Search Results for “EC” – Page 244 – media

HOF Pharma targets global expansion

With an aim to enhance its global presence and deliver high-quality medicines to a broader market, the Ahmedabad based, HOF Pharmaceuticals has shared its plans for growth. In two years, HOF Pharma has established itself as a manufacturer and exporter of tablets, capsules, and oral liquids. Reportedly, the company’s plant at Sanand, Ahmedabad meets stringent international standards. “Currently we are exporting to 12 countries across Latin America, Africa, and Southeast Asia. With twenty more specialty products in the pipeline, which will augment HOF’s export performance, we are now aiming to double our reach to 25 countries within the next year” commented Pravin Patel, Chairman, HOF Pharma. “Towards this year end, we are gearing up our Quality Management Systems (QMS) and formulation development initiatives towards regulated markets,” added Patel. HOF Pharma comprises over 150 products across various therapeutic categories. These include treatments for diabetes, cardiovascular, central nervous system disorders, immunosuppressant, anticoagulants, ...
- Source: drugdu
- 102
- May 28, 2024
Asahi Kasei Medical completes new assembly plant for Planova virus removal filters

Asahi Kasei Medical has completed the construction of its third assembly plant for Planova virus removal filters in Nobeoka, Miyazaki, Japan, and held its completion ceremony on May 24, 2024. The bioprocess business of Asahi Kasei Medical comprises Planova virus removal filters and equipment used in the manufacturing process of biotherapeutic products such as biopharmaceuticals and plasma derivatives, biosafety testing services, and biopharmaceutical Contract Development and Manufacturing (CDMO) operations. It is one of the Asahi Kasei Group’s businesses to drive future growth. Planova cellulose hollow-fibre membrane filters, developed specifically for removing viruses from biotherapeutic products, were launched in 1989, followed by Planova BioEX hydrophilic PVDF hollow-fibre membrane filters in 2009. A next-generation line of cellulose hollow-fibre membrane filters, Planova S20N, was launched in 2022 featuring robust virus removal capability and simplified operation. To further ensure stable supply, Asahi Kasei Medical has been proactively expanding production capacity for Planova including the ...
- Source: drugdu
- 69
- May 28, 2024
Blood Test Measures Immune Response to Epstein-Barr Virus in MS Patients

Multiple sclerosis (MS) is a chronic neurological condition for which there is currently no cure. It affects around three million people globally and ranks as the second most common cause of disability among young adults. The urgent need for improved treatments has led to extensive research into various viruses associated with MS, with the Epstein-Barr Virus (EBV) emerging as a significant risk factor for the disease. It remains unclear why certain individuals with MS exhibit an abnormal immune response to EBV, which typically causes no symptoms in most people. Now, a novel blood test has been developed that measures the immune response to EBV, providing new avenues for basic research into EBV’s role in MS and potential applications in clinical trials aimed at targeting the virus. Researchers at Trinity College Dublin (Dublin, Ireland) conducted studies measuring the immune response of MS patients to EBNA-1, a component of EBV that resembles ...
- Source: drugdu
- 118
- May 28, 2024
Eli Lilly Pumps $5.3B More Into Site for Making Metabolic Meds Zepbound & Mounjaro

Eli Lilly says its capital commitment to its new Indiana site is the largest manufacturing investment in the company’s history. The site will make tirzepatide, the active pharmaceutical ingredient in both Zepbound and Mounjaro. By Frank VinluaEli Lilly is boosting its ability to meet growing demand for the metabolic disorder drugs Zepbound and Mounjaro, committing $5.3 billion toward the expansion of a site that will produce the main pharmaceutical ingredient in both medications. Lilly broke ground on the Lebanon, Indiana, site in 2023. The expansion announced Friday brings Lilly’s total investment in the site to $9 billion. The company expects this facility will begin making medicines in late 2026. Mounjaro, approved in 2022 for treating type 2 diabetes, has become a blockbuster seller with 2023 revenue totaling $5.1 billion. Zepbound was approved late last year for chronic weight management. Both medications are incretins, drugs that mimic a gut hormone to ...
- Source: drugdu
- 79
- May 28, 2024
Blood Test Measures Immune Response to Epstein-Barr Virus in MS Patients

Multiple sclerosis (MS) is a chronic neurological condition for which there is currently no cure. It affects around three million people globally and ranks as the second most common cause of disability among young adults. The urgent need for improved treatments has led to extensive research into various viruses associated with MS, with the Epstein-Barr Virus (EBV) emerging as a significant risk factor for the disease. It remains unclear why certain individuals with MS exhibit an abnormal immune response to EBV, which typically causes no symptoms in most people. Now, a novel blood test has been developed that measures the immune response to EBV, providing new avenues for basic research into EBV’s role in MS and potential applications in clinical trials aimed at targeting the virus. Researchers at Trinity College Dublin (Dublin, Ireland) conducted studies measuring the immune response of MS patients to EBNA-1, a component of EBV that resembles ...
- Source: drugdu
- 124
- May 27, 2024
Q&A with Alvana Maliqi

