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With an aim to improve the quality of drugs sold in the country, the Union health and family welfare ministry has released 9th edition of Indian Pharmacopoeia (IP) 2022 containing 92 new monographs for drugs, 12 new general chapters, 1,245 monographs for formulations, 930 monographs for active pharmaceutical ingredients (APIs) as well as dissolution (..)
Trends in Psoriasis Research: Biologics, Biosimilars and New Therapies Recent innovations in biologics and biosimilars have transformed psoriasis care. Meanwhile, Innovent Biologics recently saw its New Drug Application (NDA) for picankibart, an IL-23p19 inhibitor, accepted by the Chinese National Medical Products Administration (NMPA).
Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. HPAPIs may now represent more than 30% of the drug development pipeline. Nowadays, you have drugs against cancer which have a very high impact even at a very low dosage.”.
Gilead Sciences has emerged victorious in a legal battle with the US government over patents surrounding the HIV pre-exposure prophylaxis (PrEP) drugs Descovy and Truvada following a federal jury’s verdict on May 9. This research dates to the mid-2000s when CDC scientists developed the PrEP regimen, argued the government.
The Unseen Heroes of Generic Drugs: Stability Testing 101 As a consumer, have you ever stopped to think about the rigorous process that goes into bringing a generic version of your favorite medication to market? For generic drug manufacturers, stability testing is a critical step in the development process.
Food and Drug Administration approved a drugmaker’s application for the first daily over-the-counter birth control pill for people seeking to prevent pregnancy. On July 13, 2023, the U.S.
The drug control department in Tamil Nadu will soon introduce an action plan to contain antimicrobial resistance (AMR), and a stakeholders meeting is likely to be held very soon, It is learnt from reliable source that in the state action plan, the drug control department will have a significant role in implementing the programmes.
The Drugs Technical Advisory Board (DTAB) has recommended to get comments and inputs from Indian Council of Medical Research (ICMR) for further action on restricting Nicotine Replacement Therapies (NRTs) containing upto 2 mg or 4 mg only through prescription of authorised medical practitioners, as proposed by the Tobacco Control Division (TCD).
While some contain information that’s irrelevant to most patients, others have information that can be valuable, such as ads for supplements and moisturizing creams. One urgent care center has an area just for prescription drug brochures, and I was surprised to see so many people reading them. People want changes to healthcare.
As such, we are seeing an uptick in research examining the therapeutic effects of cannabis and its constituents. However, it’s not legal federally and is considered a Schedule I drug by the U.S. Drug Enforcement Administration (DEA), meaning it has no accepted medical use and a high potential for abuse. The 2018 Farm Bill.
Research by GlobalData (Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition) shows that containment facilities are in high demand as the use of cytotoxic drugs continues to grow. Adding to these factors is that oncology accounts for the majority of marketed, containeddrugs.
2024 has been a year of growth and evolution in clinical research. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.
The power of leveraging clinical data to decipher disease mechanisms and fuel drug discovery has rapidly grown in the era of genomics and personalized medicine. Generation of strong research dataset cohorts must begin with high-quality clinical samples. Partnerships and Establishing Research Cohorts.
An investigator-led trial of Jazz Pharma’s cannabis extract-based drug Sativex in glioblastoma – an aggressive form of brain cancer – will get underway in the UK next year. Glioblastoma cells have been shown to have receptors to cannabinoids on their cell surface, and lab studies suggest cannabinoid drugs may slow tumour growth.
The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Criteria for Orphan Drug Designation.
In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: Purine derivatives-based cancer drug compositions.
Individuals invest a great deal to participate in clinical research, undertaking risks and burdens, while giving of their time and energies to advance scientific knowledge and the public good. Aggregate and Individual Research Results. Aggregate results do not contain reference to individually identifiable data.
Dill/NIST In a technique known as DNA origami, researchers fold long strands of DNA over and over again to construct a variety of tiny 3D structures, including miniature biosensors and drug-delivery containers.
The Center for Drug Evaluation and Research (CDER) has announced the rollout of the Novel Excipient Review Pilot Program in Federal Register Vol. The pilot program is the first step in allowing manufacturers to receive a preliminary review of a novel excipient, prior to drug product formulation. Container-closure changes.
