10 Unusual Applications of CRISPR Gene Editing

CRISPR has been all over the news in the past couple of years, and with reason. This gene editing tool is making gene editing easier and faster than ever, and the possibilities it has opened go well beyond human health. You might have heard of the tremendous potential CRISPR could have in treating disease. The technology is already accelerating the research on the underlying causes of all sorts of human conditions. Furthermore, it has already started clinical trials where the gene editing tool itself is used as a therapy for diseases ranging from cancer to blindness and AIDS. 

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How long will the world wait for the next pandemic of antimicrobial resistance before we act?

Article | September 29, 2022

Antimicrobial resistance (AMR) has become an increasingly serious global health problem in recent years. World Health Organization (WHO) estimates that more than 700,000 people die each year due to drug-resistant infections, and the number is expected to increase in the coming years. How does antimicrobial resistance emerge? Antimicrobial resistance (AMR) occurs when bacteria, viruses, fungi, and parasites change over time and no longer respond to medicines. It makes infections harder to treat and increases the risk of disease, severe illness, and death. When we use antibiotics, some bacteria die, but resistant bacteria can survive and even multiply. The overuse of antibiotics and substandard antibiotics make resistant bacteria more common. So, the more we use antibiotics, the more chances bacteria have to become resistant to them. The rise in AMR is caused by multiple factors including the misuse and overuse of antibiotics by humans as well as in livestock and agriculture. Although these are the main drivers in the development of drug-resistant pathogens, the emergence of substandard and falsified antibiotics is another lesser-known, huge contributory factor. Even though AMR is a leading cause of death around the world, it is tracked most closely in clinical high-income settings and developed countries. Unfortunately, this is not the case in low and middle-income countries, where the highest burden is in low-resource settings and low-and middle-income countries (LMICs). These countries are disproportionately affected, in part due to the high burden of communicable diseases. Consequences to human health of AMR AMR poses significant risks to human health, resulting in prolonged and more severe infections, extended hospitalizations, and increased healthcare expenses. It can also lead to an increased risk of death, as an infection may become untreatable. Additionally, it can reduce the effectiveness of medicines and treatments, making it more difficult to manage existing medical conditions. It is even more concerning that it can lead to the emergence of new, more dangerous strains of bacteria, viruses, and other microbes. This would mean medical procedures, such as surgery, including caesarean sections or hip replacements, cancer chemotherapy, and organ transplantation, will become riskier. Counterfeit medicines and antibiotics: Antibiotics are the most counterfeited medicines in the world, as they account for 28% of global counterfeit medicines. Substandard and falsified antibiotics are medicines that do not meet the quality standards set by regulatory authorities. Counterfeit antibiotics are estimated at 5% of the global antibiotic market. These medicines are often of inferior quality or contain incorrect ingredients or incorrect amounts of active ingredients. They may also contain toxic contaminants or be expired, posing serious consequences for patients. Sadly, counterfeit antibiotics are mostly found in LMICs due to a lack of regulation and enforcement, as well as a lack of access to quality healthcare. In many of these countries, the demand for antibiotics is higher than the supply, and counterfeit antibiotics are seen as a cheaper and more accessible alternative. Furthermore, there is a lack of awareness around the dangers of taking counterfeit antibiotics, and there is a lack of resources for health authorities to test for the authenticity of these medicines. Why are antibiotics so rife for counterfeit drugs? Counterfeiters of pharmaceuticals succeed in large part by exploiting weaknesses in supply chains, which are often fragmented with poor regulatory frameworks. Antibiotics are often counterfeited because they are in high demand and can be sold for a large profit. To combat the problem of substandard and falsified antibiotics, governments must take a multi-pronged approach. This should encompass enacting laws and regulations to ensure the quality and safety of medicines, conducting surveillance for detecting and removing substandard and falsified products from the market, as well as providing training and education to healthcare professionals and patients regarding the responsible use of antibiotics. In addition, governments must work to strengthen the pharmaceutical supply chain. This includes increasing the transparency of the supply chain, improving the quality control systems, and introducing traceability systems to track the movement of medicines from the manufacturer to the patient. Medical investment in low and middle-income countries Another neglected aspect by international NGOs and governments is investment in building local laboratory capacity in LMICs to combat antimicrobial resistance. Localized laboratory facilities can help identify, track, and prevent the spread of antimicrobial-resistant infections, as well as provide early warnings of emerging drug-resistant strains. Localized microbiology, surveillance, and quality control laboratories can also play an important role in developing new treatments and interventions for combating antimicrobial resistance. In addition, having localized laboratory capacity can provide more accurate standardized data on the prevalence of drug-resistant infections, which can help inform policy decisions and public health interventions. Affordable medicines Finally, governments must work to increase access to high-quality, affordable medicines. This includes improving the availability of generic medicines, which are typically cheaper alternatives to brand-name drugs. They also need to increase access to newer, more effective antibiotics.

