Search Results for “Clinical Trial” – Page 99 – media

Intercept’s NASH dreams may be dashed after FDA panel votes against Ocaliva’s approval bid

It looks like Intercept Pharmaceuticals’ Ocaliva still has a tough road ahead in nonalcoholic steatohepatitis (NASH) after a panel of FDA advisers voiced concerns with the company’s application package. During a one-day meeting of the FDA’s Gastrointestinal Drugs Advisory Committee, panelists voted 12 to 2—with 2 abstentions—that the benefits of Ocaliva 25 mg, also known as Obeticholic acid, or OCA, don’t outweigh the risks in NASH patients with stage 2 or 3 fibrosis. Further, in response to the question about a potential accelerated approval, panelists voted 15 to 1 against that regulatory pathway for the drug. Many of the nay-sayer’s concerns came down to Intercept’s use of a surrogate endpoint in its clinical trial. Panelists’ concerns also centered on the potential for OCA to cause drug-induced liver injury. While the FDA isn’t beholden to the advice of its advisory committees, the regulator often follows its experts’ lead. Intercept’s NASH candidate ...
- Source: drugdu
- 111
- May 23, 2023
AstraZeneca’s dapagliflozin recommended by NICE

Treatment concerns up to 150,000 patients in England with chronic heart failure The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending AstraZeneca’s dapagliflozin. The therapy, also known as Forxiga, is as an option among adults with symptomatic chronic heart failure with mildly reduced or preserved ejection fraction. Currently, there are no disease-modifying treatments for this specific condition and, thus, dapagliflozin becomes the first NICE-recommended treatment for this population. Meanwhile, evidence from a clinical trial demonstrated that adding dapagliflozin to standard care with diuretics effectively decreases the combined risk of dying from cardiovascular causes or the need attend hospital with heart failure. This was compared during the study with placebo in addition to standard care. Helen Knight, director of medicines evaluation at NICE, reflected: “Until now there have been no treatments available to delay or slow the progression of this type of heart failure. “The ...
- Source: drugdu
- 120
- May 23, 2023
NICE recommends Cara’s Kapruvia to treat CKD-associated pruritus

Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) have announced that the US’s National Institute for Health and Care Excellence (NICE) has recommended Kapruvia (difelikefalin) to treat chronic kidney disease (CKD)-associated pruritus. Kapruvia has been recommenced to treat moderate-to-severe CKD-associated pruritus in adult patients who are undergoing haemodialysis. This will allow patients in Northern Ireland, England, and Wales to get access to Kapruvia. The recommendation from NICE follows the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) authorisation of Kapruvia for the same indication in April last year. Cara Therapeutics president and CEO Christopher Posner said: “We are pleased that Kapruvia will be available to CKD patients in England, Wales and Northern Ireland who are undergoing haemodialysis and suffering from moderate-to-severe CKD-associated pruritus. “Together with VFMCRP, we are committed to bringing our first-of-its kind therapy to providers and patients around the world to help change the way pruritus ...
- Source: drugdu
- 207
- May 23, 2023
FDA accepts Ardelyx’s NDA resubmission for XPHOZAH

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy. The regulatory agency has determined that the NDA is a class 2 review, which leads to a six-month review period from the date of resubmission. It has set a user fee goal date of 17 October this year. The biopharmaceutical company expects XPHOZAH to be commercially available in Q4 2023 after an approval from the regulatory body. Ardelyx president and CEO Mike Raab said: “The acceptance of our NDA is a significant milestone in our journey to bring XPHOZAH to patients. We are excited about the prospect of working collaboratively with the FDA to finalise this review over the next few months. “We are now in ...
- Source: drugdu
- 101
- May 22, 2023
CDC

As early signs point to a potential resurgence of mpox cases in the U.S. this summer, the Centers for Disease Control and Prevention (CDC) is rolling out real-world data for Bavarian Nordic’s vaccine and urging at-risk people to take two shots.Bavarian Nordic’s Jynneos, given in two doses, is estimated to be 85.9% effective against mpox, a real-world case-match study conducted in 12 U.S. jurisdictions showed. At one dose, the vaccine was found to be 75.2% effective. The CDC released the results in its new Morbidity and Mortality Weekly Report (MMWR). The report comes as a cluster of 21 mpox cases was reported in Chicago, with several diagnoses among those who were vaccinated raising concerns over Jynneos’ efficacy. Although Jynneos’ efficacy may look similar between the partial and full doses in this study of about 900 people, the CDC is still calling for at-risk people to take two doses because the ...
- Source: drugdu
- 96
- May 22, 2023
AbbVie’s Rinvoq scores its 7th FDA nod, this one for Crohn’s disease

