There is one more loser in the Alzheimer’s disease field. On November 25, Cassava Sciences announced that the Phase III ReThink-ALZ study of Simufilam for the treatment of mild to moderate Alzheimer’s disease (AD) did not meet the pre-set dual primary endpoints, secondary endpoints, and exploratory biomarker endpoints. Affected by this news, Cassava Sciences’ stock price fell 84% that day. It seems that this may be expected. Cassava Sciences has been in great controversy because of controversies such as paper data falsification. But in any case, this still highlights the difficulty of treating Alzheimer’s disease. Simufilam is an oral small molecule drug targeting misconstructed filament protein A (FLNA). FLNA is a scaffold protein that normally exists in cells. The toxic form of amyloid beta, Aβ42, can induce changes in its structure, and the misconstructed FLNA can promote the activation of the Aβ42-α7 acetylcholine receptor signaling pathway and the Aβ42-Toll-like receptor ...
In the past week, the field of allogeneic CAR-T has heated up again due to the participation of Roche. On November 26, Roche announced that it would acquire the biotech company Poseida for up to $1.5 billion. Poseida’s R&D pipeline includes spot (allogeneic) CAR-T therapies in multiple therapeutic areas, covering hematological malignancies, solid tumors and autoimmune diseases. Due to a series of factors such as cycle and cost, the commercialization process of autologous CAR-T has been subject to certain restrictions, so the industry has never stopped exploring allogeneic CAR-T. The market has high hopes for allogeneic CAR-T. Of course, this is not smooth sailing, because due to a series of factors such as effect, it will take some time for allogeneic CAR-T to break through. Roche’s investment in Poseida this time is mainly based on the latter’s technology platform. Poseida’s non-viral platform is able to generate off-the-shelf CAR-T therapies ...
After several years of practice, the thinking of medical insurance negotiations has completely changed. Drug prices still need to be controlled, and exchanging volume for price is the unshirkable responsibility of the Medical Insurance Bureau as a large buyer. However, the tone of the negotiations has changed. In the past few years, the Medical Insurance Bureau emphasized “soul bargaining”; but in this year’s medical insurance negotiations, the official tone of the Medical Insurance Bureau has become “two-way running.” “Going in both directions” means no longer just pursuing low prices, but negotiating with a reasonable price and stable expectations. For medical insurance, including more high-quality drugs through negotiations with pharmaceutical companies is to strive for the maximum benefits for insured persons on the basis of maintaining the stable operation of the fund; and for pharmaceutical companies, entering medical insurance can usually show significant benefits. By increasing sales, the commercialization process can ...
Recently, Cardinal Health announced a major financial move, announcing the successful public offering of $2.9 billion in senior notes. The relevant details have been disclosed in the 8-K filing submitted to the U.S. Securities and Exchange Commission. On November 11, Cardinal announced that it would acquire GI Alliance and Diabetes Supply Group for $3.9 billion (approximately RMB 28.2 billion) to expand its business layout in the professional medical and home healthcare fields. Cardinal said that the funds raised from the note issuance will be used in part to provide financial support for its planned acquisition of a majority stake in GI Alliance Holdings, LLC and Advanced Diabetes Supply Group, covering related fees and expenses. The remaining funds will be used for general corporate purposes until they can be used for acquisitions. It is reported that the notes issued by Cardinal this time cover different maturities and interest rates, including $500 ...
Organiser:Algerian Ministry of Health, Algerian Healthcare Reform and Development Commission Time:April 9th -12th, 2025 Address:Les Genets, Chemin de Wilaya, Route 75, Oran, Algeria Exhibition hall:Centre des Conventions d’Oran Product range: Medical Equipment: Medical technology equipment, laboratory instruments and equipment, medical electronic equipment, medical diagnostic equipment, ophthalmic equipment and protective products, surgical instruments, emergency response equipment, hospital, dental, and medical facilities, dental service equipment, disposable medical products for hospitals and households, hospital and dental medical data processing systems, orthodontic and reconstructive equipment. Pharmaceuticals: Foreign prescription drugs, herbal preparations, nutritional health supplements such as minerals and vitamins, dietary nutrition products, homeopathic preparations, dermatological preparations, maternal and child healthcare products and infant food, personal hygiene products, incontinence products, medical consumables, etc. About Simem: The Algerian International Medical Equipment Exhibition (SIMEM) is the most renowned medical equipment exhibition in Algeria. It is the only specialized exhibition for medical devices, pharmaceuticals, and dentistry ...
