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The first orphan drug for ALS independently developed in China has applied to the FDA for listing

The world’s first oral tablet of edaravone is about to hit the market. On December 23, Aucontal Biotech submitted an application for the listing of AUKONTALS (edaravone tablets) to the US FDA for the treatment of amyotrophic lateral sclerosis (ALS). The drug was granted orphan drug status by the FDA in 2021. Aucontal Biotech said that edaravone tablets not only take the lead in dosage form innovation, but also have great clinical potential in solving the multiple treatment challenges faced by ALS patients. It is expected to become the first orphan drug listed in the United States by a domestic pharmaceutical company in the CNS field, tapping into the rare disease ALS market. ▍ALS “difficult to cross” ALS is a fatal neurodegenerative disease that gradually causes patients to lose their voluntary muscle control function by destroying motor neurons in the brain and spinal cord. The incidence of the disease is ...
- Source: drugdu
- 187
- December 31, 2024
According to industry sources, AstraZeneca’s China structure will be adjusted

▍AstraZeneca’s China oncology business organizational structure is about to be adjusted According to multiple sources in the industry, the organizational structure of AstraZeneca’s China oncology business will be adjusted from January 1, 2025. The specific adjustments are as follows: First, the oncology business will establish four independent and collaborative business units/business units: lung cancer business unit, urogynecology and digestive oncology business unit, breast cancer business unit, and blood oncology business unit; Second, the marketing department and sales team At the same time as the structural adjustment, the executive team has also undergone certain changes—Zhang Lingyan: currently AstraZeneca China Vice President, Oncology Business Lung Cancer Business Unit and Gastrointestinal Oncology Business Head, will transfer and lead the Urogynecology and Gastrointestinal Oncology Business Unit, serve as AstraZeneca China Vice President, Oncology Business Urogynecology and Gastrointestinal Oncology Business Head; Breast Cancer Business Head: This position is recruited internally and externally, and is currently ...
- Source: drugdu
- 249
- December 31, 2024
Eli Lilly’s weight loss drug is officially on the market, and the price is higher than semaglutide

Novo Nordisk’s strongest rival for semaglutide is officially commercialized in China. On December 25, the reporter noticed that many e-commerce platforms have already provided diagnosis and treatment services for Eli Lilly’s glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist telpotide (trade name: Mufengda). Telpotide’s indications include diabetes and weight loss. Currently, the prices of various merchants on the platform are different, and the specific price is subject to the final selected store price. Eli Lilly’s telpotide can be purchased on multiple e-commerce platforms Taking a merchant in an Internet hospital as an example, the price of 0.5ml: 2.5mg*4 is 2,480 yuan. According to this calculation, the price of a single piece is 620 yuan. The merchant said that its drugs are authentic, quickly registered, and reserved. The reporter contacted the merchant’s customer service as a consumer, and the staff said that the drug can be used for weight loss and ...
- Source: drugdu
- 86
- December 31, 2024
【EXPERT Q&A】What is the meaning of the red list, yellow list and green list involved in FDA import alerts?

Drugdu.com expert’s response: The import alert system of the FDA (Food and Drug Administration) is a crucial means for it to ensure the safety of imported products, particularly foods, drugs, cosmetics, medical devices, and more. Among them, the red list, yellow list, and green list are ways used by the FDA to indicate the compliance status of different categories of products. Below are their specific meanings in English: Ⅰ. Red List Definition: The red list represents the strictest warning, indicating that the product or manufacturer has serious compliance issues, often due to the product failing FDA inspections or tests. Characteristics: Once a product is placed on the red list, it will face automatic detention until the manufacturer, shipper, grower, or importer proves to the FDA that the violations have been corrected. This detention occurs without the need for FDA to inspect, examine, or sample the product, also known as “Detention ...
- Source: drugdu
- 142
- December 30, 2024
African CDC Visits China National Biotech to Enhance Cooperation in Areas like Monkeypox

On December 17, a delegation from the Africa Centers for Disease Control and Prevention (Africa CDC), accompanied by Wang Lili, a deputy researcher at the Global Public Health Center of the Chinese Center for Disease Control and Prevention, and a group of 12 people, visited the Beijing Biological Products Institute of China National Biotech. Both parties expressed their commitment to further strengthen cooperation in the prevention and control of monkeypox and other infectious diseases, and to jointly promote the research, production, and application of vaccines, diagnostic reagents, and therapeutic drugs. Additionally, they will actively work towards achieving local production in Africa to improve the accessibility and affordability of vaccines and other medical products. https://finance.eastmoney.com/a/202412263279858541.html
- Source: drugdu
- 91
- December 30, 2024
Yingkerui’s “Class 1.1 New Drug for Autoimmune Chinese Medicine” has been approved for clinical trials

