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Carvykti Demonstrates Clinically Meaningful Improvement in Patients with Relapsed or Lenalidomide-Refractory Multiple Myeloma After One Line of Prior Therapy

By Don Tracy, Associate Editor Results of the Phase III CARTITUDE-4 study showed that treatment with Carvykti achieved a more significant improvement in overall survival (OS) compared to standard therapies. Results from the second interim analysis of the Phase III CARTITUDE-4 study, which evaluated Johnson & Johnson’s (J&J) Carvykti (ciltacabtagene autoleucel; cilta-cel) for patients with relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy showed that the treatment achieved a statistically significant and clinically meaningful improvement in overall survival (OS) compared to standard therapies such as omalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).1 “Carvykti, a one-time infusion, is now the first cell therapy to significantly improve overall survival versus standard of care for patients with myeloma as early as second line,” said Jordan Schecter, MD, VP, disease area leader, multiple myeloma, Johnson & Johnson Innovative Medicine, in a press release. “As we continue to ...
- Source: drugdu
- 160
- July 8, 2024
FDA Grants Fast Track Designation to Inozyme Pharma’s INZ-701, a Treatment for Patients with ABCC6 Deficiency

By Don Tracy, Associate Editor The Fast Track designation for INZ-701 was based nonclinical pharmacology data and preliminary safety and efficacy data from the ongoing Phase I/II trial of INZ-701 in adults with ABCC6 Deficiency. The FDA has granted Fast Track Designation for Inozyme Pharma’s INZ-701, aimed to treat patients with ABCC6 Deficiency. According to the company, the Fast Track designation was based on preliminary safety and efficacy data from its ongoing Phase I/II trial of INZ-701 in adults with ABCC6 Deficiency, as well as nonclinical pharmacology data. Inozyme believes that INZ-701’s development process will benefit from more frequent engagement with the FDA and expedited regulatory review.1 “Through Fast Track designation, the FDA recognizes the potential of INZ-701 in ABCC6 Deficiency. We plan to work closely with the agency to establish an efficient path to approval. Receipt of Fast Track designation underscores our belief that INZ-701 could serve as an ...
- Source: drugdu
- 132
- July 8, 2024
EMA validates Philogen and Sun Pharma’s MAA for melanoma

The European Medicines Agency (EMA) has validated Philogen and Sun Pharmaceutical’s marketing authorisation application (MAA) for Nidlegy, a treatment for melanoma. Nidlegy is an investigational treatment for neoadjuvant (before surgical procedure) locally advanced fully resectable melanoma. The application, submitted on 4 June 2024, is based on data from the Phase III PIVOTAL study and a Phase II trial. The international, multicentre, randomised, comparator-controlled, parallel-group PIVOTAL trial assessed the efficacy and safety of Nidlegy as a neoadjuvant treatment in melanoma patients with locally advanced, fully resectable cutaneous, subcutaneous or nodal metastases accessible to intratumoural injection. A total of 256 patients were enrolled across 22 clinical centres in Italy, Germany, France and Poland. Results from the PIVOTAL trial showed that Nidlegy reduced the relapse or mortality risk by 41% versus the control arm, with a significant improvement in median recurrence-free survival and distant metastasis-free survival (DMFS). Nidlegy’s safety profile was characterised by ...
- Source: drugdu
- 129
- July 8, 2024
Pendopharm and Ascendis to distribute hypoparathyroidism treatment

Pharmascience unit Pendopharm has entered an exclusive distribution agreement with Ascendis Pharma to bring the hypoparathyroidism treatment TransCon PTH (palopegteriparatide) to the Canadian market. Pendopharm will be responsible for securing regulatory approval and overseeing the commercialisation of the product in the country. Neither companies has disclosed the financial terms of the deal. Ascendis Pharma executive vice-president and chief commercial officer Camilla Harder Hartvig stated: “We are delighted to partner with Pendopharm to bring TransCon PTH to Canada, contributing to our shared goal of making a meaningful difference in the lives of patients living with chronic hypoparathyroidism.” A parathyroid hormone (PTH) replacement therapy, TransCon PTH is aimed at treating chronic hypoparathyroidism, a rare endocrine disorder characterised by low or inadequate levels of PTH. The therapy has already secured approval in the European Union, the European Economic Area and Great Britain under the brand name YORVIPATH, specifically for adult patients. TransCon PTH ...
- Source: drugdu
- 91
- July 8, 2024
Hengrui Pharmaceuticals’ Innovative Drug HRS-7249 Injection for the Treatment of Hyperlipidemia Approved for Clinical Trials

Recently, Hengrui Pharmaceuticals’ subsidiary Fujian Shengdi Pharmaceutical Co., Ltd. received a Notice of Approval for Clinical Trial of Drugs approved by the State Drug Administration, which approved HRS-7249 Injection, a Class 1 new drug, to carry out clinical trials for the treatment of hyperlipidemia. Upon inquiry, no similar products have been approved for marketing at home and abroad for the time being. Hypertriglyceridemia (HTG) is a common type of dyslipidemia. Epidemiologic studies have shown that HTG is one of the risk factors for atherosclerotic cardiovascular disease (ASCVD) and acute pancreatitis, and is clearly associated with overweight/obesity, insulin resistance/type 2 diabetes mellitus, non-alcoholic fatty liver disease, and chronic kidney disease. Currently, triglyceride-lowering drugs often used in clinical practice have limited reduction of triglycerides and have adverse effects such as hepatic and renal impairment, increased risk of atrial fibrillation, and decreased insulin sensitivity, and safer and more effective drugs are needed for ...
- Source: drugdu
- 131
- July 8, 2024
Hengrui Pharmaceuticals’ Innovative Drug HRS-9813 Tablets for Treatment of Idiopathic Pulmonary Fibrosis Approved for Clinical Trial

