Search Results for “ oncology” – Page 17 – media

Degron Therapeutics, Takeda Ink Exclusive License and Collaboration Agreement to Develop Molecule Degraders Targeting Multiple Indications

Don Tracy, Associate Editor Joint venture expected to utilize Degron’s GlueXplorer platform to identify, validate, and optimize molecular glue degraders. Degron Therapeutics announced that it has agreed to terms on a collaboration with Takeda, which will utilize its GlueXplorer to develop molecular glue degraders targeting oncology, neuroscience, and inflammation. Upon completion of the initial stages, Takeda will take over for further development and commercialization. Under terms of the deal, Degron will receive an upfront payment, with the opportunity to receive up to $1.2 billion in milestone payments and tiered royalties on sales. The deal also includes an equity investment by Takeda in Degron and the option to expand to additional targets.1 “We are excited to collaborate with Takeda, expanding the use of our platform into new therapeutic areas,” said Lily Zou, PhD, co-founder, CEO, Degron Therapeutics, in a press release. “Degron’s differentiated and powerful GlueXplorer platform has been validated by ...
- Source: drugdu
- 77
- May 28, 2024
Q&A with Alvana Maliqi

Mike Hollan Cencora’s associate director of value and access strategy for its commercialization strategy & access solutions division discusses the current state of pre-approval information exchanges. Alvana Maliqi, Associate director of value and access strategy Alvana Maliqi served as lead author on Cencora’s latest research initiatives focused on pre-approval information exchange (PIE). She spoke with Pharmaceutical Executive about the research and how the industry can utilize this information more efficiently. Pharma Executive: What does the passage of the PIE legislation allow biopharma companies to do? Alvana Maliqi: The Consolidated Appropriations Act, 20231 (or pre-approval information exchange [PIE] legislation”) was signed into law in 2022, providing a safe harbor for pharmaceutical companies to proactively engage in PIE with payers about new products and/or new indications. Previously, this pathway was initially supported by the 2018 FDA Final Guidance for pre-approval communications. Since 2018, biopharma manufacturers are permitted to share unbiased, factual, accurate, ...
- Source: drugdu
- 134
- May 27, 2024
AstraZeneca, Nona Biosciences Strike Global License and Option Deal to Develop Monoclonal Antibodies for Tumor Targeted Therapies

Don Tracy, Associate Editor Under terms of the agreement, Nona Biosciences is expected to receive an upfront payment of $19 million, with the potential of up to $585 million in milestones. Nona Biosciences announced a major global license and option agreement with AstraZeneca, focusing on the development of monoclonal antibodies into targeted therapies for cancer treatment. Under terms of the deal, Nona Biosciences will receive an initial payment of $19 million. Additionally, the company will have the opportunity to receive up to $585 million pending the completion of milestones along with royalty payments on net sales.1 “We are delighted to announce this agreement with AstraZeneca, global leaders in developing tumor targeted therapies, to maximize the potential of our novel antibodies,” said Jingsong Wang, MD, PhD, chairman, Nona Biosciences, in a press release. “This agreement further validates our leading antibody discovery platform, and we look forward to seeing our antibodies developed ...
- Source: drugdu
- 88
- May 27, 2024
The Supplemental Applications of HANDAYUAN(adalimumab injection) for the New Indications Approved by the NMPA

Shanghai, China, May 22, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the supplemental new drug applications of its independently developed adalimumab biosimilar HANDAYUAN for the four new indications of polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, Crohn’s disease and pediatric Crohn’s disease have been approved by the National Medical Products Administration (NMPA), providing more treatment options for adult and pediatric patients with autoimmune diseases in China. HANDAYUAN has previously been approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and uveitis. To date, HANDAYUAN has been approved for eight indications in China, covering all indications of originator adalimumab in China. It is estimated that approximately 7.6%-9.4% of the global population suffers from various types of autoimmune diseases [1]. TNF-α (tumor necrosis factor-α) plays a key role in the pathogenesis of a variety of autoimmune diseases [2]. It has been proven that many autoimmune diseases such as ...
- Source: drugdu
- 113
- May 24, 2024
FDA Grants Accelerated Approval to Amgen’s Imdelltra for the Treatment of Adults with Extensive-Stage Small Cell Lung Cancer

Don Tracy, Associate Editor Imdelltra (tarlatamab-dlle) is the first T-cell engager therapy approved for extensive stage small cell lung cancer. The FDA has granted accelerated approval to Amgen’s Imdelltra (tarlatamab-dlle) for adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression following treatment with platinum-based chemotherapy. According to the company, the regulatory action was based on the promising response rate and duration of response (DoR) with Imdelltra observed in clinical studies. The action represents the first and only T-cell engager therapy approved by the FDA for ES-SLCS, and Amgen stated that further indications for the use of Imdelltra could soon follow.1 “The FDA’s approval of Imdelltra marks a pivotal moment for patients battling ES-SCLC. This DLL3-targeting therapy in ES-SCLC comprises a transformative option demonstrating long-lasting responses in pretreated patients,” said Jay Bradner, MD, EVP, research and development, chief scientific officer, Amgen, in a press release. “This ...
- Source: drugdu
- 81
- May 21, 2024
First Patient Dosed for MRCT Phase 3 Study on First-Line mCRC of Henlius Anti-PD-1 mAb Serplulimab

