Search Results for “antibody” – Page 52 – media

ADC Discontinues Zynlonta Trial in DLBCL After Seven Deaths

Pictured: Doctor checking a patient’s neck/iStock, stefanamer ADC Therapeutics is discontinuing the Phase II LOTIS-9 trial testing Zynlonta (loncastuximab tesirine-lpyl) in combination with Genentech and Biogen’s Rituxan (rituximab) for patients with previously untreated diffuse large B-cell lymphoma, the company announced Thursday afternoon. The decision to discontinue comes after the Swiss biotech decided last week to voluntarily halt enrollment in LOTIS-9 after seven patients died of extreme respiratory events. While six of the fatalities were deemed “unlikely or unrelated to the study drug,” the company nevertheless elected to suspend the entry of patients into the study. In connection with the deaths, the FDA has also placed a partial clinical hold on enrollment into LOTIS-9, according to ADC’s Thursday press release. However, the company can continue dosing diffuse large B-cell lymphoma (DLBCL) patients who were seeing clinical benefit from the experimental treatment regimen, as long as these patients have given their consent again. Once ...
- Source: drugdu
- 240
- July 25, 2023
Vir’s GSK-Backed Flu Vaccine Candidate Fails Phase II Trial

Pictured: Flu vaccine vials and syringe/iStock, vchal Topline data from the Phase II PENINSULA study showed that Vir Biotechnology’s investigational flu shot VIR-2482 fell short of its primary and all secondary efficacy endpoints, the biotech announced Thursday. Patients inoculated with the highest 1,200-mg dose of the vaccine candidate saw a 16% drop in influenza A-like illness as compared with placebo, an effect that did not satisfy statistical significance, according to Vir’s news release. PENINSULA defined this primary endpoint as PCR-confirmed influenza A infection with at least one respiratory and one systemic symptom. Phil Pang, Vir’s chief medical officer, called these findings “disappointing” in a statement, but nevertheless said that the company needs to conduct further analysis to “better understand these outcomes.” Vir plans to present these analyses at a future major medical congress. PENINSULA is double-blinded, randomized and placebo-controlled study with approximately 3,000 adult patients enrolled. VIR-2482 was given as a ...
- Source: drugdu
- 151
- July 25, 2023
Sanofi Expects Infant RSV Shot to Roll Out Before Respiratory Virus Season This Fall

Sanofi expects its infant RSV shot to roll out in the U.S. before respiratory virus season this fall, a company spokesperson said Friday. The Food and Drug Administration on Monday approved Beyfortus, a monoclonal antibody that is administered as a single dose to infants before or during their first respiratory syncytial virus season. The Sanofi spokesperson said the company does not expect any challenges with manufacturing or capacity to meet demand this RSV season. The French drugmaker jointly developed Beyfortus with AstraZeneca , which is based in England. A panel of independent advisors to the Centers for Disease Control and Prevention will meet on Aug. 3 to make recommendations about how the shot should be administered. Sanofi is working with the panel to place Beyfortus on the U.S. childhood immunization schedule, the company spokesperson said. The Affordable Care Act requires most private insurance to cover ...
- Source: drugdu
- 127
- July 25, 2023
ADC Therapeutics Pulls the Plug on Zynlonta Study After Partial FDA Hold

A week after ADC Therapeutics paused its Zynlonta trial to review seven deaths and five other respiratory events in patients who received the drug, the company has scrapped the study altogether following an FDA partial clinical hold. The trial was testing the drug, combined with Roche’s Rituxan, in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Citing the “challenges of defining the addressable segment” of the difficult-to-treat population, ADC believes the benefit-risk profile “does not support” the continuation of the study, the company said in a release. The call came after a meeting with the FDA, in which the agency slapped a partial hold on enrolling new patients in the trial. However, the agency said patients who are already on the drug and seeing clinical benefits can remain enrolled after reconsenting. After those patients are treated, ADC will take steps to wrap up the trial. ...
- Source: drugdu
- 112
- July 25, 2023
J&J’s Darzalex Stays on its Upward Trajectory as Company Adds $1B to Annual Sales Projection

In 2017, when Genmab CEO Jan van de Winkel declared its multiple myeloma drug Darzalex—which is marketed by Johnson & Johnson—had the potential for peak sales of $13 billion, he relented that it was a best-case scenario.Six years later, that best-case scenario appears possible. On Thursday, J&J reported another quarter of strong sales for the monoclonal antibody. Darzalex generated $2.43 billion in the period, a 22% increase from the second quarter of last year. After realizing sales of $6 billion in 2021 and $8 billion last year, Darzalex is on track to approach revenue of $10 billion in 2023. The drug, which was approved in 2015, was boosted in 2020 with the development of Darzalex Faspro, a subcutaneous version of the treatment which allows patients to receive doses in minutes compared to hours for the previous intravenous administration. A year ago, J&J reported that 85% of patients receiving Darzalex were using Faspro. ...
- Source: drugdu
- 117
- July 24, 2023
Sanofi Puts Up $125M to Partner on Oral Drug That Could Be Dupixent’s Successor

