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Novartis, Arvinas Agree to Strategic Collaboration to Develop Treatment for Prostate Cancer

Don Tracy, Associate Editor Partnership also includes an agreement for Arvinas to sell its preclinical AR-V7 program to Novartis. Novartis and Arvinas announced that they have agreed to terms on a collaboration to develop and commercialize ARV-766, Arvinas’ advanced Protac androgen receptor degrader designed for prostate cancer treatment. Per terms of the deal, Novartis will focus on worldwide clinical development, commercialization, and will obtain all associated rights for ARV-766 and the AR-V7 program. In turn, Arvinas will receive an upfront payment of $150 million, with the ability to receive up to $1.01 billion based on developmental, regulatory, and commercial milestones, plus royalties on sales of ARV-766. Completion of the deal depends on when regulatory approvals are met, which requires acquiescence with the Hart-Scott-Rodino Act.1 “We are thrilled to partner with an organization that shares our dedication to delivering transformative medicines to patients with significant unmet need,” said John Houston, PhD, ...
- Source: drugdu
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- April 16, 2024
Genetic Testing Combined With Personalized Drug Screening On Tumor Samples to Revolutionize Cancer Treatment

Cancer treatment typically adheres to a standard of care—established, statistically validated regimens that are effective for the majority of patients. However, the disease’s inherent variability means that a one-size-fits-all approach often falls short. Individual responses to the same drug can vary dramatically. Personalized cancer treatment, which outperforms traditional treatment methods, increasingly relies on genomics—DNA profiling of a patient’s cancer—to tailor therapy. Current genomic profiling processes can analyze thousands of genes but might take weeks to deliver results and still fail to provide complete clarity on the optimal treatment strategy. For the first time, researchers have combined genetic testing with personalized drug screening directly on tumor samples to identify the right treatment for children with relapsed cancers, offering a timelier and effective approach. The functional precision medicine approach to target cancer has been developed by researchers at Florida International University (Miami, FL, USA) combines genetic testing with a new method of ...
- Source: drugdu
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- April 16, 2024
Virtual Skin Biopsy Determines Presence of Cancerous Cells

When dermatologists spot an unusual mark on a patient’s skin, they face a choice: monitor it for some time or remove it for biopsy. Similarly, when removing breast tumors, surgeons must send excised tissues to pathologists who take several days to determine if any cancerous cells remain, leading to a second surgery for removing additional cells in about 20% of cases. Pathologists process these tissues by slicing them into thin sections and staining them with hematoxylin and eosin (H&E), which enhances the visibility of cellular structures and is crucial for diagnosing cancers and other diseases. However, this method is labor-intensive and irreversible; once a biopsy is sliced in one direction, it cannot be resectioned for alternative views. Now, a “virtual biopsy” could allow dermatologists to forego the scalpel and scan the skin to check for cancerous cells without an incision. Similarly, surgeons might soon be able to determine if they ...
- Source: drugdu
- 106
- April 16, 2024
UK charities condemn continued drug shortages

Ahandful of UK charities and community pharmacists urged the UK government to find a fix for the ongoing drug shortage issue to prevent further patient suffering. The UK Epilepsy Society, SUDEP Action, Epilepsy Action and Parkinson’s UK, joined forces to call for a meeting with the Health Secretary, Victoria Atkins. The Association of Independent Multiple Pharmacies (AIMp) found that community pharmacists are spending an average of two hours every day to find patients’ medications due to the disruptions. In a 11 April press release, Dr. Leyla Hannbeck, AIMp’s CEO, said, “The system is overly complex and shrouded in secrecy – what we need is openness and transparency. Pharmacists are in the same position as patients – we are at the end of the supply chain but are the last people to find out about medication shortages. Consequently, we are unable to plan in advance and support the people who rely ...
- Source: drugdu
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- April 16, 2024
FDA approves new administration routes for Xcopri

South Korea-based SK Life Sciences has received US Food and Drug Administration (FDA) approval for two new forms of administration of its epilepsy drug Xcopri (cenobamate), as an oral suspension mixed with water for mouth administration or via a nasogastric tube. Discovered and developed by SK Biopharmaceuticals, Xcopri is an anti-epileptic drug indicated for partial-onset seizures in adults. The therapy reduces repetitive neuronal firing by inhibiting voltage-gated sodium currents, leading to a decreased occurrence of seizures. The oral form of the treatment is taken once daily. The FDA-approved label revision is based on findings from an open-label study comparing the bioequivalence of three ways of administering the medication: swallowing a whole tablet, taking a crushed tablet in water by mouth, and using a nasogastric tube to administer a crushed tablet in water. The approval addresses the needs of patients living with epilepsy, who are unable to swallow Xcopri tablets whole, ...
- Source: drugdu
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- April 16, 2024
Candel wins FDA orphan drug designation for pancreatic cancer drug

