PharmaFocus Today – Page 199 – media

HANSIZHUANG Sets Sail in Indonesia Market

Shanghai, China, December 28, 2023 – Shanghai Henlius Biotech, Inc. (2696.HK) announces that recently, PT Kalbio Global Medika, the subsidiary of Henlius’ partner PT Kalbe Genexine Biologics (KGbio), has received the relevant registration certificates issued by Indonesia’s National Agency for Drug and Food Control (Indonesian: Badan Pengawas Obat and Makanan, the “BPOM”) for the approval of Henlius’ self-developed and manufactured anti-PD-1 mAb HANSIZHUANG (serplulimab) in Indonesia under the trade name Zerpidio® for the treatment of extensive stage small cell lung cancer (ES-SCLC). This is the first time HANSIZHUANG has been successfully approved for marketing in an overseas market, and it has become the first China anti-PD-1 mAb successfully approved for marketing in Southeast Asia. Currently, Henlius is joining hands with KGbio for the development and commercialisation in 22 countries, and the approval is expected to bring HANSIZHUANG to more patients in Indonesia. Lung cancer (LC) is one of the most ...
- Source: drugdu
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- December 30, 2023
Organon pays $50M to pick up rights to pair of Eli Lilly migraine meds in Europe

Organon, the women’s health-focused spinoff of Merck, has picked up the rights to distribute and promote a pair of migraine medicines overseas. Monday, Organon unveiled a marketing pact with Eli Lilly to take charge of Emgality and Rayvow in Europe. Emgality is approved to help prevent migraines in adults who have at least four migraine days per month, while Rayvow is cleared for acute treatment of the headache phase of migraine attacks. The commercialization agreement bolsters Organon’s existing suite of central nervous system treatments and furthers the company’s mission to help women, who are disproportionately affected by migraines, Organon’s CEO, Kevin Ali, said in a statement. Under the deal, Lilly will maintain marketing authorizations for its drugs and continue to manufacture the products. In exchange for the rights, Organon is handing over an upfront payment of $50 million. Lilly is also in line to receive other sales-based milestone payouts, the ...
- Source: drugdu
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- December 30, 2023
$15 million NCI grant awarded to investigate a type of radiation therapy for hard-to-treat cancers

The Radiopharmaceutical Therapy and Dosimetry Lab at Johns Hopkins Medicine, headed by George Sgouros, Ph.D., has been awarded a $15 million grant, to be dispersed over the next five years, from the National Cancer Institute at the National Institutes of Health. They will use these funds to investigate a type of radiation therapy for hard-to-treat cancers. The award will fund several research projects, all of which will investigate a promising cancer treatment known as alpha-particle emitter radiopharmaceutical therapy, or alpha-emitter RPT. This therapy has proved successful in treating widespread, treatment-resistant cancers through directly delivering radiation to cancer cells. Administered into the bloodstream, alpha-emitter RPT treatment delivers highly potent radiation directly to cancer cells. Radioactive atoms that emit alpha-particles (helium nuclei) are attached to special molecules that target, or latch on to, dispersed cancer cells in the body. Alpha-particles delivered to cancer cells cause massive DNA damage that kills the cancer. ...
- Source: drugdu
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- December 30, 2023
Activist shareholders urge drugmakers to re-evaluate patent strategies, human rights policies

Over the years, shareholders at the Interfaith Center on Corporate Responsibility (ICCR) have repeatedly voiced concerns on a variety of subjects to top pharma companies. Now, as 2023 comes to a close, the group is taking pharma giants to task over their patenting strategies and potential human rights shortfalls. In proposals to AbbVie, Eli Lilly, Gilead, Johnson & Johnson, Merck and Pfizer, the group is pushing the companies to review how add-on patents for medicines can affect patient access. Additionally, Bristol Myers Squibb, Pfizer and Eli Lilly face calls to review and update their human rights policies. While ICCR has voiced pharma-related complaints plenty of times in the past, its proposals haven’t been met with much enthusiasm by the companies’ larger pools of shareholders. In 2019, for instance, investors at several large pharma companies rejected the group’s proposals to study the potential link between CEO pay and drug prices. In ...
- Source: drugdu
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- December 30, 2023
Johns Hopkins researchers find minimal regret after gender affirming surgery

