A new low-cost version of the abortion pill mifepristone just received federal approval and it’s already stirring political controversy. The U.S. Food and Drug Administration (FDA) recently granted approval to Evita Solutions for its generic version of mifepristone, a medication used to end early pregnancies up to 10 weeks. The original version of mifepristone has been available in the U.S. for 25 years and is commonly prescribed alongside another medication, misoprostol, to complete a medication abortion. Evita “believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care,” the company said. While the approval process for generic drugs is usually routine, this decision quickly caused backlash from anti-abortion groups, The Associated Press reported. Students for Life Action called the approval “a stain on the Trump presidency and another sign that the deep state at the FDA must go.” Meanwhile, Republican ...
On September 30, Kangtai Biological(300601) issued an announcement that the company signed a license termination agreement with AstraZeneca UK Limited (AstraZeneca) to terminate the cooperation in the research and development, production and commercialization of ChAdOx1 adenovirus vector new crown vaccine. The termination of the cooperation on the licensed product and the signing of the termination agreement are prudent decisions made by the company after comprehensive assessment of factors such as the prevalent strains of the new coronavirus vaccine and the significant changes in the market environment, as well as its own resource allocation. The company mentioned that in the future it will concentrate its superior resources to focus on the research and development and industrialization of multi-component and multivalent vaccines, adult vaccines, innovative vaccines, and therapeutic vaccines, continue to deepen its roots in the vaccine field, and enhance its core competitiveness. By mid-2025, CanSino Biologics achieved revenue of 1.392 billion yuan and net ...
The reporter recently learned from CanSinoIt is learned that on September 29, CanSino’s independently developed 13-valent pneumococcal polysaccharide conjugate vaccine PCV13i and Asia’s first quadrivalent meningococcal polysaccharide conjugate vaccine MCV4 were shipped to the domestic and overseas markets respectively. CanSino Biologics’ independently developed 13-valent pneumococcal polysaccharide conjugate vaccine, Upexin®, was officially approved by the National Medical Products Administration in June of this year. It is China’s first pneumococcal polysaccharide conjugate vaccine to utilize a dual vector consisting of an avirulent mutant of diphtheria toxin (CRM197) and tetanus toxoid (TT). This vaccine provides enhanced protection against the four serotypes (19F, 19A, 7F, and 3) that carry the heaviest burden of pneumococcal disease in children in China. It is reported that by 2026, Upexin® will expand its reach into the domestic market, with overseas expansion also in the works. When Youpexin® was shipped domestically, Asia’s first ACYW135 group meningococcal polysaccharide conjugate vaccine (CRM197 vector) Manhaixin® also ...
Sinopharm announced that its subsidiary, Jushi Biopharmaceuticals Co., Ltd., of CSPC Pharmaceutical Group, has received the “Notice of Approval for Clinical Trial of Lencanelumab Injection” from the National Medical Products Administration (NMPA). Clinical trials of the drug will commence soon. Lencanelumab Injection is a recombinant anti-human amyloid-β monoclonal antibody and a biosimilar to Leyibao, indicated for the treatment of mild cognitive impairment and mild dementia caused by Alzheimer’s disease. The product approved for clinical trials by Sinopharm is the first biosimilar to lencanelumab injection to obtain clinical approval in China . Currently, there are only a handful of new Alzheimer’s disease drugs on the market, such as Lencaneluzumab and Donezetimumab, all developed by multinational pharmaceutical companies and relatively expensive. The clinical approval of domestically produced biosimilars suggests the potential for improved patient accessibility and reduced financial burdens in the future. Source: https://cj.sina.cn/articles/view/5953189932/162d6782c06703893e?froms=ggmp
Flu season is fast approaching in the northern hemisphere. And a taste-based influenza test could someday have you swapping nasal swabs for chewing gum. A new molecular sensor has been designed to release a thyme flavor when it encounters the influenza virus. Researchers reporting in ACS Central Science say that they plan to incorporate this type of low-tech sensor into gum or lozenges to increase at-home screenings and potentially prevent pre-symptomatic transmission of the disease. Staying home is critical to preventing the spread of infectious diseases like influenza; however, people with the flu are contagious before they develop symptoms. Current flu diagnostics like nasal swab-based PCR tests are accurate, but they are slow and expensive. At-home lateral flow tests, akin to those used to test for COVID-19, are convenient and generally low-cost, but don’t catch pre-symptomatic infections. As written in their published study, Lorenz Meinel and colleagues address these flu ...
