Search Results for “Roche” – Page 19 – media

With Takeda and Hutchmed hot on the trail, Taiho wins FDA nod for stronger Lonsurf regimen in colorectal cancer

Eight years after an initial FDA approval in heavily pretreated colorectal cancer, Taiho Oncology’s Lonsurf has won another green light in the same indication but as part of a more powerful regimen. Instead of a single-agent regimen, the FDA on Wednesday cleared Lonsurf to be used alongside bevacizumab for previously treated metastatic colorectal cancer. Patients who have tried an anti-VEGF inhibitor such as bevacizumab—originally developed by Roche as Avastin—may also qualify for this new combo. The Lonsurf-bevacizumab cocktail proved to be more efficacious than Taiho’s drug alone. Compared with Lonsurf monotherapy, the new combination significantly reduced the risk of death by 39% in a group of patients who had previously received a maximum of two prior chemotherapy regimens and an anti-VEGF agent, plus, in some cases, an anti-EGFR therapy such as Eli Lilly’s Erbitux. In that phase 3 trial, patients who received the combo lived a median 10.8 months, while ...
- Source: drugdu
- 133
- August 4, 2023
Sumitomo, Otsuka’s Schizophrenia Candidate Fails Phase III Trials

Pictured: Woman in mental anguish/iStock, Marina Demeshko Sumitomo Pharma and Otsuka Pharmaceutical announced Monday that two Phase III studies of ulotaront failed to meet primary endpoints for acutely psychotic adults living with schizophrenia. The studies, DIAMOND 1 and DIAMOND 2, pitted the trace amine-associated receptor 1 (TAAR1) agonist against a placebo. After six weeks, the studies showed improvement on the Positive and Negative Syndrome Scale (PANSS), but results were not superior to placebo. A “large placebo effect” was present in both studies “which may have masked the molecule’s therapeutic effect,” according to the press release. While placebo responses are frequently higher in psychiatric studies, Sumitomo CEO Hiroshi Nomura pointed to COVID-19 as a potential culprit for the high placebo effect as the studies were conducted throughout the pandemic. The molecule was part of a four-compound deal forged between Otsuka and Sunovion, a subsidiary of Sumitomo, nearly two years ago. The former made an upfront payment of ...
- Source: drugdu
- 100
- August 2, 2023
Biogen to Cut 1,000 Jobs as Part of $1B Cost Savings Plan

Pictured: Biogen/The Boston Globe via Getty, John Tlumacki With full FDA approval and CMS coverage for Leqembi in hand, Biogen is ramping up its launch efforts for the Alzheimer’s drug and executing a massive cost reduction program. The biotech company announced second-quarter earnings and its new cost-savings plan on Tuesday. The “Fit for Growth” program is expected to generate around $1 billion in operating expense savings by 2025, which includes a headcount reduction of approximately 1,000 jobs, or about 11% of Biogen’s workforce. Around $300 million will be reinvested into product launches and R&D programs for a net savings of $700 million. The staff reduction will be completed by 2025. The company had more than 8,700 employees in 2022, according to Statista. Biogen CFO Michael McDonnell told investors on Tuesday’s earnings call that a “substantial portion” of the $700 million in net operating expense savings are expected to come from cutting ...
- Source: drugdu
- 143
- July 27, 2023
One Simple Brain Hack Might Boost Learning and Improve Mental Health

New research from Duke found that people who imagined being a thief scouting a virtual art museum in preparation for a heist were better at remembering the paintings they saw, compared to people who played the same computer game while imagining that they were executing the heist in-the-moment. These subtle differences in motivation—urgent, immediate goal-seeking versus curious exploration for a future goal—have big potential for framing real-world challenges such as encouraging people to get a vaccine, prompting climate change action, and even treating psychiatric disorders. The findings appeared online July 25 in the Proceedings of the National Academy of Sciences. Alyssa Sinclair, Ph.D. ’23, a postdoctoral researcher working in the lab of Duke Institute for Brain Sciences director Alison Adcock, Ph.D., M.D., recruited 420 adults to pretend to be art thieves for a day. The participants were then randomly assigned to one of two groups and received ...
- Source: drugdu
- 102
- July 27, 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
- 108
- July 25, 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
- 106
- July 21, 2023
Black Patients with ICDs Have Higher Rate of Post-Implant Cardiac Events and Risk of Death

