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Dive Brief Analysts at Needham expect a U.S. Food and Drug Administration advisory panel to support the safety and efficacy of Medtronic’s renal denervation device at a meeting later this month. The meeting, which the FDA scheduled in June, will enable experts in circulatory system devices to discuss the evidence on Medtronic’s Symplicity Spyral and ReCor Medical’s rival renal denervation system. While the analysts expect Medtronic to face questions over the failure of its pivotal trial, they think the experts will vote in favor of the device, putting it on track to target a $1 billion-plus market. Dive Insight Medtronic’s multi-year effort to build confidence in renal denervation as a way to treat high blood pressure hit a snag late last year when a pivotal trial found it worked no better than drugs alone at reducing patients’ blood pressure at home. However, while the missed endpoint was an unwelcome development ...
- Source: drugdu
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- August 9, 2023
Out-of-pocket costs a barrier to treatment for opioid use disorder

Most individuals diagnosed with opioid use disorder are not on recommended medications and even fewer remain in care, according to a research letter published today in JAMA Internal Medicine by lead author Ashley Leech, PhD, assistant professor in the Department of Health Policy at Vanderbilt University Medical Center (VUMC). In 2021, there were more than 100,000 overdose deaths in the United States, with the highest rates among those ages 25-54. Just 22% of the 40,000 individuals with opioid use disorder studied by VUMC researchers continuously used buprenorphine for a full year. And among those who discontinued, many were on the medication for just over a month, which is markedly below recommended levels, the authors said. Stephen Patrick (MD, MPH, senior author, director Center for Child Health Policy at VUMC) said, “Treatment with medications like buprenorphine is safe and highly effective, reducing risk of countless adverse outcomes including overdose death. Nationwide, ...
- Source: drugdu
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- August 9, 2023
Potential treatment for inherited blindness wins FDA fast-track

The US Food and Drug Administration (FDA) is addressing inherited blindness in children after it granted HuidaGene Therapeutics a rare paediatric disease designation (RPDD) to expedite the development and review times of the company’s gene therapy candidate. China-headquartered HuidaGene’s HG004, which received an orphan drug designation in March, is a one-time gene replacement drug intended to treat patients who are affected by inherited retinal diseases (IRDs) caused by mutations in the RPE65 gene. The therapy delivers a functional version of the gene to the retinal pigment epithelium via an adeno-associated virus (AAV) vector. RPE65-induced IRDs include Leber’s congenital amaurosis (LCA), severe early childhood-onset retinal dystrophy (SECORD), early-onset severe retinal dystrophy (EOSRD), and retinitis pigmentosa (RP). The diseases are often present in toddlers and can cause night blindness and a loss of visual field and central vision. The impairment of vision at such an early age likely affects other areas of ...
- Source: drugdu
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- August 9, 2023
Biogen, Sage’s postpartum depression approval overshadowed by larger rejection

While an FDA approval is typically cause for celebration, Sage Therapeutics and Biogen have a tough road ahead to market their new postpartum depression (PPD) drug.Friday, the U.S. FDA gave the green light to zuranolone. Now going by the commercial moniker Zurzuvae, the partners’ drug represents the first and only oral treatment for women with PPD, which affects some 500,000 patients in the U.S. each year, according to Biogen and Sage. But PPD represents just a fraction of the total market Biogen and Sage were hoping to tap into. Alongside Friday’s approval, the partners also received a rejection for Zurzuvae in adults with major depressive disorder (MDD). The FDA told the partners their application didn’t provide “substantial evidence of effectiveness” and that additional studies would be needed. Sage and Biogen said they are reviewing possible next steps. The dual approval and rejection was “more disappointing than good,” according to analysts ...
- Source: drugdu
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- August 9, 2023
Eli Lilly announces positive results for Retevmo in phase 3 lung cancer study

Eli Lilly has announced positive top-line results from a late-stage study of its targeted therapy Retevmo (selpercatinib) versus the current first-line standard of care in certain non-small cell lung cancer (NSCLC) patients. The phase 3 LIBRETTO-431 trial has been evaluating Retevmo versus platinum-based chemotherapy plus pemetrexed with or without Merck’s Keytruda (pembrolizumab) as an initial treatment for adults with rearranged during transfection (RET) fusion-positive advanced or metastatic NSCLC. A pre-specified interim efficacy analysis showed that the study met its primary endpoint, with Lilly’s therapy demonstrating a statistically significant and clinically meaningful improvement in progression-free survival. As the company outlined, LIBRETTO-431 is the first randomised study to compare the safety and effectiveness of a targeted therapy to a PD-1 inhibitor plus chemotherapy in cancer patients bearing a specific biomarker. David Hyman, chief medical officer at Loxo@Lilly, said: “The LIBRETTO-431 trial aims to answer an important question about the selection of initial ...
- Source: drugdu
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- August 9, 2023
Bavarian Nordic’s chikungunya vaccine candidate shows promise in late-stage trial