Recently, Hengrui Pharmaceuticals’ subsidiary Guangdong Hengrui Pharmaceuticals Co., Ltd. received the Notice of Approval for Clinical Trial of Drugs approved by the State Drug Administration, which approved HRS-9813 tablets, a Class 1 new drug, to carry out clinical trials for idiopathic pulmonary fibrosis (IPF). Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fibrotic interstitial lung disease of unknown cause, which ultimately leads to hypoxemia, respiratory failure and even death.IPF was included in the first batch of China’s rare disease catalog in 2018, and in recent years, studies have shown that its incidence and prevalence are on the rise globally, and its prognosis is poor, and it is one of the diseases that researchers are currently working to overcome. Currently, there are limited drugs approved for the treatment of IPF at home and abroad, and there are still deficiencies in terms of safety and patient compliance.There is still a huge unmet ...
- Source: drugdu
- 131
- July 8, 2024
The Need for Contextualization and Cloud-based Integration

Data exchange lies at the heart of innovation. With the right data available, BioPharma companies can best implement advanced analytics tools for timely interventions in manufacturing deficiencies and optimize processes. By Harlan KnappBuilt-in data integrity is a bare minimum requirement in today’s BioPharmaceutical manufacturing. Good Manufacturing Practices (GMP) regulations of the Food and Drug Administration (FDA) highlight the importance of the accuracy and reliability of data across supply chains. Yet, the difficulty of achieving this milestone can still be underestimated by drug sponsors, especially when working with manufacturing partners. Although organizations are expected to demonstrate full governance of their data across the product lifecycle, their access to process data remains limited, which hinders early risk detection as well as the scalability of manufacturing. With agile manufacturing networks, novel therapeutic modalities such as mRNA vaccines and cell and gene therapies, the single-source manufacturing model using on-premise/siloed infrastructure can have an adverse ...
- Source: drugdu
- 141
- July 6, 2024
PrimeRx Launches Digital Platform for Pharmacy Drug Ordering

By Mike Hollan The platform is similar to other recent digital platforms in that it is designed to reduce drug costs. One of the main issues impacting the pharmaceutical industry is the cost of medications. Recently, several digital platforms have launched with the mission of providing more competition by providing purchasers with more options for buying drugs. While the most prominent of these platforms have been based on a direct-to-consumer model, there are other platforms that are designed for pharmacies to use as well. PrimeRX announced the launch of a new platform aimed at pharmacies named PrimeRX MARKET.1 This platform will provide users with access to over 40 different drug suppliers, along with the ability to place all of their orders through one platform, and provide research on drug prices. In a press release, PrimeRx CEO Ketan Mehta said, “We are thrilled to introduce PrimeRx MARKET to our solutions portfolio. ...
- Source: drugdu
- 93
- July 6, 2024
EMA approval of Sanofi/Regeneron’s Dupixent fills biologic gap in COPD

Following the European Medicines Agency (EMA) approval of Sanofi/Regeneron’s Dupixent (Dupilumab) on July, 03 2024, Asiyah Nawab, Pharma Analyst at GlobalData, offers her view: “Dupixent, a monoclonal antibody (mAb) targeting interleukin-4 (IL4) and interleukin-13 (IL13) pathways, has been approved by the EMA as the first biologic for uncontrolled chronic obstructive pulmonary disease (COPD) patients. It is to be used specifically as an add-on maintenance treatment, given alongside the standard of care (SoC), with a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA. The approval is set to improve the treatment landscape for COPD and offer patients a treatment option with potential to improve quality of life,” states Nawab “After reviewing the data published from Sanofi/Regeneron’s two landmark phase 3 studies (BOREAS and NOTUS), Dupixent (dupilumab) was able to significantly reduce moderate or ...
- Source: drugdu
- 120
- July 6, 2024
GSK buys COVID, influenza vaccines from retrenching CureVac

British drugmaker GSK on Wednesday, July 4 2024, bought partner CureVac out of their alliance on influenza and COVID-19 vaccine development, boosting its messenger RNA credentials and extending the German biotech company’s financial lifeline. According to the statement, GSK, will take control of CureVac’s leading experimental vaccines to fight infections, including seasonal flu and bird flu. It will pay CureVac 400 million euros ($430 million) upfront and up to 1.05 billion euros contingent on achievements. CureVac said it would cut about 30 per cent of its jobs as it focuses on mRNA-based cancer therapies and other earlier-stage projects. It added GSK’s cash payment extends funding, which would have run out at the end of next year, into 2028. Under the partnership that began in 2020 during the COVID-19 pandemic, the companies have worked together to develop mRNA vaccines for infectious diseases. Wednesday’s agreement reflects GSK CEO Emma Walmsley’s focus on ...
- Source: drugdu
- 105
- July 6, 2024

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