media – Page 321 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Cancer Biotech Lands $145M for First-in-Class Drug to Block Elusive Tumor Target

FogPharma’s lead program is a peptide that blocks a difficult-to-drug pathway inside of cells. The new financing will go toward an ongoing Phase 1/2 study in advanced solid tumors and support development of pipeline programs for other elusive cancer targets. By FRANK VINLUAN FogPharma has reached early clinical development with a therapeutic candidate that takes a novel approach to treatment of solid tumors. The company now has $145 million to continue the drug’s clinical development and advance more programs in its pipeline. Cambridge, Massachusetts-based FogPharma discovers and develops peptides capable of entering cells to address targets that drive disease. Such targets haven’t been drugged before due to the difficulty of getting a drug to act within a cell. FogPharma says its peptide drugs, which it calls Helicon therapeutics, can get inside a cell to modulate protein-protein interactions as well as protein-DNA interactions. FogPharma’s lead program is FOG-001, a Helicon therapeutic ...
- Source: drugdu
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- March 5, 2024
Biotheus’s PD-L1/VEGF dual antibody is planned to be included in breakthrough therapeutic category and has reached a licensing cooperation of over US$1 billion

Today (1st March), the official website of the Center for Drug Evaluation (CDE) of the NMPA announced that the PM8002 injection applied by Biotheus is planned to be included in the breakthrough therapy category, and the indication is the first-line treatment of inoperable locally advanced/recurrent metastatic triple-negative breast cancer with albumin-bound paclitaxel for combined injection. Public information shows that PM8002 is an anti-PD-L1/VEGF bispecific antibody independently developed by Biotheus. BioNTech has reached a cooperation agreement of more than US$1 billion with Biotheus to obtain the development, production and commercialization rights of this product worldwide (except Greater China). PM8002 is a bispecific antibody drug candidate consisting of a humanized anti-PD-L1 mono-antibody (VHH) fused to an anti-VEGF-A IgG1 antibody containing an Fc-silent mutation. This design can enrich PM8002 molecules into the tumor environment and reduce the systemic side effects caused by systemic VEGF blockade. According to an earlier press release fromBiotheus, PM8002 ...
- Source: drugdu
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- March 5, 2024
MHRA grants first approval via the new International Recognition Procedure in 30 days

A new formulation for XGEVA (denosumab), a treatment used in adults to prevent serious bone-related complications caused by bone metastasis and to treat giant cell tumour of bone in adults and adolescents, is the first product to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new International Recognition Procedure (IRP). The product was authorised in 30 days, providing UK patients with earlier access to this treatment thanks to international recognition. Launched in January this year, the IRP allows the MHRA to accelerate the assessment of new medicines by taking into account the expertise and decision-making of trusted regulatory partners in the authorisation process. As a result, medicines that have been approved in other countries with stringent regulators will get to UK patients without delay, resulting in a more rapid, efficient, and cost-effective process for life sciences companies. Denosumab (XGEVA) was authorised on 29 February 2024 ...
- Source: drugdu
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- March 5, 2024
Jacobio Pharma Receives IND Approval for P53 Y220C Activator JAB-30300 in the U.S.

BEIJING, SHANGHAI and BOSTON, March 1, 2024 /PRNewswire/ — Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received IND (Investigational New Drug) approval of its self-developed drug JAB-30300 (P53 Y220C activator) from the FDA of the U.S. Jacobio plans to initiate a Phase I/IIa advanced solid tumors clinical trial in the U.S., to evaluate safety and efficacy of JAB-30300. Jacobio also plans to submit IND in China, and will conduct clinical studies once receives the IND approval. P53 is the single most frequently altered gene in human cancers, with mutations being present in approximately 50% of all invasive tumors. JAB-30300 is an orally bioavailable small molecule activator for the treatment of patients with solid tumors harboring P53 Y220C mutation. Studies shows that, JAB-30300 has shown very high binding affinity to P53 Y220C mutant proteins. Tumor regression was achieved in multiple cancer models covering various ...
- Source: drugdu
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- March 5, 2024
WuXi Biologics’ Irish Site Awarded Three Authoritative ISO International Standard System Certifications

Dundalk, Ireland, March 1, 2024 – WuXi Biologics (2269.HK), a leading global contract research, development and manufacturing (CRDMO) services company, announced that its Dundalk, Ireland site has recently been awarded three authoritative ISO (International Organization for Standardization) accreditations at the same time, including ISO 50001 Energy Management System, ISO 14001 Environmental Management System and ISO 45001 Occupational Health and Safety Management System. ISO 50001 Energy Management System Certification, ISO 14001 Environmental Management System Certification and ISO 45001 Occupational Health and Safety Management System Certification, fully demonstrating that WuXi Biologics has always been adhering to the ESG (Environmental, Social and Governance) development strategy, and has consistently adhered to international standards and achieved outstanding results in environmental protection, sustainable energy development and employee health and safety. As a model for WuXi Biologics’ future factory, the Ireland site has been actively optimizing energy use, improving efficiency and reducing waste emissions from operations, and ...
- Source: drugdu
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- March 5, 2024
Researchers reveal COVID-19 could have small impacts on cognition and memory

