media – Page 28 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

FDA Approves Jascayd for Idiopathic Pulmonary Fibrosis Treatment

FDA announced its approval of Boehringer Ingelheim’s Jascayd (nerandomilast) tablets for the treatment of idiopathic pulmonary fibrosis (IPF). Jascayd’s approval makes it the first approved new therapy treatment for IPF in over 10 years, and with IPF being a rare, serious, and progressive disease with no cure and limited treatments, the approval marks a significant step in supporting those suffering from the disease. FDA’s approval of Jascayd was a data backed decision FDA based its approval on results collected from two Phase III trials, Fibroneer-IPF and Fibroneer-ILD.1 Jascayd’s efficiency was evaluated in both randomized, double-blind, placebo-controlled trials of adults with IPF.1 The primary endpoint was the absolute change from baseline in Forced Vital Capacity, which is the maximum amount of air a person can forcefully exhale after taking the deepest possible breath.1 Results indicated that Participants administered with Jascayd had significantly reduced FVC decline when compared to participants treated with ...
- Source: drugdu
- 92
- October 10, 2025
Popular Painkiller Less Effective, More Risky Than Thought, Evidence Review Says

By Dennis Thompson HealthDay ReporterTHURSDAY, Oct. 9, 2025 (HealthDay News) — A widely prescribed opioid painkiller is not all it’s cracked up to be, a new evidence review has concluded. The opioid painkiller tramadol does little to reduce moderate to severe pain, according to results published Oct. 7 in the journal BMJ Evidence Based Medicine. At the same time, tramadol increases a person’s risk of serious side effects, including heart disease and pre-cancerous cells, researchers found. The drug’s use should be minimized, and guidelines that recommend it reconsidered, the research team concluded. “The potential harms associated with tramadol use for pain management likely outweigh its limited benefits,” wrote the research team led by Jehad Ahmad Barakji of the Center for Clinical Intervention Research at Rigshospitalet in Copenhagen, Denmark. Tramadol is a dual-action opioid, researchers said in background notes. It works on the usual opioid receptors in the brain, much like ...
- Source: drugdu
- 91
- October 10, 2025
【EXPERT Q&A】How to inquire about pharmaceutical manufacturing enterprises and their production qualifications?

Drugdu.com expert’s response: You can obtain detailed information through the following authoritative channels: I. National Medical Products Administration (NMPA) Official Website Access Path: Visit the NMPA official website, click on “Drugs” under the navigation menu, and select “Data Query.” Choose “Pharmaceutical Manufacturers” or “Drug Production License.” Query Methods: Enter keywords such as enterprise name, license number, or unified social credit code. Supports exact or fuzzy searches. Search results include basic enterprise information (e.g., registered address, legal representative), production scope, license number, and validity period. Classification Code Explanation: Uppercase Letters: Categorize drug marketing authorization holders and product types (e.g., “A” for self-production, “B” for contracted production). Lowercase Letters: Distinguish preparation attributes (e.g., “h” for chemical drugs, “z” for traditional Chinese medicines). Usage: Combine codes to filter target enterprises (e.g., to query Beijing-based manufacturers of “granules,” select province as “Beijing,” classification code “A,” and dosage form “granules”). II. Provincial Drug Regulatory Authority Websites ...
- Source: drugdu
- 94
- October 10, 2025
PlasmidFactory and Fraunhofer IZI join forces to advance non-viral cell and gene therapies

PlasmidFactory GmbH and the Fraunhofer Institute for Cell Therapy and Immunology IZI have signed a Memorandum of Understanding to combine expertise in cell therapy process development and GMP manufacturing, aiming to accelerate non-viral cell and gene therapies for the benefit of patients. PlasmidFactory GmbH, a leading European CDMO for plasmid and Minicircle DNA, brings more than 25 years of experience and over 3,500 DNA constructs delivered worldwide. The Fraunhofer IZI contributes extensive translational capabilities in immuno-oncology, regenerative medicine, and advanced cell manufacturing. Together, they are accelerating the development of next-generation, virus-free genetic engineering platforms while maintaining the highest quality and regulatory standards. In the past, the two partners have already successfully established new manufacturing processes for CAR-T cells at Fraunhofer IZI and conducted joint research projects on virus-free gene transfer, which served as the foundation for the production of clinical cell products. By building on our long-standing collaboration, this partnership ...
- Source: drugdu
- 91
- October 9, 2025
More Patients Using GLP-1 Drugs Prior To Weight-Loss Surgery

