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US Health Officials Advise Older Travelers Not to Get a Chikungunya Vaccine

The U.S. government is advising that international travelers age 60 and older not get a chikungunya vaccine as it investigates possible side effects. The Centers for Disease Control and Prevention and the Food and Drug Administration posted notices late last week on the vaccine, Valneva’s Ixchiq. Chikungunya, spread by the bites of infected mosquitoes, is a debilitating tropical illness marked by fever and joint pain. About 100 to 200 cases are reported annually among U.S. travelers. Last year, the government began recommending the vaccine, which is made with weakened chikungunya virus, to U.S. adults who travel to countries where chikungunya is a problem. But last month, a panel of vaccine experts who advise the CDC heard about an investigation into six people 65 and older — most of them with other medical problems — who became ill with heart or brain symptoms less than a week after vaccination. More ...
- Source: drugdu
- 46
- May 14, 2025
【EXPERT Q&A】What materials should be submitted for the registration of Class III medical devices within the country?

Drugdu.com expert’s response: The registration of domestic Class III medical device products in China requires the submission of application materials to the National Medical Products Administration (NMPA). Specifically, the process is handled through its subsidiary, the Center for Medical Device Evaluation (CMDE), which is responsible for the technical review of medical device product registrations. Below is a detailed explanation: I. Submission Authority The registration materials for domestic Class III medical device products must be submitted to the National Medical Products Administration (NMPA). As the competent authority overseeing medical device regulation in China, the NMPA is responsible for the registration approval, quality supervision, and market regulation of medical devices. The Center for Medical Device Evaluation (CMDE), a subsidiary of the NMPA, specifically undertakes the technical review of medical device product registrations. II. Submission Process Preparation of Registration Materials Applicants must prepare a complete set of registration application materials in accordance with ...
- Source: drugdu
- 41
- May 14, 2025
Laimi Pharmaceuticals receives approval for supplemental application for naloxone hydrochloride injection

On May 12, Laimei Pharmaceutical issued an announcement that recently, the company received the “Notice of Approval of Drug Supplementary Application” approved and issued by the State Food and Drug Administration for two specifications of naloxone hydrochloride injection: 1ml:1mg and 2ml:2mg. 　　Naloxone hydrochloride injection is an opioid receptor antagonist, mainly used for the antagonism of respiratory depression after opioid combined anesthesia and the treatment of opioid overdose. 　　According to Yaorongyun data, the market sales of the drug in 2022, 2023 and the first half of 2024 were 420 million yuan, 559 million yuan and 264 million yuan respectively. The approval of this supplementary application means that the company can add new specifications of products, while changing the excipients and production processes in the prescription, further enhancing the market adaptability of the product. 　　In the first quarter of 2025, Laimi Pharmaceutical achieved revenue of 198 million yuan ...
- Source: drugdu
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- May 14, 2025
Rongchang Biopharma’s new drug RC278 clinical trial application accepted

On May 12, Rongchang Biopharma issued an announcement that the company recently received the “Acceptance Notice” approved and issued by the National Medical Products Administration, and the clinical trial application of the new antibody-drug conjugate injection RC278 was accepted. 　　This drug was independently developed by the company and has First-in-Class/Best-in-Class potential. It can specifically identify new tumor targets and exhibit broad-spectrum anti-tumor activity, good safety and pharmacokinetic characteristics. It aims to provide new treatment options for patients with advanced solid tumors. 　　The acceptance number mentioned in the announcement is CXSL2500368, and the application is for the registration of clinical trials of domestically produced drugs. The company’s board of directors bears legal responsibility for the authenticity, accuracy and completeness of the content of the announcement. Although the research and development prospects of the drug are promising, the announcement also reminds investors to pay attention to the high ...
- Source: drugdu
- 41
- May 14, 2025
Major progress in curing hepatitis B

Recently, the annual meeting of the European Association for the Study of the Liver (EASL) is being held. At the conference, BoWang Pharmaceuticals presented the Phase I/IIa clinical research data of its innovative small interfering RNA (siRNA) therapy BW-20507 for the treatment of chronic hepatitis B (CHB) in a poster format. BW-20507 is a siRNA molecule targeting the S region of hepatitis B virus (HBV) messenger RNA developed by Bowang Pharmaceutical based on its independent RNAi platform and unique proprietary technology. This poster summarizes the key research data of BW-20507 monotherapy in the treatment of chronic hepatitis B patients with virological suppression and nucleoside (NUC) naive treatment: BW-20507, administered subcutaneously once every four weeks for three doses, significantly reduced HBsAg levels in a dose-dependent manner, with the maximum reduction observed in the 200 mg and 400 mg dose groups being 2.9~3.2 log10 IU/mL. Among subjects with baseline HBsAg levels less ...
- Source: drugdu
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- May 14, 2025
Johnson & Johnson’s autoimmune drug approved for new indication