The US Food and Drug Administration (FDA) has granted Candel Therapeutics’ immunotherapy candidate CAN-2409 (aglatimagene besadenovec) orphan drug designation for the treatment of pancreatic cancer. Orphan drug designations are granted to medicines intended to treat rare conditions and come with benefits such as tax credits for US-based clinical trials and potentially seven years of market exclusivity in the designated indication upon agency approval. Pancreatic cancer is one of the most lethal forms of cancer, with a survival rate beyond ten years of around 5%. CAN-2409 was also granted fast track designation in pancreatic cancer by the FDA in December 2023, meaning the candidate is in line for expedited development and review times. CAN-2409 is an off-the-shelf immunotherapy that is a combination of a genetically modified adenovirus and the herpes simplex virus thymidine kinase (HSV-tk) gene. The drug works by inducing T cell response at both the targeted tumour and at ...
- Source: drugdu
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- April 16, 2024
YuanSong Bio-technology Receives Another Clinical Trial Approval, Its Innovative Lysoma Virus Product Receives Implied Clinical Trial Approval from China CDE

On April 12, 2024, Shanghai Yuansong Biotechnology Co., Ltd (“Yuansong Biotechnology”) announced that its self-developed lysosomal virus Class I new drug “Recombinant L-IFN Adenovirus Injection (YSCH-01)” has received implied clinical trial approval from the Center for Drug Evaluation of the State Drug Administration (CDE) and has been approved to conduct Class I clinical trials in China. The Center for Drug Evaluation (CDE) of the State Drug Administration has granted implied consent for clinical trials and approved to conduct Phase I clinical trials in China for the indication of advanced solid tumors. The approval of this IND filing by the CDE in China is another important progress made by YuanSong Biotech in exploring the clinical study of YSCH-01, in addition to the clinical approval by the US FDA in December 2023 for two original IIT programs under development, including capsular delivery for recurrent gliomas and lysosomal viral nebulized delivery for the ...
- Source: drugdu
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- April 16, 2024
【EXPERT Q&A】How to handle the medical device network sales record certificate?

Drugdu.com expert’s response: To apply for the certificate of record-filing for online sales of medical devices, the following steps are typically involved: Preparation of Qualifications: Firstly, the medical device online sales enterprise needs to ensure compliance with relevant regulations and requirements, including business licenses, medical device operation permits, etc. Application for Record-filing: Submit the record-filing application to the relevant regulatory authority, which is usually the National Medical Products Administration (NMPA) or local drug regulatory department. The application needs to include basic information about the enterprise, information about the sales platform, types and quantities of medical devices sold, and other relevant information. Record-filing Review: The regulatory authority will review the record-filing application. The review process typically includes assessing whether the sales platform meets requirements and whether the medical devices sold comply with regulatory standards. Issuance of Certificate: If the record-filing application passes the review, the regulatory authority will issue the certificate ...
- Source: drugdu
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- April 16, 2024
InterPharma 2024

Organiser: JI EXPO Time:9 – 12 Oct 2024 address：Jl. Gatot Subroto, RT.1/RW.3, Gelora, Tanahabang, Kota Jakarta Pusat, Daerah Khusus Ibukota Jakarta 10270,Indonesia Exhibition hall: Balai Sidang Jakarta Convention Center Product range: Apis, intermediates, natural extracts, excipients, formulations, custom manufacturing, biopharmaceuticals, fine chemicals, laboratory equipment, instruments, laboratory appliances, water treatment, environmental and quality control, technical publications, pharmaceutical products, pharmaceuticals, pharmaceutical engineering, materials and packaging, pharmaceutical machinery and equipment About InterPharma： Jakarta Pharmaceutical Exhibition (InterPharma) is the largest and most influential pharmaceutical exhibition in Indonesia. It is one of the important pharmaceutical, pharmaceutical and packaging professional exhibitions in Southeast Asia. It can exhibit the range of apis, intermediates, biopharmaceuticals, medical supplies, material packaging, pharmaceutical machinery and equipment, etc. At the same time, various conferences will be held to discuss the future development trend of the pharmaceutical industry, and the market potential is huge.
- Source: drugdu
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- April 16, 2024
Enrollment of Subjects in Phase III Clinical Trial for Inhaled Aerosol Drug in Children by Kexing Biopharm

SHENZHEN, China, April 10, 2024 /PRNewswire/ — Recently, Kexing Biopharm (688136.SH) announced that the Phase III clinical trial of Human Interferon α1b Inhalation Solution developed by its wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., had completed the enrollment of first patient and dosing. This drug is indicated for respiratory syncytial virus-associated lower respiratory infections (pneumonia, bronchiolitis) in children. It is designed specifically for children by using a nebulizer, which can directly deliver the active ingredients to the lesion site, resulting in a rapid onset of therapeutic effect, improved pediatric patient compliance and safety. As mentioned by relevant R&D directors of Kexing Biopharm, the Phase I clinical dose-escalation and bronchoalveolar lavage studies of Kexing Biopharm’s Human Interferon α1b Inhalation Solution were completed in October 2023. In these studies, the drug safety, tolerability and concentration in the lungs were systematically and comprehensively validated. The results showed high local drug concentration in the ...
- Source: drugdu
- 106
- April 15, 2024

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