Search Results for “Clinical Trial” – Page 94 – media

Labcorp forms spin-off of Fortrea

Labcorp, the laboratory service supplier based in the US, has completed the spin-off of Fortrea, to create the newly formed contract research organisation that will give pharmaceutical and biotechnology organisations access to global Phase I-IV clinical trial management, patient access and technology solutions. Fortrea made a cash distribution of around $1.6bn as partial consideration for the assets that Labcorp contributed to Fortrea in connection with the spin-off. Labcorp will use the distribution toward a $1bn accelerated share repurchase program and pay down $300m of debt maturing this year. Whatever is left of the funds will be distributed among shareholders. The spin-off distribution was completed on 30 June 2023 to stockholders of record as of the close of business on 20 June 2023. Labcorp’s stockholders each received one share of Fortrea common stock for every share of Labcorp common stock they held as of the record date. The spin-off will pass ...
- Source: drugdu
- 111
- July 6, 2023
first interchangeable biosimilar to Humira rolls out across US

Boehringer Ingelheim’s new autoinjector pen administering Cyltezo (adalimumab-adbm) is now available to patients living with chronic inflammatory diseases in the US. The Cyltezo pen autoinjector, which is a biosimilar to AbbVie’s blockbuster Humira (adalimumab), received approval from the US Food and Drug Administration (FDA) in May 2023. Boehringer Ingelheim originally received FDA approval for the drug in 2017, and then further approval as an interchangeable biosimilar in 2021. The 40mg/0.8ml pre-filled Cyltezo Pen will be offered in two, four and six-pack options. AbbVie has enjoyed a prosperous monopoly of the adalimumab market with Humira generating $21.2bn in global sales in 2022. With several biosimilars likely to flood the market in 2023 and the company losing exclusivity, AbbVie said it expects its sales of the drug to decline 37% in 2023. Challengers to Humira are now vying for market share. Organon and Samsung Bioepsis launched an autoinjector pen on 1 July, ...
- Source: drugdu
- 131
- July 5, 2023
Australia authorizes MDMA, magic mushrooms for medical treatment

Australia on Saturday became one of the first countries in the world to allow the use of MDMA and magic mushrooms for medical treatment, in a bid to tackle certain mental health conditions. From July 1, authorized psychiatrists will be able to prescribe the drugs, also known as ecstasy and psilocybin, for the treatment of post-traumatic stress disorder and some types of depression. Authorities in Canada and the United States allow the medical use of one or both of the drugs, but only in clinical trials or with special permits. In February, Australia reclassified the drug entirely, after the country’s Therapeutic Goods Administration said trials had found the substances to be “relatively safe” when used in a “medically-controlled environment”. Supporters of the move hope the drugs can provide breakthroughs for mental health patients, when other treatments have failed. Mike Musker, a mental health and suicide prevention researcher at the University ...
- Source: drugdu
- 110
- July 4, 2023
CDC recommends RSV vaccines from Pfizer, GSK for adults 60 and older

The Centers for Disease Control and Prevention on Thursday recommended that adults ages 60 and above receive a single dose of RSV vaccines from Pfizer and GSK after consulting their doctors. Outgoing CDC Director Rochelle Walensky signed off on the recommendation, which an advisory panel of outside experts made last week. That endorsement says seniors should work with their health-care providers to decide if taking a shot is right for them. The CDC said the shots are expected to be available to the public this fall, when respiratory syncytial virus – along with Covid and the flu – typically begins to spread at higher levels. “These vaccines provide an opportunity to help protect older adults against severe RSV illness at a time when multiple respiratory infections are likely to circulate,” the CDC said in a statement. The virus is a common respiratory infection that usually causes mild, cold-like symptoms, but ...
- Source: drugdu
- 107
- July 2, 2023
TME Pharma reveals positive NOX-A12 data

GLORIA trial shows increased survival levels among newly diagnosed brain cancer patients TME Pharma – a company concentrating on the development of therapies for treating cancer – has announced a positive update on the survival of first-line glioblastoma patients taking part in the company’s GLORIA trial. Across the wider GLORIA clinical trial, TME is researching the effectiveness of NOX-A12 among newly-diagnosed brain cancer patients who will not benefit from standard chemotherapy. Meanwhile, the expanded arm of the study is focusing on the candidate – a CXCL12 inhibitor – in combination with standard of care radiotherapy and bevacizumab. Following 15 months of the research, 83% of trial patients (five out of six) were still alive. Furthermore, as long as treatment or follow-ups for these patients continues, median overall survival will improve. The expected median overall survival for patients under existing standard of care, with chemotherapy refractory tumours – and whose tumour ...
- Source: drugdu
- 142
- July 1, 2023
Bayer and BlueRock announce positive early-stage results for Parkinson’s cell therapy