In developing immunology treatment Rinvoq, AbbVie is employing the same game plan it used to make predecessor Humira a megablockbuster. And the company seems to be getting better at it.Thursday, AbbVie scored its seventh FDA approval for Rinvoq in a span of less than four years, getting the JAK inhibitor across the finish line as a treatment for Crohn’s disease. A look at Humira’s approval history shows that AbbVie has become more efficient in adding indications to its immunology blockbusters. After Humira was initially blessed in 2002, it took AbbVie 10 years to get the TNF blocker endorsed for its seventh disease type. Coincidentally, Rinvoq’s new FDA approval came hours after the U.K.’s National Institute for Health and Care Excellence signed off on the drug for Crohn’s disease. This is the second gastroenterology indication for Rinvoq after it won approval for ulcerative colitis in March of last year. Rinvoq’s first ...
- Source: drugdu
- 122
- May 21, 2023
Neuralink competitor Paradromics gets one step closer to FDA approval for its brain implant

A growing team of nearly 50 employees at the neurotech startup Paradromics is working on a brain implant that sounds like the work of science fiction. And it has caught the attention of federal regulators. Paradromics, founded in 2015, is developing a device that could help patients with severe paralysis regain their ability to communicate by deciphering their neural signals. And on Thursday, the Austin, Texas-based company announced that it has received the Breakthrough Device designation from the Food and Drug Administration for its flagship system, called the Connexus Direct Data Interface. CEO Matt Angle said the designation, in addition to a $33 million funding round the company also announced Thursday, will help Paradromics bring its device to market. Paradromics is part of the emerging brain-computer interface, or BCI, industry. A BCI is a system that deciphers brain signals and translates them into commands for external technologies. Experts believe the ...
- Source: drugdu
- 120
- May 21, 2023
AbbVie nabs seventh FDA approval for Rinvoq, adds Crohn’s disease indication

Beth Snyder Bulik Senior Editor AbbVie picked up another indication for blockbuster Rinvoq on Thursday, this time for Crohn’s disease. The seventh FDA approval for the JAK inhibitor is specifically for use in moderate to severe Crohn’s patients who have had inadequate response or intolerance of at least one TNF blocker. While there are several other biologics already on the market to treat moderately to severely active Crohn’s including J&J’s Stelara, Takeda’s Entyvio and AbbVie’s own Skyrizi, the FDA noted that Rinvoq is the first oral drug. The approval was based on results from three studies, the U-EXCEED and U-EXCEL initial trial and the U-ENDURE maintenance trial, determining statistical significance in the co-primary endpoints of endoscopic response and clinical remission. AbbVie consultant and gastroenterologist Edward Loftus, who was a U-EXCEL investigator, said in a news release, “Based on the clinical trial results, treatment with RINVOQ shows both early and long-term ...
- Source: drugdu
- 119
- May 21, 2023
In a new look at Novo’s Wegovy data, researchers spell out weight loss for teens

Kyle LaHucik May Associate Editor A few months after the FDA approved the weight loss drug Wegovy for adolescents, researchers are out with a post-hoc look at the late-stage data, this time finding that 45% of the teens taking Novo Nordisk’s drug dipped below the clinical cutoff for obesity. The analysis, presented by University of Minnesota pediatrics professor Aaron Kelly at this week’s European Congress on Obesity in Dublin, gives new insight into the popular drug, which is part of the ballooning obesity R&D field that has Novo and Eli Lilly in the lead and biopharmas like Amgen and Boehringer Ingelheim racing to catch up. The results from the same study, the STEP TEENS trial, were published in the New England Journal of Medicine last December, shortly before the FDA expanded the original 2021 label for adults to include teens 12 years old and older. Almost three-quarters (74%) of teens ...
- Source: drugdu
- 99
- May 21, 2023
Abbott wins FDA spinal cord stimulation approval to challenge Nevro for back pain market

Dive Brief The U.S. Food and Drug Administration has approved Abbott’s spinal cord stimulation devices for the treatment of non-surgical back pain. Abbott landed the label expansion after showing its BurstDR spinal cord stimulation technology improved outcomes more than conventional medical management in people with chronic back pain who were ineligible for surgery. The label expansion comes 16 months after Nevro won FDA approval in non-surgical refractory back pain and four months after Boston Scientific released data on its rival device in the setting. Dive Insight: Abbott competes with Boston Scientific, Medtronic and Nevro for the spinal cord stimulation market and the four players are continually looking to expand into new areas where they are free from the intense competition that characterizes the core indications. Nevro unlocked an opportunity early last year, when it said it was the only company with specific labeling to treat non-surgical refractory back pain. Now, ...
- Source: drugdu
- 131
- May 20, 2023

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