By Dennis Thompson HealthDay ReporterWEDNESDAY, Oct. 8, 2025 (HealthDay News) — Many more folks fighting excess weight are using weight-loss drugs like Ozempic or Zepbound to cut pounds before undergoing bariatric surgery, a new study says. The use of these drugs before surgery rose 16-fold among patients preparing for weight-loss surgery, researchers reported Sunday at the American College of Surgeons’ annual meeting in Chicago. “While patients previously believed they had to choose between GLP-1 receptor agonists and surgery, we’re now seeing that people are using both,” said lead researcher Dr. Stefanie Rohde, a general surgery resident at the Ohio State University Wexner Medical Center in Columbus. “We know that patients can use GLP-1s after bariatric surgery to amplify their weight loss,” Rohde said in a news release. “But all of this is still very new in terms of how to manage patients effectively.” For the study, researchers looked at the ...
- Source: drugdu
- 118
- October 9, 2025
CanSino accelerates global deployment of dual vaccines

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 departed from Tianjin and was sent to Indonesia. ...
- Source: drugdu
- 114
- October 9, 2025
Subsidiary’s chorionic follicle-stimulating hormone αN02 injection approved for marketing in China

Changchun High-techChangchun High-Tech Industry (Group) Co., Ltd. (hereinafter referred to as ” Changchun High-Tech “) issued an announcement stating that its subsidiary Changchun Jinsai Pharmaceutical Co., Ltd. (hereinafter referred to as “Jinsai Pharmaceutical”) recently received the “Drug Registration Certificate” approved and issued by the State Food and Drug Administration. Its application for the choriofollicle-stimulating hormone αN02 injection has been approved for marketing in China. The approved indication is for use in combination with a gonadotropin-releasing hormone antagonist for controlled ovarian stimulation to induce the development of multiple follicles. A single subcutaneous injection of choriofollicle-stimulating hormone αN02 injection (Jinsaijia®) replaces the 7-day use of follicle-stimulating hormone for assisted reproduction .Ovarian stimulation therapy brings new options. In recent years, demand for assisted reproductive technology has continued to grow. In 2015, Jinsai Pharmaceutical launched the first domestically developed recombinant human follicle-stimulating hormone (RFH) for injection (Jinsai Heng®). This short-acting formulation, administered daily, was ...
- Source: drugdu
- 112
- October 9, 2025
Pfizer and the U.S. government reached a drug pricing agreement to bring U.S. drug prices in line with other developed countries

After the U.S. stock market opened on Tuesday, Pfizer,　　which has been deeply affected by the uncertainty of U.S. pharmaceutical policies this year,The company’s stock price rose by over 4% at one point. Multiple sources indicate that Pfizer CEO Albert Bourla will visit the White House later on Tuesday to announce drug pricing policies and a $70 billion domestic investment plan with Trump. ( Pfizer daily chart, Source: TradingView) In addition to Pfizer, many large pharmaceutical companies also rose .Bristol-Myers Squibb rose nearly 3%.Up 2%, AmgenUp 1%. If the news is true, Pfizer has resolved at least two policy uncertainties : US President Trump once wrote to Pfizer and 16 other pharmaceutical companies asking for price cuts, and demanded that prices in the United States should not be more expensive than those in developed countries such as Europe (the “most favored nation” policy); Trump also announced tariffs on branded drugs last ...
- Source: drugdu
- 108
- October 9, 2025
Another pharmaceutical giant terminates AAV gene therapy business

According to foreign media reports, Biogen has terminated all gene therapy projects based on adeno-associated virus (AAV) capsids. In fact, Biogen deprioritized gene therapy as early as 2023. Now, as part of its ongoing capital allocation strategy, the company will completely abandon AAV technology. Biogen is a biotechnology company with deep expertise in rare and genetic diseases. The company said it will continue to focus on this area in the future and concentrate its resources on advanced therapies and drugs that have greater potential and are more likely to bring better therapeutic effects to patients. Most of the team members who were previously responsible for AAV vector research and development have been reassigned to other positions within the company, but a small number of people are still facing layoffs, involving R&D, operations, technology and other positions. Biogen is not the first company to abandon AAV technology. AAV (adeno-associated virus) is ...
- Source: drugdu
- 120
- October 9, 2025
Signed a licensing agreement with Glenmark Specialty for the Ruikang trastuzumab project, with revenue potentially exceeding US$1.1 billion.

Hengrui Medicine recently announced the signing of a licensing agreement with Glenmark Specialty SA for the Ruikang Trastuzumab project. The agreement provides for a paid license to Glenmark Specialty SA for the company’s innovative Class 1 drug, Ruikang Trastuzumab (SHR-A1811), for which the company holds independent intellectual property rights. Ruikang Trastuzumab is an antibody-drug conjugate (ADC) independently developed by Hengrui that targets HER2. It binds to and is internalized by HER2-expressing tumor cells. Within the tumor cell lysosome, trastuzumab releases a toxin through proteolytic cleavage, inducing cell cycle arrest and ultimately apoptosis. The released toxin is highly permeable, exerting a bystander effect and further enhancing anti-tumor efficacy. The company’s Ruikang Trastuzumab was approved for marketing in China in May 2025. It is indicated for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have previously received ...
- Source: drugdu
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- October 9, 2025

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