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Pharma Tech

Tips for Managing Chronic Pain Beyond Prescription Painkillers

Article | July 13, 2022

Painkillers like Oxycontin, Percocet, and Vicodin, have been prescribed by primary physicians, surgeons, dentists, and other healthcare providers to patients suffering from varying levels of pain. Though these medications have proven to be an effective source of pain relief, they have also proven to be highly addictive. In fact, it has even been reported that there are more cases of a drug overdose and deaths from prescription painkillers than heroin or cocaine. While there are a number of factors that play into this opioid epidemic, educating doctors and patients on alternative solutions to managing chronic pain is a great place to start combatting this nationwide crisis.

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Pharma Tech

What are the advantages of PCD Pharma Company?

Article | July 20, 2022

PCD Pharma stands for propaganda distribution. A PCD company gives brand name and support to its franchises. They also provide distribution rights and monopoly rights within a particular region. If a person wants to establish their business, it is a must for them to know the pros and cons of the business to make a sound decision. Needless to mention that PCD company has a lot to contribute in the medical filed. Worldwide in a medical field, A PCD Pharma Company is playing an essential and crucial role in the rapid growth. The pharma industry is progressing t a fast pace. The company uses the latest technologies for each brand which ensures the safety of products and accepts the responsibility of human health & life by providing better outcomes. To have a drug license number and company registration, the cost to establish the company is quite cost-effective that is15000-20000rs. So this gives people a brilliant opportunity to have their unit without digging a big hole in their bank balance. Indian produces exquisite quality products, which make pharma companies a considerable success.

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WALGREEN’S IN HOT WATER OVER PHONY PHARMACIST

Article | February 11, 2020

The drugstore chain agreed to pay $7.5 million in fines after an unlicensed pharmacist at several San Francisco Bay locations illegally filled more than 700,000 prescriptions over a ten-year period. According to California prosecutors, Kim Thien Le stole license numbers from other pharmacists to fill prescriptions for Fentanyl, morphine, and other painkillers. Le pleaded guilty to multiple felony impersonation counts. Walgreen’s agreed to the settlement to avoid being charged with consumer fraud in Alameda and Santa Anna Counties. Prosecutors alleged that Walgreen’s failed to verify Le’s license and did not conduct a thorough background check. The company insisted it has taken remedial measures.

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Adare Pharma Solutions Acquires Frontida BioPharm to Expand Leading CDMO Offerings

