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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.
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.
As a result, in 1990, the agency eliminated certain “provisionally listed” uses of the chemical — meaning cosmetics and externally applied drugs. That same year, the FDA also said it would “take steps” to ban its use in foods, ingested drugs and supplements. But those steps were never taken.
A former Merck & Co scientist could face up to 10 years in prison after he was accused of stealing trade secrets relating to drugs including the cancer immunotherapy Keytruda by US authorities. The post Ex-Merck & Co scientist accused of stealing trade secrets could face jail appeared first on.
Documentation for a faster drug authorisation process. The information in the download document is intended for executives, manufacturers, distributors, suppliers, technicians, research scientists, product development scientists, and other individuals involved in the pharmaceutical industry.
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.
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. The number of mental health apps vetted by scientists pales compared to the plethora out there.
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.
The growing demand for innovative drugs and a limited number of blockbuster drugs has led to the growth of the pharmaceutical contract manufacturing market, which has fuelled contract commercial dose manufacturing and marketing. Contract marketing of commercial doses.
Scientists at Goethe University within the international consortium COVID19-NMR refine previous 2D models The genetic code of the SARS-CoV2 virus is exactly 29,902 characters long, strung through a long RNA molecule. It contains the information for the production of 27 proteins.
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.
The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). The guidance also contains some useful information, despite the limitations described above.
Pharmaceutical benefit managers and management companies serve as intermediaries between insurance companies, pharmacies, and drug manufacturers. They bring together employers/plan sponsors, health insurers, plan members, drug wholesalers, pharmacies, and drug companies to facilitate better health outcomes at an affordable cost.
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.
API peptides and proteins-based drugs have gained much attention in the past decade. Victoza, Copaxone, Lupron, Zoladex, Sandostatin, and Somatuline are some of the popularly marketed peptide API therapeutic drugs while more than 600 peptide-based pharmacological leads are being investigated worldwide, across various phases of development.
Pharmaceutical solid dosage forms are the most popular in the pharmaceutical industry and are one of the most used drug delivery methods across patient groups. The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing or hiring decision.
Medical interventions typically recommended during this stage include drugs to treat depression and hormone replacement therapies (HRT). Scientists are now looking at drugs to help address mood changes during perimenopause that fill this gap.
Furthermore, the list includes clinical supply packaging, as well as labelling, storage, and logistics service providers for drug trial projects. The download contains detailed information on clinical trial packaging companies and their product and service lines, alongside contact details to aid your purchasing or hiring decision.
The information contained within the download document is designed for pharmaceutical executives, developers, research scientists and associates, regulatory solutions consultants, and any other individual involved in API biologics production in the pharmaceutical industry.
The US Food and Drug Administration (FDA) has issued warnings about the risk of abuse of amphetamine stimulants like Adderall, stating that use for “prolonged periods of time may lead to drug dependence and must be avoided.” The first generic versions of Strattera were approved in 2017 when the drug went off patent.
The FDA’s Investigational New Drug (IND) application regulations cover all US clinical activities for drugs and biologics. INDs must contain full study reports of nonclinical and clinical (if available) studies. Applications for the Conduct of Clinical Studies: INDs vs CTAs. Pediatric Plans: PSPs vs PIPs. Labeling: PI vs SmPC.
Sustained viral suppression is achieved through antiretroviral (ARV) therapy, which often consists of a cocktail of two or more ARV drugs that work to inhibit viral replication. HIV drug resistance has ben a problem since ARV drugs were first introduced in the late 1980s.
The potential to use these scientific breakthroughs to make a real difference to patients’ lives is what drives many highly skilled scientists to the world of drug development. Yet commercialising a drug is no easy journey, hence why just 10% of new drug candidates succeed in making it to market.
The demand for PDFs of drugs spanning a broad range of therapeutic areas will likely continue to grow. But the challenges for drug producers developing PDFs are numerous and varied. But the challenges for drug producers developing PDFs are numerous and varied. PDF scale and reformulation challenge manufacturers.
Using advanced tableting instrumentation, formulation scientists can perform feasibility experiments that help to improve yields and secure product scale-up later on. This allows formulation scientists to develop tablets as if they were using production equipment, so there is less surprise when they move to industrialisation.
For decades, formulation scientists have relied on the assumption that common pharmaceutical excipients are biologically inert. For example, Advil tablets contain 18 inactive ingredients alongside ibuprofen, the drug’s active pharmaceutical ingredient (API). But just how inert are these excipients?
