drug approval Articles
-
Receipt and storage of cGMP controlled raw materials regulations and best practices
Abstract: Receipt and Storage of cGMP Controlled Raw Materials Regulations and Best Practices Manufactures of drugs who lack a defined raw material processing have received FDA 483s and lost several batches of products. Designing the Receipt, Handling and Processing, Specification, Inventory Tracking, and Qualification of cGMP Controlled Raw Materials is critical to Life sciences personnel to ...
-
Lack of robust regulations for generic drugs warning labels leads to outcry
Abstract: An original drug manufacturer seeking new drug approval from the FDA is responsible for accurately and adequately labeling the new drug. A manufacturer of a generic drug is only responsible for making sure its warning label is the same as the reference drug. This has led to an outcry from patients and drug manufacturers as generics makers cannot be held legally responsible for any ...
-
Biotechnology: a case of delayed international convergence?
Catching up and leapfrogging regularly occur in capitalist economies, both at the level of entire countries and specific industries. The USA has taken the lead in biopharmaceuticals and has kept it for over fifty years. Biotechnology is now helping the US pharmaceutical industry to keep its global leadership patent and product figures for biotechnology drugs indicate that the USA is keeping its ...
-
Top 5 benefits of wastewater treatment for pharmaceutical industries
Waste waters are generated as the outcomes of various processes like chemical synthesis, fermentation, etc in a pharmaceutical industry. Hence, wastewater treatment has become mandatory for these industries to maintain the optimum quality. Moreover, such treatments are inevitable for the companies to meet the desired legal standards in pharmaceutical production. Violating such requirements can ...
-
What’s a life-saving drug worth? It depends…
The risk? According to Medicinenet.com, only 5 in 5,000 drugs that enter preclinical testing advance to human trials. And only 1 of these 5 drugs ultimately gets approved for sale, which means the chance for a new drug to make it to market is 1 in 5,000. That’s a lot of R&D ...
By Vistex Inc
-
Implementation of FDA’s new antibiotic rules
On Wednesday, December 11, 2013, the U.S. Food and Drug Administration (FDA) announced two coordinated actions based on its belief “that production use indications such as ‘increased rate of rate of weight gain’ or ‘improved feed efficiency’ are no longer appropriate for the approved conditions for medically important antimicrobial drugs.” First, it released ...
-
A Brief Introduction to Functional PEGs
Due to its biological inertness and good biocompatibility, polyethylene glycol (PEG) has a wide range of applications in the pharmaceutical industry, biological materials, cosmetics, and analytical science. A number of compounds, such as proteins, peptides, oligonucleotides, drugs and liposomes, after being modified by PEG covalent bonding, can effectively extend the circulation time in the body, ...
-
Field Orthopaedics gets FDA approval for world’s smallest orthopaedic screw
The Brisbane-based designer of the world’s smallest orthopaedic screw has invoiced US hospital suppliers $900,000 in the three weeks since the device gained Food & Drug Administration approval, and he hopes it can soon be made in Brisbane too. Field Orthopaedics, founded in 2016 by former Army doctor Chris Jeffery alongside a team of doctors and engineers including hand surgeon Greg ...
-
Huateng Pharma Supplies Minoxidil Intermediate 2,4-Diamino-6-chloropyrimidine (CAS NO.156-83-2)
Minoxidil was first introduced by Upjohn Company of the United States, and was first used as an oral drug for the treatment of refractory hypertension in the 1970s. In later clinical applications, doctors observed hair regrowth and generalized excessive hair in balding patients, which led to the development of minoxidil preparations. Minoxidil can increase local blood supply, stimulate the ...
-
J.Med.Chem publish; Predicting Regioselectivity of AO, CYP, FMO and UGT Metabolism Using Quantum Mechanical Simulations and Machine Learning
Abstract – Unexpected metabolism in modification and conjugation phases can lead to the failure of many late-stage drug candidates or even withdrawals of approved drugs. Thus, it is critical to predict the sites of metabolism (SoM) for enzymes, which are known to interact with drug-like molecules, in the early stages of the research. The study presents methods for predicting the ...
