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Debiopharm commences pivotal glioblastoma therapy study

The therapy is a brain-penetrant used in various combinations in patients with progressive glioblastoma Debiopharm – a company focusing on future standards of cancer care and infectious diseases – has announced the beginning of its open-label phase 1/2 research of its candidate Debio 0123. The therapy is a brain-penetrant and selective WEE1 inhibitor, used in combination with temozolomide (TMZ) in patients with recurrent or progressive glioblastoma (GBM). It is also being studied in combination with TMZ/RT (SOC) in newly diagnosed patients. The commencement phase of the clinical study aims to establish the recommended phase 2 doses of the treatment. Ultimately, Debiopharm is aiming to meet the pressing requirement for novel treatment interventions to boost quality of life and clinical outcomes for patients living with GBM. Among cancer cells, DNA damage response (DDR) pathways are often upregulated due to genomic instability, increasing the chances of resistance to DNA-damaging therapies. Blocking DNA ...
- Source: drugdu
- 110
- May 22, 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
- 105
- 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
- 115
- May 22, 2023
After IRA, Minnesota’s drug affordability proposal draws PhRMA’s ire

Even after Congress and the Biden administration passed the Inflation Reduction Act (IRA) last summer, some states are looking to further strengthen their drug pricing laws.This week, Minnesota’s legislature endorsed a proposal to create a statewide Prescription Drug Affordability Board. The board would have the power to set upper payment limits on certain high-cost pharmaceuticals, local newspaper Red Lake Nation News reports. The bill also includes provisions to stop price gouging on generics. It’s now on its way to Minnesota Governor Tim Walz for a signature. But that’s where the pharmaceutical industry’s lobby group is hoping to stop the proposal. Wednesday, the Pharmaceutical Research and Manufacturers of America (PhRMA) called on the governor to not sign the bill. The board would “do little to help patients and likely harm future access to medicines,” PhRMA’s senior vice president of state advocacy, Scott LaGanga, said in a statement. “This is a bad ...
- Source: drugdu
- 103
- 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
- 127
- May 21, 2023
Adonis Rakes In $17.3M to Optimize Providers’ Revenue Cycles

Adonis — a New York-based startup seeking to create better, more reliable revenue outcomes for providers across the country — has gained capital from some major investors since it launched last year. On Wednesday, the company announced the close of a $17.3 million Series A funding round led by General Catalyst. The round — which brings the startup’s total funding to nearly $23 million — also included investments from Homebrew, Bling Capital and Max Ventures. Adonis, which is a revenue cycle automation platform purpose-built for healthcare, was named after the Greek god known for youthfulness and renewal. “When thinking about the existing state of the revenue cycle, we realized there was dire need for refreshed thinking and a new perspective,” said Adonis CEO Akash Magoon in a recent interview. “Adonis was founded as an organization that would take a refreshed approach to solving some of the biggest administrative burdens through ...
- Source: drugdu
- 131
- May 21, 2023
Dermavant’s Vtama cream shows promise in phase 3 atopic dermatitis trial

Dermavant Sciences has reported positive results from a phase 3 trial of its plaque psoriasis-approved Vtama (tapinarof) cream in adults and children aged as young as two years with moderate to severe atopic dermatitis. More commonly referred to as eczema, atopic dermatitis is one of the most common inflammatory skin diseases, affecting over 26 million people in the US alone and up to 30% of children worldwide. The disease causes itchy, red, swollen and cracked skin, usually affecting the folds of the arms, back of the knees, hands, face and neck. Dermavant’s ADORING 1 trial met its primary endpoint, with 45.4% of Vtama-treated patients experiencing improvements in an investigator assessment of lesions. This is compared to 13.9% of patients who received vehicle cream. Benefits were also seen across key secondary endpoints, including 55.8% of patients experiencing improvements on the EASI test, which is used to measure the extent and severity ...
- Source: drugdu
- 117
- 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
- 123
- May 21, 2023
Blood Test Taken After Miscarriage Can Predict Future Risk of Pregnancy Loss

By LabMedica International staff writers www.labmedica.com/ Image: Early blood test may unravel secrets of pregnancy loss (Photo courtesy of Freepik) Approximately 10% of women experience pregnancy loss, a percentage that is higher in regions where pregnancies frequently occur later in a woman’s reproductive years. Various factors contribute to pregnancy loss, including hormonal imbalances, endocrine disorders, clotting issues, or lifestyle-related factors. Despite the fact that one in four pregnancies results in a miscarriage, little has been done to investigate the underlying causes, with the primary focus being on the process of uterus evacuation post-miscarriage. Now, a new study has found that a post-miscarriage blood test as early as the fifth week of pregnancy could shed light on the cause and, in some instances, guide preventative treatment strategies. These findings could potentially help prevent 5% of the annual 30 million miscarriages worldwide. In the study, a team of researchers at Hvidovre Hospital ...
- Source: drugdu
- 107
- 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
- 124
- May 21, 2023

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