In a Viewpoint article published Dec. 27, 2023, in JAMA Surgery, three Johns Hopkins researchers urge the medical community to dismiss a widely held, but scientifically unsupported belief that many people who are transgender and gender diverse (TGD), and undergo gender affirming surgery (GAS), later regret their decision to undergo such procedures. The researchers are: Harry Barbee, Ph.D., assistant professor and interdisciplinary social scientist at the Johns Hopkins Bloomberg School of Public Health; Bashar Hassan, M.D., a postdoctoral research fellow in plastic and reconstructive surgery at the Johns Hopkins Center for Transgender and Gender Expansive Health (CTH) and the University of Maryland Medical Center’s R Adams Cowley Shock Trauma Center; Fan Liang, M.D., medical director at the CTH and assistant professor of plastic and reconstructive surgery at the Johns Hopkins University School of Medicine In their article, the three report findings from a retrospective look at the limited amount of ...
- Source: drugdu
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- December 30, 2023
Original and patented consumables are given priority to be included in medical insurance

The era of medical insurance access management has arrived, the catalog of consumables has been dynamically adjusted, and many places have clearly supported the entry of new technologies and new consumables into medical insurance. 1. Original, patented and centralized purchasing consumables will be included in the medical insurance catalog with priority Recently, the Shaanxi Provincial Medical Insurance Bureau issued the “Notice of the Shaanxi Provincial Medical Insurance Bureau on Further Improving the Payment Management of Medical Insurance Medical Consumables” (hereinafter referred to as the “Notice”). It is clarified that the implementation of the access management of the medical insurance medical consumables catalog will be promoted and the province’s unified catalog of medical insurance medical consumables will be steadily formulated. According to the “Notice”, the payment management of medical insurance medical consumables must follow four principles: first, ensuring basics, second, encouraging innovation, third, being fair and open, and fourth, dynamic adjustment. ...
- Source: drugdu
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- December 30, 2023
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
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- December 30, 2023
Jemincare Announces 6 Approvals of Clinical Trials for its Innovative Drugs

SHANGHAI, Dec. 26, 2023 /PRNewswire/ — Jemincare, a leading pharmaceutical company from China, announced that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., recently received 6 approvals of clinical trials for its innovative drugs in the field of cancer, kidney and anti-infectious diseases, including 4 approvals from National Medical Products Administration (NMPA) and 2 approvals from the U.S. Food & Drug Administration (FDA). On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria. Drug resistance of antibiotics, especially carbapenem resistance, in Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa has risen year by year. Preclinical studies on its mechanism show that JMKX003801 can overcome carbapenem resistance with very broad antibacterial spectrum. On December 12, NMPA has approved a clinical trial for JMKX003142 to treat renal edema. There are about 120 million patients of chronic kidney disease (CKD) in ...
- Source: drugdu
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FDA Issues Alert to Mitigate Risks to a Widely Used Allergy, Nausea Drug

The FDA said promethazine hydrochloride, a generic drug used to manage allergies and motion sickness, should be administered by intramuscular injection. Intravenous injection can cause chemical irritation and tissue damage, an FDA alert states. By FRANK VINLUAN An old drug with a wide range of uses now has a new FDA alert that could spare patients from some severe reactions. The FDA communication covers promethazine hydrochloride, a medicine approved for managing allergic reactions, motion sickness, and post-operative nausea and vomiting. It’s also used as a sedative or as an adjunct to analgesics. While promethazine is available in oral formulations, the FDA alert issued Wednesday covers versions administered either as a deep intramuscular injection or as a slow intravenous injection. The agency now says it recommends administration by deep intramuscular injection to reduce the risk of severe chemical irritation and damage to tissues. If promethazine must be dosed intravenously, the FDA ...
- Source: drugdu
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- 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
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- December 30, 2023

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