Biogen’s Leqembi (lecanemab) offer renewed hope to patients and researchers. Despite their promise, these therapies …

Source: Clinical Trials Arena - Label Pending
Published on 10:19 GMT

Real-World Comparison of Cabazitaxel Versus 177Lu-PSMA Radiopharmaceutical Therapy in Metastatic Castration-Resistant ...

177Lu-vipivotide tetraxetan prostate-specific membrane antigen (177Lu-PSMA) therapy is under current scientific investigation and aims to become established in the treatment of metastatic castration-resistant prostate cancer (mCRPC). However, real-world …

Source: UroToday - Neutral
Published on 11:40 GMT

Alnylam reveals trial outcomes of nucresiran for ATTR amyloidosis treatment

Alnylam Pharmaceuticals has revealed new interim data from its Phase I trial of nucresiran, a ribonucleic acid interference (RNAi) therapeutic for transthyretin (ATTR) amyloidosis treatment. The study showed significant reductions in serum TTR levels in …

Source: Clinical Trials Arena - Label Pending
Published on 11:40 GMT

Eli Lilly reports outcomes from Phase III trial of tirzepatide for HFpEF

Eli Lilly has reported comprehensive outcomes from the Phase III SUMMIT trial of tirzepatide for individuals with heart failure with preserved ejection fraction (HFpEF) and obesity. The double-blind, multi-centre, randomised, parallel, placebo-controlled …

Source: Clinical Trials Arena - Label Pending
Published on 15:11 GMT

Eli Lilly's Zepbound/Mounjaro Shows Cardiovascular Benefits In Patients With Obesity-Related Heart Failure

On Saturday, Eli Lilly And Co LLY released detailed results from the SUMMIT Phase 3 trial showing tirzepatide reduced the risk of worsening heart failure events in adults with heart failure with preserved ejection fraction (HFpEF) and obesity. The 731- …

Source: Benzinga - Neutral
Published on 15:24 GMT

Echinocandin Dosing Considerations in Obese Patients: A Review

Obesity is a worldwide epidemic and widespread in the US, affecting over one third of the population. According to the Centers for Disease Control and Prevention (CDC), all US states have an obesity prevalence that exceeds 20% and obesity …

Source: ContagionLive - Label Pending
Published on 08:12 GMT

EMA committee recommends approval of Merck's Keytruda plus chemotherapy as first─line treatment for adult patients with ...

Merck, known as MSD outside of the United States and Canada, announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Keytruda (pembrolizumab), Merck’s anti-PD- …

Source: Pharmabiz.com - Neutral
Published on 08:10 GMT

Samsung Bioepis gets positive EMA opinion for biosimilars targeting Amgen's Prolia, Xgeva

Samsung Bioepis said it has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for marketing authorization of Obodence and Xbryk, biosimilars of Amgen’s Prolia and Xgeva. These …

Source: Korea Biomedical Review - Neutral
Published on 15:55 GMT

Artificial Intelligence Applications in Lymphoma Diagnosis and Management: Opportunities, Challenges, and Future ...

Introduction Lymphoma, a heterogeneous group of blood cancers, presents significant diagnostic and therapeutic challenges due to its complex subtypes and variable clinical outcomes.1 Accurate diagnosis and classification of lymphoma are critical for …

Source: Dove Medical Press - Neutral
Published on Nov 13, 2024

ACT EU workshop on ICH E6 R3 (principles and Annex 1) , Online, European Medicines Agency, Amsterdam, the Netherlands, ...

As part of the published Accelerating Clinical Trials in the EU (ACT EU) multi-annual workplan 2022-2026 and acknowledging the important role of ICH E6 as the global regulatory guideline for GCP, the ACT EU Priority Action – GCP Modernisation is conducting …

Source: European Medicines Agency - Label Pending
Published on 03:45 GMT

EMA committee recommends approval of Bristol Myers' repotrectinib to treat advanced ROS1─positive NSCLC & NTRK─positive ...

Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for repotrectinib, a next-generation tyrosine kinase inhibitor (TKI), as a treatment for adult …

Source: Pharmabiz.com - Neutral

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Published on November 18, 2024 - 11:49 GMT

President Lai attends 2024 EU Investment Forum

TAIWAN, November 18 - President Lai attends 2024 EU Investment Forum On the afternoon of November 18, President Lai Ching-te attended the opening of the 2024 European Union Investment Forum. In remarks at the event, President Lai stated that as we face the …

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Published on November 18, 2024 - 16:57 GMT

Vacancy: (Junior) Legal Officer – EU Asylum Law

17th November 2024 | News The European Council on Refugees and Exiles (ECRE) is looking to recruit a (Junior) Legal Officer – EU Asylum Law. The position will be appointed at either Junior Legal Officer or Legal Officer level, depending on the successful …

Distribution channels: Politics

Published on November 18, 2024 - 12:59 GMT

InLac spotlights cheese production with Iberian character

Europe is well known for its extensive cheese heritage, and among them are blended cheeses, InLac explains. WASHINGTON, WA, UNITED STATES, November 18, 2024 /⁨EINPresswire.com⁩/ -- The EU is a world cheese power and Spain plays a prominent role, …

Distribution channels: ...
Published on November 18, 2024 - 06:26 GMT

Biodiesel Market Worth US$ 70.9 Billion by 2032

Global Biodiesel Market projected to grow at a CAGR of 3.4% from 2023 to 2032. WILMINGTON, DE, UNITED STATES, November 18, 2024 /⁨EINPresswire.com⁩/ -- According to a new report published by Allied Market Research, the biodiesel market size …

Distribution channels: Energy Industry, Environment ...

Published on November 18, 2024 - 12:45 GMT

Bio Solvents Market to Reach USD 5.7 Billion by 2032 Driven by Sustainable Alternatives & Increased Industrial Adoption

"The rising demand for eco-friendly solvents is driven by global industrial focus on sustainability and regulatory compliance " AUSTIN, TX, UNITED STATES, November 18, 2024 /⁨EINPresswire.com⁩/ -- The Bio Solvents Market …

Distribution channels: Chemical Industry ...
Published on November 18, 2024 - 09:12 GMT

Hydrogen Fuel Cell Train Market Provides an In-Depth Insight of Trends and Landscape Outlook 2035

The hydrogen fuel cell train market is expected to grow due to eco-friendly transportation demand, government support, and advancements in hydrogen technology. WILMINGTON, DE, UNITED STATES, November 18, 2024 /⁨EINPresswire.com⁩/ -- According to …

Distribution channels: Automotive Industry, Energy Industry ...
Published on November 18, 2024 - 12:00 GMT

TIS2024: 10 key trends to define the new tourism landscape

The key trends identified at TIS2024 are moving towards a smarter, more inclusive and climate change-adapted tourism MADRID, SPAIN, November 18, 2024 /⁨EINPresswire.com⁩/ -- The fifth edition of TIS - Tourism Innovation Summit 2024, held from …

Distribution channels: Companies, Technology ...
Published on November 18, 2024 - 10:15 GMT

Compañía Nacional de Chocolates Partners with Farmforce to Launch the Traceability and Zero Deforestation Program (PTCD)

Compañía Nacional de Chocolates launches the Traceability and Zero Deforestation Program with Farmforce, enhancing sustainable cocoa production standards. OSLO, OSLO, NORWAY, November 18, 2024 /⁨EINPresswire.com⁩/ -- The Compañía Nacional de …

Distribution channels: Agriculture, Farming & Forestry Industry, Environment ...

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Published on November 18, 2024 - 17:00 GMT

(Video) The legacy of the November 2019 uprising in Iran

A characteristic of this uprising was its organized nature and the cooperation of the people and rebellious youth to overcome the regime’s security forces. PARIS, FRANCE, November 18, 2024 /⁨EINPresswire.com⁩/ -- The National Council of Resistance …

Distribution channels: Human Rights, International Organizations ...
Published on November 18, 2024 - 15:00 GMT

IEC Group Launches Annual Global EOR Study 2025

BASINGSTOKE, UNITED KINGDOM, November 18, 2024 /⁨EINPresswire.com⁩/ -- “The EOR market is a battleground of rapid growth and fierce competition, offering unparalleled opportunities for companies that can innovate and adapt, while those who lag risk …

Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...
Published on November 18, 2024 - 15:00 GMT

