PharmaFocus Today – Page 12 – media

Johnson & Johnson aims to become the “number one” company

Johnson & Johnson recently announced that the U.S. FDA has approved CAPLYTA (Lumateperone) as an adjunctive therapy in combination with an antidepressant for the treatment of major depressive disorder (MDD) in adults. This is the first new drug approved under Johnson & Johnson’s leadership since its acquisition of Intra-Cellular. 01. Major products acquired through acquisition CAPLYTA (Lumateperone) is a first-in-class small molecule drug developed by Intra-Cellular, but its origins can be traced back to Bristol-Myers Squibb (BMS). Intra-Cellular acquired the original patent for the compound from BMS in 2005 and continued to advance its research and development based on that. In January 2025, Johnson & Johnson acquired Intra-Cellular for a staggering $14.6 billion, strengthening its pipeline in the field of central nervous system (CNS) diseases. Lumateperone is a once-daily oral atypical antipsychotic. Its exact mechanism of action is not fully understood, but studies show that at therapeutic doses, it antagonizes ...
- Source: drugdu
- 75
- November 13, 2025
HHS Removes Misleading Safety Warning Information on Menopausal Hormone Therapy Label

The U.S. Department of Health and Human Services (HHS) announced a label change for menopausal hormone therapies (MHT) or hormone replacement therapies (HRT) following an FDA request. The agency demanded the removal of broad “black box” warnings from HRT products for menopause, citing a desire to improve clarification of the benefit/risk considerations of using these medications.1 Both Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, M.D., M.P.H. announced the agency’s intentions to change the label at a press conference held at HHS.1 “Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment,” said Secretary Kennedy. “For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their ...
- Source: drugdu
- 74
- November 13, 2025
Global Tuberculosis Diagnoses Rise to a Record, but Deaths Fall, WHO Reports

NEW YORK (AP) — The number of people diagnosed with tuberculosis worldwide rose again last year, eclipsing 2023’s record total, World Health Organization officials said Wednesday. About 8.3 million people across the globe were reported as newly diagnosed with TB in 2024. Not all infections are diagnosed and the new numbers represent 78% of the estimated number of people who actually fell ill last year, the WHO noted. WHO officials see the increase as an indication that screening and treatment are improving after health care disruptions during the COVID-19 pandemic. Globally, the number of deaths caused by TB fell in 2024 to 1.23 million, down from 1.25 million the year before. U.S. tuberculosis cases continued to rise last year — reaching the highest level in more than a dozen years, according to preliminary data released earlier this year. The vast majority of U.S. TB cases are diagnosed in people born ...
- Source: drugdu
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- November 13, 2025
Anke Biotech increases its investment in Boshengji and acquires exclusive national commercialization rights for its CD7-CAR-T cell therapy

　　China Securities Journal (Wang Luo) – On November 11, Anke Biotechnology…The company announced on its official WeChat account that it has signed a Capital Increase Agreement and an Exclusive Agency Framework Agreement with Boshengji Pharmaceutical Technology (Suzhou) Co., Ltd., establishing a new round of in-depth strategic cooperation. According to the agreements, Anke Biotechnology , as Boshengji’s second-largest shareholder, will invest an additional 30 million yuan to increase Boshengji’s capital. Simultaneously, Anke will leverage its commercial advantages to obtain the exclusive nationwide distribution rights for Boshengji’s core product, PA3-17 injection. This move marks a formal upgrade from early R&D cooperation and equity investment to a comprehensive strategic partnership based on “capital binding and joint business operation.” 　　This collaboration revolves around Boshengji’s core investigational product—PA3-17 injection, the world’s first Investigational New Drug (IND) approved product targeting CD7 autologous CAR-T cells. Developed independently by Boshengji Anke Cell Technology Co., Ltd., a wholly-owned subsidiary ...
- Source: drugdu
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- November 12, 2025
Zhifei Biological’s subsidiary receives approval for clinical trials of its DPT vaccine for adolescents and adults

　　On November 11, Zhifei Biological Products Co., Ltd.(300122) issued an announcement stating that the company recently received approval from the National Medical Products Administration to allow its wholly-owned subsidiary to conduct clinical trials of its adsorbed acellular pertussis-diphtheria-tetanus (diphtheria-tetanus) combined vaccine (for adults and adolescents). 　　This vaccine aims to prevent infectious diseases such as diphtheria, tetanus, and pertussis, filling the market gap in domestic DPT (diphtheria, pertussis, and tetanus) vaccines for adolescents and adults. This approval marks a significant advancement for the company in vaccine development; the adolescent and adult DPT vaccine is a new generation of acellular vaccine, using separately purified active ingredients. 　　The company stated that if the clinical trials proceed smoothly, it will further enhance its market competitiveness, enrich its product line, and lay the foundation for long-term development. While this approval will not have a significant impact on near-term performance, future product development progress will improve ...
- Source: drugdu
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- November 12, 2025
Increasing Market Supply of Influenza Vaccines; 48 Batches of Quadrivalent Influenza Virus Split Vaccine Have Been Released

