PharmaFocus Today – Page 22 – media

Bankruptcy and divestment, breathing giant achieves rebirth

Recently, Zoll announced that it has completed the previously announced acquisition of some assets of Vyaire Medical’s ventilator business. In August of this year, these two companies announced this transaction after Vyaire initiated Chapter 11 bankruptcy proceedings. Now that the dust has settled on the acquisition, Zoll will launch Vyaire’s Bellavista, Fabian, LTV, and 3100 HFOV series of ventilators, further expanding its respiratory care product line. It is worth mentioning that Vyaire was an important force in the supply of ventilators during the early stages of the COVID-19 pandemic, but applied for bankruptcy protection due to operational difficulties. And Medtronic also chose to withdraw due to the fact that its ventilator business is no longer profitable. Zoll’s acquisition undoubtedly brings new vitality and hope to the market. 01. The rise and fall of rising stars in ventilators Zoll stated that the acquired product line of ventilators and their related consumables, ...
- Source: drugdu
- 75
- October 18, 2024
A medical device enters the innovation channel

Recently, the Shanghai Medical Products Administration announced that in accordance with the requirements of the “Special Review Procedure for Class II Innovative Medical Devices in Shanghai”, the Shanghai Medical Products Administration has organized relevant experts to review the special review application for Class II innovative medical devices in the city, and intends to agree to allow Shanghai Futuo Zhida Medical Technology Co., Ltd. (hereinafter referred to as “Futuo Zhida”) to enter the special review procedure for its disposable pulmonary nodule three-dimensional identification positioning marker. Developing innovative technologies with AR navigation systems Founded in 2018, Futo Zhida is a subsidiary of Fosun Pharma, focusing on innovative medical devices and surgical development. Its team has rich experience and a global perspective in the development of image navigation algorithms, intervention consumables design, and production. According to the Chinese Journal of Tuberculosis and Respiratory Sciences, the incidence rate and mortality of lung cancer rank ...
- Source: drugdu
- 64
- October 18, 2024
Johnson & Johnson’s “Class 1 new drug for prostate cancer” approved for clinical trials in China

On October 12, according to the official website of CDE, Johnson & Johnson’s Class 1 new drug JNJ-78278343 injection obtained implicit approval for clinical trials and is suitable for the treatment of adult male patients with advanced prostate cancer. According to public information, JNJ-78278343 is a KLK2-CD3 bispecific antibody and T cell redirection product, which is designed to target KLK2 and induce T cell activation by binding to CD3 on T cells. This product has potential immunomodulatory and anti-tumor activity. After administration, it can bind to CD3 on T cells and KLK2 on tumor cells expressing KLK2, thereby redirecting T cells to tumor cells expressing KLK2, resulting in T cell-mediated lysis of KLK2-expressing tumor cells. At present, Johnson & Johnson has conducted a number of studies on JNJ-78278343 for prostate cancer internationally. Among them, the Phase 1 study of JNJ-78278343 monotherapy for advanced prostate cancer is expected to be initially ...
- Source: drugdu
- 70
- October 18, 2024
WuXi AppTec frequently mentioned this word during its Investor Day. Where does the confidence come from?

Recently, WuXi AppTec held an investor open day event called “CRDMO Ultimate Empowerment Journey”. At the event, WuXi AppTec executives mentioned the word “far ahead” many times. Although they said it with a calm face, the message they conveyed was “low-pitched and high-profile”, which won many applause and laughter from the audience. Why can they say that? Where does the confidence come from? If you really achieve “far ahead”, what is the secret? I just came back from WuXi AppTec’s investor day event, and I will highlight the key points for you. Both quantity and quality, the industry contribution is “far ahead” From the perspective of molecular types, the current research and development of small molecules is still the “main force” of current research and development and listing. Whether it is the number of drugs approved by the US FDA or the number of molecular pipelines under development, small molecules ...
- Source: drugdu
- 80
- October 18, 2024
Deepen the anti-corruption in the pharmaceutical industry and strictly prohibit 8 major behaviors

Another province issued compliance guidelines, 8 behaviors need to be closely watched. On October 14, the Jiangxi Provincial Market Supervision Administration issued the “Compliance Guidelines for Anti-Commercial Bribery in the Pharmaceutical Industry” (hereinafter referred to as the “Guidelines”), becoming another province to issue pharmaceutical compliance guidelines after Fujian and Chongqing. The “Guidelines” are divided into four chapters and 15 articles. The so-called pharmaceutical companies refer to operating entities engaged in the production, research and development, sales and other related commodities and related businesses of medical products such as drugs and medical devices, including but not limited to drug/medical device marketing authorization holders (MAHs), drug/medical device contract research organizations (CROs), drug/medical device contract manufacturing organizations (including CMOs, CDMOs), drug/medical device contract sales organizations (CSOs), and drug/medical device commercial distribution companies. Among them, 8 behaviors that may be suspected of commercial bribery are specifically listed, and pharmaceutical companies and medical and health ...
- Source: drugdu
- 81
- October 18, 2024
Zhan Jiufu talks about Sanming medical reform again

