PharmaFocus Today – media

14 breakthrough devices approved for market launch

The FDA’s Breakthrough Devices Program is a voluntary program aimed at accelerating the review of breakthrough technologies or technologies that can more effectively treat or diagnose life-threatening or irreversible debilitating diseases or conditions. According to data from PharmSmart Medical Devices, there are a total of 32 breakthrough device products that have been approved for market by the US FDA in 2024. According to publicly available information from the FDA, the types of 32 products are mainly focused on passive implantable devices, with orthopedic and cardiovascular implants being the main ones. This article introduces 14 types of implantable devices, as follows: 01. Chest and Abdominal Branch Stent (W.L. GORE&ASSOCYTES, INC.) Indications: Patients with thoracoabdominal aortic aneurysm, as well as those with high surgical risk and proximal renal aortic aneurysm. The main researcher of this product, Dr. Michel Makarou, director of vascular surgery at the University of Pittsburgh School of Medicine, stated ...
- Source: drugdu
- 28
- January 21, 2025
Zhengda Tianqing challenges Microchip Biotechnology alone, original anti-cancer drugs are challenged for patent invalidation, and cumulative sales exceed 2.3 billion

Domestic original anti-cancer drugs encounter patent challenges. On January 16, Microchip Biotechnology (688321.SH) issued an announcement stating that on December 30, 2024, Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd. (hereinafter referred to as “Zhengda Tianqing”) filed a request for invalidation of the company’s cedabendamine product patent with the State Intellectual Property Office. After formal review, the State Intellectual Property Office issued a “Notice of Acceptance of Invalidation Request” on January 13, 2025. According to the announcement, the patent involved in the case is an invention patent for “an E-configuration benzamide compound and its pharmaceutical preparation and application” (patent number: ZL201410136761.X). This patent is one of the series of patents that ChipScreen Biotech has laid out for its product line of ChipScreen Biotech, which was applied for by ChipScreen Biotech to the State Intellectual Property Office on April 4, 2014, and was authorized on May 17, 2017. The patent is valid until ...
- Source: drugdu
- 38
- January 20, 2025
the national alliance centralized procurement is coming, which may stir up the biosimilar market

On January 16, the share price of Innovent Biologics (HK01801, share price 30 Hong Kong dollars, market value 49.14 billion Hong Kong dollars) fell by more than 10%, with the largest drop exceeding 14%. The market view generally links the drop in share price to a meeting two days ago. According to the official website of the Anhui Provincial Medical Security Bureau, on January 14, the provincial medical security work conference was held in Hefei. The meeting made arrangements for the provincial medical insurance work in 2025 from seven aspects, of which the third article mentioned “leading the national biological drug alliance centralized procurement”. It is reported that chemical drugs are usually also called small molecule drugs, with simple chemical structures. As long as the chemical structures are consistent, the active ingredients are generally considered to be the same. Biological drugs are usually called macromolecular drugs, but due to their ...
- Source: drugdu
- 37
- January 20, 2025
The first major pharmaceutical merger in 2025

On January 13, Johnson & Johnson announced that it had reached a final agreement with Intra-Cellular Therapies to acquire all outstanding shares of the latter at a price of US$132 per share, with a total transaction value of approximately US$14.6 billion. Intra-Cellular Therapies is a biopharmaceutical company focused on the development and commercialization of drugs for the treatment of central nervous system (CNS) diseases. Its core asset is a once-daily oral antipsychotic product Caplyta (lumateperone). The drug is a 5-hydroxytryptamine 2A (5-HT2A) receptor antagonist and dopamine receptor D2 modulator, first developed by Bristol-Myers Squibb (BMS). In 2015, Intra-Cellular Therapie obtained a license from BMS for global development. In December 2019, Caplyta was approved by the FDA for the treatment of adult patients with schizophrenia, and in December 2021 it was approved for the adjuvant treatment of depressive episodes associated with bipolar disorder type I or type II (bipolar depression). In ...
- Source: drugdu
- 33
- January 20, 2025
Over 4.4 billion US dollars! GLP-1 opens a new chapter

There is no doubt that this is the era of GLP-1. Recently, in less than a month, three GLP-1 transactions were concluded one after another, involving an amount exceeding US$4.4 billion. First, Merck introduced the small molecule GLP-1RA HS-10535 from Hansoh Pharmaceuticals, and then Jixing Pharmaceutical introduced the global (except Greater China) development and commercialization rights of the oral small molecule GLP-1RA CX11 from Wingtech Pharmaceuticals. Recently, Verdiva Bio, an overseas Biotech company, has introduced the rights to once-weekly oral inoglutide from Xianweida Biotech. Among these transactions, a significant trend has attracted attention-the oral dosage form of GLP-1 drugs has become the focus of competition among pharmaceutical companies. Both emerging biotechnology companies and established pharmaceutical giants are all focusing their R&D resources on oral GLP-1 drugs, and a fierce competition around oral dosage forms has begun. The advantages are fully demonstrated . Currently, the mainstream GLP-1 drugs are mainly injections. ...
- Source: drugdu
- 35
- January 20, 2025
Legendary Biology’s 11 early cell therapy pipelines are advancing; Lilly GLP-1 drug sales fall short of expectations | Medical Early Reference

