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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
- 158
- 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
【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
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- March 15, 2024
CPhI Korea 2024

Organiser: Informa Markets Time:27 – 29 August 2024 address：513, Yeongdong daero, Gangnam-gu, Seoul Exhibition hall: COEX Product range: Raw materials: Vitamins, hormones, sulfonamides, antipyretic analgesics, tetracycline, amino acids and their derivatives, chloramphenicol, digestive system drugs, other anti-infective drugs, penicillins, aminoglycosides, lincomycin, cardiovascular system drugs, anti-parasitic diseases drugs, cephalosporins, macrolides, respiratory system drugs, central nervous system drugs, other Western medicine raw materials Excipients and dosage forms: excipients, flow AIDS, enteric materials, antioxidants, sweeteners, penetration enhancers, preservatives, disintegrators, coating materials, surfactants, sunshades, flavors, filter AIDS, stabilizers, lubricants, plasticizers, solvents, flavor straighteners, coloring agents, clarifying agents, PH regulators, etc Natural extract: plant extract, animal extract, traditional Chinese medicine raw material, functional food raw material, health care raw material, nutrition and health raw material, supplement, dietary fiber, cosmetic raw material About CPhI Korea ： Seoul Pharmaceutical Raw Materials Exhibition (CPhI Korea) is the largest and most influential pharmaceutical raw materials exhibition in South Korea. In ...
- 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
NHS campaign urges over 900,000 young adults to catch up on missed MMR vaccine

The NHS has announced it is targeting young adults to catch up on their missed measles, mumps and rubella (MMR) vaccines as part of the NHS catch-up campaign. In England, more than 900,000 adults aged 19 to 25 years will be invited to book an appointment for their missed vaccine. Following on from the national health service’s recent reminder for 200,000 16- to 19-year-olds to receive the MMR vaccine, the NHS campaign will target young adults in areas more at risk: the West Midlands, Greater Manchester and London. MMR are highly infectious illnesses that can lead to blindness, deafness and swelling of the brain. Currently one of the most infectious diseases globally, with no medical treatment available, one adult or child infected with measles can pass the disease on to around 15 other unvaccinated individuals. According to the UK Health Security Agency (UKHSA), between October 2023 and March 2024, approximately ...
- Source: drugdu
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- March 14, 2024
Epic Pharma of Queens to rent a Westbury building from drugmaker P&L Development

A Queens-based drugmaker wants to rent another drugmaker’s Westbury office and warehouse, officials said. Epic Pharma LLC, a manufacturer of generic drugs, would lease 609-2 Cantiague Rock Rd. from the building’s owner, P&L Development LLC, which also produces generic drugs. Epic would occupy “essentially all of the space” in the 105,000-square-foot facility for “warehouse and distribution operations,” along with offices, said P&L president Evan Singer. An Epic executive didn’t respond to requests for comment last week and on Monday. P&L used the Cantiague Rock Road building as a corporate office and warehouse through last December. But the family-owned business no longer needs the space because some of its 575 employees in Nassau County work remotely at least part of the week. “P&L offers employees a hybrid working environment, which lessens the need for such a large corporate office,” Singer said, adding the company has consolidated its operations into other buildings ...
- Source: drugdu
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- March 14, 2024

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