Search Results for “EC” – Page 66 – media

Elpiscience and Astellas Enter into Research Collaboration and License Agreement for Novel Bispecific Macrophage Engager

Shanghai and Suzhou, TOKYO, December 28, 2023 – Elpiscience Biopharma, Ltd. (Chairman and CEO: Darren Ji, MD, Ph.D., “Elpiscience”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced a research collaboration and license agreement for novel bi-specific macrophage engagers, ES019 and another program. The two companies will collaboratively conduct early-stage research for these two programs. Elpiscience will also grant Astellas the right to add up to two additional programs to be included in the collaboration. If Astellas exercises its option, Elpiscience will grant Astellas the exclusive right to further research, develop, manufacture and commercialize the products for each program. Elpiscience is a privately held, clinical-stage biopharmaceutical company dedicated to developing next-generation immuno-oncology therapies for cancer patients worldwide. Their Bispecific Macrophage Engager Platform (BiME®) is anti-tumor associated antigen (TAA) and anti-signal-regulatory protein α (SIRPα) bispecific antibody-based platform to activate Tumor Associated Macrophage (TAM) phagocytosis killing towards ...
- Source: drugdu
- 142
- January 2, 2024
Sanofi’s ‘SR604 Injection’ Approved in China, ‘Yipian Lida’ Supports Lipid Management with ‘Dual Standards’

Sanofi announced that its rosuvastatin and ezetimibe tablets (I) (Yipian Lida®) have been approved by the National Medical Products Administration (NMPA) of China for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) patients. As the first approved and marketed combination formulation of rosuvastatin and ezetimibe in China, Yipian Lida® marks the beginning of a new era in potent combination lipid-lowering therapy. A single dose achieves a greater than 50% reduction in low-density lipoprotein cholesterol (LDL-C), effectively and continuously lowering LDL-C to target levels, supporting ‘Dual Standards’ in lipid management, and providing a new and powerful option for patients with lipid abnormalities. Academician Ge Junbo from Zhongshan Hospital, affiliated with Fudan University, stated, “In the face of the increasingly serious burden of cardiovascular diseases, effective control and management of risk factors are crucial. Only by controlling LDL-C to ideal levels early can we reduce the incidence of adverse events and ...
- Source: drugdu
- 166
- January 1, 2024
Shanghai RAAS’s New Drug ‘SR604 Injection’ Clinical Trial Application Accepted

On December 21, 2023, Shanghai RAAS received the ‘Acceptance Notification’ from the National Medical Products Administration regarding the clinical trial application for ‘SR604 Injection.’ SR604 Injection is a humanized monoclonal antibody that combines with human activated protein C with high affinity and specifically inhibits the anticoagulant function of human activated protein C. It is intended for the prophylactic treatment of bleeding in patients with hemophilia A/B and congenital coagulation factor deficiency. Currently, routine prophylactic treatment for hemophilia worldwide involves intravenous injection of blood-derived or recombinant coagulation factors 2-3 times a week. SR604 is intended to undergo a Phase I clinical trial for subcutaneous injection prophylactic treatment every 4 weeks. Some preclinical research findings from this project have already been published in the international hematology research journal Blood in the form of a cover article. As of the disclosed information, there are no products on the global market targeting the same ...
- Source: drugdu
- 139
- January 1, 2024
Boston Scientific initiates new Farapulse trial, expects FDA approval in 2024

BY SEAN WHOOLEY The Farapulse PFA system. [Image courtesy of Boston Scientific]Boston Scientific (NYSE: BSX)+ announced today that it initiated the AVANT GUARD clinical trial to evaluate its Farapulse pulsed-field ablation (PFA) system. The company also says it now anticipates FDA approval for Farapulse in the first quarter of 2024. AVANT GUARD looks at the safety and effectiveness of Farapulse as a first-line treatment for persistent AFib. Boston Scientific says this makes it the only trial studying the use of PFA as a frontline therapy in patients with this form of AFib. Farapulse is already a known commodity in the competitive PFA space. The nonthermal treatment uses electric fields to selectively ablate heart tissue. Boston Scientific bought Farapulse for nearly $300 million in 2021. The company shared its high hopes for the technology at its Investor Day event earlier this year, with analysts projecting FDA approval and rapid adoption in ...
- Source: drugdu
- 178
- December 30, 2023
Innovative Drug FXI Inhibitor SHR-2004 Injection Phase I Healthy Human Study Results Shine at ASH

Recently, the 65th American Society of Hematology Annual Meeting (ASH) was held in San Diego, USA. As one of the largest and most comprehensive international conferences covering both malignant and non-malignant hematology, ASH attracts over 25,000 hematologists from more than 100 countries each year, sharing cutting-edge advances and breakthrough clinical data in hematology. At this conference, the independently developed (Factor XI) FXI inhibitor SHR-2004 injection by Hengrui Pharmaceuticals was presented as a poster. The research results are encouraging, supporting further clinical exploration in the prevention or treatment of venous thromboembolic diseases. Research Background SHR-2004 injection is a humanized monoclonal antibody that selectively binds to coagulation factors FXI and FXIa, inhibiting the activation of FXI by FXIIa and thereby blocking the cascade reaction process of the endogenous coagulation pathway, exerting an anticoagulant effect. Preclinical studies have shown that SHR-2004 prolongs activated partial thromboplastin time (APTT) and inhibits FXI activity. This study ...
- Source: drugdu
- 136
- December 30, 2023
Key Leadership Lessons for Biotech Executives from a Hospital Administrator