Bayer AG and its subsidiary, BlueRock Therapeutics LP, have announced positive topline results from an early-stage study of an experimental Parkinson’s disease stem cell therapy. In the phase 1 study of bemdaneprocel, the treatment was shown to be well-tolerated in all 12 patients involved in the study, and transplanted cells grew as intended in the patients’ brains at one-year post-transplant. The companies said that, based on these positive results, planning is already underway for a phase 2 study that is expected to begin enrolling patients in the first half of 2024. There is no cure for Parkinson’s disease, a progressive and chronic neurological disorder that affects an estimated ten million people worldwide. The disease is caused by nerve cell damage in the brain, which leads to decreased levels of dopamine. The loss of these dopaminergic neurons results in a progressive decline of motor function and symptoms such as tremors, muscle ...
- Source: drugdu
- 108
- July 1, 2023
BioXcel’s Positive Alzheimer’s Agitation Data Overshadowed by Principal Investigator Fabrications

By David Adam Pictured: Person holding a cell phone in front of computer with stock data/iStock The release of positive topline results Thursday from the Phase III trial of BioXcel Therapeutics’ Alzheimer’s-related agitation treatment was overshadowed by disclosures to the SEC about fabricated email correspondences pertaining to the study’s safety data. In a Thursday SEC filing, BioXcel said that a trial site’s principal investigator—who enrolled 40% of the study participants at that site—was found to have fabricated email correspondences related to the timing of the filing for a serious adverse event (SAE) with the company’s vendor responsible for the monitoring of drug safety. The adverse event occurred in a subject in the placebo arm, the company said. In May 2023, it “came to the company’s attention that this same principal investigator in the TRANQUILITY II clinical trial may have fabricated email correspondence purporting to demonstrate that the investigator timely submitted ...
- Source: drugdu
- 104
- July 1, 2023
Vitamin D supplements may reduce risk of serious cardiovascular events in older people

Vitamin D supplements may reduce the risk of major cardiovascular events such as heart attacks among people aged over 60, finds a clinical trial published by The BMJ. The researchers stress that the absolute risk difference was small, but say this is the largest trial of its kind to date, and further evaluation is warranted, particularly in people taking statins or other cardiovascular disease drugs. Cardiovascular disease (CVD) is a general term for conditions affecting the heart or blood vessels and is one of the main causes of death globally. CVD events such as heart attacks and strokes are set to increase as populations continue to age and chronic diseases become more common. Observational studies have consistently shown a link between vitamin D levels and CVD risk, but randomized controlled trials have found no evidence that vitamin D supplements prevent cardiovascular events, possibly due to differences in trial design that ...
- Source: drugdu
- 188
- June 30, 2023
FDA rejection sets back Regeneron’s plan to defend top-selling eye drug

Dive Brief: Regeneron Pharmaceuticals is facing a delay for a much-anticipated new version of its best-selling eye medicine after failing to win U.S. approval on Tuesday because of a manufacturing issue. The Food and Drug Administration issued a complete response letter for the high-dose version of Eylea, citing inspection findings at a third-party facility that fills vials of the medication. Regeneron said it’s working with the FDA and the third party to resolve the issues “as quickly as possible.” Importantly, the FDA did not cite any issues with the drug’s safety or efficacy and isn’t asking for new clinical trials. The agency also did not find any issues with the labeling or manufacturing of the actual drug substance, Regeneron said. Dive Insight: While the issue sounds relatively minor, any delay is significant for Regeneron, and the company’s shares tumbled around 11% during trading sessions on Tuesday and Wednesday. Eylea is ...
- Source: drugdu
- 104
- June 30, 2023
Eli Lilly experimental obesity drug helped patients lose up to 24% of their weight, study says

Eli Lilly’s experimental drug helped patients lose up to 24% of their weight after almost a year, the highest reduction seen in the obesity treatment space to date, according to new mid-stage clinical trial results released Monday. The phase two trial followed 338 adults who were obese or overweight and either received the pharmaceutical company’s injection, retatrutide, or a placebo each week. Patients who took a 12-milligram dose of retatrutide lost 17.5% of their body weight, or 41 pounds, on average after 24 weeks, compared with 1.6% for those who received the placebo. Patients lost 24.2%, or 58 pounds, on average after 48 weeks. Those who took the placebo lost 2.1% of their body weight after that same time period. The trial’s researchers said average weight loss did not appear to plateau after 48 weeks, suggesting a longer study could show even more. Eli Lilly is currently recruiting patients for ...
- Source: drugdu
- 108
- June 29, 2023

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