Some people introduce me as an expert and professor. I say I am nothing. This is not because I am modest, but because I seek truth from facts. I graduated from a normal school and don’t have much theory. I am just the actual operator of Sanming medical reform, at most a “construction team leader”. I put my energy into establishing Sanming medical reform, and I also established the Fujian Provincial Medical Insurance Office. Recently, the state has conveyed a lot of information about the Sanming medical reform experience. From the notice issued by the National Medical Insurance Bureau, the National Health Commission and other five ministries and commissions, to the National Medical Insurance Bureau’s release of documents in May, to the recent press conference held by the National Health Commission, stating that the Sanming medical reform experience will be implemented nationwide within 5 years… On September 27, I just ...
- Source: drugdu
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- October 18, 2024
Dano Pharmaceuticals announces over 300 million RMB E-round financing to accelerate the late stage clinical development and commercialization of core new drug products | Aurora Family

Danuo Pharmaceutical On October 16, 2024, Danno Pharmaceutical, an investment company of Aurora Borealis, announced the completion of the first batch of delivery for over 300 million RMB in Series E financing. This round of financing is jointly led by Zhongshan Venture Capital and AMR Action Fund, a subsidiary of Zhongshan Investment Holdings. The funds obtained will be used to support the core new drug research and development pipeline, including the late stage clinical trials and commercialization of TNP-2198, a new drug candidate for treating Helicobacter pylori infection, and TNP-2092, a new drug candidate for treating implanted medical device infection. Dr. Ma Zhenkun, founder, chairman, and CEO of Danno Pharmaceuticals, said: We are delighted to receive support from Zhongshan Venture Capital and AMR Fund. Danno Pharmaceuticals is committed to addressing the dual challenges of bacterial resistance and tolerance, providing solutions for bacterial infections and metabolic related diseases that still lack ...
- Source: drugdu
- 69
- October 17, 2024
IPHASE ABC family P-gp transporter membrane vesicles have been successfully developed!

P-glycoprotein (P-gp) belongs to the ATP Binding Cassette (ABC) protein family and is an ATP dependent transmembrane efflux transporter. It is mainly encoded by the multidrug resistance gene (MDR1), also known as ABCB1 gene, in the human body. P-gp is related to multidrug resistance and drug drug interactions (DDIs). Drug regulatory authorities in the United States, Europe, and China have successively issued guidance principles, listing transporter mediated DDI research as an important indicator for evaluating the safety and efficacy of new drugs. It is also explicitly stated that in vitro studies should be conducted to evaluate whether the investigational drug is a substrate, inhibitor, or inducer of P-gp, providing reference for in vivo studies. Based on the above requirements, IPHASE/Huizhi and Yuanji have successfully constructed SLC transporter cells, including OATP1B1, OATP1B3, OAT1, OAT3, OCT2, MATE1, and MATE2-K. In addition, they have also successfully constructed the first P-gp transporter membrane vesicle ...
- Source: drugdu
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- October 17, 2024
Hengrui Medicine’s PD-1 combination therapy is re-registered for listing in the United States

On October 15, Hengrui Medicine issued an announcement announcing that it had received a “confirmation letter” from the FDA, and the resubmitted PD-1 monoclonal antibody carrelizumab injection combined with apatinib mesylate tablets for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma The biologics license application (hereinafter referred to as “BLA”) was accepted by the FDA. According to the Prescription Drug User Fee Act (PDUFA), the FDA’s target review date for carrelizumab injection is March 23, 2025. In October 2023, Hengrui Medicine reached a licensing agreement with Elevar Therapeutics, granting the latter exclusive rights to develop and commercialize carrelizumab liver cancer combination therapy worldwide, excluding Greater China and South Korea. In May this year, HLB-LS, the parent company of Elevar Therapeutics, announced that it had received a complete response letter (CRL) from the FDA regarding the new drug application (NDA) for carrelizumab combined with apatinib for the first-line ...
- Source: drugdu
- 66
- October 17, 2024
3.7 billion blockbuster antihypertensive drug, Shandong New Era approved for listing!

Yesterday (October 14), the official website of the National Medical Products Administration (NMPA) announced that the Sacubitril Valsartan Sodium Tablets submitted by Shandong New Era Pharmaceuticals were approved and passed the review. Sacubitril Valsartan Sodium Tablets is an antihypertensive drug used for adult patients with chronic heart failure with reduced ejection fraction. As the world’s first breakthrough innovative drug in the field of heart failure treatment, Sacubitril Valsartan Sodium Tablets entered the Chinese market in 2017 for the treatment of heart failure, and was later included in the 2020 National Medical Insurance Catalogue. In June 2021, it was first approved in China for the treatment of essential hypertension. In 2021, in-hospital sales exceeded 2 billion yuan in one fell swoop, a year-on-year increase of 170%. According to the Zhongkang Kaisi system, the sales of hypertension drugs in graded hospitals in 2023 will reach about 24.2 billion yuan. In the subdivided ...
- Source: drugdu
- 70
- October 17, 2024

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