In a nation where the majority of store-bought food contain incomprehensible ingredients and employ labeling tactics designed to confuse consumers, understanding the nature of our snacks and meals can often prove difficult. Related: Scientists Urge the FDA to Ban Red 3 Color Additive 1.
More than three decades ago, scientists at the National Cancer Institute began exploring ways to fight cancer using the patient’s immune system. The data are used for decision-making during drug development (purpose). Their work formed the basis of what is now a promising cancer treatment that doesn’t require surgery or radiation.
Many drugs can cause dry mouth. This side effect is sometimes associated with the whole class of medicines rather than a particular drug, making dry mouth management even more critical, as there may be little room for changing the medication. List of common drugs that cause dry mouth. List of common drugs that cause dry mouth.
In a recent paper, researchers at GlaxoSmithKline (GSK) and the Cambridge Crystallographic Data Centre (CCDC) combined their proprietary (GSK) and published (CCDC) datasets to better train machine learning (ML) models to predict stable polymorphs to use in new drug candidates. What are the key differences between the CCDC and GSK datasets?
SMi Group’s 14 th Annual Conference and Exhibition: Pre-Filled Syringes and Injectable Drug Devices 2022 – 12 th – 13 th January 2022. Sustainability for Drug Devices Focus Day – 14 th January 2022. The Future of Drug Delivery and Combination Product Device Design. London, UK www.pre-filled-syringes.com/Pharmaphorum.
The patch itself is made of biodegradable nanocellulose and contains no plastic additives. Behfar, senior scientist at VTT, in the news release. Aayush Jaiswal, research scientist at VTT said, “Ours is the first nanocellulose-based ECG patch with no plastic additives.
As weve previously blogged, a PCCP is a mechanism established by Congress under the Food and Drug Omnibus Reform Act (FDORA) to streamline post-market changes to medical devices. Data management practices should include how the manufacturer plans to obtain and use training, tuning, and test data to support each AI-DSF modification.
If you are developing a drug, for example, for infantile epilepsy, then you need to know if your drug target is expressed in the brain and also during early development. Likewise, some patients may have a different version of a gene with respect to people on whom a drug has been tested, which means that drug might not work.”.
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. Biobanking will continue to play an integral role in accelerating drug discovery and development, which will necessitate access to a larger array of biological samples.
If passed, the bill would make California the first state to ban the sale and manufacture of foods containing titanium dioxide, among other chemicals and dyes. Related: Scientists Urge the FDA to Ban Red 3 Color Additive What is Titanium Dioxide?
Cochrane Collaboration (a world-wide collaboration of scientists) looked at the effectiveness of melatonin in the management o jet lags. Each 1ml of melatonin contains 1mg of melatonin. The screening questionnaire is then reviewed by a doctor who issues a private prescription with drugs being delivered to the patients home.
Albany Molecular Research Inc (AMRI), a global provider of advanced drug development and manufacturing solutions, announced that they have signed a supply agreement with AstraZeneca. The genetic material contains SARS-CoV-2 spike protein.
Various Active Pharmaceuticals & Biotechnological Companies including Cassava Sciences, INmune Bio, Cognito Therapeutics, Cortexyme among others presented their new and upcoming drugs, therapies, shared their research studies and clinical data. An Awaited Ulcerative Colitis Phase 2 Seres Therapeutics Trial Drug Crashed Down.
Dr Craig Johnstone, Chief Operating Officer of Evotec, commented: “Successful, fully-integrated drug discovery and development requires specific expertise as well as cutting-edge technologies and capabilities. To this end, Alloy seeks to democratize access to foundational drug discovery platforms and services to scientists worldwide.
Food and Drug Administration (FDA) for the development of LX9211 in diabetic peripheral neuropathic pain. The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs that are being developed to treat serious conditions and fill unmet medical needs. THE WOODLANDS, Texas, Dec. About LX9211.
The list also contains companies providing regulatory services, validations, package design verification testing, quality and microbial testing as well as different products, such as sterile barrier pouches and rigid trays for sterile implants, blister packages, strip packages, vials, ampoules, caps, bottles, desiccants and more.
The dark genome – a loose term that covers non-coding regions of the genome that are capable of regulating the expression of genes, previously rather inaccurately referred to as junk DNA – is increasingly being explored by biopharma companies for new drug targets.
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