PharmaFocus Today – Page 160 – media

WuXi Advanced Therapies’ Philadelphia Site Approved by FDA to Start Manufacturing Iovance’s Melanoma T-cell Therapy

Don Tracy, Associate Editor Amtagvi is the first one-time, individualized T-cell therapy approved by the FDA for any solid tumor cancer. WuXi Advanced Therapies announced that it has officially received approval from the FDA to begin analytical testing and manufacturing of Amtagvi (lifileucel), Iovance Biotherapeutics’ recently approved treatment for advanced melanoma. According to a company press release, the treatment is a tumor-derived autologous T cell immunotherapy, specifically developed for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody. This also marks the first one-time, individualized T cell therapy to be approved by the FDA for any solid tumor cancer. “We congratulate Iovance on this major milestone in their quest to address unmet patient needs in the treatment of advanced melanoma. WuXi ATU has partnered with Iovance since 2015, and we are thrilled to help them through each step of the drug development pipeline – from ...
- Source: drugdu
- 168
- February 22, 2024
Adverse Event Prompts FDA Hold on Tests of Drug in Atopic Dermatitis & Asthma

The FDA clinical hold follows a a report of liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule. By FRANK VINLUAN Rapt Therapeutics aim to bring patients oral alternatives to injectable or infused immunology medications has hit a setback. A Rapt drug candidate in mid-stage clinical development in atopic dermatitis and asthma has been placed under an FDA clinical hold after a serious adverse event reported in a study participant, the company announced Tuesday. The patient, a participant in the atopic dermatitis study, experienced liver failure. According to Rapt, the cause of the liver failure is unknown but has been characterized as potentially related to the company’s experimental drug, zelnecirnon. South San Francisco-based Rapt said the FDA verbally notified the ...
- Source: drugdu
- 157
- February 22, 2024
Sperogenix Therapeutics introduced for US$124 million! New drug for Duchenne muscular dystrophy planned to be included in priority review

Today (February 18), the official website of the Center for Drug Evaluation (CDE) of the NMPA of China announced that the vamorolone oral suspension applied by Sperogenix Therapeutics is scheduled to be included in the priority review, and the indication is Duchenne muscle aged 4 years and above. Public information shows that this is a new rare disease drug introduced by Sperogenix Therapeutics from Santhera Pharmaceuticals for US$124 million. It has been approved to treat DMD in the United States and the European Union. It is reported that vamorolone has achieved positive results in the key clinical study VISION-DMD and three open-label studies and expansion studies. In the VISION-DMD study, compared with placebo, the vamorolone group reached the primary endpoint after 24 weeks of treatment, and the difference in the time required from lying to standing was statistically significant compared with the placebo group. Additionally, male patients treated with vamorolone ...
- Source: drugdu
- 133
- February 22, 2024
AstraZeneca’s Tagrisso combination approved by FDA for advanced lung cancer

AstraZeneca’s (AZ) Tagrisso (osimertinib) has been approved by the US Food and Drug Administration (FDA) in combination with chemotherapy to treat a subset of advanced lung cancer patients. The epidermal growth factor receptor-mutated (EGFR)-tyrosine kinase inhibitor has specifically been authorised for use alongside chemotherapy in adults with locally advanced or metastatic EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). An estimated 200,000 people in the US are diagnosed with lung cancer each year and NSCLC accounts for up to 85% of all lung cancer cases. Approximately 15% of NSCLC patients in the US have an EGFRm, with this population “particularly sensitive” to treatment with an EGFR-tyrosine kinase inhibitor that blocks the cell-signalling pathways that drive the growth of tumour cells, AZ said. The FDA’s decision was supported by positive results from the late-stage FLAURA2 trial, which randomised more than 500 patients with locally advanced or metastatic EGFRm NSCLC to receive the ...
- Source: drugdu
- 131
- February 22, 2024
ABPI publishes new prescribing support guide for healthcare professionals

The Association of the British Pharmaceutical Industry (ABPI) has published a new guide to how the pharmaceutical industry can support healthcare professionals (HCPs) with prescribing decisions. The report, No More, No Less: a Guide to the Appropriate Prescribing of Medicines and the Role of Industry, highlights the responsibilities that pharmaceutical companies have to ensure they provide accurate information to support high-quality healthcare. Every year in the UK, over one billion medicines are prescribed and dispensed from more than 18,000 preparations licenced for use by the Medicines and Healthcare products Regulatory Agency. The current resources available for pharmaceutical companies to support the quality, safety and efficacy of medicine include the Summary of Product Characteristics, medical information and pharmacovigilance expertise, as well as medical advisers. In the UK, most pharmaceutical companies provide a Medical Information Service (MIS) for HCPs, patients and the public via telephone or email. In addition, MIS personnel or ...
- Source: drugdu
- 100
- February 22, 2024
Recombinant Herpes Zoster Vaccine Independently Developed by Shanghai Institutes for Biological Products of China Receives Clinical Trial Approval Notice

