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Sanofi signs $1.2bn licensing agreement for Novavax’s Covid-19 vaccine

Sanofi has signed a $1.2bn licensing agreement with Novavax to co-commercialise its stand-alone adjuvanted Covid-19 vaccine. Starting in 2025, the drugmaker will co-commercialise the vaccine worldwide, except for in countries such as India, South Korea, and Japan where Novavax already has existing partnerships in place. As per the “co-exclusive” agreement, Sanofi will also support certain R&D, regulatory, and commercial expenses. The American vaccine company has faced tough times in the post-Covid-19 landscape, going as far as to issue a “going concern” warning in 2023 about its ability to continue operating. At the time, Novavax said it was subject to “significant uncertainty” concerning future sales and funding from the US Government. Following the deal with Sanofi, the removal of this warning was noted in Novavax’s first quarter 2024 financial results and operational highlights released today. Novavax CEO John Jacobs told CNBC that the agreement with Sanofi would allow it to lift ...
- Source: drugdu
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- May 14, 2024
BIO-THERA BAT1308 (PD-1) in combination with BAT8006 (ADC- FRα) approved for clinical trials in advanced solid tumors

BIO-THERA Biopharmaceutical Co., Ltd. (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company today announced that it has received a Notice of Approval of Drug Clinical Trial from the State Drug Administration, which approves the clinical trial application of the Company’s investigational drug BAT1308 in combination with BAT8006 for the treatment of advanced solid tumors. BAT1308 injection is a humanized anti-PD-1 monoclonal antibody independently developed by BIO-THERA. Its active ingredient is an antibody targeting human programmed cell death protein 1 (PD-1) expressed by Chinese hamster ovary cells, which belongs to the immunoglobulin IgG4κ subtype, and is capable of binding specifically to human PD-1 with high affinity, thus blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2. BAT1308 is able to bind to PD-1 on the surface of T-cells and release the inhibitory effect of ...
- Source: drugdu
- 132
- May 14, 2024
The Impact of Micropayments in Clinical Trials

Micropayments provide an additional incentive for patients to complete required tests, procedures, and diary entries, ensuring that sites, sponsors, and CROs are able to collect the required data needed to complete a clinical trial on time and on budget. By Tanya Kogan on May 10, 2024 Clinical trials today require more patient involvement than ever before. Yet longer, more frequent site visits or participation that requires extensive travel can impact a patient’s willingness to participate in and remain in a clinical trial over the long term. As a result, patient recruitment and retention can be a challenge for sites and pharmaceutical companies, especially when the target patient population is small or geographically dispersed. Sadly, the average dropout rate across clinical trials is 30 percent. With the increasing need for consistent and accurate patient data, sponsors and sites are investing in electronic patient-reported outcomes (ePRO) and electronic clinical outcomes assessment (eCOA) ...
- Source: drugdu
- 101
- May 13, 2024
Biotech’s Road to Recovery Takes a Wobbly Turn

Barbara Ryan Now-unclear timing on rate cuts puts onus back on fundamentals. Barbara Ryan, Founder, Barbara Ryan Advisors As of the writing of this column (May 1), the XBI stood at $88.30, well off of its recent recovery high of $102+ on Feb. 27, but still more significantly above the Oct. 27, 2023, low of $64. For context, the index hit an all-time high of $140 in October of 2020 (the COVID-19 “sugar high”), which was followed by a painful three-year decline of 54% from peak to trough, a bloody run for biotech specialists to be sure. The least fortunate early-stage companies who went public with limited capital and no proof-of-concept data fared far worse; some falling 90+%, others are no longer in business, and those who have survived have done so by making difficult decisions, including reprioritizing programs, restructuring to extend cash runways, or pursuing reverse mergers or shut-downs/liquidations. ...
- Source: drugdu
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- May 13, 2024
FDA posts final guidance on remanufacturing medical devices

Dive Brief The Food and Drug Administration published final guidance on the remanufacturing of medical devices on Thursday. Acting on feedback from groups including Advamed, the FDA has changed the title of the text and added a section on the regulatory requirements for remanufacturers. The new section, which applies to original equipment manufacturers and service providers, is intended to help entities that are less familiar with the medical device regulatory requirements. Dive Insight The FDA published draft guidance in 2021 to clarify the distinction between device remanufacturing and servicing. Many reusable medical devices are serviced. Previously, it was unclear when servicing became so extensive that it qualified as remanufacturing. The draft defined remanufacturing as an act done to a finished device that significantly changes the performance, safety or intended use, including renovating, repackaging or restoring products. After assessing feedback on the draft, the FDA has retained its definition of remanufacturing ...
- Source: drugdu
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- May 13, 2024
Novel Biomarkers to Improve Diagnosis of Renal Cell Carcinoma Subtypes