On May 9, Johnson & Johnson announced that its blockbuster drug Guselkumab was approved by the National Medical Products Administration for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response, or intolerance to traditional treatments or biologics. This event marks the official entry of interleukin 23 (IL-23) targeted era into the treatment of ulcerative colitis in China. 1. China’s first As the world’s first approved fully humanized IL-23 inhibitor, guselkumab (trade name: Tenoyada) precisely regulates the immune response through a unique dual mechanism of action: it not only directly binds to the IL-23 cytokine, but also targets IL-23-enriched CD64+ inflammatory cells, blocking this core pathogenic factor that drives immune-mediated diseases such as ulcerative colitis (UC) from the source. Today, guselkumab was officially approved by the China National Medical Products Administration for the treatment of adult patients with moderate ...
- Source: drugdu
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- May 14, 2025
Chairman of Baili Tianheng donates 30 million yuan to Fudan University to support the development of innovative drug target discovery and other teacher training needs

On May 12th, a reporter from The Paper learned that Zhu Yi, founder, chairman, and chief scientific officer of Sichuan Baili Tianheng Pharmaceutical Co., Ltd. (Baili Tianheng, 688506), donated RMB 30 million in cash to establish the “Fudan University Baili Tianheng Distinguished Professor” project, supporting Fudan University’s faculty construction needs in areas such as “innovative drug target discovery” and “brain and brain like intelligence research”, and strengthening the construction and development of strategic talent teams. Zhu Yi was born in 1963 and graduated with a bachelor’s degree in Radio Physics from Sichuan University. Later, he was admitted to the Master’s program in Biophysics at Fudan University and is a graduate of the Biology Department of Fudan University in 1984. Zhu Yi stated that whether it is making generic drugs or innovative drugs, there is always a knowledge framework of biology behind them. The study experience at Fudan University laid ...
- Source: drugdu
- 53
- May 13, 2025
‘This is my most important and impactful post’

On Sunday evening local time, US President Trump announced on the social platform Truth Social that he will sign an executive order at the White House tomorrow morning at 9am (21:00 Beijing time on Monday). Prescription drugs and drug prices will almost immediately decrease by 30% to 80%, and the United States will purchase drugs at the lowest prices in the world. Trump said: For many years, the world has been puzzled: why are prescription drugs and medications priced much higher in the United States than in other countries? Sometimes, the same drug, produced by the same pharmaceutical company in the same laboratory or factory, can be sold for five to ten times more in the United States than in other countries! This question is always difficult to explain and awkward, because ultimately, there is no reasonable and legitimate answer. For many years, pharmaceutical companies have consistently stated that ‘research ...
- Source: drugdu
- 52
- May 13, 2025
Adverse waist-to-height ratio trajectories during childhood linked to early cardiometabolic risk

New research being presented at this year’s European Congress on Obesity (ECO) in Malaga, Spain (11-14 May) reveals that adverse waist-to-height ratio trajectories (a marker for central obesity) during childhood may increase cardiometabolic and cardiovascular risk at 10 years old. Notably, children with gradually increasing central obesity from birth were more likely to show early signs of metabolic and cardiovascular risk by age 10. This included elevated blood pressure and higher levels of biomarkers linked to systemic inflammation and metabolic dysfunction, such as triglycerides, insulin resistance (HOMA-IR), glycoprotein acetyls (GlycA), and high-sensitivity C-reactive protein (hs-CRP). “With rapidly rising rates of childhood obesity worldwide, it is important to understand how central obesity during childhood is already linked to early signs of metabolic deterioration, including elevated blood pressure and circulating biomarkers associated with future cardiometabolic disease.” Dr. David Horner, lead author from the University of Copenhagen, Denmark. Obesity in childhood and ...
- Source: drugdu
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- May 13, 2025
Zepbound Beats Wegovy for Weight Loss in First Head-To-Head Trial of Blockbuster Drugs

People taking Eli Lilly’s obesity drug, Zepbound, lost nearly 50% more weight than those using rival Novo Nordisk’s Wegovy in the first head-to-head study of the blockbuster medications. Clinical trial participants who took tirzepatide, the drug sold as Zepbound, lost an average of 50 pounds (22.8 kilograms) over 72 weeks, while those who took semaglutide, or Wegovy, lost about 33 pounds (15 kilograms). That’s according to the study funded by Lilly, which was published Sunday in the New England Journal of Medicine. Both drugs are part of a new class of medications that work by mimicking hormones in the gut and brain that regulate appetite and feelings of fullness. But tirzepatide targets two such hormones, known as GLP-1 and GIP, while semaglutide targets GLP-1 alone, said Dr. Louis Aronne, director of the Comprehensive Weight Control Center at Weill Cornell Medicine. “Two drugs together can produce better weight loss,” said Aronne, ...
- Source: drugdu
- 55
- May 13, 2025

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