Search Results for “antibody” – Page 53 – media

Pfizer Inks Potential $7B Deal with Flagship to Deepen Pipeline

Pfizer is looking to enrich its pipeline with up to 10 new innovative medicines by partnering with startup creator Flagship Pioneering, the companies announced Tuesday. Under the terms of the agreement, Pfizer and Flagship will each contribute an upfront investment of $50 million. The collaboration will leverage Flagship’s rich ecosystem of biotechnology platforms and more than 40 human health companies. Pfizer and Flagship will explore up to 10 single-asset programs, which Pfizer will fund and have the option to acquire. Flagship and its companies will be eligible to receive up to $700 million in milestones and royalties for each program that hits the market, giving Tuesday’s deal a maximum potential value of $7 billion. This partnership will bring together expertise from Pfizer and Flagship “to maximize discovery and development potential from inception to impact,” Paul Biondi, executive partner at Flagship and president of Pioneering Medicines, said in a statement. ...
- Source: drugdu
- 106
- July 20, 2023
Pukang Biotechnology Completes Phase IV Clinical Trial of Hepatitis A Vaccine

Recently, Zhejiang Pukang Biotechnology Co., Ltd. has completed the Phase IV clinical trial titled “Single-Arm, Multi-Center Evaluation of the Safety and Immunogenicity of Freeze-Dried Live Attenuated Hepatitis A Vaccine in Chinese Children Aged 18-24 Months” and received the final report. This Phase IV clinical study, involving a large sample size of 10,000 cases across multiple centers, aimed to observe the safety and immunogenicity of the freeze-dried live attenuated Hepatitis A vaccine in the real world. The study results show that after a single dose of the vaccine, the AEFI incidence rate in the 18-24 month-old children was 0.34%, with no serious AEFI reported, and an antibody seroconversion rate of 98.91%. This confirms the vaccine’s good safety and immunogenicity profile, providing richer data support for its widespread application. The freeze-dried live attenuated Hepatitis A vaccine (H2 strain), developed and produced by Zhejiang Pukang Biotechnology Co., Ltd., simulates ...
- Source: drugdu
- 144
- July 20, 2023
Acumen Shares Positive Results for Investigational Alzheimer’s Disease Therapy at AAIC

Acumen Pharmaceuticals has presented positive topline results from an early-stage study of its investigational Alzheimer’s disease therapy at this year’s Alzheimer’s Association International Conference (AAIC). The drug, ACU193, works by targeting and binding to amyloid beta oligomers, a toxic and soluble version of the amyloid protein that forms brain plaques associated with Alzheimer’s disease. Results from the phase 1 randomised, placebo-controlled INTERCEPT-AD study of 62 patients with early Alzheimer’s disease showed the candidate was generally well tolerated throughout both single-ascending and multiple-ascending dose cohorts. Patients who received higher doses of the drug also showed a reduction in amyloid plaque after six to 12 weeks, the company said, adding that the study suggests the drug can be given as a monthly intravenous infusion. Commenting on the positive results, Acumen’s president and chief executive officer, Daniel O’Connell, said: “ACU193’s observed dose-related central target engagement, rapid reduction of ...
- Source: drugdu
- 125
- July 19, 2023
Eli Lilly Strengthens the Case for Going Early in Alzheimer’s Treatment

Alzheimer’s disease patients in the earliest stages of their disease benefited the most from Eli Lilly drug donanemab, which is expected to receive an FDA decision by the end of 2023. Full results from the drug’s pivotal study were presented during the during the Alzheimer’s Association International Conference. Eli Lilly has submitted its Alzheimer’s disease drug candidate for FDA review, and the pharmaceutical giant is now revealing a more complete look at the clinical data supporting an application that could make the therapy the second anti-amyloid antibody to win full regulatory approval. Lilly had previously said its drug, donanemab, led to a 35% slowing in the decline associated with Alzheimer’s. Those results were for patients with intermediate levels of tau, another protein that’s also characteristic of Alzheimer’s progression. In patients with low-to medium-levels of tau, representing an earlier stage of the disease, treatment with the Lilly drug led to a ...
- Source: drugdu
- 116
- July 19, 2023
Roche in Talks to Buy Stomach Drug from Roivant for $7B

Ulcerative colitis and Crohn’s disease are big business, and Roche could be all in, according to a report that has the Swiss pharma in talks to acquire a late-stage candidate from Roivant Sciences for upwards of $7 billion. The deal—which would be one of the largest struck by newly seated CEO Thomas Schinecker—could be announced in the coming days, according to The Wall Street Journal, which broke the news Thursday evening. Sources familiar with the talks cautioned that they could still break down and that another suitor could emerge, the WSJ reported. The drug at the center of the rumored discussions is RVT-3101, an anti-TL1A antibody that recently showed positive results in a Phase IIb study in patients with moderate to severe ulcerative colitis (UC). After 56 weeks of treatment, 36% of participants who received the optimum dose of the drug achieved clinical remission, according to Roivant, which announced the results in June. This was a marked increase ...
- Source: drugdu
- 127
- July 18, 2023
Healthy Breast Fat may Protect Against Invasive Breast Cancer

