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Roche partners with Cardiff researchers to uncover new research into dementia

Affecting 55 million people globally, dementia impairs the ability to remember, think or make decisionsRoche and the Cardiff University Brain Research Imaging Centre (CUBRIC) have partnered to uncover new research to understand the structural changes of dementia. Using cutting-edge imaging and machine learning (ML), researchers will analyse the brains of patients living with Parkinson’s disease (PD) and Alzheimer’s disease (AD). Dementia is a general term used for the impaired ability to remember, think or make decisions that interferes with day-to-day activities and affects 55 million people globally, according to Alzheimer’s Society. Currently the most common form of dementia, AD is a progressive neurological disease that affects the part of the brain that controls thought, memory and language. PD is a progressive neurodegenerative disorder that affects the body’s nervous system. The main symptoms include shaking, slow movements and stiffness. The study will use advanced MRI to understand the bigger structural changes ...
- Source: drugdu
- 130
- March 16, 2024
Par Pharmaceutical Issues Recall of Single Lot of Treprostinil

Mike Hollan The voluntary recall was ordered due to potential silicon particulate exposure. Endo International plc issued a press release announcing that one of its pharmaceutical companies, Par Pharmaceuticals, is issuing a voluntary recall of a single lot of one of its medications.1 The lot, which is being recalled on the consumer, may potentially be tainted with silicon particulates in the product solution. The recalls order is for one lot of Treprostinil Injection 20mg/20ml (1mg/mL). This specific lot was reportedly distributed to wholesalers between June 16, 2022 and October 17, 2022. According to the company, it has yet to receive any reports of injuries due to the contamination, and the recall appears to be a preemptive move. Endo warns that particulates entering the body through an injected solution may cause of a variety of problems. The particulates may simply cause local irritation or swelling at the site of the injection. ...
- Source: drugdu
- 136
- March 15, 2024
Novartis Pays $90M for Molecules That Could Take STING Out of Inflammation

Placing research in the hands of a large pharmaceutical company is a goal of many biotech companies. IFM Therapeutics has now done it three times and its latest deal is the second time Novartis is the acquirer. By FRANK VINLUANFor more than four years, Novartis has foot the bill for a partner’s preclinical development of molecules with the potential to target a pathway implicated in inflammatory disorders. Now the pharmaceutical giant has seen enough progress to plunk down $90 million to buy the company, IFM Due, and continue its inflammation drug research. The acquisition announced Wednesday is the culmination of a 2019 agreement that Novartis reached with IFM Due’s parent company, IFM Therapeutics. In exchange for fully funding IFM Due’s R&D, Novartis gained an option to acquire all of that biotech’s stock. IFM Due’s research focuses on cGAS, a protein that regulates STING, a pathway in the innate immune system ...
- Source: drugdu
- 164
- March 15, 2024
AbbVie’s Produodopa approved by SMC to treat Parkinson’s disease patients in Scotland

The progressive neurological disorder affects approximately 12,400 people in Scotland AbbVie’s Produodopa (foslevodopa-foscarbidopa) has been accepted by the Scottish Medicines Consortium (SMC) for use within NHS Scotland to treat advanced levodopa-responsive Parkinson’s disease (PD). PD patients with severe motor fluctuations and hyperkinesia or dyskinesia when previous available combinations of PD medicinal products have not provided satisfactory results and who are not eligible for deep brain stimulation will be eligible for the treatment. Affecting around 12,400 people in Scotland, PD is a progressive neurological disorder that results from the loss of dopamine-producing brain cells and is characterised by tremor, muscle rigidity, slowness of movement and difficulty with balance. Patients with advanced PD are marked by more severe and complex symptoms, including severe motor deficits, a risk of falling and cognitive problems. The SMC’s decision is supported by data from two phase 3 clinical trials, M15-741 and M15-736, which demonstrated that Produodopa ...
- Source: drugdu
- 193
- March 15, 2024
US study reveals age-related skin changes could contribute to melanoma metastases

Around 200,000 people in the US are expected to be diagnosed with the skin cancer this year Researchers from the Johns Hopkins Kimmel Cancer Center have revealed that age-related changes in the skin could also contribute to higher rates of melanoma metastases, a form of skin cancer, in older people. Recognised as the deadliest form of skin cancer, according to the Melanoma Research Foundation, melanoma is often caused by too much sun exposure. In 2024, it is estimated that 200,000 people in the US will be diagnosed with the condition. Published in Nature Aging, the study showed that increased stiffness in ageing skin increases the release of ICAM1, a protein that regulates endothelial and epithelial barrier function, stimulating blood vessel growth in the tumour and promoting its growth. Researchers treated older mice with melanoma with drugs that block ICAM1 by reducing a gene known as HAPLN1, which indirectly increases ICAM1 ...
- Source: drugdu
- 153
- March 15, 2024
Hengrui Medicine’s new “PARP inhibitor” HRS-1167 combination therapy for advanced solid tumors received clinical approval