On February 20, the recombinant herpes zoster vaccine, a Class I new drug independently developed by Shanghai Institutes for Biological Products of China, received a notice of approval for clinical trial from the State Drug Administration. Herpes zoster is a common viral infectious disease caused by the reactivation of varicella-zoster virus latent in the human sensory ganglia, with severe nerve pain and skin herpes as the main symptoms. According to relevant data, there are about 1.56 million new cases of herpes zoster in people aged 50 years and above every year in China. Herpes zoster and its complications seriously affect the work and life of patients. Vaccination against herpes zoster is an important measure for the prevention of herpes zoster and postherpetic neuralgia, but at present there are limited varieties of herpes zoster vaccine available in China. Shanghai Institutes for Biological Products (SIBI) has independently developed a recombinant herpes zoster ...
- Source: drugdu
- 88
- February 22, 2024
ASTRUM-004 Featured on the Cover of Cancer Cell

On February 12, 2024, the Volume. 42 Issue. 2 of Cancer Cell, a highly regarded oncology journal with an impact factor of 50.3, was published online. ASTRUM-004, Henlius’ pivotal phase 3 clinical study of anti-PD-1 mAb HANSIZHUANG (serplulimab) plus chemotherapy as first-line treatment for previously untreated locally advanced or metastatic squamous non-small-cell lung cancer (sqNSCLC), was highlighted on the front cover of the issue. This marks the first time a clinical study of an innovative Chinese drug has been featured on the journal’s cover in its 22-year history. The study was led by Professor Caicun Zhou from Shanghai Pulmonary Hospital. “Zhou et al. report the results of a phase 3 trial that demonstrates the efficacy and safety of serplulimab plus chemotherapy as first-line treatment for patients with advanced squamous non-small-cell lung cancer (sqNSCLC).” The editors highly commended ASTRUM-004 and the cover design. “The cover features a collage of pathology slices ...
- Source: drugdu
- 146
- February 22, 2024
Hengrui Medical made a new breakthrough in the field of medical nuclide preparation and successfully prepared 64Cu in batch.

Recently, Hengrui Medical ushered in a new breakthrough in the field of medical nuclide preparation, and its subsidiary Tianjin Hengrui Medical Co., Ltd. has realized the independent mass production of copper chloride [64Cu] solution with stable and controllable quality through independent projects and technological research, and the PET imaging of the labeled drug is good for small animals. This breakthrough of Hengrui Medicine lays the foundation for the development of 64Cu-labeled diagnostic drugs, and can also provide the industry with the nuclide for the R&D and production of such drugs. In 2021, eight national ministries and commissions jointly issued the Medium- and Long-term Development Plan for Medical Isotopes (2021-2035), which explicitly pointed out that 64Cu is an isotope with broad application prospects, and the key technology of gas pedal preparation of 64Cu is the key task of the plan. Radiopharmaceuticals refer to a special class of drugs containing radionuclides for ...
- Source: drugdu
- 134
- February 22, 2024
Spit Test Detects Breast Cancer in Five Seconds

Breast cancer is the most commonly diagnosed cancer worldwide, with over 2.3 million new cases and approximately 685,000 deaths reported in 2020. Currently, mammography, ultrasound, MRI, and biopsies are the primary methods for diagnosing breast cancer. Despite their effectiveness, these techniques have several drawbacks, such as high costs, limited accessibility, potential inaccuracies in early detection in young women with dense breast tissue, invasiveness, and radiation exposure risks, especially for radiation-sensitive patients. Given the increasing prevalence of breast cancer in women, there is an urgent need for more innovative and efficient detection methods. Now, a saliva test that screens for breast cancer is showing promising results in experimental testing. Developed collaboratively by researchers from the University of Florida (Gainesville, FL, USA) and National Yang Ming Chiao Tung University (Hsinchu City, Taiwan), this innovative hand-held device can detect breast cancer biomarkers using just a small saliva sample. The device operates by applying ...
- Source: drugdu
- 107
- February 21, 2024
Accurate Blood Test for Detecting Malignant Brain Tumors Could Help Patients Avoid Risky Surgery

Globally, brain tumors comprise 85%-90% of all primary central nervous system (CNS) tumors, representing approximately 300,000 cases (1.6%) out of the total 19,300,000 annual cancer incidences. They also account for around 250,000 (2.5%) of the total 10,000,000 annual cancer-related deaths. Presently, the standard of care (SoC) for diagnosing intracranial space-occupying lesions (ICSOL) involves histopathological evaluation (HPE) of tumor tissue specimens, which are typically obtained through surgical excision or biopsy. However, surgical resection or biopsy can be particularly challenging for patients with poor performance status, comorbidities, or reluctance to undergo invasive procedures. These procedures carry well-documented risks, including pain, discomfort, intracranial hemorrhage, cerebral edema, infections, and even morbidity and mortality. Now, a simple blood test could help diagnose patients with brain tumors, saving them from undergoing invasive, highly risky surgery. In a world-first, researchers at Imperial College London (London, UK) have proved a new technique for glial tumors including glioblastoma (GBM), ...
- Source: drugdu
- 159
- February 21, 2024

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