On December 24, according to the official website of CDE, Yingke Rui’s Class 1.1 new Chinese medicine “Shendai Rectal Suppository” obtained implicit approval for clinical trials. It is indicated for mild to moderate active ulcerative colitis with damp-heat and blood stasis syndrome. Inflammatory bowel disease (IBD) is a type of disease that causes inflammation of the digestive system, and the number of patients worldwide is on the rise. IBD mainly includes ulcerative colitis and Crohn’s disease, of which ulcerative colitis is common in patients aged 20 to 30 years old. Clinical manifestations include persistent or recurrent diarrhea, mucus, pus and blood in the stool accompanied by abdominal pain, and even skin lesions and mucosal lesions. At present, the cause of the disease has not been fully clarified. According to statistics, the global prevalence of ulcerative colitis in 2023 is about 5 million cases, and the incidence rate continues to show ...
- Source: drugdu
- 122
- December 30, 2024
Bristol-Myers Squibb “Big Purge”

On April 26, 2023, an unexpected announcement pushed Bristol-Myers Squibb into the spotlight. The announcement revealed the leadership transition of Bristol-Myers Squibb: its CEO Dr. Giovanni Caforio, after eight years in charge of the company, announced that he would step down and pass the leadership baton to Chief Commercialization Officer Chris Boerner. This marks the curtain call of Giovanni Caforio, and at the same time, it also brings unprecedented challenges to Chris Boerner. For Bristol-Myers Squibb, the severe test of the patent cliff is hanging over its head. In order to ensure a smooth transition, Caforio’s resignation is not effective immediately. After a carefully arranged transition period, Caforio will not officially hand over the baton until November 1, 2023, and a new chapter for Bristol-Myers Squibb will begin. This change of leadership is not only of great significance to Bristol-Myers Squibb itself, but also affects the fate of many biotechnology ...
- Source: drugdu
- 77
- December 30, 2024
The first new drug for chronic sinusitis with nasal polyps in China was approved

On December 23, Conoya announced that its independently developed Class 1 new drug Kangyueda® (Sepkibaimab Injection) was approved for marketing by the National Medical Products Administration for the treatment of chronic sinusitis with nasal polyps (CRSwNP). Previously, this indication was included in the priority review. The prevalence of chronic sinusitis in my country is 8%, of which about one-third are patients with chronic sinusitis with nasal polyps. The pathogenesis of chronic sinusitis with nasal polyps is complex, and the clinical symptoms such as nasal congestion, hyposmia and runny nose caused by it seriously affect the quality of life of patients. Clinically, the treatment of this disease faces difficulties such as refractory and recurrent, and innovative treatment methods are urgently needed. Kangyueda® (sipkizumab) is a highly effective, humanized monoclonal antibody targeting the interleukin-4 receptor α subunit (IL-4Rα). It is the first IL-4Rα antibody drug approved for marketing in China and the ...
- Source: drugdu
- 280
- December 30, 2024
Tirzepatide’s new indication is approved by the FDA, becoming the first drug to treat “snoring”

Today, Eli Lilly and Company announced that the U.S. FDA has approved its blockbuster therapy Zepbound (tirzepatide) to improve snoring in obese patients with moderate to severe obstructive sleep apnea (OSA). Zepbound can help these patients improve sleep disorders, but they need to be combined with a low-calorie diet and increased physical activity. Trial results show that after one year of Zepbound treatment, up to 50% of patients no longer have symptoms related to OSA. According to the press release, Zepbound is the first prescription drug approved for the treatment of obese patients with moderate to severe OSA. Frequent snoring may be a sign of OSA. This condition is caused by the complete or partial collapse of the patient’s upper airway during sleep, resulting in airway obstruction, which may cause apnea or weakened breathing, and may be accompanied by decreased blood oxygen saturation or waking up during sleep. OSA can ...
- Source: drugdu
- 116
- December 28, 2024
Another senior executive of Baiyunshan was taken away within half a year

On December 20, Baiyunshan (600332.SH) issued an announcement stating that it had received a written resignation report submitted by Huang Haiwen, the company’s deputy general manager, on the same day. “Due to personal reasons, Huang Haiwen resigned from the position of deputy general manager of the company and all positions in the company’s affiliated enterprises.” Baiyunshan said that after his resignation, Huang Haiwen no longer held all positions in the company and its affiliated enterprises. This is the third senior executive of Baiyunshan to announce his resignation from “all positions” this year, following the resignation of the company’s former chairman Li Chuyuan (later officially announced to be dismissed) in July this year and director Zhang Chunbo in August. Reporters confirmed from multiple independent information sources that Huang Haiwen has been taken away by relevant departments for investigation. It is worth noting that Huang Haiwen, 43 years old, has a resume ...
- Source: drugdu
- 90
- December 28, 2024

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