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European Commission greenlights Mirati’s Krazati in KRAS-mutated NSCLC

Mirati Therapeutics has received conditional marketing authorisation from the European Commission for Krazati (adagrasib), a targeted treatment for patients with KRASG12C-mutated advanced non-small cell lung cancer (NSCLC). Mirati filed a marketing authorisation application to the European Medicines Agency (EMA) for Krazati in this indication in May 2022. In November 2023, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorisation to the therapy. In October 2023, pharma-giant Bristol Myers Squibb acquired Mirati for a total value of $4.8bn. The deal is expected to close by the end of Q1 2024. Krazati was the company’s lead marketed drug and significant driver for potential revenues. According to GlobalData’s Pharma Intelligence Center, Krazati is forecast to generate $1.24bn in sales in 2029. Krazati is a small molecule RAS inhibitor which suppresses cancer cell signalling and prevents cell proliferation by inhibiting mutant KRAS, a signalling protein which acts as a molecular ...
- Source: drugdu
- 187
- January 13, 2024
FUTURE-SUPER study was published in The Lancet Oncology, China’s pharmaceutical innovation helps advanced TNBC to move towards precision treatment

Recently, the FUTURE series of studies has brought good news again. The results of the FUTURE-SUPER clinical trial led by the team of Prof. Zhimin Shao and Prof. Zhonghua Wang from the Affiliated Cancer Hospital of Fudan University have been announced, which fully confirmed the effectiveness and safety of the first-line precision treatment based on the “Fudan typing”, and is about to change the clinical practice of the treatment of TNBC. The results of the study will be announced in 2023. The results of the study were first announced at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2023, which attracted the attention of scholars around the world, and on January 9, 2024, the study was published in The Lancet Oncology, the top international oncology journal, with an impact factor as high as 51.1 under a fast-track system. The clinical study is also another landmark achievement of the ...
- Source: drugdu
- 198
- January 13, 2024
BIO-THERA BAT7104 (PD-L1&CD47) Injection in combination with BAT4706 (CTLA-4) Injection for the treatment of advanced malignant tumors approved for Phase Ib/II clinical trials

BIO-THERA Biopharmaceutical Co., Ltd. (SSE: 688177), a global science-based and innovative biopharmaceutical company located in Guangzhou, China, is 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 of the People’s Republic of China (“SDA”), which approved the application for Phase Ib/II clinical trial of BAT7104 injection in combination with BAT4706 injection for the treatment of advanced malignant tumors. BAT7104 is a bispecific antibody against PD-L1 and CD47 developed by BIO-THERA and is intended to be developed for the treatment of tumors.BAT7104 activates macrophages to phagocytose tumor cells by blocking the CD47/SIRPα pathway; BAT7104 relieves tumor cells from inhibiting T-cells through the PD-L1/PD-1 pathway by blocking the PD-L1/PD-1 pathway, achieving adaptive immunity and solid immunity. inhibition, realizing the combined anti-tumor effect of adaptive and intrinsic immune systems. Through affinity differentiation design, ...
- Source: drugdu
- 199
- January 13, 2024
Moderna Highlights Respiratory Product Pipeline at JP Morgan Healthcare Conference

Pharmaceutical Executive Editorial Staff Moderna’s vaccine revenue dropped from $18.4 billion in 2022 to $6.7 billion in 2023, however the company anticipates profitability this year powered by COVID-19 vaccine sales and the launch of its mRNA-based respiratory syncytial virus vaccine. Sales of Moderna’s COVID-19 vaccine dropped from $18.4 billion in 2022 to $6.7 billion in 2023, which was ultimately above projections, the company announced in a business update presented at the at 42nd annual JP Morgan Healthcare Conference. The significant decline in people seeking immunizations for COVID-19 products last year comes at a time when the virus is still surging worldwide. The decline resulted in shares of Moderna dropping by approximately 45% last year; however, the shares are up more than 60% following a drop to approximately $70 per share in November 2023. Moderna projected that it would reach the lower end of its forecast range of $6 billion to ...
- Source: drugdu
- 107
- January 13, 2024
FDA Accepts New Drug Application for Shorla Oncology’s Novel Treatment for Breast, Ovarian Cancer

Pharmaceutical Executive Editorial Staff SH-105 eliminates the need for powder reconstitution, which Shorla stated will bolster the novel product’s efficiency and lower the risks associated with drug preparation. The FDA has accepted Shorla Oncology’s New Drug Application (NDA) for SH-105 to treat patients with breast and ovarian cancers. The NDA was given a Prescription Drug User Fee Act action date of June 29, 2024. “This innovative drug will offer hospital pharmacists and patients access to a differentiated, ready to administer, injectable product with unique characteristics that’s expected to facilitate rapid adoption once approved,” said Orlaith Ryan, Shorla Oncology chief technical officer and cofounder, in a press release. The novel therapy is a formulation of a well-established freeze-dried powder medication that has been in use dating back to the 1950s. The ready-to-dilute liquid formulation eliminates the need for powder reconstitution, which Shorla stated will bolster the product’s efficiency and lower the ...
- Source: drugdu
- 235
- January 13, 2024
Menstrual Blood Testing Technology Eliminates Need for Finger Prick or Lab Blood Draw