　　Southern Finance, November 11th – According to CLS (China Lianhe Securities), from Hualan Biological…According to sources, as of now, the company has approved and released influenza vaccines in 2025.54 batches of vaccines have been released, including 48 batches of quadrivalent influenza virus split vaccine. Since October, and especially November, public awareness of influenza vaccination has increased significantly, and the demand orders from disease control centers across the country have increased significantly compared to the same period last year. The company is increasing its market supply of influenza vaccines and will expedite the transportation of vaccines nationwide through cold chain systems after receiving orders from disease control centers across the country to meet the vaccination demand. https://finance.eastmoney.com/a/202511113561078126.html
- Source: drugdu
- 129
- November 12, 2025
Bohui’s innovative freeze-dried Haemophilus influenzae type b conjugate vaccine clinical trial approved

　　On November 11th, Bohui Innovation(300318) issued an announcement stating that its controlling subsidiary, Langfang Bohui, and Baihui Biotechnology jointly applied for the development of freeze-dried influenza B virus.The Haemophilus influenzae conjugate vaccine has received a Drug Clinical Trial Approval Notice from the National Medical Products Administration, agreeing to conduct clinical trials. This vaccine is intended to prevent invasive infections caused by Haemophilus influenzae type b . The relevant application number is CXSL2500616, and the notification number is 2025LP02755. 　　The announcement states that drug development is characterized by high investment, high risk, and long cycles, and carries risks such as clinical trial results falling short of expectations and failure to obtain approval from relevant authorities. This receipt of the “Drug Clinical Trial Approval Notice” is considered a milestone in the development process and is not expected to have a significant impact on the company’s recent performance. 　　In the first three quarters ...
- Source: drugdu
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- November 12, 2025
What diet do people with type 2 diabetes really want? Study reveals flexibility beats strict meal plans

British adults with diabetes overwhelmingly favor simple, adaptable eating patterns over rigid low-calorie meal replacements, highlighting that personal choice may be key to long-term adherence and better health outcomes. In a recent article published in the Journal of Human Nutrition and Dietetics, researchers investigated the dietary approaches preferred by British adults with type 2 diabetes (T2D) and the reasons behind these preferences. They found that most participants preferred moderately calorie-restricted or low-carbohydrate food-based diets, prioritizing ease of following instructions and simplicity as the most important qualities of an adequate diet. Relationship Between Type 2 Diabetes and Dietary Management T2D is closely linked with obesity and overweight, and dietary weight loss remains central to its management. However, many individuals struggle to adhere to prescribed diets due to barriers such as cultural food practices, social routines, and complex diet structures. Current UK Recommendations for Low Energy Diets In the UK, CLEDs, which ...
- Source: drugdu
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- November 12, 2025
Utah researchers uncover microglia as key regulators of anxiety in the brain

Anxiety disorders are some of the most common mental health conditions in America, affecting about one in five people nationwide. But much remains unknown about the roots of anxiety in the brain. Now, research at the University of Utah has identified two surprising groups of brain cells in mice that act as “accelerators” and “brakes” for anxiety. Unexpectedly, the brain cells that regulate anxiety aren’t neurons, the cells that link together to make circuits and pass signals over long distances in the body. Instead, a kind of immune cell called microglia appears to fundamentally regulate whether mice are anxious or not. One group of microglia spurs anxiety responses; the other group tamps them down. “This is a paradigm shift,” says Donn Van Deren, PhD, postdoctoral research fellow at the University of Pennsylvania, who did the research as a postdoctoral research fellow in human genetics at University of Utah Health. “It ...
- Source: drugdu
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- November 12, 2025
Phase II Clinical Trial Approved for 9MW3811 Injection in Pathological Scarring

On November 10, Maiwei Biotechnology (688062) issued an announcement stating that the company recently received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration, which approved the application for Phase II clinical trial of 9MW3811 injection for the indication of pathological scars. The clinical trial notification number for this drug is 2025LP02967. The approval conclusion shows that it meets the relevant requirements for drug registration and allows clinical trials to be conducted. 9MW3811 is a humanized monoclonal antibody targeting human IL-11 independently developed by the company. It has high target affinity and signal blocking ability and is expected to demonstrate efficacy in various diseases such as pathological scars and pulmonary fibrosis. The company plans to launch its Phase II clinical trial for pathological scars by the end of 2025 and has entered into an exclusive licensing agreement with CALICO LIFE SCIENCES LLC. CALICO has already paid ...
- Source: drugdu
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- November 11, 2025

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