PharmacyChecker pays close attention and has performed considerable research related to where drugs are made. Most notably, by researchingdrug labels and contacting drug companies, we found that 71% of brand name drugs sold in the U.S. has proved itself to be too dependent on drug imports from China.
Launching a new drug can be a risky business, with regulatory approval no guarantee that private, commercial, and government-funded insurers will reimburse it. One general trend throughout Europe is the use of cost-containment measures to control public spending.
Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs. Wholesalers can be either full-line wholesalers, who purchase the complete product line of a company, or specialised companies, which purchase speciality drugs to sell to clinics and hospitals. GDP and GMP advisory.
The American Medical Association (AMA) recently announced the recipients of the 2023 Electronic Health Record (EHR) Use Research Grant Program. Nine organizations will receive a total of $589,000 for research focused on studying the use of EHR systems.
To make matters worse, a former executive at Cerebral, a well-funded online mental health startup, claims in a labor lawsuit that the company fired him after he complained that the company was too quick to prescribe powerful stimulant drugs. Do online mental health apps work? Mental wellness apps are basically the Wild West of therapy.
For 2023, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again increased the number of drugs they exclude from their standard formularies. Each exclusion list now contains about 600 products. d/b/a Drug Channels Institute.
FDA published notice recently that the Office of Prescription Drug Promotion (OPDP) was proposing some new research related to the promotion of medicines by pharmaceutical companies. The research was new (kind of) but the direction was more of the same old focus – direct-to-consumer advertising (DTC).
The list includes companies that provide a range of services, including but not limited to: · New product/health plan innovation research. Pricing research. Documentation for a faster drug authorisation process. . Documentation for a faster drug authorisation process. Concept evaluation testing. Marketing trend analysis.
Medicare could waste up to $605 million per year on the controversial Alzheimer’s drug aducanumab if it is eventually approved for widespread use because it is supplied in vials containing fixed doses that may not be appropriate for all patients–resulting in the trashing of large volumes of unused drug, new UCLA research finds.
Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure.
The Food and Drug Administration wants to update its rules for which foods can be branded “healthy.” It would update the “healthy” label guidelines from 1994 to match up-to-date nutrition research — a notoriously messy and heavily debated field. Read the rest…
Merck has secured approval from the US Food and Drug Administration (FDA) for KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) for first-line treatment of some adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC). 12% experienced a complete response and 55% a partial response.
For 2023, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again increased the number of drugs they exclude from their standard formularies. Each exclusion list now contains about 600 products. d/b/a Drug Channels Institute.
A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy.
According to Adam Bradbury, GlobalData PharmSource analyst “[…] evidence indicates that containment facilities are in high demand and will be increasingly so in future as the oncology pipeline and the use of cytotoxic drugs continues to grow.” These turnkey solutions cover every process through the drug manufacturing life cycle.
Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. percent and 22.5 percent, respectively, compared to placebo.
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Here are what I found in over two years of research with online health seekers. Email is still a great digital marketing tool, and our audiences felt that if the email contained updated health information and tips for living with certain health problems, they would open and read it. 6ix: Lack of drug comparisons.
Compass Pathways and its potential magic mushroom depression drug went public last week – and now psychedelic therapy firm Mind Medicine is aiming to follow suit by up-listing its shares on the Nasdaq. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5
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Pharmaceutical drugresearch and development (R&D) activities are capital-intensive, which makes the outsourcing of clinical dose manufacturing and marketing popular. The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing or hiring decision.
Various factors have contributed to the need and growth of API chemical suppliers such as rising healthcare expenditure, increasing disposable incomes, growing geriatric population, increasing incidence of chronic diseases, patent expiration of blockbuster drugs, increased consumption of generic drugs, and intervention of the new generation APIs.
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A UCLA research team has found that drugs being sold as fentanyl contain high amounts of the industrial chemical bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate, or BTMPS. This new substance of concern emerged in the illicit drug supply nearly simultaneously in multiple U.S. locations from coast-to-coast.
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