Adare Pharma Solutions | December 02, 2021

Adare Pharma Solutions ("Adare"), a technology-driven contract development and manufacturing organization (CDMO), announced the acquisition of Frontida BioPharm ("Frontida"), a vertically integrated CDMO focused on oral formulations. The acquisition reinforces Adare's commitment to transform drug delivery by providing world class solutions from product development through commercial scale manufacturing and packaging. Adare's portfolio of offerings for its customers will expand to include new capabilities such as high potency compound handling and packaging services. The combination of the two organizations will further establish Adare as a leader in the development and manufacturing of life saving medications in complex dosage forms. "We are devoted to improving the quality of life for patients by solving the most complex formulation challenges for our customers, and we believe this acquisition will bolster our ability to achieve our mission. Frontida and Adare share a commitment to quality and innovation, and we are excited to continue growing together. The combined company will lead in the space of oral formulations, while expanding the services and technical offerings we provide to meet the needs of our customers and their patients." Vivek Sharma, Chief Executive Officer of Adare Dr. Song Li, Frontida's Chairman added, "We are very excited about the opportunities this transaction is expected to provide to both existing and new clients. Our combined resources and capabilities will result in enhanced support and talent to ensure the success of their development and commercialization programs. This transaction is also a testament to the hard work, dedication, and caring culture of the team who has helped Frontida grow, enabling continued investment into the Philadelphia area, which is a respected home for pharmaceutical development and manufacturing. We look forward to continuing our work together to provide innovative, life-enhancing products to the US and global markets." Together, the combined company will offer an expanded suite of solutions for complex oral formulations, such as taste masking, controlled release, high potency formulation manufacturing, and bioavailability enhancement. The addition of Frontida brings Adare's manufacturing footprint to seven sites globally and expands Adare's integrated, end-to-end offering to its partners. The combined organization will be led by Vivek Sharma. Adare is backed by private equity firms Thomas H. Lee Partners and Frazier Healthcare Partners. RBC Capital Markets, LLC acted as exclusive financial advisor to Adare for this transaction. About Adare Adare Pharma Solutions is a leading specialty contract development and manufacturing organization (CDMO) and global provider of advanced pharmaceutical technologies, development services, and manufacturing. The Company utilizes its differentiated pharmaceutical technology and microbiome platforms to develop novel, improved medicines, and therapies for the global market.

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Pharmacy Market

Narrativa Raises $1.3M to Help Pharma Companies Accelerate the FDA Drug Approval Process

Narrativa | May 19, 2021

Narrativa, which has developed an artificial intelligence (AI) medical writing platform to assist pharmaceutical firms in speeding up drug approval and lowering overall compliance costs, recently completed a $1.3 million funding round. The Los Angeles-based firm currently uses its SaaS platform to automate the production of Clinical Study Reports (CSRs) and other regulatory reports for several pharmaceutical firms and other clinical research organizations (CROs). The AI-writing assistant platform utilizes advanced Natural Language Generation (NLG) to process millions of data points from clinical trials and generate readable and understandable written medical narratives, improving accuracy and minimizing the time and expense of producing critical (and time-consuming) regulatory documents. "The pharma industry has evolved as a result of the availability and quality of data from clinical trials, with the most significant impact on drug discovery. To detect trends, test hypotheses, and understand the effectiveness of treatments, pharmaceutical firms have often focused on empirical data. It's time to put artificial intelligence to work assisting medical authors in the development of regulatory documents "Narrativa's founder and CEO, David Llorente, says. Pharmaceutical firms spend more than $1.5 billion on regulatory documentation, and it may take up to a year to complete the paperwork for FDA approval of a new drug. The amount of time taken on regulatory documentation significantly lengthens the time it takes for new drugs to reach the market. About Narrativa Narrativa was established in 2015 with the idea that technology should be used to positively transform the world. Narrativa, named one of the most important companies in the field of NLG by Samsung, helps companies expand by anticipating trends and converting data into the human language in real-time. Narrativa creates automated content in a variety of areas, including finance, pharmaceuticals, insurance, media, and gaming, using its artificial intelligence system and machine learning experience.

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Alliance for Regenerative Medicine Published its Response to EU Pharmaceutical Roadmap

Alliance for Regenerative Medicine | July 07, 2020

The Alliance for Regenerative Medicine (ARM), the leading international advocacy organisation dedicated to realising the promise of regenerative medicines and advanced therapies, today published its response to the EU Pharmaceutical Strategy Roadmap which is designed to improve and accelerate patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry. The full response can be found on the European Commission website. While ARM welcomes the Roadmap’s recognition of the wider industry’s contribution to the EU economy and its focus on ensuring patients’ access to safe, state-of-the-art therapies, ARM wants to ensure a continued pathway for the EU to benefit from innovative and life-changing advanced therapy medicinal products (ATMPs).

