Search Results for “antibody” – Page 20 – media

Eli Lilly Shows Appetite for Oral Immunology Drugs, Swallowing Morphic in $3.2B Deal

Eli Lilly’s Morphic acquisition brings an oral small molecule that blocks the same target as Entvyio, an injectable inflammatory bowel disease drug from Takeda Pharmaceutical. The Morphic deal follows Lilly’s 2023 acquisition of Dice Therapeutics, another company developing oral immunology medications. By Frank VinluanEli Lilly has immunology and inflammation products administered by injection, but the pharmaceutical giant is among the companies interested in bringing patients more convenient pill formulations. Its $3.2 billion acquisition of Morphic comes with a lead drug candidate that’s an oral small molecule in mid-stage development for inflammatory bowel disease. According to deal terms announced Monday, Lilly is paying $57 in cash for each share of Waltham, Massachusetts-based Morphic. That price represents a 79% premium to Morphic’s closing stock price on Friday. The deal, which has been approved by the boards of directors of both companies, is expected to close in the third quarter of this year. ...
- Source: drugdu
- 104
- July 10, 2024
Sanofi & Regeneron Drug Dupixent Gets EMA Approval as the First Biologic COPD Med

European Medicines Agency approval of Dupixent in chronic obstructive pulmonary disease makes the drug the first biologic therapy approved for treating the prevalent respiratory condition. In COPD, Dupixent addresses what’s called type 2 inflammation. By Frank Vinluan Inflammation that develops in chronic obstructive pulmonary disorder stems from different causes. A new regulatory decision in Europe makes Sanofi and Regeneron Pharmaceuticals drug Dupixent the first biologic therapy approved for COPD driven by one particular type of inflammation. The European Medicines Agency (EMA) has approved Dupixent for adults with uncontrolled COPD that is also characterized by raised blood levels of eosinophils, a type of white blood cell. COPD patients typically take multiple medications to manage the chronic condition. The new Dupixent approval, announced just prior to the Independence Day holiday in the U.S., covers use of the injectable drug as an add-on maintenance treatment for patients whose COPD is uncontrolled by available therapies. ...
- Source: drugdu
- 87
- July 9, 2024
EMA approval of Sanofi/Regeneron’s Dupixent fills biologic gap in COPD

Following the European Medicines Agency (EMA) approval of Sanofi/Regeneron’s Dupixent (Dupilumab) on July, 03 2024, Asiyah Nawab, Pharma Analyst at GlobalData, offers her view: “Dupixent, a monoclonal antibody (mAb) targeting interleukin-4 (IL4) and interleukin-13 (IL13) pathways, has been approved by the EMA as the first biologic for uncontrolled chronic obstructive pulmonary disease (COPD) patients. It is to be used specifically as an add-on maintenance treatment, given alongside the standard of care (SoC), with a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA. The approval is set to improve the treatment landscape for COPD and offer patients a treatment option with potential to improve quality of life,” states Nawab “After reviewing the data published from Sanofi/Regeneron’s two landmark phase 3 studies (BOREAS and NOTUS), Dupixent (dupilumab) was able to significantly reduce moderate or ...
- Source: drugdu
- 107
- July 6, 2024
Moderna Awarded $176 Million from the Biomedical Advanced Research and Development Authority to Expedite Development of mRNA-Based Influenza Vaccines

By Don Tracy, Associate Editor Funding from the Biomedical Advanced Research and Development Authority (BARDA) is expected to support the late-stage development and licensure of a pre-pandemic vaccine targeting the H5 influenza virus. The Biomedical Advanced Research and Development Authority (BARDA) has granted Moderna a $176 million project award under the Rapid Response Partnership Vehicle (RRPV) Consortium, with the goal of expediting the development of mRNA-based pandemic influenza vaccines. Reportedly, the award is expected to support the late-stage development and licensure of a pre-pandemic vaccine targeting the H5 influenza virus, a subtype known for causing severe avian influenza and posing a potential risk to humans.1 “mRNA vaccine technology offers advantages in efficacy, speed of development, and production scalability and reliability in addressing infectious disease outbreaks, as demonstrated during the COVID-19 pandemic,” said Stéphane Bancel, CEO, Moderna, in a press release. “We are pleased to continue our collaboration with BARDA to ...
- Source: drugdu
- 136
- July 5, 2024
Biogen completes $1.15bn HI-Bio acquisition to expand immunology presence

As Eli Lilly’s Kisunla (donanemab) enters the Alzheimer’s treatment space, its leading competitor Biogen is undergoing therapy diversification after completing its $1.15bn acquisition of Human Immunology Biosciences (HI-Bio). The deal, which was agreed upon in May this year and includes $650m in milestone payments, sees Biogen bolster its pipeline with US-based HI-Bio’s anti-CD38 monoclonal antibody candidate felzartamab. Biogen’s head of development Priya Singhal said the company is “very excited” about the addition of felzartamab to its rosters in a 2 July press release, adding that Biogen will advance the candidate to Phase III now the transaction is complete. Felzartamab has already demonstrated positive Phase II data in a range of immune-mediated diseases, including IgA nephropathy (IgAN), antibody-mediated rejection (AMR), and primary membranous nephropathy (PMN). The Phase III development plans are for all three diseases, according to Biogen. Felzartamab was originally developed by MorphoSys as a possible competitor to Johnson & ...
- Source: drugdu
- 86
- July 5, 2024
Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi

Eli Lilly’s Kisunla is now FDA approved for treating patients in the early stages of Alzheimer’s disease. In addition to slowing cognitive decline and disease progression, clinical trial results showed that amyloid beta plaques were reduced to the point where some patients could stop taking the infused therapy. By Frank VinluanEli Lilly Alzheimer’s disease drug has received its long-awaited FDA approval, bringing patients a treatment that works similarly to an Eisai medication for the neurodegenerative disorder but with dosing advantages that patients might prefer. The Tuesday regulatory decision comes less than a month after an FDA advisory committee voted unanimously that the benefits of the Lilly drug in slowing cognitive decline outweigh its safety risks. The approval covers the treatment of Alzheimer’s patients with mild cognitive impairment or mild dementia, the same population that was evaluated in clinical trials. Known in development as donanemab, Lilly will market its new Alzheimer’s ...
- Source: drugdu
- 114
- July 4, 2024
Henlius Receives Approval in Japan for Phase 3 MRCT of Anti-PD-1 mAb Serplulimab Combo on First-Line mCRC

Shanghai, China, July 2, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the clinical trial notification (CTN) for phase 3 international multicenter clinical study (ASTRUM-015) of Henlius’ self-developed anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) in combination with bevacizumab and chemotherapy in patients with metastatic colorectal cancer (mCRC) has been permitted by Japan’s Pharmaceuticals and Medical Devices Agency. The study has previously completed dosing of the first subject in China, and the regulatory registration and clinical development is advancing efficiently in more countries and regions around the world. Colorectal cancer (CRC) is one of the most common malignant cancers globally. Over 1.9 million newly diagnosed cases and more than 900,000 deaths were estimated in 2022, and the incidence rates were highest in Europe and Oceania [1]. It is estimated that, by 2040, the burden of CRC will increase to 3.2 million new cases per year (an increase of 63%) and ...
- Source: drugdu
- 78
- July 4, 2024
CDC’s Advisory Committee Unanimously Recommends Vaxelis to Prevent Invasive Hemophilus Influenzae Type B in American Indian and Alaska Native Infants

Don Tracy, Associate EditorThe inclusion of Vaxelis in the CDC’s preferential recommendations is expected to influence vaccine administration strategies and public health policies in high-risk populations moving forward. Haemophilus influenzae bacteria, 3D illustration. Image Credit: Adobe Stock Images/Dr_Microbe Image Credit: Adobe Stock Images/Dr_Microbe The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has unanimously voted to add Vaxelis to its preferential recommendations for the treatment of American Indian and Alaska Native infants with invasive Hemophilus influenzae type B (Hib). Developed as a collaboration between Merck and Sanofi, Vaxelis is the only hexavalent combination vaccine available in the United States. Vaxelis could potentially offer the advantage of reducing the number of injections needed in the first year of life compared to other vaccine schedules. Moving forward, the recommendation has the potential to significantly influence vaccine administration strategies and public health policies, especially in high-risk populations.1 “We ...
- Source: drugdu
- 85
- July 2, 2024
Sarclisa Combination Improves Progression-Free Survival in Patients with Newly Diagnosed Transplant-Ineligible Multiple Myeloma

Don Tracy, Associate Editor Reportedly, data from the IMROZ study marks the first time an anti-CD38 monoclonal antibody combined with standard-of-care therapy has demonstrated significant improvement in progression-free survival for newly diagnosed transplant-ineligible multiple myeloma. Results from the IMROZ Phase III trial show that Sanofi’s Sarclisa (isatuximab-irfc) in combination with standard-of-care therapy comprised of lenalidomide and dexamethasone (VRd) significantly reduced the risk of disease progression or death by 40% compared to a solo VRd regimen in patients with newly diagnosed transplant-ineligible multiple myeloma (MM). According to the company, the data represents the first time an anti-CD38 monoclonal antibody combined with VRdsupported a significant improvement in progression-free survival (PFS) for these patients. “The significant progression-free survival (PFS) benefit observed with Sarclisa combination therapy compared to VRd is important and encouraging for patients with newly diagnosed multiple myeloma. Effective frontline therapy has the potential to modify the course of the disease, which ...
- Source: drugdu
- 67
- July 1, 2024
Level Up Your Self Love, Check Your Status

Don Tracy, Associate Editor As a part of National HIV Testing Day, the Centers for Disease and Control Prevention encourages testing as a part of taking charge of individual health and wellness. Today is National HIV Testing Day (NHTD) and as part of this year’s theme, “Level up your self-love: check your status,” individuals across the United States are being encouraged to get tested to show value, respect, and compassion for each other by taking charge of our health and wellness, according to the Centers for Disease and Control Prevention (CDC). “HIV testing is an essential entry point for services such as PrEP for those without HIV, and HIV treatment for those who have HIV,” reports the CDC. “Testing programs have been critical contributors to the 12% decrease in estimated HIV infections from 2018 to 2022, and a major factor contributing to ongoing disparities in HIV is a lack of ...
- Source: drugdu
- 94
- June 29, 2024

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