media – Page 48 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

FDA Expands Indication for Amgen’s Repatha to Include Adults with High LDL-Cholesterol at Increased Risk of Major Cardiovascular Events

The FDA has updated the label for Amgen’s Repatha (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) linked to uncontrolled low-density lipoprotein cholesterol (LDL-C). The expanded indication removes the prior restriction that patients must already have diagnosed cardiovascular disease (CVD), broadening access to individuals considered to have an elevated risk.1 What Milestones have Shaped Repatha’s Label Expansion Over the Years? “Far too many adults at risk of cardiovascular disease are not achieving their LDL-C goals, despite it being one of the most modifiable risk factors for a heart attack or stroke,” said Murdo Gordon, EVP, global commercial operations, Amgen, in a press release. The FDA also extended the approval of Repatha to include it as a standalone therapy for patients with homozygous familial hypercholesterolemia (HoFH), a rare inherited condition that causes dangerously high cholesterol levels. The agency further underscored that Repatha should be prescribed in ...
- Source: drugdu
- 169
- August 26, 2025
Hidden Fat Deposits Accelerate Heart Aging, Study Says

By Dennis Thompson HealthDay ReporterMONDAY, Aug. 25, 2025 (HealthDay News) — Hidden fat deposits packed around abdominal organs like the stomach, intestines and liver could be increasing people’s risk of heart disease, a new study says. Excessive amounts of this hidden fat — also called visceral fat — is tied to faster aging of the heart, researchers report in the European Heart Journal. This fat can’t be seen from the outside, and some people can have large amounts of visceral fat even if they have a healthy weight, researchers noted. “Our research shows that ‘bad’ fat, hidden deep around the organs, accelerates aging of the heart,” senior researcher Dr. Declan O’Regan, a professor at the MRC Laboratory of Medical Sciences at Imperial College London, said in a news release. “But some types of fat could protect against aging — specifically fat around the hips and thighs in women,” he added. ...
- Source: drugdu
- 117
- August 26, 2025
Walvax’s 23-valent pneumococcal vaccine enters the Latin American market for the first time

According to a report from Southern Finance on August 26, Walvax BioAccording to news, recently, the 23-valent pneumococcal polysaccharide vaccine (hereinafter referred to as “23-valent pneumococcal vaccine”) produced by Yuxi Watson Biotechnology Co., Ltd. , a subsidiary of Walvax Biotechnology Holdings, completed its first export delivery to El Salvador, marking the first time that Walvax Biotechnology has exported 23-valent pneumococcal polysaccharide vaccine to El Salvador.The product has officially launched in the Latin American market. As the world’s first preservative-free 23-valent pneumococcal polysaccharide vaccine, it is suitable for children over 2 years old and high-risk adults. Global sales have exceeded 14 million doses. https://finance.eastmoney.com/a/202508263494831241.html
- Source: drugdu
- 113
- August 26, 2025
New Advances in Hand Eczema Treatment

LEO Pharma recently announced that the FDA has approved ANZUPGO (delgocitinib) Cream (20 mg/g) for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults. Delgocitinib is a pan-JAK inhibitor that simultaneously inhibits JAK1, JAK2, JAK3, and TYK2, suppressing the signaling of proinflammatory cytokines (such as IL-4, IL-13, and IL-23) and alleviating skin inflammation and itching. Degatinib cream is the world’s first topical JAK inhibitor specifically used to treat moderate to severe chronic hand eczema and is expected to become a new treatment option for CHE patients. Principles and R&D progress Hand eczema is the most common hand skin disease, presenting as a variety of lesions including erythema, papules, blisters, scaling, hyperkeratosis, and fissures. Most patients with hand eczema develop the condition into a chronic condition. Chronic hand eczema (CHE) refers to hand eczema that persists for more than three months or recurs two or more times within a ...
- Source: drugdu
- 107
- August 26, 2025
Sino Biopharmaceutical’s Zonaptinib Receives CDE Breakthrough Therapy Designation

On August 20, Sino Biopharmaceutical (01177) announced that its selective HER2 tyrosine kinase inhibitor, Zonectinib, has again received Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (CFDA). Zonectinib is indicated for the first-line treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) harboring activating mutations in the HER2 tyrosine kinase domain (TKD). This Breakthrough Therapy designation was based on data from the BeamionLUNG-1 clinical trial. Studies have shown that the 5-year survival rate of patients with advanced non-small cell lung cancer is less than 30%. Among them, about 2%-4% of non-small cell lung cancer is driven by HER2 gene mutations. Currently, the first-line treatment for patients with advanced HER2 mutation NSCLC is still chemotherapy ± immunotherapy.No new drugs have been officially approved in China. Zonectinib, a covalently bound, oral, selective HER2 small molecule inhibitor developed by Boehringer ...
- Source: drugdu
- 103
- August 26, 2025
Nasal Spray Live Attenuated Influenza Vaccine Obtains Drug Registration Certificate

