media – Page 3 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Giants increase investment, and triple antibody becomes a “new outlet”

Recently, AbbVie spent $700 million upfront to introduce IGI Therapeutics SA (IGI)’s new trispecific antibody drug ISB 2001, with exclusive rights to develop, manufacture and commercialize in North America, Europe, Japan and Greater China. According to the agreement, IGI will receive a $700 million upfront payment and is eligible to receive up to $1.225 billion in development, regulatory and commercial milestone payments, as well as tiered double-digit net sales royalties. According to public information, ISB 2001 is a trispecific antibody targeting CD38, BCMA and CD3. It is currently in Phase 1 clinical development for the treatment of relapsed/refractory multiple myeloma and has been granted orphan drug designation and fast track status by the FDA. Currently, a number of dual-antibody drugs targeting BCMA and CD3 have been approved for marketing for multiple myeloma, including Johnson & Johnson’s Tecvayli, Pfizer’s Elrexfio and Regeneron’s Lynozyfic. ISB 2001 adds CD38 to the combination to ...
- Source: drugdu
- 84
- July 23, 2025
【EXPERT Q&A】How should the clinical evaluation path for Class II active medical devices be selected?

Drugdu.com expert’s response: The selection of clinical evaluation pathways for Class II active medical devices should be based on product risk levels, technical characteristics, and data availability, with evaluations completed through three pathways: exemption from clinical trials, comparison with predicate devices, or clinical trials. The specific analysis is as follows: I. Core Pathway Selection Criteria Exemption from Clinical Trials Pathway Applicable Conditions: The product is listed in the Catalogue of Medical Devices Exempt from Clinical Evaluation and fully aligns with the descriptions in the catalogue. Key Operational Points: Submit comparative data between the product and the catalogue entries, along with a comparison statement with legally marketed medical devices already approved in China (covering fundamental principles, structural composition, performance requirements, etc.) to demonstrate equivalence. Typical Examples: Low- to moderate-risk products such as general surgical instruments and certain rehabilitation aids. Comparison with Predicate Devices Pathway Applicable Conditions: The product is essentially equivalent to a legally ...
- Source: drugdu
- 116
- July 23, 2025
FDA Approves New Prefilled Syringe Presentation of GSK’s Shingrix for Shingles Prevention

The FDA has approved a new prefilled syringe presentation of Shingrix, GSK’s recombinant zoster vaccine for the prevention of shingles (herpes zoster). According to the company, the updated format eliminates the need for reconstitution of two separate vials, streamlining administration and reducing complexity for healthcare providers. The approval is based on data showing technical comparability to the current two-vial version.1 How Will the New Shingrix Presentation Benefit Providers and Patients? “The prefilled syringe presentation of GSK’s shingles vaccine is good news, providing a convenient method of administration,” said Brigid Groves, VP, professional affairs, American Pharmacists Association, in a press release. “The FDA approval is a positive step toward driving prevention of this painful disease, and as a practicing pharmacist I welcome the availability of this new presentation.” Same Shingrix Indications, Streamlined Format GSK stated that the new presentation maintains the same indications: for adults aged 50 years and older, ...
- Source: drugdu
- 294
- July 22, 2025
Specially engineered antibody delivers RNA therapy to treatment-resistant tumors

A specially engineered antibody capable of delivering RNA therapies to hard-to-reach, treatment-resistant tumors significantly shrank tumor size and improved survival in animal models, according to a study published July 16 in Science Translational Medicine. The study provides evidence that, once injected into the bloodstream, the antibody TMAB3, combined with a type of RNA that stimulates an innate immune reaction, can localize to tumors and penetrate and destroy stubborn diseased cells in pancreatic, brain, and skin cancers. “Delivery of RNA-based therapies to tumors has been a challenge. Our finding that TMAB3 can form antibody/RNA complexes capable of delivering RNA payloads to tumors provides a new approach to overcome this challenge.” From Peter Glazer, senior author and Robert E. Hunter Professor of Therapeutic Radiology and Genetics at Yale School of Medicine (YSM) In addition to Glazer and Yale first authors Elias Quijano, PhD; Diana Martinez-Saucedo, PhD; Zaira Ianniello, PhD; and Natasha Pinto-Medici, ...
- Source: drugdu
- 87
- July 22, 2025
Phase III clinical trial of Tian Tan Biological’s intravenous injection of human immunoglobulin for new indications

On the evening of July 17th, Tiantan Biotechnology disclosed an announcement on the progress of clinical trials for its subsidiary companies’ drugs. According to the announcement, Chengdu Rongsheng Pharmaceutical Co., Ltd., a subsidiary of the company, has completed clinical ethics review and pre enrollment preparations for the newly added indication of chronic inflammatory demyelinating polyneuropathy in its marketed product “Intravenous human immunoglobulin (pH4)” (10%, 50ml). The Phase III clinical trial has been officially launched recently. This new indication is the first clinical study in China to approve the use of intravenous immunoglobulin products for the indication of chronic inflammatory demyelinating polyneuropathy. The main procedures required for the approval of new indications for the above-mentioned products include completing phase III clinical trials, submitting a new indication permit application, and obtaining approval for new indications after being reviewed by the Drug Evaluation Center of the National Medical Products Administration and approved by ...
- Source: drugdu
- 45
- July 22, 2025
Can probiotics help you sleep better?