Recently, AstraZeneca announced an important personnel change on its official website, appointing Bob Li, an Asian scientist at Memorial Sloan-Kettering Cancer Center (MSK) in the United States, as the new head of global medical affairs for oncology. He will report directly to David Fredrickson, head of AstraZeneca’s oncology business unit. Although Mr. Li is 42 years old and his position has not yet reached the company’s senior management, his Chinese identity and background have attracted widespread public attention. Mr. Li, an Australian-Chinese born in Shanghai, has served as a physician ambassador for China and the Asia-Pacific region at MSK, and is also a senior fellow in global public health at the China Analysis Center of the Asia Society Policy Institute. Mr. Li’s career shows that he has established cooperative relationships with many medical organizations in China, including a cooperative project between MSK and the China Thoracic Tumor Research Collaborative Group. ...
On November 27, Jixing Pharmaceutical announced that the National Medical Products Administration has approved the new drug application for its ophthalmic product, Varenicline tartrate nasal spray, to increase the tear secretion of patients with dry eyes. According to the data of “Chinese Dry Eye Expert Consensus (2020)”, the current incidence of dry eye in my country is about 21%-30%. Dry eye is closely related to excessive eye use, wearing contact lenses and other lifestyle habits. Common symptoms include dry eyes, foreign body sensation, burning sensation, itchy eyes, pain, red eyes, visual fatigue, blurred vision, and vision fluctuations. Natural tear deficiency and tear film instability are the core mechanisms of dry eye. Varenicline tartrate nasal spray is a highly selective acetylcholine receptor agonist that promotes natural tear secretion to stabilize the tear film by activating the trigeminal parasympathetic pathway. The approval data is based on the results of three key clinical ...
On November 28, the results of the 2024 medical insurance catalog negotiation were announced: 91 new drugs were added to the national medical insurance drug catalog, of which 89 were included by negotiation/bidding, and another 2 were selected in the national centralized procurement. After checking the medical insurance drugs, Sina Medical Editor found that the 4 CAR-T products that had passed the preliminary review did not appear on the list. Regarding “Why is it difficult for CAR-T to enter the medical insurance catalog”, at the press conference held by the National Medical Insurance Administration on the morning of November 28, Wang Guodong, deputy director of the Medical Insurance Management Center of the National Medical Insurance Administration, introduced that some expensive cell and gene therapy drugs have been launched one after another, and it is difficult to fully support them by relying solely on basic medical insurance. At present, the National ...
According to CanSino’s official WeChat account, the supplemental application for CanSino Biologics’ ACYW135 group meningococcal polysaccharide conjugate vaccine (CRM197 carrier), referred to as “Mankexin®,” has been accepted by the National Medical Products Administration (NMPA) and a notice of acceptance has been issued. This supplemental application expands the age range for the use of Mankexin® from “3 months to 3 years (47 months) children” to “3 months to 6 years (83 months) children.” Mankexin® received approval from the NMPA on December 29, 2021. https://finance.eastmoney.com/a/202411263251192857.html
Drugdu.com expert’s response: In the field of medical devices, risk estimation, risk assessment, and risk rating are crucial steps in risk management, each with its own clear definition and distinction. Ⅰ. Definitions 1. Risk Estimation (1)Definition: The process of assigning values to the probability of occurrence and severity of harm. (2)Content: This typically involves analyzing factors such as the design, manufacturing process, and usage environment of medical devices to identify potential risk points. The purpose of risk estimation is to identify potential risks and provide a foundation for subsequent risk assessment. 2. Risk Assessment (1)Definition: The process of comparing “estimated risks” with “given risk criteria” to determine the acceptability of risks. (2)Content: Risk assessment is a more in-depth and systematic process that involves detailed analysis of identified risks, including the likelihood, severity, and effectiveness of risk control measures. The purpose of risk assessment is to determine the priority of risks ...
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