Search Results for “FDA” – Page 153 – media

77.4% ORR! Abbisko to present the updated clinical phase Ib data of Pimicotinib (ABSK021) at the 2023 ASCO Annual Meeting

SHANGHAI, May 28, 2023 /PRNewswire/ — Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) today announced that the updated results of Phase Ib study of its CSF-1R inhibitor Pimicotinib (ABSK021) in treating patients with advanced tenosynovial giant cell tumor (“TGCT”), will be released at the 2023 American Society of Clinical Oncology (“ASCO”) annual meeting to be held in Chicago, USA from June 2 to June 6, 2023. The data demonstrates the excellent antitumor efficacy and the safety profile of Pimicotinib in the treatment of patients with advanced TGCT and will be presented with the title of “EFFICACY AND SAFETY PROFILE OF PIMICOTINIB (ABSK021) IN TENOSYNOVIAL GIANT CELL TUMOR (TGCT): PHASE 1B UPDATE” in a poster presentation with the poster Bd# of “493”. Among the data released by Abbisko, the most remarkable result is the objective response rate (ORR) of the 50 mg QD dose group of Pimicotinib (ABSK021), which reached 77.4% ...
- Source: drugdu
- 132
- May 31, 2023
EU regulators recommend yanking authorization for Novartis’ sickle cell med Adakveo after phase 3 miss

After Novartis’ sickle cell disease medicine Adakveo flopped in a phase 3 trial, European regulators promised to take a closer look at its prior approval. Now, the re-examination has come back with a recommendation to revoke authorization. The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended snatching back Novartis’ approval after concluding that the med’s benefits did not outweigh the risks. The decision was based on the results of the phase 3 STAND trial, where the drug didn’t outperform placebo. Specifically, Adakveo (crizanlizumab) couldn’t reduce the number of painful crises leading to a healthcare visit. Adakveo-treated patients saw an average of 2.5 painful crises resulting in a healthcare visit over their first year of treatment, while patients in the placebo group had an average of 2.3. Another nail in the coffin was the average number of crises requiring a home healthcare visit or treatment, which ...
- Source: drugdu
- 162
- May 30, 2023
Merck’s Keytruda, Novartis’ Kisqali face their moment of truth in early-stage cancers

Two cancers studies are slated to grab significant attention at the upcoming American Society of Clinical Oncology 2023 annual meeting, and each could lead to a major label expansion for the companies involved. With KEYNOTE-671, Merck is looking to shake up how nonmetastatic non-small cell lung cancer (NSCLC) is treated by testing Keytruda both before and after surgery. For its part, Novartis will elaborate on the postsurgery data for Kisqali in early breast cancer from the NATALEE trial. When the company said the trial met its endpoint, investors sent the Big Pharma’s stock price up by 8% in a single day. Before the official data revelations on June 2 for NATALEE and June 3 for KEYNOTE-671, Fierce Pharma gathered expectations for the two studies from oncology leaders at Penn Medicine and MD Anderson Cancer Center plus market analysts at multiple firms. The NATALEE study could open a market that’s worth ...
- Source: drugdu
- 120
- May 30, 2023
Bristol Myers’ $4B plan for Reblozyl takes shape in blood cancer anemia—with one caveat

Bristol Myers Squibb’s Reblozyl could be an effective initial treatment for anemia patients who are suffering from a group of blood cancers called myelodysplastic syndromes (MDS) and are at a relatively lower risk of progression. That’s the conclusion reached by Olatoyosi Odenike, M.D., from the University of Chicago Medical Center, after she reviewed data from the phase 3 COMMANDS trial that are slated to be presented at the 2023 American Society of Clinical Oncology (ASCO) annual meeting. Odenike is an invited ASCO expert and an opinion leader in the MDS field. The COMMANDS trial is the first study in decades that has shown a benefit for a new agent against erythropoiesis-stimulating agents (ESAs) in low- to intermediate-risk MDS, Noah Berkowitz, M.D., Ph.D., senior vice president of hematology development at BMS, said in an interview with Fierce Pharma. If the FDA eventually agrees with Odenike’s finding, Reblozyl could move from behind ...
- Source: drugdu
- 262
- May 29, 2023
Elon Musk’s brain chip firm says US approval won for human study

By James FitzGerald BBC News Elon Musk’s brain-chip firm says it has received approval from the US Food and Drugs Administration (FDA) to conduct its first tests on humans. The billionaire’s Neuralink implant company wants to help restore people’s vision and mobility by connecting brains with computers. It says it does not have immediate plans to start recruiting participants. Mr Musk’s previous ambitions to begin tests came to nothing. The regulator itself is yet to comment. An earlier bid by Neuralink to win FDA approval was rejected on safety grounds, according to a report in March by the Reuters news agency that cited multiple current and former employees. • What is Neuralink? Neuralink hopes to use its microchips to treat conditions such as paralysis and blindness, and to help certain disabled people use computers and mobile technology. The chips – which have been tested in monkeys – are designed to ...
- Source: drugdu
- 113
- May 29, 2023
Acurable prepares to challenge ResMed for sleep apnea diagnosis market

