PharmaFocus Today – Page 130 – media

Another medical device is scheduled for priority approval

Recently, the Jiangsu Provincial Medical Products Administration released the “Announcement of the Examination Results of Priority Approval Applications for Class II Medical Devices (No. 3 of 2025)”, intending to approve the priority registration process for the ultraviolet phototherapy device of Xuzhou Kono Medical Instrument Equipment Co., Ltd. (hereinafter referred to as “Kono Medical”). Heavy equipment, registration process accelerates Ultraviolet radiation is an invisible light with a wavelength between 100-400nm, which can be divided into UVC radiation (100-280nm), UVB radiation (280-320nm), and UVA radiation (320-400nm). Ultraviolet radiation has sufficient energy to destroy the DNA structure of microorganisms, thus effectively inhibiting the activity of viruses and bacteria. Research has shown that ultraviolet radiation has the effects of accelerating blood circulation, relieving pain, and promoting epithelial regeneration, making it effective in treating diseases such as herpes, psoriasis, and atopic dermatitis. In addition, ultraviolet radiation also promotes the production of vitamin D, which can ...
- Source: drugdu
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- March 11, 2025
Gilead adds new liver disease drug

Seladelar is currently the first and only therapy that has achieved significant improvements in biochemical reactions, normalization of alkaline phosphatase, and relief of itching compared to placebo. This approval means that rare liver disease patients in the European Economic Area (EEA) will have an important new treatment option. From MASH dilemma to PBC breakthrough The development process of Seladelar is full of twists and turns. Originally developed by CymaBay, in 2006, Johnson&Johnson reached a comprehensive development and commercialization agreement with CymaBay Therapeutics for metabolic disease drugs. Johnson&Johnson obtained authorization for three drugs, including Seladelar. In February 2024, Geely Dehao invested $4.3 billion to acquire CymaBay Therapeutics, acquiring the core pipeline drug Seladelar. On August 9, 2024, just one week before the FDA PDUFA date of Seladelar in the United States (August 14), Gilead quickly made a move and purchased Seladelar’s global royalties from Johnson&Johnson for $320 million. Behind this series ...
- Source: drugdu
- 249
- March 11, 2025
Innovative therapy for ALS, updated progress

Source of Medicine Intelligence Network: Medicine Intelligence Network Recently, Shize Biotechnology announced that its self-developed universal iPSC derived subtype neural precursor cell injection product XS-228 injection has been fully approved by the US FDA for registration in clinical trials for the treatment of amyotrophic lateral sclerosis (ALS). This breakthrough not only marks an innovative breakthrough in the field of cell therapy in China, but also brings new hope to patients with ALS. One of the ‘Four Deadly Diseases of the World’ ALS, as one of the “Four Deadly Diseases of the World”, its complexity and harmfulness cannot be ignored. ALS (amyotrophic lateral sclerosis) is a rare and progressive neurodegenerative disease that primarily affects motor neurons in the brain and spinal cord. These neurons are responsible for controlling muscle movement. As they gradually regress and die, patients may experience symptoms such as muscle weakness, atrophy, and stiffness, ultimately leading to the ...
- Source: drugdu
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- March 11, 2025
Enatuzumab approved in China for the treatment of relapsed or refractory multiple myeloma

On March 10, Pfizer announced that the targeted immunotherapy Iregio® (Enatuzumab) was conditionally approved by the National Medical Products Administration for the treatment of adult patients with relapsed or refractory multiple myeloma who had previously received at least three lines of treatment (including a proteasome inhibitor, an immunomodulator, and an anti-CD38 monoclonal antibody). https://finance.eastmoney.com/a/202503103341149628.html
- Source: drugdu
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- March 11, 2025
Cialis approved in China for the treatment of active Crohn’s disease in adults

On March 10, AbbVie announced that the China National Medical Products Administration (NMPA) approved Cialis® for the treatment of adult patients with moderate to severe active Crohn’s disease who have insufficient response, loss of response or intolerance to traditional treatment or biologics. The approval includes two dosage forms: risankizumab injection and risankizumab injection (subcutaneous injection). Cialis® is the world’s first interleukin-23 (IL-23) inhibitor approved for adult patients with moderate to severe active Crohn’s disease. After approval, it is also the first IL-23 inhibitor in China with a portable dosing device. https://finance.eastmoney.com/a/202503103341127889.html
- Source: drugdu
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- March 11, 2025
“Generic name” circulation breaks the dilemma of purchasing medicines. Shenzhen Medical Insurance launches new “dual channel” drug regulations