Alternative Family Services Joins California Family Resource Association

Alternative Family Services is paving the way to becoming a full-service Family Resource Center. SANTA ROSA, CA, UNITED STATES, November 18, 2024 /⁨EINPresswire.com⁩/ -- Alternative Family Services (AFS), a prominent foster family agency serving …

Distribution channels: Culture, Society & Lifestyle, Human Rights ...
Published on November 18, 2024 - 14:21 GMT

Global Fund for Widows’ 16th Annual Gala: Corporate, Private, and Individual Supporters Unite for Widows’ Rights

H.E. Graça Machel, H.E. Hilda Suka-Mafudze, and Kisioki Moitiko were honored for advancing economic opportunity and rights for widows and women. NEW YORK, NY, UNITED STATES, November 18, 2024 /⁨EINPresswire.com⁩/ -- The Global Fund for Widows’ ( …

Distribution channels: Human Rights, International Organizations ...
Published on November 18, 2024 - 14:17 GMT

Sustainable Media Center Welcomes New Leadership to Board of Directors, Trustees, and Advisory Board

NEW YORK, NY, UNITED STATES, November 18, 2024 /⁨EINPresswire.com⁩/ -- The Sustainable Media Center is proud to announce significant additions to its leadership, expanding its intergenerational community of over 190 leaders in media, technology, …

Distribution channels: Business & Economy, Media, Advertising & PR ...
Published on November 18, 2024 - 14:00 GMT

AEON MINING launches new user-friendly cloud mining contract

OH, UNITED STATES, November 18, 2024 /⁨EINPresswire.com⁩/ -- AEON MINING, a prominent player in the cloud mining industry, has unveiled groundbreaking innovations aimed at democratising and increasing the profitability of cryptocurrency mining. …

Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...
Published on November 18, 2024 - 14:00 GMT

Top Doctor Magazine Features Robert F. Kennedy Jr. in Special Issue: A Vision for the Future of American Healthcare

Exclusive interview with Robert F. Kennedy Jr. unveils his bold plans for U.S. healthcare reform under President-elect Trump's administration. CA, UNITED STATES, November 18, 2024 /⁨EINPresswire.com⁩/ -- Top Doctor Magazine proudly announces …

Distribution channels: Business & Economy, Healthcare & Pharmaceuticals Industry ...
Published on November 18, 2024 - 14:00 GMT

Investor Calls for Resignation of Exxon CEO After He Calls for Trump to Keep U.S. in Paris Agreement

Darren Woods criticized for prioritizing climate schemes that legitimize opponents of oil and gas production FALLS CHURCH, VA, UNITED STATES, November 18, 2024 /⁨EINPresswire.com⁩/ -- On November 14th, National Legal and Policy Center (NLPC) sent …

Distribution channels: Banking, Finance & Investment Industry, Energy Industry ...
Published on November 18, 2024 - 13:00 GMT

QAwerk Report Reveals Significant Accessibility Barriers for People with Disabilities in U.S. Voter Registration Sites

QAwerk conducted an accessibility evaluation of 43 U.S. online voter registration websites, finding that 65% have medium or low accessibility levels. NEW YORK, NY, UNITED STATES, November 18, 2024 /⁨EINPresswire.com⁩/ -- QAwerk, a leading software …

Distribution channels: Human Rights, IT Industry ...
Published on November 18, 2024 - 12:45 GMT

Dr. Peter Black's NoFear Delivers a High-Stakes Thriller

Dr. Peter Black, renowned for his medico-political thrillers, returns with NoFear, the fourth book in the Dr. Duncan MacGregor series. GREATER LONDON, LONDON, UNITED KINGDOM, November 18, 2024 /⁨EINPresswire.com⁩/ -- Dr. Peter Black, renowned for …

Distribution channels: Book Publishing Industry, Human Rights ...
Published on November 18, 2024 - 11:00 GMT

WFWP Hosts United Nations Day Panel on Peacebuilding with Attendance from Allatra and Creative Society Delegates

VIENNA, AUSTRIA, November 18, 2024 /⁨EINPresswire.com⁩/ -- The Women's Federation for World Peace (WFWP) hosted a significant panel discussion titled “The UN Vision: The Role of Youth and Civil Society to Usher in a Peaceful Society” on United …