Bavarian Nordic has shared positive top-line results from a late-stage study of its chikungunya virus vaccine candidate in adults and adolescents. Chikungunya is a mosquito-borne viral disease for which there is currently no approved vaccine or effective treatment. Infection leads to symptomatic disease after four to eight days following the bite of an infected mosquito, with clinical symptoms including acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. More than 3,200 people aged 12 to 64 years were enrolled and randomised to receive either a single intramuscular injection of Bavarian Nordic’s virus-like particle-based vaccine candidate, CHIKV VLP (PXVX0317), or placebo. Results showed that the vaccine was highly immunogenic in healthy adolescents and adults at up to 22 days post-vaccination, as demonstrated by the strong induction of chikungunya neutralising antibodies in 98% of those in the active group. CHIKV VLP induced significant neutralising antibodies in ...
- Source: drugdu
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- August 9, 2023
Iveric Gets FDA Approval in Geographic Atrophy After Being Acquired by Astellas

By Tristan Manalac Pictured: Astellas’ American headquarters in Illinois/iStock, JHVEPhoto The FDA on Friday approved Iveric Bio’s intravitreal avacincaptad pegol, now to be marketed as Izervay, for the treatment of geographic atrophy secondary to age-related macular degeneration. The regulatory win comes three months after the New Jersey biotech was bought by Astellas Pharma for $5.9 billion. The companies completed the acquisition last month. Friday’s approval makes Izervay the first authorized geographic atrophy (GA) treatment that has significantly slowed down GA progression at 12 months across two Phase III studies, according to Astellas’ announcement. The eye injection also offers a new treatment option to physicians and patients across the U.S., Iveric Bio President Pravin Dugel said in a statement. Discovered and developed by Iveric, Izervay is an intravitreally administered inhibitor of the complement C5 protein. By blocking the cleavage of C5, the eye injection also disrupts more downstream processes, including the formation ...
- Source: drugdu
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- August 9, 2023
unrNektar Flags Lilly’s Miscalculations in Rezpeg Atopic Dermatitis Trials

By Tristan Manalac Pictured: Nektar signage at its headquarters in California/iStock, Sundry Photography Nektar Therapeutics on Monday revealed that former partner Eli Lilly had incorrectly calculated efficacy data for its investigational regulatory T-cell stimulator rezpegaldesleukin (rezpeg), which the company is developing as a treatment for atopic dermatitis. At the 31st Congress of the European Academy of Dermatology and Venereology (EADV), held in September 2022, Lilly presented data from a Phase Ib study of rezpeg, showing that while the candidate elicited positive and dose-dependent improvements in key efficacy measures, these effects ultimately fell short of statistical significance. At 12 weeks, Lilly erroneously reported the 12-µg/kg and 24-µg/kg doses of rezpeg were associated with a 53% and 66% improvement in Eczema Area and Severity Index (EASI) scores, respectively, whereas placebo induced a 49% improvement relative to baseline, Nektar reported. Neither dose was significantly superior to placebo, according to the company. However, Nektar’s ...
- Source: drugdu
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- August 9, 2023
A review of treatment strategies

A new editorial paper was published in Oncoscience (Volume 10) on June 28, 2023, entitled, “Adenoid cystic carcinoma of the head and neck – treatment strategies of a highly malignant tumor with variable localizations.” In this new editorial, researchers Florian Dudde, Kai-Olaf Henkel and Filip Barbarewicz from the Army Hospital Hamburg discuss head and neck tumors, which are among the most common malignancies. In this anatomical region, squamous cell carcinoma (SCC) is the most common malignant entity. However, there are also other malignant tumors that, unlike SCC, originate in the salivary glands of the head and neck region, such as mucoepidermoid carcinoma or adenoid cystic carcinoma (ACC). In general, tumors originating from the minor salivary glands often show a higher degree of malignancy than tumors of the major salivary glands (parotid gland, submandibular gland, sublingual gland). Consequently, the ACC in particular is often localized in the area of the hard ...
- Source: drugdu
- 129
- August 8, 2023
Study helps understand how RNA modification promotes pancreatic cancer

Chemical modifications of RNA molecules, such as m6A, can critically impact gene expression, influencing various aspects of cancer development and progression. However, while studies into m6A modification of messenger RNA (mRNA) have been extensive, exploration of its impact on lncRNAs, especially within the context of PDAC, has been relatively limited. In an innovative study published in the Genes & Diseases journal, a team from The Children’s Hospital, Zhejiang University School of Medicine, People’s Hospital of Hangzhou Medical College and University of Mississippi Medical Center employed a methylated RNA immunoprecipitation (MeRIP) strategy to uncover the role of LINC00901, an m6A-modified long noncoding RNA (lncRNA), in promoting the proliferation, survival, and invasiveness of pancreatic ductal adenocarcinoma (PDAC) cells, thus leading to tumor growth. Intriguingly, the study suggests that the m6A reader protein YTHDF1 negatively regulates LINC00901 expression. The team identified two m6A sites on LINC00901 essential for its interaction with YTHDF1. Their ...
- Source: drugdu
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- August 8, 2023

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