Black patients with implantable cardioverter defibrillators (ICDs) have a significantly higher burden of disease than white patients with the same device, according to a new study from University of Rochester Medical Center (URMC) cardiology researchers. Analyzing data from clinical trials conducted over a 20-year period by the Clinical Cardiovascular Research Center (CCRC) at URMC, investigators concluded that not only did Black patients with ICDs tend to be significantly younger than white patients, but they also had a higher rate of post-implant cardiac events and risk of death. When a patient is at risk for cardiac arrest, an ICD helps to monitor their heart rhythm, and if an abnormality is detected, the device delivers a shock of electricity to reset the heartbeat to a normal rhythm. The study, published in Circulation, examines the rate of events that a patient experiences after their ICD is implanted. After three years of ...
- Source: drugdu
- 129
- July 19, 2023
NVIDIA Doubles Down on AI Drug Discovery with $50M Recursion Investment

Clinical-stage biotech Recursion continues to go from strength to strength. After its recent acquisition of Cyclica and Valence, the company announced a partnership with—and $50 million investment from—NVIDIA on Wednesday. Under the agreement, the tech giant is giving Recursion a $50 million private investment in public equity. The two companies are looking to accelerate the development of Recursion’s AI foundation models to help the biopharma industry create improved patient therapies more quickly. “With our powerful dataset and NVIDIA’s accelerated computing capabilities, we intend to create groundbreaking foundation models in biology and chemistry at a scale unlike anything that has ever been released in the biological space,” Recursion CEO Chris Gibson said in a statement. Recursion has built a massive biological and chemical database via its Recursion OS, which exceeds 23 petabytes and has three trillion searchable compound and gene relationships. The company has been training machine-learning algorithms on this dataset to tackle the complex ...
- Source: drugdu
- 127
- July 14, 2023
Anti-inflammatory Drugs Do Not Lead to a Swifter Hospital Exit

Anti-inflammatory drugs may reduce deaths due to Covid-19, but they do not help speed up the recovery for those in hospital, according to a recent study. Results from s study, published in The Journal of the American Medical Association, demonstrated that giving abatacept, cenicriviroc, or Johnson and Johnson’s Remicade (infliximab) in addition to standard of care did not decrease time to recovery for patients hospitalised with Covid-19 pneumonia. The standard of care included in this study involved Gilead Sciences’ Veklury (remdesivir) and the corticosteroid dexamethasone. Patients who took either one of the three drugs recovered after a similar number of days compared to those who were on placebo. The investigators also measured mortality across the sub-studies by day 28 – which did show slight differences, though not statistically significant. Abatacept and Remicade led to a narrow decrease in patient deaths – a 4.1% and 4.4% difference respectively, whilst ...
- Source: drugdu
- 135
- July 13, 2023
Immunotherapy significantly improves overall survival for advanced NSCLC patients

A global study, led by UCL and UCLH and sponsored by Roche, has shown that the cancer immunotherapy atezolizumab significantly improved the overall survival of advanced stage non-small cell lung cancer patients who were not able to be treated with platinum-containing chemotherapy, when compared to single-agent chemotherapy. The trial results, published today in The Lancet, are good news for non-small cell lung cancer patients who are not eligible for standard of care platinum-based chemotherapy, due to concerns about their ability to withstand the treatment. Lung cancer is the leading cause of cancer death worldwide, with around 2.2 million new cases and 1.8 million deaths a year. The majority of patients present with advanced stage non-small cell lung cancer (NSCLC) . For the fittest patients with advanced stage NSCLC, first-line immunotherapy with or without platinum-based doublet chemotherapy (PDC) is now established as the standard of care treatment. This follows several randomized ...
- Source: drugdu
- 127
- July 9, 2023

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