Distribution channels: Business & Economy, Human Rights ...
Published on November 18, 2024 - 11:04 GMT

OSCE promotes intelligence-led policing to strengthen efforts against crime in Moldova

From 11 to 15 November, the OSCE gathered representatives from Moldova's General Police Inspectorate in a series of meetings to strengthen national policing strategies through an intelligence-led policing (ILP) framework. The discussions helped …

Distribution channels: Politics
Published on November 18, 2024 - 16:57 GMT

Vacancy: (Junior) Legal Officer – EU Asylum Law

17th November 2024 | News The European Council on Refugees and Exiles (ECRE) is looking to recruit a (Junior) Legal Officer – EU Asylum Law. The position will be appointed at either Junior Legal Officer or Legal Officer level, depending on the successful …

Distribution channels: Politics
Published on November 16, 2024 - 00:20 GMT

Futurum Academy Set to Shape Saudi Arabia’s Future Leaders for Vision 2030 and Beyond

Empowering the next generation in Saudi Arabia, Futurum Academy is set to drives innovation and leadership development aligned with Vision 2030’s goals. RIYADH, SAUDI ARABIA, November 15, 2024 /⁨EINPresswire.com⁩/ -- Futurum Academy, a not-for- …

Distribution channels: Banking, Finance & Investment Industry, Business & Economy ...
Published on November 15, 2024 - 17:25 GMT

Illinois International Port District Receives Federal Funding as Part of the Clean Ports Program

Funded through the EPA, in collaborative partnership with the IEPA, award aligns with Port plans for sustainability and regional economic growth CHICAGO, IL, UNITED STATES, November 15, 2024 /⁨EINPresswire.com⁩/ -- The Illinois International Port …

Distribution channels: Energy Industry, Environment ...
Published on November 15, 2024 - 16:53 GMT

Javier Palomarez, USHBC President, Congratulates Hispanic U.S. Senators and Senators-elect Serving the 119th Congress

WASHINGTON, DC, UNITED STATES, November 15, 2024 /⁨EINPresswire.com⁩/ -- The United States Hispanic Business Council (USHBC) congratulates the Hispanic U.S. Senators and Senators-elect serving in the 119th Congress: Senators Ted Cruz (R-TX), Marco …

Distribution channels: Business & Economy, Companies ...
Published on November 15, 2024 - 16:34 GMT

Pennsylvania Legislature Passes Measure to Include Pets in Domestic Violence Settings

HB1210 Passes Senate After Years of Animal Wellness Action Advocacy Work HARRISBURG, PA, UNITED STATES, November 15, 2024 /⁨EINPresswire.com⁩/ -- Pennsylvania lawmakers gave final approval this week to HB1210, a groundbreaking bill that explicitly …

Distribution channels: Agriculture, Farming & Forestry Industry, Culture, Society & Lifestyle ...
Published on November 15, 2024 - 13:16 GMT

World's Best Hair Transplant in 2024: Latest Announcements and Updates

World's Best Hair Transplant in 2024: New Announcements About Hair Transplant ISTANBUL, BAKIRKOY, TURKEY, November 15, 2024 /⁨EINPresswire.com⁩/ -- Hair transplantation has become one of the most sought-after medical procedures worldwide, as …

Distribution channels: Beauty & Hair Care, Business & Economy ...
Published on November 15, 2024 - 13:00 GMT

THE NATIONAL SPACE SOCIETY CONGRATULATES GEORGE WHITESIDES ON HIS CONGRESSIONAL WIN

Former Executive Director of the Organization Takes Seat in California’s 27th District KENNEDY SPACE CENTER, FL, UNITED STATES, November 15, 2024 /⁨EINPresswire.com⁩/ -- The National Space Society (NSS) congratulates George Whitesides on his …

Distribution channels: Aviation & Aerospace Industry, Business & Economy ...
Published on November 16, 2024 - 00:45 GMT

Assad and Hezbollah hunker down in Syria

This article is part of an MEI strategic initiative that examines how to enhance regional cooperation between the United States and its partners on addressing the challenges posed by Iran across the region, particularly in key areas like Lebanon, Syria, …

Distribution channels: Politics