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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
- 173
- 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
- 147
- January 1, 2024
NFL players to kick off ‘My Cause My Cleats’ with a focus on Type 1 diabetes

NFL players aim to boost awareness of Type 1 diabetes under a new charitable campaign. The “My Cause My Cleats” campaign will see NFL players wear custom-painted cleats during some football games to raise awareness and funds for charitable causes. In 2024, Type 1 diabetes has become a core theme, with Mark Andrews of the Baltimore Ravens, Orlando Brown Jr. of the Cincinnati Bengals, Blake Ferguson of the Miami Dolphins, Collin Johnson of the Chicago Bears, Chad Muma of the Jacksonville Jaguars, Nate Peterman of the Chicago Bears, and Kevin Radar of the Tennessee Titans, all lacing up for the cause. More than 1.4 million Americans are affected by Type 1 diabetes, an autoimmune disease that causes the pancreas to produce little or no insulin. The disease typically hits at a young age, and is separate from Type 2 diabetes, which typically affects adults and can be related to obesity. ...
- Source: drugdu
- 188
- January 1, 2024
Amgen’s request for full approval of Lumakras in lung cancer denied by FDA

Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California pharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod. Lumakras was granted accelerated approval in May 2021 to treat second line KRAS G12C-mutated NSCLC. The company was asked by the FDA to launch a confirmatory trial and a dose optimization study to gain a full approval. The therapy faced an advisory committee meeting in October where a panel was asked to consider whether the primary endpoint for the phase 3 CodeBreak 200 trial could be reliably interpreted in Amgen’s study. The committee voted 10-2 against the measure, suggesting that they were unimpressed with Amgen’s trial design. Despite the negative vote, the agency was not expected to remove Lumakras from the market, but instead request another confirmatory trial. Amgen now says that’s exactly ...
- Source: drugdu
- 225
- January 1, 2024
Opdualag licensed for patients with advanced melanoma

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (27 December) approved the advanced melanoma medicine Opdualag (nivolumab-relatlimab) for patients from the age of 12. This is a cancer medicine used to treat advanced melanoma, a type of skin cancer that can spread to other areas of the body. The main risk factor for melanoma is exposure to ultraviolet light, which comes from the sun and is used in sunbeds. Around 17,000 cases of melanoma are diagnosed every year in the UK, although not all of those are advanced melanoma. Opdualag has been authorised through Project Orbis, a global partnership between the MHRA, the Therapeutics Goods Administration in Australia, Health Canada, the Health Sciences Authority in Singapore, Swissmedic, Agência Nacional de Vigilância Sanitária in Brazil and Israel’s Ministry of Health, coordinated by the US Food and Drug Administration. This programme reviews and approves promising cancer drugs, helping patients to ...
- Source: drugdu
- 113
- January 1, 2024
The latest domestic innovative COVID-19 drug Taizhongding® is exclusively available on Meituan’s online drug shopping website

On December 28, the innovative COVID-19 drug Taizhongding® developed by Guangsheng Zhonglin Technology Co., Ltd. (hereinafter referred to as Guangsheng Zhonglin), an innovative drug subsidiary of Fujian Guangshengtang Pharmaceuticals, was exclusively launched on the Meituan drug purchase online . It is understood that Taizhongding® is currently the only small molecule antiviral drug in China that widely covers the XBB series of mutant strains. The relevant person in charge of Fujian Guangshengtang Pharmaceutical stated that they chose Meituan Medicine as the online launch channel for Taizhongding® because they hope to cooperate with Meituan Medicine to further enhance the awareness and accessibility of innovative drugs. Give patients in need more treatment options. Search volume for COVID-19 drugs increases, domestic innovative drugs provide new solutions for patients Recently, the new coronavirus variant JN.1 has once again attracted public attention. Authoritative data shows that in early November this year, JN.1 accounted for about 4% ...
- Source: drugdu
- 103
- January 1, 2024
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
- 354
- 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
- 173
- 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
- 209
- 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
- 94
- December 30, 2023

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