Dive Brief Acurable is preparing to challenge ResMed and Resonea for the sleep apnea diagnosis market in the U.S. Having received 510(k) clearance in February, Acurable plans to start selling its AcuPebble Ox100 device in the U.S. this summer. The device records the sounds of the patient’s respiratory and cardiac functions and monitors blood oxygen levels to assess suspected obstructive sleep apnea. ResMed acquired a rival device, now sold as onesleeptest, through its 2021 Ectosense takeover and Resonea offers some of the same capabilities through its Drowzle Pro mobile application. Dive Insight AcuPebble Ox100 builds on an older Acurable device, AcuPebble SA100, that received 510(k) clearance in the summer of 2021. Like the older device, AcuPebble Ox100 features a sensor that the patient sticks to their neck to record respiratory and heart sounds. The acoustic signals are processed and analyzed by algorithms to detect sleep apnea. The new device combines ...
- Source: https://www.medtechdive.com/news/acurable-launch-sleep-apnea-diagnosis/651232/
- 103
- May 28, 2023
Researchers identify potential new treatment for those who act out their dreams while sleeping

Mount Sinai researchers have published what they say is the first study to identify a new form of treatment for rapid eye movement (REM) sleep behavior disorder. This condition affects more than 3 million Americans, mostly adults over the age of 50, who often unknowingly physically act out their dreams with vocal sounds or sudden, violent arm and leg movements during slumber, leading to significant injury to themselves or bed partners. The new study, published in the Journal of Neuroscience, outlines a novel model to better characterize how REM sleep behavior disorder develops due to neurodegeneration—when brain cells lose function over time—which is associated with the accumulation of tau protein. This model provides an early-life biomarker of impending deterioration of the brain, which could guide future prevention and treatment. The paper also demonstrates for the first time that sleep medications known as dual orexin receptor antagonists—commonly used to treat insomnia, or difficulty falling ...
- Source: Journal of Neuroscience
- 242
- May 27, 2023
Mirati’s long wait for next lung cancer med ends in phase 3 failure

After a five and a half month wait, Mirati Therapeutics finally has the answer it’s been waiting for on a lung cancer med called sitravatinib: The therapy did not improve survival in a phase 3 study. Back in December 2022, Mirati said that the SAPPHIRE trial would continue to its final analysis instead of getting an interim readout as planned. The company had hoped to use the early data to support an FDA application for approval in second- and third-line non-small cell lung cancer (NSCLC). Mirati was looking for a 3.5-month overall survival benefit, but, according to a brief update Wednesday afternoon, that measure was not successful at the final analysis. The company is not releasing the data set at this time but promised to do so “at a future date.” Patients who are experiencing clinical benefit may continue on treatment at the discretion of the principal investigators. The failure ...
- Source: drugdu
- 110
- May 27, 2023
Roche Terminates Second Phase II Schizophrenia Trial

By Kate Goodwin https://www.biospace.com/ Pictured: Blue Roche logo on white building/Smith Collection/Gado/Getty Images Roche has terminated a second Phase II trial of its investigational schizophrenia drug ralmitaront, leaving an uncertain future for the company’s program targeting the psychiatric disorder. The first trial, which was canceled last year, was studying the effects of ralmitaront as a monotherapy in patients with an acute exacerbation of positive symptoms of schizophrenia or schizoaffective disorder. The second trial, which was recently terminated, was investigating the impact of the treatment on negative symptoms associated with the two conditions. “In a preliminary analysis, the primary endpoint was negative, and ongoing portions of the study have therefore been discontinued,” according to an update on the second Phase II trial posted to the ClinicalTrials.gov website. Roche’s latest first quarter 2023 pipeline presentation included the asset, pushing its New Molecular Entity submission back into the “2026 and beyond” category. No ...
- Source: drugdu
- 106
- May 25, 2023
The power of genetics — how research into gene sequencing could revolutionize biopharma

Unlocking the potential of human genetics is key to many advances in the biopharma industry. From immunotherapies that treat cancer to potential cures for rare diseases to mapping the genome for incredible medical discoveries, researchers have still only scratched the surface of what is possible in gene science. Just last week, the FDA approved the first-ever gene therapy that can be applied directly to the skin to treat patients known as “butterfly children” because of how fragile their skin can be. These kinds of forward-thinking medicines have come about due to the ever more advanced understanding of how genetics cause certain conditions. And early research in the genetic space — even that which might not appear directly related to medicine — has given scientists the tools to make better treatments down the road. Some of those treatments are on their way to helping patients soon. One cell therapy in late-stage ...
- Source: drugdu
- 117
- May 25, 2023

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