Sanofi is interested in Recludix Pharma’s approach to treating inflammation with an oral small molecule that targets a protein thought to be undruggable. If it works, the drug could have safety and dosing advantages over currently available biologic drugs, including blockbuster Sanofi drug Dupixent. By FRANK VINLUAN Photo: Nathan Laine/Bloomberg, via Getty Images Sanofi is a dominating presence in inflammation and immunology with Dupixent, a blockbuster drug whose sales continue to grow in multiple approved indications. That product is an antibody administered by injection, so several companies are vying to compete by developing oral alternatives. Now Sanofi is joining them. The Paris-based pharmaceutical giant has struck up a partnership with Recludix Pharma. The deal focuses on the biotech’s preclinical oral small molecules, which have potential applications in a range of immunological and inflammatory diseases. Sanofi has committed to $125 million in near-term payments to Recludix to begin the alliance. San ...
- Source: drugdu
- 110
- July 22, 2023
Phase III Data Show Keytruda’s Promise in Earlier-Stage Cervical Cancer

Pictured: Merck Research Laboratories headquarters in Silicon Valley/iStock, Michael Vi Merck’s anti-PD-1 blockbuster Keytruda (pembrolizumab) aced one of its primary efficacy metrics in the Phase III KEYNOTE-A18 study, the company announced Wednesday. Though its news release was sparse with specific data from the study, Merck said that an independent Data Monitoring Committee found that Keytruda with chemoradiotherapy led to a significant and clinically meaningful improvement in progression-free survival (PFS), as compared with chemoradiotherapy alone. “[T]hese results reinforce our research efforts in earlier stages of disease where there is a greater potential for better outcomes,” Gursel Aktan, vice president of global clinical development at Merck Research Laboratories, said in a statement. KEYNOTE-A18, also known as ENGOT-cx11/GOG-3047, is a randomized and double-blinded trial enrolling 980 patients with newly diagnosed, locally advanced cervical cancer. To be eligible, patients must also be classified as high-risk, defined as having stage 1B2 to 2B and lymph ...
- Source: drugdu
- 107
- July 21, 2023
Researchers Report on Inhibitory Effect of Glioblastoma Signals to Macrophages

Glioblastoma (histology slide). Credit: Wikipedia/CC BY-SA 3.0 “Don’t eat me,” is how one might translate the signal that the cancer cells in a glioblastoma send to the macrophages (white blood cells specialized in removing dead and dying cellular matter) in the brain. Immunotherapy attempts to enable these cells to eradicate the abnormal cells, but so far, it has met with little success when it comes to glioblastomas. Researchers led by Professor Gregor Hutter from the Department of Biomedicine at the University and University Hospital Basel have recently used patient data, experiments with mice, and samples from human tumors to study one of these “don’t eat me” signals and its inhibitory effect. Their findings, which may pave the way for effective immunotherapies for glioblastomas, are now being published in Science Translational Medicine. The signal is based on sugar molecules called sialic acid glycans on the surface of the cancer cells. These sugar molecules are ...
- Source: drugdu
- 128
- July 21, 2023
US FTC Requests More Information on Pfizer’s Proposed $43bn Seagen Acquisition

The US Federal Trade Commission (FTC) has requested more information and documentary material regarding Pfizer’s proposed $43bn acquisition of Seagen. The second request is a standard review procedure by which the FTC and the Antitrust Division of the US Department of Justice investigate mergers and acquisitions. If a second request is submitted, the law forbids merging companies from completing a transaction until they have substantially complied with the additional investigatory request. The Pfizer/Seagen agreement, which was originally announced in March this year, would mark a significant boost to the US pharma’s oncology pipeline. At the time of the announcement, Pfizer’s oncology portfolio included 24 approved drugs, while Seagen’s included Adcetris for lymphomas, Padcev for bladder cancers, Tivdak for cervical cancer, and Tukysa for breast and colorectal cancers. The deal would also grant Pfizer access to Seagen’s drug development pipeline as well as its proprietary ...
- Source: drugdu
- 222
- July 21, 2023
Pfizer Group B Strep Vaccine for Infants Returns Encouraging Mid-Stage Trial Results

Pfizer on Wednesday said its experimental vaccine targeting the potentially deadly bacterial disease Group B Streptococcus returned strong mid-stage clinical trial results, a promising step as the drug inches toward potential approval. Pfizer is among several drugmakers racing to develop the world’s first shot targeting Group B strep disease, which is linked to nearly 150,000 infant deaths worldwide each year, especially in lower-income countries. The Food and Drug Administration in September granted breakthrough therapy designation to Pfizer’s vaccine, which is intended to expedite the development and review of the shot. Pfizer’s single-dose shot generated antibodies that may provide infants with meaningful protection against the disease, according to the data released Wednesday from a phase two clinical trial. The jab is administered to expectant mothers, who pass vaccine-induced antibodies to their fetuses. One of the company’s vaccines targeting respiratory syncytial virus also uses that maternal vaccination method. ...
- Source: drugdu
- 110
- July 21, 2023

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