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India’s DCGI approves Orchid Pharma’s API Enmetazobactam

Orchid Pharma has secured approval from the Drugs Controller General of India (DCGI) to manufacture and market its new chemical entity (NCE), the active pharmaceutical ingredient (API) Enmetazobactam. The DCGI also approved the production and marketing of the finished dosage form (FDF) of Cefepime and Enmetazobactam as a dry powder injectable. The antibiotic drug combination is specifically indicated for complicated urinary tract infections (cUTI), including the treatment of acute pyelonephritis. Other indications comprise hospital-acquired pneumonia (HAP), ventilator-associated pneumonia, and bacteremia when associated with or suspected to be linked to either cUTI or HAP. Orchid Pharma’s new combination drug addresses the urgent need for effective treatments against severe infections caused by resistant bacteria, a critical concern in the global health community’s fight against antimicrobial resistance (AMR). The United Nations and the World Health Organization have declared AMR to be a “silent pandemic”, attributing to five million deaths in 2019. The company ...
- Source: drugdu
- 124
- June 7, 2024
Resolution unveils data for liver disease treatment at EASL 2024

Resolution Therapeutics Limited, in collaboration with the University of Edinburgh, has presented compelling clinical data at the EASL Congress 2024 in Milan, Italy, showcasing the significant potential of macrophage cell therapy for treating advanced liver cirrhosis. The MATCH Phase 2 study, led by Dr Paul Brennan from the University of Dundee and Professor Stuart Forbes, has revealed that autologous non-engineered macrophages are safe and effective for patients with liver cirrhosis, showing a marked improvement in patient survival and transplant-free survival over thirty months post-randomisation. Professor Forbes – a founder of Resolution Therapeutics and Professor of Transplantation and Regenerative Medicine at the University of Edinburgh – reflected: “We are greatly encouraged by the data from the MATCH Phase 2 study and this long-term follow-up study. We will continue monitoring patients with the aim of reporting further data at the AASLD meeting in November 2024.” Resolution has also introduced a proprietary discovery ...
- Source: drugdu
- 100
- June 7, 2024
Sanofi’s Sarclisa shows significant promise in treating myeloma

Sanofi’s Sarclisa, a novel treatment for multiple myeloma, has demonstrated a substantial improvement in progression-free survival for patients ineligible for transplant. The phase 3 IMROZ study revealed that Sarclisa (also known as isatuximab), combined with a VRd regimen, reduced the risk of disease progression or death by 40% compared to VRd alone. The study, which was presented at the American Society of Clinical Oncology (ASCO) annual meeting, marks a significant advancement in the treatment of newly diagnosed multiple myeloma (NDMM). The full data, published in the New England Journal of Medicine, will inform future regulatory submissions. Professor Graham Jackson, a haematologist and advisor for Myeloma UK, highlighted the importance of the findings: “Effective first-line treatment is essential in managing and delaying disease progression for newly diagnosed multiple myeloma patients. He added: “The significant progression-free survival demonstrated in the IMROZ study reinforces the potential of isatuximab-VRd to improve outcomes for newly ...
- Source: drugdu
- 87
- June 7, 2024
Phase III Trial Data Presented at ASCO Show Imfinzi Improves Survival in Limited-Stage Small Cell Lung Cancer

Don Tracy, Associate Editor Results of the ADRIATIC trial indicated that treatment with Imfinzi after standard-of-care concurrent chemoradiotherapy improves overall survival and progression-free survival in patients with limited-stage small cell lung cancer.AstraZeneca announced a significant milestone from the ADRIATIC trial, which is evaluating the safety and efficacy of Imfinzi (durvalumab) for the treatment of limited-stage small cell lung cancer (LS-SCLC) in patients who haven’t progressed following concurrent chemoradiotherapycCRT. According to the company, the trial found that administration of Imfinzi after standard-of-care cCRT greatly improves overall survival (OS) and progression-free survival (PFS) compared to placebo. These results were presented at the 2024 American Society of Clinical Oncology Annual Meeting during the Plenary Session.1 “The ADRIATIC results represent a breakthrough in limited-stage small cell lung cancer, a highly aggressive disease where recurrence rates are high and only 15 to 30 per cent of patients survive five years,” said David R. Spigel, chief ...
- Source: drugdu
- 156
- June 6, 2024
Data Presented at ASCO Show Improved Complete Response with Jemperli as a First-Line Treatment for Locally Advanced Rectal Cancer in Patients with Mismatch Repair Deficient Status

Don Tracy, Associate Editor Results of the Phase II AZUR-1 trial show that 100% of participants achieved a clinical complete response when treated with Jemperli for locally advanced rectal cancer in patients with mismatch repair deficient status. Updated results from the Phase II AZUR-1clinical trial of Jemperli (dostarlimab) show the promise of the medication as a treatment for mismatch repair deficient (dMMR) locally advanced rectal cancer in offering an alternative to surgery, according to GSK. The trial, performed in partnership with Memorial Sloan Kettering Cancer Center (MSK), found that Jemperli produced a 100% clinical complete response (cCR) in participants administered the drug, according to data presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.1 “The data showing no evidence of disease in 42 patients is remarkable. These results bring us one step closer to understanding the potential of dostarlimab in this curative-intent setting for patients with dMMR ...
- Source: drugdu
- 110
- June 6, 2024
New Cancer Detection Method as Quick and Easy as Blood Test

