A couple of months after posting positive late-stage data for its quadruplet-in-one-pill for quelling HIV, J&J says it’s filed a marketing application with the FDA ahead of a planned marketing campaign.
A long-acting, two-drug HIV regimen being co-developed by ViiV Healthcare and Janssen Sciences Ireland UC has shown comparable viral suppression rates to a three-drug regimen in a Phase II trial, indicating its potential to reduce the dosing burden for patients and thus improve treatment adherence. The LATTE-2 study assessed long-acting, injectable formulations of cabotegravir (ViiV) and rilpivirine (Janssen, branded Edurant), given every four or eight weeks to patients with HIV-1 infection who had already achieved viral suppression with a daily three-drug oral regimen of cabotegravir plus two nucleoside reverse transcriptase inhibitors (NRTIs). Following 96 weeks of maintenance treatment, viral suppression rates for the two-drug regimen dosed every eight weeks (94 percent) or every four weeks (87 percent) were comparable to the rate observed in patients continuing with a three-drug oral regimen (84 percent). In the study, data from which were published in The Lancet and presented at the annual conference ...
US-based point-of-care (POC) diagnostics developer OraSure Technologies has obtained prequalification from the World Health Organisation (WHO) for its OraQuick HIV Self-Test (HIVST).
According to the Medicine Intelligence Data Investment Pattern Database, Yangqi Medical Chip, committed to becoming a pioneer in precision nuclear medicine, recently announced the completion of tens of millions of yuan in PreA round financing. This round of financing is led by Anfeng Venture Capital, and the raised funds will mainly be used for market promotion of approved products, approval of new product research and development, and expansion of the pet radiotherapy market. Yangqi Medical Core was established in 2021, and its core founding team is composed of clinical experts in nuclear medicine, nuclear physics and artificial intelligence, tumor radiotherapy, and radiation physics from Stanford, Alibaba, and other domestic and foreign institutions. The company is headquartered in Shenzhen and has research and development centers in Hangzhou and Shanghai. It is reported that Yangqi Medical Core is deeply involved in the fields of nuclear medicine and tumor radiation therapy. In response ...
Recently, the Equipment Review Center of the National Medical Products Administration released the results of the priority approval application for medical devices (No. 14 of 2024), and Shanghai Qigong Medical Technology Co., Ltd. (hereinafter referred to as Qigong Medical)’s product – endovascular stent – passed the priority approval green channel. It is worth mentioning that this product is urgently needed in clinical practice and there are no registered medical devices of the same variety in China. Qigong Medical focuses on innovative vascular intervention products Against the backdrop of an aging population, the incidence of cardiovascular diseases in China continues to rise, with high mortality rates, difficult treatment, and high risks associated with aortic disease. At present, the clinical treatment options for aortic diseases in China mainly include surgical open treatment and endovascular intervention treatment. Endovascular intervention therapy is a rapidly developing clinical treatment technique in recent years, which combines a ...
The cold winter of CXO has lasted for three full years since the second half of 2021. From industry leaders to emerging pharmaceutical companies, everyone has felt the chill. However, since the second half of 2024, the entire industry has shown some signs of recovery. Against the backdrop of interest rate cuts in Europe and the United States, the situation in the pharmaceutical investment and financing market has reversed, orders from many listed companies have begun to grow, and the industry turning point is about to come. Haoyuan Pharmaceutical is one of the first CXO companies to feel the warmth. Since the end of August, the stock price has risen from a low of 18.49 yuan/share to a high of 46.52 yuan/share, an increase of more than 150%. Haoyuan Pharmaceutical stock price trend Image source: Oriental Fortune What is the secret of Haoyuan Pharmaceutical behind the fluctuations in stock prices? ...
In 2024, 207 varieties passed/are deemed to have passed the consistency evaluation in October, involving 203 companies (counted as group companies), of which 47 companies passed multiple varieties, and Zhengda Tianqing Pharmaceutical Group Co., Ltd. had the largest number of varieties passed. Chiatai Tianqing ranked first in the “number of varieties passed by the company” 1. Overall situation In October, a total of 207 varieties passed/are deemed to have passed the consistency evaluation: 151 varieties were deemed to have passed the consistency evaluation when they were launched as newly registered classified generic drugs; 59 varieties passed the evaluation with supplementary applications for generic drug consistency evaluation, an increase of 20 varieties compared to September. According to the statistics of the approval documents for marketed drugs, 12 varieties were launched in October as newly registered classified generic drugs, and the first was deemed to have passed the consistency evaluation, and 3 ...
According to the CDE official website, two new traditional Chinese medicines have obtained implicit permission for clinical trials. They are the Category 2.3 new drug “Xuesaitong Soft Capsules” from China Resources Shenghuo and the Category 1.1 new drug “Jiuwei Zhengxiao” from the Institute of Clinical Basic Medicine of the China Academy of Chinese Medical Sciences. Particles”. Xuesaitong soft capsule: carotid atherosclerosis Xuesaitong soft capsule has the functions of activating blood circulation, removing blood stasis, unblocking meridians and activating meridians, and its main component is total saponins of Panax notoginseng. Currently, this drug has been approved for use in the meridian recovery period of ischemic stroke (cerebral infarction) caused by blood stasis blockage. Symptoms include hemiplegia, numbness on one side of the body, crooked mouth and tongue, and slurred speech. This time, China Resources Shenghuo’s Class 2.3 new Chinese medicine “Xuesetong Soft Capsule” has obtained another implied clinical trial license, which ...
On the evening of November 12, BeiGene released its third quarter 2024 U.S. stock performance report and A-share main financial data announcement. In the third quarter, BeiGene continued its strong growth momentum, achieving revenue of 7.139 billion yuan, a year-on-year increase of 26.9%. Global product revenue reached 7.079 billion yuan, a year-on-year increase of 65.1%. The overall performance is eye-catching . In the first three quarters of 2024, BeiGene’s total operating revenue reached 19.136 billion yuan, a year-on-year increase of 48.6%. Products continue to increase in volume at a high speed, with product revenue of 18.986 billion yuan in the first three quarters, a year-on-year increase of 72.9%. Whether it is total revenue or product revenue, the first three quarters have exceeded last year’s full-year revenue of 17.423 billion yuan, and the performance is very eye-catching. According to the U.S. stock financial report, BeiGene’s financial situation continues to improve, with ...
Recently, according to the Mail on Sunday report in the UK, global orthopedic giant Smith&Nephew has received a stern warning from shareholders due to poor performance. Smith&Nephew’s shareholders have lost patience with CEO Deepak Nath’s strategic development speed, claiming that if the company’s performance cannot be improved, Deepak Nath will be dismissed and Smith&Nephew will also face the splitting of its orthopedic department internally. It is reported that the stock price of Xerox Hui has dropped by up to 44% in the past five years. With this year’s performance still not “clear up”, the emotions of shareholders are difficult to calm, further putting pressure on Deepak Nat. Century old enterprises face crisis Shi Lehui was founded in the UK in 1856, a well-established company with over a hundred years of history. Its main businesses include orthopedics, sports medicine and otolaryngology, and advanced wound management. Currently, Shi Lehui is at the ...
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