On August 25, BCHT(688276) issued an announcement that the company received the nasal spray influenzaDrug registration certificate for live attenuated vaccine. The company’s approved nasal spray live attenuated influenza vaccine can simulate natural influenza virus infection through nasal inoculation , forming the first immune barrier in the respiratory tract to prevent influenza virus invasion. In the first quarter of 2025, BCHT achieved revenue of 162 million yuan and net profit attributable to shareholders of the parent company of 1.06 million yuan. https://finance.eastmoney.com/a/202508253493526324.html
- Source: drugdu
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- August 26, 2025
Xinjiang Medical Exposition

Organiser: Xinjiang Medical Exhibition Organizing Committee Time：September 5-7, 2025 address：No. 3 Hongguangshan Road, Shuimogou District, Urumqi, Xinjiang Uygur Autonomous Region Exhibition hall：Xinjiang International Convention and Exhibition Center Product range: Medical Exhibition Area: Medical imaging equipment, intelligent monitoring, diagnostic, and treatment devices, testing equipment, in vitro diagnostic reagents, surgical instruments and consumables, patient bed care equipment and appliances. Health and Wellness Exhibition Area: Rehabilitation medicine, rehabilitation equipment, assistive devices, physiotherapy equipment and supplies, travel and residential care for the elderly, health and wellness industry image project displays, health and wellness insurance industry. Dental and Ophthalmology Exhibition Area: Dental diagnostic equipment, dental treatment equipment, dental auxiliary equipment, eye health diagnosis and treatment, ophthalmic medical equipment, vision testing instruments and equipment. Traditional Chinese Medicine Exhibition Area: Chinese herbal medicines, Chinese medicine decoction pieces, traditional Chinese medicine diagnostic instruments, moxibustion products, traditional Chinese medicine physiotherapy + Internet products, traditional Chinese medicine equipment, packaging. Epidemic ...
- Source: drugdu
- 246
- August 26, 2025
How a single gene reshapes pain perception through polyamine signaling

In a recent study published in the journal Nature, an international team of researchers showed that solute carrier family 45 member 4 (SLC45A4) is a pain gene that encodes a neuronal polyamine transporter. Chronic pain affects one in five adults and has an adverse effect on the quality of life. Unfortunately, available treatments are often inadequate, with poor tolerability and efficacy. Polyamines, such as spermidine, spermine, and putrescine, are regulatory metabolites reported to contribute to chronic pain. They play crucial roles in nucleic acid synthesis and stability, cell signaling, and growth. Polyamines are implicated in neurological disorders, such as stroke and epilepsy. They can regulate neuronal excitability through ion channel interactions and have been linked to pain. Polyamines exhibit altered levels in pain states in humans and modulate pain behavior in animal models. Nevertheless, the systems influencing polyamine transport in the nervous system remain unclear. The study and findings In ...
- Source: drugdu
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- August 25, 2025
Flu Shot Season is At Hand

By Carole Tanzer Miller HealthDay ReporterSATURDAY, Aug. 23, 2025 (HealthDay News) — With a longtime vaccine critic leading the nation’s health departments, you might be wondering whether there’s a new flu shot this fall. There is — and Health and Human Services Secretary Robert F. Kennedy Jr. says most Americans should get it. He’s basing that recommendation on the advice of a board he appointed to advise the federal government on vaccines. The U.S. Centers for Disease Control and Prevention (CDC) says people 6 months old and up should get a flu shot. That’s pretty much the same advice the CDC has given in the past. This year’s version of the flu vaccine should be widely available soon, according to KFF Health News. No shortages are anticipated. So when should you roll up your sleeve? The best time to take the jab is September, October or early November, doctors say. ...
- Source: drugdu
- 118
- August 25, 2025
Betta Pharmaceuticals discloses clinical research progress on ensartinib for postoperative adjuvant indications

Betta PharmaceuticalsOn the morning of August 25th, the company announced that in April 2022, the National Medical Products Administration (NMPA) approved the clinical trial of Ensartinib Hydrochloride Capsules (Bemena®, hereinafter referred to as “Ensartinib”) for the adjuvant treatment of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) after surgery. Recently, an interim analysis of the clinical trial, as assessed by the Independent Data Monitoring Committee (IDMC), demonstrated positive results, meeting the study’s pre-specified primary endpoint and demonstrating statistically significant and clinically important benefits. Detailed data from this study will be presented at a major international academic conference this year. The company’s team is actively preparing application materials and aiming to submit the NDA for this new indication as soon as possible. https://finance.eastmoney.com/a/202508253492884316.html
- Source: drugdu
- 111
- August 25, 2025

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