Traditional methods of blood testing require invasive procedures administered by medical professionals, and can be time-consuming as well as expensive. Not everyone has the time, access, and financial means to get laboratory results for blood work, however, billions of women globally have their period every single month. Until now, menstrual samples had never previously been explored as a diagnostic source for health information. Now, for the first time, a safe and simple technology allows menstrual blood samples to be used as an alternative to traditionally collected venous blood draws. This breakthrough provides an opportunity for testing important biomarkers for millions of menstruating women across the world. Qvin (Menlo Park, CA, USA) has proved the clinical relevancy of menstrual blood for several important biomarkers. The company’s Q-Pad technology uses menstrual blood to gain health insights in a non-invasive, convenient manner and can be used for testing anywhere in the world. The ...
- Source: drugdu
- 109
- January 13, 2024
New Blood Test Identifies Neuroendocrine Subtype of Advanced Prostate Cancer

Roughly 10-15% of individuals with metastatic castration-resistant prostate cancer (CRPC) eventually develop neuroendocrine prostate cancer (NEPC), a challenging cancer subtype. This transformation is marked by a change from androgen-dependent cancer cells to those that no longer respond to androgens. Diagnosing NEPC typically involves a biopsy from a metastatic tumor, but this can be uncertain due to timing issues and the heterogeneous nature of metastatic tumors. Now, researchers have developed a blood test that can reliably detect NEPC and differentiate it from CRPC-adenocarcinoma (CRPC-adeno). In previous research, an international team of researchers from Dana-Farber Cancer Institute (Boston, MA, USA and the University of Trento (Trento, Italy) examined biopsy tissue samples to identify genetic and epigenetic shifts accompanying this shift from cancer cells that are dependent on hormones called androgens to cancer cells that no longer even recognize androgens. They discovered distinctive genome-wide epigenetic alterations, particularly in DNA methylation, that differentiate CRPC-adeno ...
- Source: drugdu
- 106
- January 13, 2024
Livanova to close loss-making circulatory support business

Dive Brief Livanova is closing its circulatory support unit to focus on larger, faster-growing cardiopulmonary and neuromodulation opportunities. The advanced circulatory support (ACS) business sells the Lifesparc device, which pumps blood during cardiovascular surgeries, but sales have fallen and then flatlined since peaking in 2021. In a note to investors, Stifel analysts said they supported the decision to wind down the unit by the end of 2024, predicting it will benefit revenue growth and profitability and increase focus at the company. Dive Insight Livanova expanded its circulatory support offering by acquiring Tandemlife for $200 million upfront in 2018 and received 510(k) clearance for Lifesparc the next year. ASC remained a small part of the broader business, though. Over the first nine months of last year, ASC brought in $30.2 million, almost exclusively in the U.S., and accounted for about 4% of total sales. The unit has contracted in recent years. ...
- Source: drugdu
- 101
- January 12, 2024
Multiplexed POC Testing IVD Solution Performs Molecular and Immunoassays from Various Body Fluids on Single Platform

A hybrid in vitro diagnostics (IVD) solution for multiplexed point-of-care testing (xPOCT) can perform both molecular and immunoassays from several body fluids on a single platform. The hybrid and scalable technology aims to deliver lab-comparable test results in a single patient encounter, significantly reducing the diagnostic timeline. Picodya’s B-Matrix diagnostic system is the world’s first POC hybrid solution that can run IVD tests, both immunoassays and molecular assays on the same device at lab-comparable quality, on multiple patient samples, simultaneously within minutes. The B-Matrix is designed to minimize turnaround time, and deliver better outcomes while lowering costs. The B-Matrix is powered by Picodya’s proprietary PicoFluidic technology which enables the system to operate at high capacity testing for a panel of markers simultaneously, using just pico volumes of reagents and controls. This allows for ultra-fast results within as quickly as 15 minutes and at a fraction of the cost for comparable ...
- Source: drugdu
- 179
- January 12, 2024
FDA Fast Tracks SELLAS Life Sciences’ CDK9 Inhibitor for Acute Myeloid Leukemia

Pharmaceutical Executive Editorial Staff SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 is being evaluated in an ongoing Phase I/II study in combination with Venclexta and Vidaza for patients with relapsed or refractory acute myeloid leukemia. The FDA has granted Fast Track Designation to SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML). The regulatory action was based on safety and efficacy data for the drug, which is being evaluated in an ongoing Phase I/II study (NCT04588922) in combination with Venclexta (venetoclax) and Vidaza (azacytidine) for patients with AML. “Receiving fast track designation for SLS009 for relapsed or refractory AML, following the recent orphan drug designation for the same indication, underscores the potential for SLS009 and highlights the critical unmet need for patients with AML who face a poor prognosis due to the progressive nature of the disease,” ...
- Source: drugdu
- 166
- January 12, 2024

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