Shanghai, China, May 15, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient has been dosed in the phase 3 stage of the international multi-centre clinical trial (ASTRUM-015) of the company’s self-developed anti-PD-1 mAb HANSIZHUANG (serplulimab) in combination with bevacizumab and chemotherapy in patients with metastatic colorectal cancer (mCRC). The leading principal investigator is Professor Rui-Hua Xu from Sun Yat-sen University Cancer Center and State Key Laboratory of Oncology in South China. Currently, for mCRC patients, immunotherapies have been proven to bring hope to patients with mismatch repair deficiency (dMMR)/microsatellite instability-high (MSI-H) but have not yet shown meaningful positive outcomes in those with proficient mismatch repair (pMMR)/ microsatellite stable (MSS), and there is no immunotherapy approved globally for the first-line treatment of mCRC. HANSIZHUANG is expected to become the world’s first anti-PD-1 mAb for the first-line treatment of mCRC. Colorectal cancer (CRC) is one of the most ...
- Source: drugdu
- 76
- May 17, 2024
Companies prepare for ADC trial readouts at ASCO 2024

As the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting approaches at the end of this month, Merck & Co joined a host of other companies that have announced upcoming data presentations for their oncology clinical studies at the event. The ASCO annual meeting, taking place from 31 May to 4 June, gathers pharmaceutical companies, healthcare providers and experts, to discuss the latest trends in oncology and share new data from ongoing and completed clinical studies. In the last few days, several companies such as Merck & Co, Astellas, and Pfizer have announced upcoming data presentations to look for at the premier cancer conference. In a 15 May press release, Merck & Co announced that it would present data from its Phase III study (NCT06312176), investigating the antibody-drug conjugate therapy (ADC), Sac-TMT (sacituzumab tirumotecan), in previously treated locally recurrent or metastatic triple-negative breast cancer. Pfizer will also be presenting ...
- Source: drugdu
- 116
- May 17, 2024
Understanding Payer Perceptions

Tasmina Hydery, PharmD With competition for follow-on-biologics on the upswing—and a potential market boom perhaps around the corner—continued education and course-setting for all stakeholders in charting the access landscape is paramount. Tasmina Hydery, PharmD, Associate Director, Market Access and Healthcare Consulting, Cencora Headlined by the launch of nine biosimilars for Humira (adalimumab), the biosimilars market landscape in the US has undergone a significant shift in the last 18 months. The rapid pace of progress—including the emergence of pharmacy-benefit biosimilars—reflects the investment in this space and the growth forecasted over the next half-decade, when the market could reach more than $100 billion.1 Driven by a robust pipeline of products in preclinical and clinical development, the biosimilars market is poised to continue its upward growth trajectory and expand into new therapeutic areas; however, challenges remain. The adoption of adalimumab biosimilars, thus far, remains low and underscores some of the challenges biosimilar manufacturers ...
- Source: drugdu
- 79
- May 15, 2024
Oregon and Lantern collaborate to develop drug candidate for various cancer indications

Anticancer drugs will be responsible for 90% of nearly 612,000 predicted US cancer deaths in 2024 Oregon Therapeutics and Lantern Pharma have entered into a strategic artificial intelligence (AI)-driven collaboration to optimise the development of a protein disulfide isomerase (PDI) inhibitor drug candidate for a variety of novel and targeted cancer indications. XCE853 is being developed by Oregon in various indications, including drug-resistant ovarian and pancreatic cancer, certain haematological cancers and several paediatric cancers, including central nervous system cancers. Nearly 612,000 deaths are predicted to occur in the US in 2024 due to cancer and resistance to anticancer drugs will be responsible for 90% of those deaths. Under the terms of the agreement, Lantern will receive equal intellectual property (IP) co-ownership and drug development rights in newly discovered biomarkers, novel indications, and pharmacological use strategies for XCE853, while Oregon is entitled to financial benefits resulting from the licensing of the ...
- Source: drugdu
- 101
- May 13, 2024
AstraZeneca Finalizes Equity Investment, Research Collaboration with Cellectis

Don Tracy, Associate Editor Joint venture aims to develop up to 10 new cell and gene therapy products targeting areas with high unmet medical needs. AstraZeneca announced that it has officially completed its equity investment and research collaboration agreement with Cellectis, a biotechnology company specializing in gene editing technologies. According to the company, the agreement is expected to result in a collaboration to develop up to 10 different cell and gene therapy (CGT) products in areas such as oncology, immunology, and rare diseases. Regarding terms of the deal, Cellectis earned an upfront payment of $105 million, which included $25 million in cash and $80 million in an equity investment. Cellectis will have the opportunity to profit further through an investigational new drug (IND) option fee, and additional payments based on development, regulatory, and sales milestones that could range from $70 million to $220 million.1 The collaboration, which was first announced ...
- Source: drugdu
- 105
- May 9, 2024

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