NO.1 Legendary Biology’s 11 Early Cell Therapy Pipelines are Advancing On January 15th Beijing time, Dr. Huang Ying, CEO of Legendary Biotech, gave a speech at the 43rd J.P. Morgan Healthcare Annual Meeting (JPM). Huang Ying introduced the progress of Legendary Biotech’s core products, core technology platforms, and research pipelines. The company has currently established a CAR-T cell therapy product portfolio that includes 11 early-stage research and development pipelines, covering multiple fields such as hematological malignancies, solid tumors, and autoimmune diseases. Comment: The report shows that Legendary Biology is advancing multiple research pipelines for autologous cell therapy/allogeneic cell therapy. These investigational therapies have a wide range of indications, not limited to multiple myeloma, but also include solid tumors such as autoimmune diseases, non Hodgkin lymphoma, small cell lung cancer, acute lymphoblastic leukemia, and hematological tumors. NO.2 Sanofi/Regenerator IL-33 monoclonal antibody has been re approved for clinical use in China The ...
- Source: drugdu
- 56
- January 17, 2025
Sinopharm and Beite Pharmaceutical have reached a strategic cooperation framework for overseas commercialization

Recently, Sinovac Biotech Co., Ltd. (hereinafter referred to as “Sinovac Biotech”) and Chengdu Beite Pharmaceutical Co., Ltd. (hereinafter referred to as “Beite Pharmaceutical”) signed an intention agreement, intending to achieve overseas commercial strategic cooperation for some of Beite Pharmaceutical’s formulation products. Both parties plan to adopt various cooperation models, including but not limited to overseas commercialization rights for specific products and regions, localized technology transfer in overseas markets, and cooperative development. According to the list of products that can be cooperated with provided by Beite Pharmaceutical, after both parties sign a formal cooperation agreement, Sinopharm will have the commercial cooperation rights of the products in the designated overseas regions. Beite Pharmaceutical is a high-tech enterprise specializing in pharmaceutical innovation and the R&D, production and sales of high-quality drugs. It has long been committed to the four major R&D directions of characteristic APIs, high-end generic drugs, innovative drugs and new ...
- Source: drugdu
- 49
- January 17, 2025
Medtronic, lock in the next acquisition target

On January 13, 2025, global medical technology giant Medtronic (NYSE: MDT) announced that it had reached an exclusive distribution agreement with Contego Medical in the United States. In addition, Medtronic’s additional investment in Contego and the option to acquire the company are also important components of this agreement. 01. Exclusive distribution and locked acquisition According to the agreement signed with Contego Medical, Medtronic will become the sole distributor of Contego’s existing commercial product portfolio in the US market. Contego Medical focuses on providing innovative revascularization treatment options aimed at treating carotid and peripheral vascular diseases. Its product portfolio has gained widespread recognition in the medical industry for its unique technology and clinical efficacy. This agreement specifically covers Contego’s recently approved Neuroguard IEP 3-in-1 carotid stent system by the US Food and Drug Administration (FDA). The system integrates high-performance stents, posterior dilation balloons, and embolization protection (IEP) filters, providing safer and ...
- Source: drugdu
- 54
- January 17, 2025
Johnson&Johnson’s 1 medical device approved for market launch

Recently, Johnson&Johnson MedTech announced its Dual Energy ThermoCool SmartTouch ™ The SF catheter has obtained European CE certification and is used to treat arrhythmias such as atrial fibrillation. It is understood that this product is the second CE approved dual energy ablation catheter. The first one is Medtronic’s Sphere-9 ablation catheter, which is a multifunctional, high-density (HD) mapping and pulsed field (PF) and radiofrequency (RF) ablation catheter used to treat persistent atrial fibrillation and tricuspid valve isthmus dependent atrial flutter. It was approved by the FDA in October 2024. The second dual energy ablation catheter Dual Energy ThermoCool SmartTouch ™ The SF catheter is an ablation catheter with a porous head end saline infusion, which combines Thermocol smartpouch technology with SF catheter porous infusion technology. This product combines contact force sensing and advanced porous tip ablation technology, and adds stronger operability and torque to achieve excellent control. It is understood ...
- Source: drugdu
- 52
- January 17, 2025
Net loss after deducting non-recurring items is expected to be 155 million to 220 million yuan in 2024, and revenue and profit of vaccine segment will drop sharply

Wantai Bio announced on January 15 that it expects to achieve net profit attributable to the parent company’s owners of 86 million to 120 million yuan in 2024, a year-on-year decrease of 90.38% to 93.11%; it is expected that the net profit attributable to the parent company’s owners after deducting non-recurring gains and losses in 2024 will be -155 million to -220 million yuan. During the reporting period, the company’s vaccine segment was affected by market adjustments, government centralized procurement and the expansion of the age of the nine-valent HPV vaccine, and sales were not as expected. The revenue and profit of the vaccine segment dropped sharply, resulting in a net loss. At the same time, the company promoted international market sales through multiple methods and channels, and overseas operating income increased by 55% compared with the same period last year. The diagnostics segment benefited from the accelerated advancement of ...
- Source: drugdu
- 49
- January 17, 2025

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