In a recent review article published in the journal Frontiers in Microbiology, researchers summarized the current scientific knowledge on the effects of probiotic supplementation on sleep quality and mood in individuals with insomnia. Based on the evidence from randomized controlled trials (RCTs), they concluded that probiotic interventions may significantly improve sleep quality (with moderate certainty) and reduce symptoms of depression (with very low certainty) without increasing the risk of adverse events. However, these results were highly heterogeneous, and the overall strength of evidence varied between outcomes. A high burden of insomnia Insomnia is a widespread sleep disorder characterized by difficulty falling or staying asleep, or experiencing non-restorative sleep, that occurs frequently over at least three months. It can occur on its own (primary insomnia) or due to other conditions (secondary insomnia), though the two are often difficult to distinguish. The disorder is linked to heightened brain activity and physiological imbalances, ...
- Source: drugdu
- 52
- July 22, 2025
Gene Therapy Maker Sarepta Tells FDA It Won’t Halt Shipments Despite Patient Deaths

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene therapyWASHINGTON (AP) — Drugmaker Sarepta Therapeutics said late Friday it won’t comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy following the death of a third patient receiving one of its treatments for muscular dystrophy. The highly unusual move is a latest in a string of events that have hammered the company’s stock for weeks and recently forced it to lay off 500 employees. The company’s decision not to comply with the FDA also places future availability of its leading therapy, called Elevidys, in doubt. The FDA said in a statement Friday night that officials met with Sarepta and requested it suspend all sales but “the company refused to do so.” The agency has the authority to pull drugs from the ...
- Source: drugdu
- 44
- July 22, 2025
Federal Pharmaceuticals subsidiary obtains approval for new antibiotic product

On July 17, United Laboratories (03933) announced that the injection of amoxicillin sodium and clavulanate potassium (specifications: 0.6g, 1.2g) applied by the company’s wholly-owned subsidiary, Zhuhai United Laboratories Co., Ltd. Zhongshan Branch, has been approved by the China National Drug Administration and successfully passed the generic drug quality and efficacy consistency evaluation. This product is a broad-spectrum penicillin antibiotic with the characteristics of significantly enhanced antibacterial activity and is suitable for the treatment of a variety of infections. This approval will further consolidate the company’s dominant position in the anti-infection field. The company said it will continue to focus on new product development and promote consistency evaluation, which is expected to create greater benefits for the company and its shareholders. https://finance.eastmoney.com/a/202507183460816649.html
- Source: drugdu
- 39
- July 22, 2025
Yuanda Pharmaceutical’s world’s first nasal spray product for the treatment of dry eyes enters clinical application

According to the announcement made by Yuanda Pharmaceutical on the evening of July 17, the company’s first nasal spray product for increasing tear secretion in patients with dry eye syndrome, Varenicline Tartrate Nasal Spray (OC-01), has been officially approved and implemented the first batch of commercial prescriptions in mainland China at the First Affiliated Hospital of Sun Yat-sen University and Shenzhen Eye Hospital. This marks that the only nasal spray product currently approved for increasing tear secretion in patients with dry eye syndrome in China has officially entered clinical application. It is disclosed that dry eye is a common chronic ocular surface disease in clinical practice. The incidence of dry eye in China is about 21%-30%, and the number of dry eye patients is conservatively estimated to be about 360 million. At present, dry eye patients visiting outpatient clinics in medical institutions account for more than 30% of the total ...
- Source: drugdu
- 41
- July 22, 2025
The Central Plains Zhengzhou Medical Device Exhibition (CWMEE)

Organiser: CWMEE Organizing Committee Time：September 11-13, 2025 address：No.1 Central Park, Business Inner Ring Road, Zhengdong New District, Zhengzhou City, Henan Province Exhibition hall：Zhengzhou International Convention and Exhibition Center Product range: Medical Devices: Various new medical instruments and medical supporting instruments, cardiac monitors, medical imaging equipment, biochemical analyzers, blood pressure monitors, thermometers, and other types of home medical equipment. Testing Equipment and Supplies: Blood analysis systems, biochemical analysis systems, immunoanalysis systems, bacterial analysis systems, urine analysis systems, clinical laboratory testing auxiliary equipment, diagnostic reagents, blood testing reagents, etc. Diagnostic Equipment: Ultrasound diagnostic equipment, X-ray imaging diagnostic equipment, electrocardiogram and encephalogram monitoring equipment, scanning equipment, biochemical testing equipment, rehabilitation and physiotherapy equipment, functional examination equipment, pathological diagnostic equipment, endoscopic examination equipment, optical instruments, and examination and diagnostic equipment for neurology, orthopedics, otolaryngology, ophthalmology, etc. Therapeutic Equipment: Surgical equipment for internal and external medicine, radiotherapy equipment, nuclear medicine treatment equipment, laser equipment, physiotherapy ...
- Source: drugdu
- 75
- July 22, 2025

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