Researchers have found a possible explanation as to why higher breast density and older age increase the risk of breast cancer. In an innovative study, researchers at the Turku Bioscience Centre, InFLAMES Flagship of the University of Turku, and Turku University Hospital, Finland, have made an extraordinary discovery that turns conventional wisdom on its head. Their findings reveal that healthy fat cells in the breast, also known as adipocytes, secrete a potent factor called IGFBP2, which acts as a barrier against invasive breast cancer progression. Dr. Emilia Peuhu (Study Key Collaborator) said, “Adipocytes generally get a bad rap for promoting cancer progression, but this study demonstrates that healthy breast fat can play a protective role in the maintenance of tissue homeostasis and cancer containment. It’s time to re-evaluate our assumptions and recognize the important role of these unsung heroes.” Breast cancer patients who experience the transition ...
- Source: drugdu
- 106
- July 18, 2023
Untangling the Amyloid-Tau Connection to Inform New Drug Development

For the first time, Alzheimer’s patients in the U.S. have a treatment that has shown the ability to modify the disease in some patients. But experts have called Leqembi—developed by Eisai and Biogen—a “modest win” and a “first step” in the fight against Alzheimer’s disease. The next step could lie in untangling the correlation between amyloid and tau proteins—and defining what it means for drug development. The predominant theory is that Alzheimer’s is caused by the accumulation of two proteins—amyloid-beta and tau—in the brain. The anti-amyloid hypothesis received regulatory validation in June 2021 when the FDA approved Aduhelm (aducanemab) based on clinical data showing that the drug’s reduction of amyloid-beta plaques was reasonably likely to predict clinical benefit. A more solid endorsement arrived last week with the traditional approval of Leqembi (lecanemab). Leqembi and Aduhelm—along with and Eli Lilly‘s donanemab, which the company is expected to submit for regulatory approval soon—are anti-amyloid antibodies. All of these therapies have secondary ...
- Source: drugdu
- 135
- July 17, 2023
Roche’s Ocrevus Shows Promise as a Subcutaneous Injection in Phase 3 MS Trial

Roche has announced positive results from a late-stage study of Ocrevus (ocrelizumab) as a twice-yearly subcutaneous injection in patients with relapsing forms of multiple sclerosis (MS) or primary progressive MS. Over 2.8 million people worldwide are affected by MS, a disabling and unpredictable neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves, disrupting communication between the brain and the rest of the body. Relapsing-remitting MS accounts for approximately 85% of MS cases and is characterised by episodes of new or worsening signs or symptoms followed by periods of recovery, while primary progressive MS affects about 15% of patients and is marked by steadily worsening symptoms. Roche’s Ocrevus is a humanised monoclonal antibody designed to target a type of immune cell thought to be a key contributor to myelin and axonal damage, which can lead to disability in people with ...
- Source: drugdu
- 132
- July 17, 2023
Roche’s New Subcutaneous Version Measures up to IV Ocrevus in Multiple Sclerosis

With the multiple sclerosis market growing rapidly—from $18.9 billion in 2020 to a projected $29.8 billion in 2030, according to GlobalData—Roche is primed to take advantage with Ocrevus (ocrelizumab).Now the monoclonal antibody, which racked (PDF) up nearly $7 billion in sales last year, appears on the verge of gaining an added advantage with a more convenient way to be administered. A phase 3 study has shown that a new, subcutaneous version of Ocrevus has proven to be non-inferior to the current infused treatment as measured by the level of drug in the blood, 12 weeks after administration. Specific numbers were not included in Roche’s release but the company said that the trial achieved both its primary and secondary endpoints. The injected version also matched the performance of the infused treatment in controlling magnetic resonance imaging (MRI) lesion activity in the brain over 12 weeks, Roche said. The injected regimen of Ocrevus is a ...
- Source: drugdu
- 171
- July 15, 2023
Eisai, Biogen’s Leqembi May Face Rollout Hurdles Now, but Experts Still Like the Alzheimer’s Drug

After a full FDA approval last week triggered Medicare coverage of Eisai and Biogen’s Leqembi, doctors are still trying to work out the logistics of testing and reimbursement. But at least two experts remain positive about the drug’s efficacy and safety profile.The new Leqembi label carries a boxed warning about the risks of brain bleeding and swelling known as amyloid-related imaging abnormalities (ARIA). But two Alzheimer’s opinion leaders suggested the side effect is manageable typically by extensive monitoring in the first six months, Leerink Partners analysts said in a Wednesday note. But the two experts were split on whether they intend to treat patients with the ApoE ε4 genetic trait. The FDA label requires testing for that biomarker before initiating Leqembi to inform the risk of ARIA. While one expert felt comfortable giving Leqembi to APOE4 carriers as long as the patients are informed of the risk, the other ...
- Source: drugdu
- 103
- July 15, 2023

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