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FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. But Otsuka must overcome hurdles facing digital therapeutics products, which have yet to gain traction among payers. By FRANK VINLUAN A software app that modifies behavior through a series of lessons and exercises has received FDA clearance for treating patients with major depressive disorder, making it the first prescription digital therapeutic for this indication. The product, known as CT-152 during its development by partners Otsuka Pharmaceutical and Click Therapeutics, will be commercialized under the brand name Rejoyn. Rejoyn is an alternative way to offer cognitive behavioral therapy, a type of talk therapy in which a patient works with a clinician in a series of in-person sessions. In Rejoyn, the cognitive behavioral therapy lessons, exercises, and reminders are digitized. The treatment is intended for use ...
- Source: drugdu
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- April 4, 2024
FDA Approves Alexion’s Voydeya as Add-on Treatment for Adults with Extravascular Hemolysis

Don Tracy, Associate Editor Treatment approved in combination with ravulizumab or eculizumab, representing minority demographic still suffering after receiving C5 inhibitor therapy for extravascular haemolysis. Alexion, AstraZeneca Rare Disease announced that the FDA has approved Voydeya (danicopan) as an add-on therapy for the treatment of extravascular haemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH), in combination with ravulizumab or eculizumab. According to the company, the medication treats patients with significant EVH despite receiving C5 inhibitor therapy. The approval was based on positive results from the Phase III ALPHA trial, which found that Voydeya improved hemoglobin levels while providing the benefit of avoiding transfusions after a primary 12-week period. Additionally, there was no significant increases reported related to safety concerns, with common adverse reactions including headache, nausea, arthralgia, and diarrhea.1 “The approval of first-in-class, Factor D inhibitor Voydeya marks an important advancement in the treatment of PNH and builds on ...
- Source: drugdu
- 98
- April 4, 2024
3M spins out Solventum

Dive Brief 3M completed a spinoff of its healthcare business, Solventum, on Monday. The company started trading on the New York Stock Exchange under the ticker SOLV and was quoted at $67.96 a share at midday. The new company will sell 3M’s medical devices, including its stethoscopes, IV port protectors and negative pressure wound therapy devices. It also houses 3M’s dental, health IT and filtration products. Solventum CEO Bryan Hanson told investors in March the spinoff will be one of the top three in medical device history, citing its global scale and more than $8 billion in revenue last year. Dive Insight Solventum told investors last month that the standalone company expects organic revenue in a range of from minus 2% to 0% in 2024, and a free cash flow of from $700 million to $800 million. The four business units that make up the company — MedSurg, dental solution, ...
- Source: drugdu
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- April 4, 2024
Alexion’s Voydeya gains FDA approval for extravascular haemolysis

Alexion, AstraZeneca Rare Disease has received approval from the US Food and Drug Administration (FDA) for Voydeya (danicopan) as an add-on therapy to treat extravascular haemolysis (EVH) in adults with paroxysmal nocturnal haemoglobinuria (PNH). A first-in-class, oral Factor D inhibitor, Voydeya has been developed for patients who continue to suffer from EVH despite treatment with C5 inhibitors such as Ultomiris (ravulizumab) or Soliris (eculizumab). The FDA’s decision is grounded in the positive outcomes of the ALPHA Phase III trial, which demonstrated that Voydeya met its primary endpoint of haemoglobin change from baseline to week 12, alongside all key secondary endpoints. The drug was generally well-tolerated with no new safety concerns. As part of the ALPHA double-blind, placebo-controlled, multiple-dose trial, patients were enrolled and randomised to receive Voydeya or placebo apart from their ongoing Soliris or Ultomiris therapy over 12 weeks. It aimed to assess the superiority of Voydeya as an ...
- Source: drugdu
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- April 4, 2024
Ipsen joins the ADC club with deal worth up to $900m

Ipsen has joined the slew of companies developing antibody-drug conjugates (ADC) with the announcement of a new global licensing agreement with Sutro Biopharma for the development of the latter’s STRO-003. Ipsen declared that the deal would give it exclusive worldwide rights to develop and commercialise the ROR1-targeting ADC STRO-003. Ipsen is accountable for Phase I preparations, including investigational new drug application (IND) submissions. The Paris, France-headquartered company will also be responsible for the later clinical development and global commercialisation of STRO-003. Under the partnership, Sutro Biopharma could receive up to $900m in prospective upfront, development, and commercial milestone-based payments. This is inclusive of $90m in near-term payments in the form of tiered royalties on global sales, and an equity investment, dependent on Ipsen’s successful development and commercialisation strategy. STRO-003 is one of three named ADCs being developed in Sutro’s clinical pipeline. In June 2023, Sutro announced plans to submit INDs ...
- Source: drugdu
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- April 4, 2024
First Patient Dosed in Clinical Trial of YOLT-101 for the Treatment of FH