While it may appear that hospital administrators and biotech CEOs have quite dissimilar jobs because they face different challenges daily, this article attempts to conveys the value of some of the underlying principles that one can develop in the field of hospital administration, that may have some value in other healthcare fields and in other executive positions. By PETE O’HEERON When one thinks of the dynamic biotech landscape, with many early-stage firms delving into therapies for diverse maladies, such as cancer or heart disease, to any of a number of rare diseases, the executive leadership image that arises is certainly quite different than one might imagine for a healthcare executive, such as a hospital administrator. While patient health might be an end goal for both, the milieu within which they operate is seemingly quite distinct. It is certainly not typical for individuals to transition between these two realms, and yet, ...
- Source: drugdu
- 161
- December 29, 2023
Pfizer’s Hospira recall spree bleeds into 2024 with product pulls for multiple hospital drugs in shortage

After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes. What’s more, the company’s latest product pulls threaten to intensify the ongoing shortages of several critical hospital drugs. Shortly before the holiday, Pfizer’s Hospira announced two separate recalls over the potential presence of glass particulates in vials and syringes of certain meds. In the case of injectable cancer medication bleomycin—of which Hospira is recalling one lot—a confirmed customer report alerted the company to the presence of glass particulates within a single vial, the company said in a notice posted on the FDA’s website. The second recall, which covers three drugs—two strengths of injectable sodium bicarbonate, plus one lot of atropine sulfate injection—kicked off after the company flagged “the potential presence of glass particulate matter” during routine product inspection. In both cases, Pfizer and Hospira said they hadn’t received ...
- Source: drugdu
- 191
- December 29, 2023
AstraZeneca to buy China’s Gracell Biotechnologies in $1.2 billion deal

Dec 26 (Reuters) – AstraZeneca (AZN.L) said on Tuesday it will buy Gracell Biotechnologies (GRCL.O) for up to $1.2 billion as the Anglo-Swedish pharma company furthers its cell therapy ambitions and boosts its presence in China, the world’s second-largest pharmaceuticals market. The cash deal, which adds several experimental therapies to AstraZeneca’s portfolio, values Gracell at $2 per ordinary share, or $10 per American Depository Share, of Gracell, representing a premium of 61.6% from its last close on Dec. 22. The shareholders will also receive a non-tradable contingent value right of $0.30 per ordinary share, if certain regulatory milestones are met. Shares of China-headquartered Gracell surged 60% in premarket trading in the United States. Gracell’s CAR-T cell therapy works by extracting disease-fighting white blood cells known as T-cells from a patient, re-engineered to attack cancer and infused back into the body. H.C. Wainwright analyst Emily Bodnar said this could be AstraZeneca’s ...
- Source: drugdu
- 178
- December 28, 2023
Completion of Phase I Clinical Trial for GLP-1/GIP Dual Receptor Agonist (Injectable THDBH120) with First Subject Enrolled

Tonghua Dongbao Pharmaceutical Co., Ltd. (hereinafter referred to as “the Company” or “Tonghua Dongbao”), a wholly-owned subsidiary Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., received the approval notice for the clinical trial of injectable THDBH120 (GLP-1/GIP dual receptor agonist) from the National Medical Products Administration Drug Evaluation Center. The company has initiated the Phase I clinical trial and recently completed the enrollment of the first subject. After the approval for clinical use of injectable THDBH120, the company completed the enrollment of the first subject in the Phase I clinical trial in just around half a month, showcasing the company’s accelerated progress in the research and development of innovative products, as well as its ability and determination to transition into an innovative pharmaceutical enterprise. The company will further explore and uncover the potential of injectable THDBH120 in other indications such as obesity, continually opening up new therapeutic areas to maximize the value ...
- Source: drugdu
- 191
- December 28, 2023
Moderna and Merck’s Novel Cancer Vaccine, Keytruda Combo Cuts Risk of Skin Cancer Death, Recurrence by Half

Pharmaceutical Executive Editorial Staff Adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Merck’s Keytruda lowered the risk of recurrence or death by 49% compared with Keytruda monotherapy. Findings from the KEYNOTE-942/mRNA-4157-P201 clinical trial show that Moderna’s investigational individualized neoantigen therapy plus Merck’s Keytruda (pembrolizumab) lowered the risk of death or relapse by nearly half in patients with resected high-risk melanoma (stage III/IV) following complete resection. A planned analysis of the Phase IIb randomized trial found that at a median follow-up of approximately three years, adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Keytruda continued to show a clinically meaningful improvement in recurrence-free survival (RFS) by lowering the risk of recurrence or death by 49% compared with Keytruda monotherapy. “As we continue to follow participants in the KEYNOTE-942/mRNA-4157-P201 study, we are excited to see such a robust clinical benefit with mRNA-4157 (V940) as adjuvant treatment in combination with Keytruda ...
- Source: drugdu
- 211
- December 27, 2023

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