Renal cell carcinomas (RCCs) are notably diverse, encompassing over 20 distinct subtypes and generally categorized into clear cell and non-clear cell types; around 20% of all RCCs fall into the non-clear cell RCCs (non-ccRCC) category, with many subtypes being exceedingly rare and not extensively studied. Despite their varied molecular characteristics, non-ccRCCs are commonly treated with therapies designed for the more prevalent clear cell type, which impacts the effectiveness of the treatments. The differential diagnosis of non-ccRCC tumors poses significant challenges due to the overlapping morphological characteristics and the current biomarkers’ lack of specificity. A study has now uncovered new biomarkers in RCCs that could enhance the accuracy of diagnoses and potentially improve treatment strategies. This research utilized an integrative approach to examine comprehensive proteogenomic data from both cc and non-cc RCCs, advancing previous genomic-focused studies and deepening the understanding of the mechanisms driving renal cell carcinomas. These discoveries provide a ...
- Source: drugdu
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- May 13, 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
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- May 13, 2024
OneChain’s CAR T trial treats its first cortical T-cell ALL patient

The subtype accounts for 20% of all T-cell leukaemias, a rare form of blood cancer which produces too many abnormal T-cells OneChain Immunotherapeutics (OCI), a biotechnology company that specialises in developing CAR T cell therapies for oncological diseases, has announced that the CARxALL clinical trial has dosed its first cortical T-cell acute lymphoblastic leukaemia (coT-ALL) patient with OC-1, a CAR T therapy. Being conducted at Hospital Clínic and Hospital Sant Joan de Déu in Barcelona, the trial is open to both paediatric and adult patients worldwide. T-cell leukaemia is a rare form of blood cancer that occurs when the bone marrow produces too many abnormal T-cells, a type of white blood cell that protects the body from infections. The subtype, coT-ALL, accounts for 20% of T-cell leukaemias and is characterised by a poor prognosis in patients who do not respond to existing therapies. CAR T therapies are a form of ...
- Source: drugdu
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- May 13, 2024
Johns Hopkins scientists depict molecular pathway to track replication in cancer cells

Johns Hopkins Medicine scientists have revealed a molecular pathway that lures cells down a path of genome duplication, a hallmark of cancer cells, which could potentially lead to new therapies and could stop the growth of cancers. Published in Science, the study reveals the consequences of molecules and enzymes triggering and regulating the process of making new cells out of the cells’ genetic material. Cells follow an orderly routine that begins with making a copy of their entire genome, followed by separating the genome copies and dividing the replicated DNA evenly into two “daughter” cells. When doing so, cells that are stressed can mistakenly run the risk of copying their genome again. Focusing on human cells that line breast ducts and lung tissue, scientists analysed thousands of images of single cells as they went through cell division and developed glowing biosensors to tag cyclin dependent kinases (CDKs), which play a ...
- Source: drugdu
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- May 13, 2024
Chiesi and Gossamer collaborate to develop drug to treat respiratory diseases

Chiesi Group and Gossamer Bio have announced a global collaboration and license agreement to develop and commercialise seralutinib to treat respiratory diseases. Chiesi will support Gossamer’s ongoing work for seralutinib in pulmonary arterial hypertension (PAH), as well as its development in pulmonary hypertension associated with interstitial lung disease (PH-ILD). Predicted to affect up to 50,000 people in the US, PAH is a rare, progressive condition that causes high blood pressure in the lungs’ arteries. It is estimated that PH-ILD affects up to 100,000 patients in the US. Seralutinib is an inhaled inhibitor designed to be delivered via a dry powder inhaler for the potential treatment of pulmonary hypertension. As part of the deal, Chiesi will pay Gossamer $160m as a development reimbursement and the biopharmaceutical company will also be eligible to receive up to $146m in regulatory milestones and $180m in sales milestones. Under the terms of the agreement, Gossamer ...
- Source: drugdu
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- May 13, 2024

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