SHANGHAI, April 2, 2024 /PRNewswire/ — YolTech Therapeutics announced that the first patient has been dosed with YOLT-101, the company’s in vivo genome editing candidate being developed as a single dose, potentially curative therapy for Familial Hypercholesterolemia(FH), marking the commencement of an Investigator-Initiated Trial (IIT). Familial Hypercholesterolemia (FH) is a genetic disorder that affects the body’s ability to remove low-density lipoprotein (LDL) cholesterol from the blood. It is characterized by high levels of LDL cholesterol, also known as “bad” cholesterol, which can lead to an increased risk of early heart disease. YOLT-101, developed independently by YolTech, aims to intervene in specific genetic mutations associated with Familial Hypercholesterolemia. Leveraging advanced gene editing technology and lipid nanoparticle (LNP) delivery, YOLT-101 promises to provide effective treatment options for patients. The preclinical data of YOLT-101 indicate that a single dose of the drug resulted in a significant reduction of LDL-C levels lasting nearly two ...
- Source: drugdu
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- April 4, 2024
YolTech Therapeutics to Participate in 2024 Cell & Gene Meeting on the Mediterranean

SHANGHAI, March 27, 2024 /PRNewswire/ — YolTech Therapeutics, a trailblazing biopharmaceutical company specializing in gene editing, is delighted to announce its participation in 2024 Cell & Gene Meeting on the Mediterranean. The event will take place from April 9th to 11th, 2024, at the esteemed Rome Cavalieri, A Waldorf Astoria Hotel, situated at Via Alberto Cadlolo, 101, 00136 Roma RM, Italy. The Cell & Gene Meeting on the Mediterranean stands as the premier conference uniting the ATMP (Advanced Therapy Medicinal Products) community from Europe and beyond. Covering an extensive array of commercialization topics spanning market access, regulatory issues, manufacturing, and financing within the sector, this program boasts expert-led panels, extensive one-on-one partnering capabilities, exclusive networking opportunities, and over 60 dedicated presentations by leading publicly traded and privately held companies in the space. YolTech is poised to make a significant impact at this event, showcasing its pioneering advancements in in vivo ...
- Source: drugdu
- 135
- April 4, 2024
CanSinoBio Invited to Boao Forum for Asia 2024 Annual Conference

On the afternoon of March 29, the Boao Forum for Asia (BFA) 2024 Annual Conference came to an end. During the four-day conference, nearly 2,000 Chinese and foreign guests from more than 60 countries and regions focused on the theme of “Asia and the World: Common Challenges, Common Responsibilities”, exchanged views on the world economy, scientific and technological innovation, social development, international cooperation and other issues, and discussed the propositions of the times together. Dr. Xuefeng Yu, Chairman and CEO of CanSinoBio, was invited to attend the forum and discussed with more than 20 medical and health experts, industry think tanks and representatives of innovative enterprises from China, the United Arab Emirates, Kenya, Nigeria, South Africa, Singapore, and India on the theme of “Health without Borders – International Medical and Healthcare Cooperation. Through the development of new quality productivity, strengthen the global cooperation to eliminate health disparities and promote global ...
- Source: drugdu
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- April 4, 2024
Latest Research Results of Magnesium Isoglycyrrhizinate GM-DILI-002 Announced

Recently, the 33rd Annual Meeting of the Asia-Pacific Association for the Study of the Liver (APASL 2024) presented a study (GM-DILI-002) analyzing the efficacy of Chiatai Tianqing magnesium isoglycyrrhizinate (MgIG) in the treatment of liver injury associated with a novel antitumor drug based on real-world data from China, and the results of the study (No. 100906 and No. 100910) fill the evidence-based Gap. This real-world, non-interventional, multi-center, retrospective study was conducted in three main settings. The study was based on an e-diagnostic system that screened and analyzed data from a population of 1,710 patients who met international liver biochemical criteria related to DILI (drug-induced liver injury) during treatment with novel antineoplastic agents. In recent years, the emergence of new antitumor drugs, such as molecular targeting and immune checkpoint inhibitors, has led to a continuous improvement in the survival of tumor patients, but at the same time the problem of drug-related ...
- Source: drugdu
- 216
- April 4, 2024
Researchers Present First Study Using Biomimetic AI Digital Twins

Mike Hollan The study used technology developed by a variety of companies, including RYLTI. AI digital twins are here. A group of researchers presented the first study to use digital twins created using AI. According to a press release,1 the group consisted of researchers from Genzeva, LumeGene, RYLTI, Brigham & Women’s Hospital of Harvard University, and QIAGEN Digital Insights worked together to bring the digital creations into a study on the molecular mechanisms of endometrial-related disorders. Dr. William G. Kearns, co-founder, CEO, and chief scientific officer at Genzeva and LumaGene, led the study. In a press release, he said, “This landmark study demonstrated a way to combine omics and a digital twin ecosystem to understand the molecular mechanism of disease better. By incorporating Genzeva’s multiomics platform, QIAGEN’s Digital Insight, and RYLTI’s pioneering biomimetic AI platform for genomic analyses we uncovered hidden dark data with insights that may never have been ...
- Source: drugdu
- 161
- April 3, 2024

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