Mike Hollan Cencora’s associate director of value and access strategy for its commercialization strategy & access solutions division discusses the current state of pre-approval information exchanges. Alvana Maliqi, Associate director of value and access strategy Alvana Maliqi served as lead author on Cencora’s latest research initiatives focused on pre-approval information exchange (PIE). She spoke with Pharmaceutical Executive about the research and how the industry can utilize this information more efficiently. Pharma Executive: What does the passage of the PIE legislation allow biopharma companies to do? Alvana Maliqi: The Consolidated Appropriations Act, 20231 (or pre-approval information exchange [PIE] legislation”) was signed into law in 2022, providing a safe harbor for pharmaceutical companies to proactively engage in PIE with payers about new products and/or new indications. Previously, this pathway was initially supported by the 2018 FDA Final Guidance for pre-approval communications. Since 2018, biopharma manufacturers are permitted to share unbiased, factual, accurate, ...
- Source: drugdu
- 127
- May 27, 2024
Cure Genetics Announced Promising Safety and Efficacy Data of CAR-NKT Product CGC729 for RCC at ASGCT 2024

SUZHOU, China, May 23, 2024 /PRNewswire/ — On May 10, 2024, Cure Genetics announced the safety and efficacy data of their CAR-NKT product, CGC729, for patients with relapsed and refractory metastatic renal cell carcinoma (R/R mRCC) in an oral presentation at the 27th Annual Meeting of the American Society for Gene & Cell Therapy (ASGCT) in Baltimore. This marked the first-in-human trial using CAR-NKT therapy for R/R mRCC, demonstrating a good safety profile and encouraging anti-tumor activity. This phase I dose-escalation clinical trial was conducted at Fudan University Shanghai Cancer Center using a single-arm, 3+3 design to evaluate the safety and efficacy of CGC729 at three dose levels (DL1: 5 x 106/m2; DL2: 1.5 x 107/m2; DL3: 4.5 x 107/m2) in the treatment of R/R mRCC patients who had at least two lines of prior therapy. As of April 2024, five patients were enrolled and received a single infusion of ...
- Source: drugdu
- 110
- May 27, 2024
Positive Results Achieved in Phase III Study of Benmosubimab in Combination with Anlotinib for First-Line Treatment of Advanced Renal Cell Carcinoma

Recently, Chiatai Tianqing Pharmaceutical Group’s randomized, open, positive drug-parallel controlled, multicenter Phase III clinical study of Benmelstobart (TQB2450), a Class 1 innovative biologic drug, in combination with Anlotinib, a Class 1 innovative drug, for the first-line treatment of advanced unresectable or metastatic renal cell carcinoma (RCC) has completed the protocol-prescribed interim analysis of the ETER100 study. ETER100 study) has completed the protocol-prescribed interim analysis, and the Independent Data Monitoring Committee (IDMC) has determined that the primary study endpoint of progression-free survival (PFS, based on independent imaging assessment) has met the protocol-prescribed superiority cut-off, and that the secondary endpoint of overall survival (OS) has shown a trend toward benefit. The Company has communicated with the Center for Drug Evaluation (CDE) of the State Drug Administration of China regarding the marketing application for this indication, and has obtained the CDE’s consent to submit a marketing application for the addition of this new ...
- Source: drugdu
- 122
- May 27, 2024
Emcure and Gennova to resume mRNA collaboration with HDT

Emcure Pharmaceuticals and its biotech subsidiary, Gennova Biopharmaceuticals have amicably resolved all legal disputes with HDT Bio Corporation. The litigation between them, including before US courts and the arbitral tribunal in London, has been settled and dismissed. Gennova and HDT, who previously collaborated on the successful development of Gennova’s mRNA Covid-19 vaccines, will once again collaborate on the development and commercialisation of mRNA vaccines. The parties have entered into a long-term agreement to develop mRNA vaccines against a broad range of infectious diseases, in India and several other countries. As part of their agreement, HDT has granted a license to Gennova to use HDT’s patented mRNA vaccine technology in multiple fields. https://www.business-standard.com/companies/news/emcure-gennova-settle-legal-dispute-with-us-based-hdt-bio-sign-agreement-124052300762_1.html
- Source: drugdu
- 142
- May 27, 2024
Gerresheimer to acquire Blitz LuxCo Sarl, for EUR 800 million

Gerresheimer Glas GmbH, an indirect subsidiary of Gerresheimer AG, has signed a purchase agreement with funds advised by Triton for the acquisition of Blitz LuxCo Sarl, the holding company of the Bormioli Pharma Group (Bormioli Pharma). The purchase price is based on a determined enterprise value of around EUR 800 million, which corresponds to an adj. EBITDA multiple of around 10 Bormioli Pharma, has 9 production sites in Europe. The Group generates revenues of around EUR 370 million and an adj. EBITDA margin of around 21 per cent. Bormioli Pharma has a complementary portfolio of pharmaceutical primary packaging made of glass and plastic, as well as closure solutions, accessories, and dispensing systems. With this acquisition, Gerresheimer strengthens its European footprint with additional production sites, especially in Southern Europe, and underpins its market position as a leading full-service provider and global partner for the pharmaceutical and biotech industries. The acquisition is ...
- Source: drugdu
- 114
- May 27, 2024

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