PharmaFocus Today – Page 212 – media

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
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- 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
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- 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
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- 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
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- 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
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- 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
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- March 15, 2024
Weight Loss Industry Market Hit New High in 2023 Due to Weight Loss Drugs and Other Medical Interventions

Mike Hollan The medical side of the market is growing while the commercial side seems to be struggling. A new study reveals just how strong of a year 2023 was for the weight loss drug industry. Anti-obesity medications (AOMs) have seen a surge in popularity over the past year. This is due to a variety of factors, including the increase in demand for drugs like Wegovy and Ozempic. The two drugs became so popular in 2023 that Wegovy’s developer Novo Nordisk had to temporarily limit the supply of lower, beginner doses of the medication. While it’s clear that AOMs had a good year in 2023, a new report details the heights of that success. According to a study conducted Marketdata LLC and published in Research and Markets, the weight loss market in 2023 rose to a historic peak. In a press release,1 Research and Markets explains that the boom in ...
- Source: drugdu
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- March 14, 2024
Trial Shows Lilly’s Lebrikizumab Produces Improvements in Atopic Dermatitis Severity, Particularly in Individuals with Skin of Color

Don Tracy, Associate Editor First of its kind study reported major improvements in skin clarity and itch relief in over two-thirds of participants. New trial data show that 68% of participants with skin of color suffering from moderate-to-severe atopic dermatitis who were administered Eli Lilly’s lebrikizumab experienced at least a 75% reduction in disease severity, including skin clearance and itch relief. The study notes that people with skin of color have faced a lack of representation in previous clinical trials and are more likely to experience severe symptoms of atopic dermatitis and face delays in diagnosis and treatment.1 “People with skin of color are disproportionately affected by atopic dermatitis, often experiencing more severe symptoms, a delay in diagnosis and a lengthier timeframe to find appropriate treatment. They also have been historically underrepresented in clinical trials, which means we have lacked data pertaining to the treatment of patients with skin of ...
- Source: drugdu
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- March 14, 2024
Myopia control drug Xingqimeioupin® is approved for marketing

On March 11, 2024, Sinqi Pharmaceutical Co., Ltd. officially announced that its undependetly developed drug, Xingqi Meioupin® 0.01% Atropine Sulfate Eye Drops indicated for the slowing of the myopia progression in children aged 6 to 12 years from -1.00D to -4.00D (astigmatism ≤1.50D, anisometropia ≤1.50D). Currently, there are no similar products approved for myopia-related indications in China. Xingqi Meioupins® adopts the exclusive MYOSTAFORT® innovative technology, the preparation is more stable, the eye drops are more comfortable, and no preservatives are added, bringing safety, effectiveness, convenience, accessibility and reasonable price to the vast number of myopic children and adolescents in China. In China, there is a high incidence of myopia, low age of onset, and a high proportion of high-grade myopia. Myopia prevention and control has become a national policy. In 2021, the National Health Commission announced: In 2020, our domestic overall myopia rate among children and adolescents was 52.7%, including ...
- Source: drugdu
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- March 14, 2024

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