PharmaFocus Today – Page 183 – media

Eisai to divest rights for two therapies to Kaken

Eisai has signed an agreement for the divestiture of rights for Merislon and Myonal, two of its long-standing products in Japan, to Kaken Pharmaceutical. The transaction is valued at Y3.8bn ($25.10m). Merislon treats vertigo and equilibrium disturbances and Myonal is a muscle relaxant, which patients have used since their respective launches in 1969 and 1983. The agreement stipulates that Eisai will complete the transfer of marketing capabilities by March 2025, followed by manufacturing and marketing approval transfer. The deal will not impact Eisai’s consolidated financial forecast for 31 March 2024. The company stated: “Eisai has determined that divesting rights for these products to Kaken, which has strengths in the products’ disease areas, is the optimal choice to ensure they continue contributing to a greater number of patients.” Eisai will continue to focus on creating and delivering products to target diseases with higher unmet medical needs such as neurology, oncology and ...
- Source: drugdu
- 212
- April 5, 2024
Zhongde Meilian HuGen 21HS Fluorescent Assay Kit Launched on the Market

Recently, ANKE Bio’s member company, Wuxi Zhongde Meilian HuGen 21HS fluorescence detection kit was launched on the market, which contains 18 new autosomal loci, 1 CODIS locus, 1 sex locus and 1 Y-chromosome locus, and can be used in conjunction with other ANKE Bio kits to detect at least 73 autosomal STR loci, which is able to meet the new requirements of the Technical Specification for Biological Half-Sibling Relationships (SF/T 0131-2023), making the identification of half-sibling relationship more accurate and reliable. It is able to meet the new requirements in the technical specification of biological half-sibling relationship identification (SF/T 0131-2023), which makes the identification of half-sibling relationship more accurate and reliable. The new autosomal loci also have many applications other than half-sibling detection, which can provide new possibilities for kinship identification or other forensic evidence cases. In the field of biology, half-siblings are individuals with multiple offspring having the same ...
- Source: drugdu
- 195
- April 5, 2024
Jazz Pharmaceuticals Completes Biologics License Application for Zanidatamab for HER2-Positive Metastatic Biliary Tract Cancer

Don Tracy, Associate Editor Approval would mark first HER2-targeted therapy for biliary tract cancer in the United States. Jazz Pharmaceuticals announced that it has completed its Biologics License Application (BLA) for zanidatamab, an investigational bispecific antibody treatment targeting HER2-positive metastatic(BTC). Aiming for accelerated approval, zanidatamab has the potential to be the first HER2-targeted therapy indicated for BTC in the United States. According to the company, the BLA was based on findings from the Phase IIb HERIZON-BTC-01 trial for zanidatamab. The primary study endpoint of confirmed objective response rate (cORR) by independent central review (ICR) was deemed a success, as the 80 enrolled patients demonstrated a cORR of 41.3%. The HERIZON-BTC-302 Phase III started recently and is currently in the process of enrollment.1 “This important milestone brings us one step closer to delivering zanidatamab, a targeted treatment option, to patients living with HER2-positive BTC, a type of cancer that is associated ...
- Source: drugdu
- 183
- April 5, 2024
FDA Approves Abbott’s i-STAT TBI Whole Blood Rapid Test to Assess Patients for Concussions at Bedside

Don Tracy, Associate Editor The concussion test, which shows results after 15 minutes, can help evaluate patients up to 24 hours after injury, company says. The FDA has approved Abbott’s i-STAT TBI cartridge to use with whole blood for rapid bedside assessment of patients with suspected concussions. The company stated this regulatory action is significant because previously available concussion tests required plasma or serum and lab processing. The device has been found to provide lab-quality results in 15 minutes to evaluate patients over the age of 18 years up to 24 hours after injury. Abbott stated the approval is an important milestone, citing that many individuals may have to wait following an injury to obtain proper treatment for the symptoms of a concussion.1 “Emergency departments can be a busy place. It’s important to be able to triage patients quickly,” Geoffrey Manley, MD, PhD, chief, neurosurgery, Zuckerberg San Francisco General Hospital, ...
- Source: drugdu
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- April 5, 2024
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
- 165
- 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
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- 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
- 166
- April 4, 2024

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