The approval is for pediatric patients living with either moderate-to-severe plaque psoriasis, who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis. This approval expands indications of use beyond the initial adult population and is the first and only pediatric approval for an interleukin-23 inhibitor. The approval is based on results from the phase 3 PROTOSTAR study in which the coprimary end points of Psoriasis Area Severity Index (PASI) 90 and Investigator’s Global Assessment (IGA) score of 0/1 were achieved at week 16. More than half of patients (56 percent) receiving Tremfya achieved PASI 90 versus 16 percent of patients receiving placebo. For IGA score, at week 16, two-thirds (66 percent) of patients receiving Tremfya achieved high levels of skin clearance (score 0/1) versus 16 percent of patients receiving placebo. Complete clearance (IGA 0) at week 16 was achieved by nearly 40 percent of pediatric patients receiving Tremfya ...
Drugdu.com expert’s response: The “generic drug consistency evaluation” marked on Moxifloxacin Hydrochloride Tablets indicates that this generic drug has undergone comparative quality and efficacy trials with the original branded drug and has been proven to possess equivalent quality and efficacy. Specific Meaning and Background Definition and Purpose: The generic drug consistency evaluation is a systematic assessment conducted on already-marketed generic drugs. It requires that generic drugs maintain consistency with the original branded drug in terms of active ingredients, dosage forms, specifications, routes of administration, and therapeutic effects. The core objective is to ensure that generic drugs can serve as substitutes for the original branded drugs, delivering the same therapeutic effects while guaranteeing public safety and efficacy in medication use. Policy Background: China initiated the generic drug consistency evaluation program in 2016, aiming to enhance the overall quality of generic drugs through a phased approach to quality consistency evaluation. Drugs that ...
Even though many years have passed since the start of the COVID-19 pandemic, the effects of infection with SARS-CoV-2 are not completely understood. This is especially true for Long COVID, a chronic condition that can develop after COVID-19 that causes a variety of lasting symptoms. Among the most common and debilitating of these is cognitive impairment, often referred to as “brain fog,” which affects over 80% of people with Long COVID. Given the hundreds of millions of global cases, Long COVID represents a massive public health and socioeconomic challenge, as it severely impacts people’s ability to work and perform daily activities. Unfortunately, despite its prevalence, the underlying causes of Long COVID and brain fog remain poorly understood. Previous imaging studies have shown some structural changes in the brain, but they could not pinpoint the molecular dysfunctions responsible for the cognitive symptoms. Since it’s difficult to observe the molecules that govern ...
Depending on which vaccine they received, HPV infections fell by 76% to 98% over 17 years among vaccinated women, researchers reported in the journal JAMA Pediatrics. But infections also fell by 72% to 76% among unvaccinated women during the same period, results showed. “There are two encouraging takeaways from our study,” said senior researcher Dr. Jessica Kahn, chair of head and neck pathology at the Albert Einstein College of Medicine in New York City. “First, HPV vaccines work remarkably well in a real-world setting, even among women at high risk for HPV and who may not have received all vaccine doses,” she said in a news release. “Second, we saw clear evidence of herd immunity, meaning when enough people are vaccinated, the vaccine indirectly protects unvaccinated people by reducing overall virus transmission.” Kahn said these results “reinforce the potential of the HPV vaccine to prevent infection and, ultimately, eliminate cervical cancer globally.” Long-lasting ...
an investor asked on the investor interaction platform: When is the company’s nine-valent vaccine expected to be launched? What is its current stage? What is the annual production capacity of the company’s production line? Watson Bio(300142.SZ) stated on the investor interaction platform on September 24 that the company’s related work on the Phase III clinical study of the nine-valent HPV vaccine is ongoing. If there is any substantial and phased progress in the research and development of the company’s vaccine, the company will disclose it in a timely manner. Please pay attention to the relevant information disclosed by the company for subsequent progress. Source;https://finance.eastmoney.com/a/202509243522306220.html
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