-
FDA Approved Peptide Drugs in the First Half of 2023
The FDA's Center for Drug Evaluation and Research (CDER) regulatory approval of a total of 26 NME (New Molecular Entity) drugs in the first half of 2023. It is worth noting that the 26 drugs approved include 4 peptide drugs, accounting for 15% of the total. In the past 2022, the FDA has approved only three peptide drugs: Tirzepatide, Lutetium 177Lu Vipivotide Tetraxetan and Terlipressin, of which ...
-
A Review of Therapies For Alzheimer's Disease
Alzheimer's disease (AD) is a progressive, irreversible neurodegenerative disease clinically manifested by cognitive impairment, behavioral abnormalities, and social deficits. It is predicted that by 2050, the number of people 65 and older with dementia in the United States could reach 13.8 million. In China, more than 15.07 million elderly people aged 60 or over suffer from dementia, of which ...
-
Three generations of ADC: Nearly a decade of development-PI
Antibody-drug conjugate (ADC), a compound that connects a cytotoxic small-molecule drug to a monoclonal antibody via a rationally established linker, which selectively delivers an efficient cytotoxic agent into the tumor, has made significant progress in the previous decade. The first ADC drug approved by the US FDA was gemtuzumab ozogamicin (Mylotarg) in 2009. Currently, the FDA has authorized ...
-
ADC Drugs For Breast Cancer Treatment
Breast cancer is the malignant tumor with the highest morbidity and mortality among women worldwide. At present, the main therapeutic methods include surgery, chemotherapy, radiotherapy, endocrine therapy and targeted therapy, etc. The development and marketing of new drugs have far-reaching significance in improving the survival of breast cancer patients and changing the pattern of breast cancer ...
-
Representative structures of FDA-approved ADCs
Since they were originally explored in animal models in the 1960s, antibody-drug conjugates (ADCs) have seen many booms. The initial ADC clinical studies took place in the 1980s, and Mylotarg, the first ADC drug, was approved in 2000. The removal of Mylotarg, however, came as a huge shock to the industry, and it was relaunched in 2017. The launch of a number of clinically and commercially ...
-
Brief Introduction of ADC Drug Production Technology
Drug-to-antibody ratio (DAR, drug-to-antibody ratio) The number of cytotoxic drugs connected to each antibody is the drug-to-antibody ratio (DAR). When the DAR increases, the drug metabolism rate of ADC drugs increases, the half-life decreases, and the systemic toxicity increases. Ideally, when the DAR is 4, the drug has the highest efficacy. Therefore, in actual production, the drugs with DAR ...
By BOC Sciences
-
Custom fit helmets – can they help protect against concussions?
It appears that high-contact sports such as hockey and football are becoming much more violent. Although both sports have made efforts to remove unnecessary hits from the game, concussions are inevitable when athletes are as strong and fast as they are today. The only reasonable solution is to improve the safety equipment the players use in hopes of protecting them from a traumatic brain ...
-
What Revisions Has U.S. Pharmacopoeia Made to Pharmaceutical Excipients?
Pharmaceutical excipients are natural or synthetic substances formulated together with the active ingredients of the drug, whose purpose is to increase the formulations containing effective active ingredients or endow the active ingredients in the final dosage form with therapeutic effects, such as promoting drug absorption or solubility. Pharmaceutical excipients can also be used in the ...
-
What are the ADC drugs?
Antibody-drug conjugates (ADCs) continue to rise at home and abroad, but ADCs are not a new thing. Why has ADC been surging for so many years? What kind of magic power it contains, and what makes its growth path so tortuous? Let's take a brief look at the magical "magic bullet"-ADC. ADC (antibody-conjugated drug) is not a new concept. As early as the early 20th century, the Nobel Prize winner ...
By BOC Sciences
-
Do Peptide Drugs Need Acylation Blocking at Nα?
The formation of 2,5-diketopiperazine (DKP) with a bicyclic structure is one of the most detrimental side reactions and degradation pathways affecting peptide synthesis. Despite its crucial role as a versatile building block in drug discovery, the formation of DKP reactions is highly undesirable in the production of peptide drugs. DKP formation can occur during the process of peptide drug ...
Need help finding the right suppliers? Try XPRT Sourcing. Let the XPRTs do the work for you