Researchers have unveiled a groundbreaking method to detect cancer, potentially simplifying the process to just taking a blood test. This technique, which boasts a 98.7% accuracy rate, combines optical imaging technology with fluorescent imaging. The method’s capability to identify cancer at its initial stages could significantly enhance the effectiveness of treatments. The highly accurate method developed by a research team at the University of Houston (Houston, TX, USA) enables the examination of extracellular vesicles or EVs—nanometer-sized membrane sacs present in the bloodstream that can transport various cargoes, including proteins, nucleic acids, and metabolites. In 2020, the research team introduced PANAROMA, an optical imaging technology featuring a glass slide covered with gold nanodiscs. This setup permits the observation of light transmission changes and the determination of nanoparticles as small as 25 nanometers in diameter. The technology’s name, PANORAMA, stands for Plasmonic Nano-aperture Label-free Imaging, highlighting its critical features. For this particular ...
- Source: drugdu
- 89
- June 6, 2024
POC STI Test Shortens Time from ED Arrival to Test Results

In a 2024 sexually transmitted infections (STIs) surveillance report by the World Health Organization (WHO), over 2.5 million cases were recorded, alongside a rise in the inappropriate use of antibiotics to treat these STIs. This misuse has contributed to the development of antimicrobial-resistant strains of Neisseria gonorrhoeae (NG), prompting WHO to issue new guidelines for diagnosing STIs, including the use of point-of-care (POC) tests, focusing particularly on reducing antimicrobial resistance. The increasing STI rates have posed a significant challenge to hospital emergency departments, as traditional tests do not yield results quickly enough to guide treatment decisions during a patient’s visit. Consequently, clinicians often must decide on treatment before obtaining definitive results, exacerbating the issue of antibiotic resistance. Now, a new study has demonstrated that a POC polymerase chain reaction (PCR) test can reduce the time from specimen collection to STI result to just 47 minutes per patient, compared to the ...
- Source: drugdu
- 140
- June 6, 2024
FDA fast tracks Quince Therapeutics’ rare ataxia drug EryDex

California-based biotech Quince Therapeutics has won fast track designation from the US Food and Drug Administration (FDA) for its ataxia-telangiectasia (A-T) drug EryDex. According to the 3 June announcement, fast track designation was awarded to address a high unmet medical need for patients with A-T. The status allows for earlier interactions with the FDA as Quince seeks accelerated approval, and also the possibility to undergo rolling reviews. A-T is a rare disease of the nervous and immune systems, affecting motor movement and speech. EryDex utilises autologous intracellular drug encapsulation (AIDE) technology to administer dexamethasone sodium phosphate (DSP) into a patient’s red blood cells. Red blood cells filled with DSP are then reinfused into the patient, allowing for the slow release of steroids over several weeks, without the long-term toxicity commonly associated with chronic administration. The FDA lifted a partial clinical hold that was on the drug in October 2023, advancing ...
- Source: drugdu
- 83
- June 6, 2024
Weiguang Bio’s Human Plasminogen Complex Officially Approved

On May 21st, Weiguang Biological officially obtained the Certificate of Drug Registration of Human Plasminogen Complex approved by the State Drug Administration, adding one new product to its product pipeline! Up to now, Weiguang Bio has 11 products in three categories of blood products, and the comprehensive plasma utilization rate ranks the leading level in the industry. Prothrombin Complex Concentrate (PCC) approved by Weiguang is a concentrated preparation rich in coagulation factors II, VII, IX and X made from healthy human plasma, separated and purified by gel adsorption, ultrafiltration and other advanced technologies, and lyophilized by S/D and dry heat viral inactivation process. The ratio of Factor II, Factor VII, Factor IX and Factor X in the finished product is 1:1:1:1, all of them are 300IU, which is one of the rare four-factor PCC in the industry, and the quality of the product is at the leading level in the ...
- Source: drugdu
- 105
- June 6, 2024
invoX Pharma’s FS222 delivers encouraging solid tumour treatment results

invoX Pharma Limited has presented updated findings from its phase 1 study of FS222, showcasing significant anti-tumour activity in patients with advanced solid tumours. The data, revealed at the 2024 American Society of Clinical Oncology Annual Meeting, highlights FS222’s potential as a ground-breaking treatment option. FS222, a CD137/PD-L1 bispecific antibody, is part of invoX’s innovative product pipeline. The phase 1 trial involved 100 subjects and aimed to establish the drug’s safety and maximum tolerated dose. The study also assessed FS222’s anti-tumour activity, pharmacokinetics, and pharmacodynamics. The treatment, administered every four weeks, led to increased T cell proliferation and CD8+ T cell infiltration within tumours. While treatment-related adverse events were dose-dependent, they remained manageable and reversible. Dr Elena Garralda, Director of Early Drug Development at Vall d’Hebron University Hospital, commented on the drug’s potential: “While there have been great advances in immuno-oncology research, existing treatments continue to face challenges with response ...
- Source: drugdu
- 68
- June 6, 2024

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