“The drug name on the hospital’s external prescription is the same as the drug in the pharmacy, why can’t I buy it?” “Why can’t the community health center issue an external prescription, and I have to go to the hospital?” Recently, the Shenzhen Medical Insurance Bureau launched a new “dual channel” drug management regulation, taking the lead in the province to upgrade the circulation of external prescriptions from “trade name” to “generic name”, and launched the community health external prescription circulation service. These problems that once troubled the general public are being solved. “Dual channel” drugs refer to national medical insurance negotiated drugs with high clinical value, urgent need for patients, and low substitutability. There are currently more than 600 kinds in Shenzhen. In order to ensure the patient’s drug needs, when such drugs are not available in the hospital, they can be purchased at the pharmacy through external prescriptions, ...
- Source: drugdu
- 375
- March 11, 2025
The company exported a batch of PPR vaccines to Mongolia a few years ago, and currently has no other overseas sales cases

Tiankang Bio said on the investor interaction platform on March 10 that the company had exported a batch of PPR vaccines to Mongolia a few years ago, and currently has no other overseas sales cases. In the future, the company will continue to pay attention to international market demand, actively evaluate and explore qualified vaccine product export opportunities, and expand its overseas business layout. https://finance.eastmoney.com/a/202503103341125095.html
- Source: drugdu
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- March 11, 2025
Will not transfer main business or inject assets to Tiankang Pharmaceutical

On March 6, Tiankang Bio said on the investor interaction platform that the company currently has no plan to transfer its main business to Tiankang Pharmaceutical, nor does it have any plan to inject assets into Tiankang Pharmaceutical. In December 2024, Tiankang Bio announced that its holding subsidiary Tiankang Pharmaceutical intends to apply for a public offering of shares to unspecified qualified investors and list on the Beijing Stock Exchange. Tiankang Bio believes that this move will help further enhance Tiankang Pharmaceutical’s production capacity and R&D and innovation capabilities, promote business development, and improve its governance level and industry competitiveness. After the completion of this public offering, Tiankang Bio will still be the controlling shareholder of Tiankang Pharmaceutical, and both the company and Tiankang Pharmaceutical will be able to continue to maintain independence and sustainable operating capabilities. Recently, an investor asked on the interactive platform whether Tiankang Pharmaceutical will transfer ...
- Source: drugdu
- 279
- March 10, 2025
The first tumor vaccine is expected to be launched in 2027 to treat this cancer

On March 5, local time, American vaccine manufacturer Moderna said at an investor conference that the company is expected to launch its first tumor vaccine in 2027. At the close of the day, Moderna’s stock price rose nearly 16%. Moderna is developing a personalized tumor vaccine with Merck and has conducted late-stage clinical trials on patients with severe skin cancer (melanoma). Stephen Hoge, president of Moderna, said at an investor conference on Wednesday that the first tumor vaccine may have the opportunity to bring “considerable revenue” to the company. Moderna released interim research data on the vaccine as early as the end of 2023, showing that the possibility of death or cancer recurrence in melanoma patients treated with this vaccine and Merck’s cancer therapy Keytruda was reduced by half. This tumor vaccine is based on Moderna’s mRNA technology. Previously, mRNA COVID-19 vaccines have proven that they can activate the body’s ...
- Source: drugdu
- 348
- March 10, 2025
Another pharmaceutical company changes ownership

The entry of Shaoguan Gaoteng has brought new opportunities to Chengda Bio, but whether it can break through still needs time to test. Recently, Chengda Bio issued an announcement stating that the Liaoning Provincial State-owned Assets Supervision and Administration Commission officially withdrew and the company changed to a “no actual controller” status. The change began with the reorganization of the board of directors of its controlling shareholder Liaoning Chengda. Shaoguan Gaoteng took control of Liaoning Chengda by nominating four non-independent directors (more than half of the seats), and indirectly held 54.67% of Chengda Bio’s shares. Shaoguan Gaoteng is a wholly-owned subsidiary of Guangdong Private Investment Co., Ltd. (Guangdong Private Investment), which was established by the Guangdong Provincial Government and focuses on strategic areas such as new energy and life sciences. In 2019, Guangdong Private Investment increased its holdings in Liaoning Chengda through Shaoguan Gaoteng, and became the largest shareholder with ...
- Source: drugdu
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- March 10, 2025

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