Recently, Hengrui and its subsidiaries SUZHOU SUNCADIA BIOPHARMACEUTICALS and Chengdu Suncadia Medicine received the “Drug Clinical Trial Approval Notice” approved and issued by the National Medical Products Administration to conduction a Ib/Phase II clinical study for HRS-1167 tablet (Merck code: M9466) combined with SHR-A1921 for injection or combined with bevacizumab or combined with abiraterone acetate tablets (I) and prednisone/prednisolone (AA-P) for the treatment of with advanced solid tumors. In October 2023, Hengrui and Merck reached a strategic cooperation. Merck obtained the exclusive rights to develop, produce and commercialize HRS-1167 (M9466) outside mainland China. This is also the first time for Hengrui to reach a strategic cooperation with large multinational companies. Poly(ADP-ribose) polymerase (PARP) is a multifunctional protein post-translational modification enzyme widely found in eukaryotic cells. It plays a role in maintaining gene stability and maintaining telomere length. Studies have found that PARP inhibitors can hinder DNA damage repair by selectively ...
- Source: drugdu
- 192
- March 15, 2024
FDA Seeks $7.2 Billion to Enhance Food Safety and Nutrition, Advance Medical Product Safety, and Strengthen Public Health

Today, the U.S. Food and Drug Administration (FDA) announced it is requesting $7.2 billion as part of the President’s fiscal year (FY) 2025 proposed budget. This funding will allow the agency to enhance food safety and nutrition, advance medical product safety, help support supply chain resiliency, strengthen the agency’s public-health and mission-support capacity, and modernize the FDA’s infrastructure and facilities. The request includes an increase of $495 million—or 7.4 percent above the FY 2023 funding level. The FDA’s request reflects the agency’s top priorities in key areas of importance for human and animal health. “The FDA continues to protect the health and well-being of millions of people,” said FDA Commissioner Robert M. Califf, M.D. “This new funding request will help us build on our accomplishments and also modernize our agency and operations as we plan for the future. Our request for critical investments will help us address our most urgent ...
- Source: drugdu
- 147
- March 15, 2024
Everest Medicines’ Partner Calliditas Therapeutics Announces U.S. FDA Grants an Additional Seven-Year Orphan Drug Exclusivity Period for Nefecon®

SHANGHAI, March 12, 2024 /PRNewswire/ — Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”)’s licensing partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) announced that the U.S. FDA has granted an orphan drug exclusivity period of seven years for Nefecon®, expiring in December 2030 based on Calliditas obtaining full approval with a new indication for this drug product in December 2023. Following full approval in December 2023, Nefecon® is indicated “to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression”. The exclusivity period reflects the new indication covering all adult patients with primary IgAN at risk of disease progression based on a confirmed reduction of kidney loss reflecting a clinical benefit on kidney function for adult patients with primary IgAN. “We congratulate our partner for receiving seven more years of market exclusivity for Nefecon® in the ...
- Source: drugdu
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- March 15, 2024
BIO-THERA’s BAT8008 (ADC-Trop2) for injection in combination with BAT1308 (PD-1) for the treatment of advanced solid tumors was approved for Phase IB-II clinical trial.

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 BAT8008 for injection in combination with BAT1308 for the treatment of advanced solid tumors. BAT8008 is an antibody-drug coupling (ADC) developed by BIO-THERA to target Trop2, a tumor-associated calcium signal transducer (TACSTHERA), to be developed for the treatment of solid tumors. Trop-2 (Trophoblast cell-surface antigens 2, Trop2), a member of the tumor-associated calcium signal transducer (TACSTD) family of genes, is involved in the regulation of intracellular calcium concentration.Trop2 is not expressed or is lowly expressed in normal human tissues, but is highly expressed in a variety ...
- Source: drugdu
- 206
- March 15, 2024
【EXPERT Q&A】How to handle the Class II medical device management record, what materials need to handle?

Drugdu.com expert’s response: To apply for the record-filing of the distribution of Class II medical devices, the following materials are usually required: 1.Copy of the enterprise’s business license; 2.Medical Device Distribution License; 3.Identification of the legal representative; 4.Product registration certificate or record-filing certificate; 5.Quality management system documentation for medical devices; 6.Labels and instructions for medical device products; 7.Qualification certificates for sales personnel; 8.Proof of relevant premises use; 9.Other relevant documents that may be required. The required materials may vary depending on specific local requirements and regulations. It is advisable to consult the local medical device regulatory authority for the latest application guidelines and the list of required materials before proceeding with the record-filing process.
- Source: drugdu
- 156
- March 15, 2024

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