Different factors, such as illness duration and virus variant, impacted patients cognitive abilities Imperial College London (ICL) researchers have revealed that people who have recovered from COVID-19 could have small but long-lasting impacts on the performance of cognitive and memory tasks. Published in the New England Journal of Medicine, the REACT Long COVID study enrolled over 140,000 participants, including long COVID patients, who undertook at least one cognitive task. COVID-19 is an infectious disease caused by the SARS-CoV-2 virus. For some patients, the condition can lead to long COVID, where symptoms can last up to 12 weeks. Using an innovative online cognitive assessment via the Cognitron platform, researchers detected subtle changes in different areas of brain function, including memory, reasoning, executive function, attention and impulsivity. The study revealed small deficits that were still detectable after a year or more following infection, including in people who had a short duration of ...
- Source: drugdu
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- March 5, 2024
ICL uses AI to help doctors assess lung cancer from ‘virtual biopsies’

TMR-CT will help doctors select treatment and predict the spread of lung cancer in patients Imperial College London (ICL) researchers have used artificial intelligence (AI) to identify information about the chemical makeup of lung tumours from medical scans of lung cancer. Published in npj Precision Oncology, the study demonstrates, for the first time, how medical imaging in combination with AI can be used to provide ‘virtual biopsies’ for cancer patients. Responsible for around 35,000 deaths each year, lung cancer is the most common cause of cancer death in the UK. Supported with funding from the National Institute for Health and Care Research’s Imperial Biomedical Research Centre, the non-invasive method works to classify the type of lung cancer patients have. Researchers used data from 48 lung cancer patients recruited from University Hospital Reina Sofia in Spain to develop an AI-powered, deep learning assessment tool called tissue-metabolomic-radiomic-CT (TMR-CT). Using the data, researchers ...
- Source: drugdu
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- March 5, 2024
Pfizer’s Bivalent Respiratory Syncytial Virus Vaccine Shows Promising Efficacy Across Two Seasons

Davy James Abrysvo was found to produce durable efficacy against respiratory syncytial virus across two seasons in adults 60 years of age and older. Top-line data from the ongoing, pivotal Phase III RENOIR clinical trial (NCT05035212) demonstrated that Pfizer’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine Abrysvo produces durable efficacy against respiratory syncytial virus (RSV) across two seasons in adults 60 years of age and older. Efficacy against RSV-associated lower respiratory tract disease (LRTD), defined as three or more symptoms, was 88.9% after the first season, whereas efficacy was 77.8% after the second season.1 “We are encouraged by the level of protection that we observed after two full RSV seasons for Abrysvo,” Annaliesa Anderson, PhD, Pfizer senior vice president and chief scientific officer, Vaccine Research and Development, said in a press release. “This new data indicate that broad and durable protection against both types of RSV that cause ...
- Source: drugdu
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- March 4, 2024
Profound Medical, Siemens Healthineers collab on ultrasound ablation

Profound Medical (Nasdaq:PROF) announced today that it entered into a non-exclusive collaboration with Siemens Healthineers. The two companies aim to lay the groundwork for Profound to begin marketing a complete therapeutics solution. They want to combine the Profound TULSA-PRO system with the Siemens Magnetom Free.Max magnetic resonance (MR) scanner. While this combination falls under the remit of Profound’s own sales force, the company also plan to market TULSA-PRO as a standalone offering. This enables customers to use the technology with the MR hardware of their choice. TULSA-PRO performs the company’s transurethral ultrasound ablation (TULSA) procedure. It employs real-time MR guidance for precision while killing targeted prostate tissue through sound absorption technology. The system enables surgeons to ablate whole- or partial-gland prostate tissue in patients with low- intermediate- or high-risk prostate cancer. It also treats benign prostatic hyperplasia (BPH). It can treat prostate cancer patients on active surveillance seeking treatment of ...
- Source: drugdu
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- March 4, 2024
Tandem cycling boosts well-being for Parkinson’s patients and care partners

Pedaling on a stationary bicycle built for two may improve the health and well-being for both people with Parkinson’s disease and their care partners, according to a small, preliminary study released today, February 29, 2024, that will be presented at the American Academy of Neurology’s 76th Annual Meeting taking place April 13–18, 2024, in person in Denver and online. Jennifer Trilk, PhD, University of South Carolina School of Medicine in Greenville, said, “Our study found that a unique cycling program that pairs people with Parkinson’s disease with their care partners can improve the physical, emotional and mental well-being of both cyclists to improve their quality of life. It is just as important that care partners also receive care, so that is why we included them as the cycling partner. The goal of our small study was to determine if tandem cycling was beneficial. The next step will be to confirm ...
- Source: drugdu
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- March 4, 2024

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