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Business Insights

Adare Pharma Solutions Acquires Frontida BioPharm to Expand Leading CDMO Offerings

Adare Pharma Solutions | December 02, 2021

Adare Pharma Solutions ("Adare"), a technology-driven contract development and manufacturing organization (CDMO), announced the acquisition of Frontida BioPharm ("Frontida"), a vertically integrated CDMO focused on oral formulations. The acquisition reinforces Adare's commitment to transform drug delivery by providing world class solutions from product development through commercial scale manufacturing and packaging. Adare's portfolio of offerings for its customers will expand to include new capabilities such as high potency compound handling and packaging services. The combination of the two organizations will further establish Adare as a leader in the development and manufacturing of life saving medications in complex dosage forms. "We are devoted to improving the quality of life for patients by solving the most complex formulation challenges for our customers, and we believe this acquisition will bolster our ability to achieve our mission. Frontida and Adare share a commitment to quality and innovation, and we are excited to continue growing together. The combined company will lead in the space of oral formulations, while expanding the services and technical offerings we provide to meet the needs of our customers and their patients." Vivek Sharma, Chief Executive Officer of Adare Dr. Song Li, Frontida's Chairman added, "We are very excited about the opportunities this transaction is expected to provide to both existing and new clients. Our combined resources and capabilities will result in enhanced support and talent to ensure the success of their development and commercialization programs. This transaction is also a testament to the hard work, dedication, and caring culture of the team who has helped Frontida grow, enabling continued investment into the Philadelphia area, which is a respected home for pharmaceutical development and manufacturing. We look forward to continuing our work together to provide innovative, life-enhancing products to the US and global markets." Together, the combined company will offer an expanded suite of solutions for complex oral formulations, such as taste masking, controlled release, high potency formulation manufacturing, and bioavailability enhancement. The addition of Frontida brings Adare's manufacturing footprint to seven sites globally and expands Adare's integrated, end-to-end offering to its partners. The combined organization will be led by Vivek Sharma. Adare is backed by private equity firms Thomas H. Lee Partners and Frazier Healthcare Partners. RBC Capital Markets, LLC acted as exclusive financial advisor to Adare for this transaction. About Adare Adare Pharma Solutions is a leading specialty contract development and manufacturing organization (CDMO) and global provider of advanced pharmaceutical technologies, development services, and manufacturing. The Company utilizes its differentiated pharmaceutical technology and microbiome platforms to develop novel, improved medicines, and therapies for the global market.

Read More

Pharmacy Market

Narrativa Raises $1.3M to Help Pharma Companies Accelerate the FDA Drug Approval Process

Narrativa | May 19, 2021

Narrativa, which has developed an artificial intelligence (AI) medical writing platform to assist pharmaceutical firms in speeding up drug approval and lowering overall compliance costs, recently completed a $1.3 million funding round. The Los Angeles-based firm currently uses its SaaS platform to automate the production of Clinical Study Reports (CSRs) and other regulatory reports for several pharmaceutical firms and other clinical research organizations (CROs). The AI-writing assistant platform utilizes advanced Natural Language Generation (NLG) to process millions of data points from clinical trials and generate readable and understandable written medical narratives, improving accuracy and minimizing the time and expense of producing critical (and time-consuming) regulatory documents. "The pharma industry has evolved as a result of the availability and quality of data from clinical trials, with the most significant impact on drug discovery. To detect trends, test hypotheses, and understand the effectiveness of treatments, pharmaceutical firms have often focused on empirical data. It's time to put artificial intelligence to work assisting medical authors in the development of regulatory documents "Narrativa's founder and CEO, David Llorente, says. Pharmaceutical firms spend more than $1.5 billion on regulatory documentation, and it may take up to a year to complete the paperwork for FDA approval of a new drug. The amount of time taken on regulatory documentation significantly lengthens the time it takes for new drugs to reach the market. About Narrativa Narrativa was established in 2015 with the idea that technology should be used to positively transform the world. Narrativa, named one of the most important companies in the field of NLG by Samsung, helps companies expand by anticipating trends and converting data into the human language in real-time. Narrativa creates automated content in a variety of areas, including finance, pharmaceuticals, insurance, media, and gaming, using its artificial intelligence system and machine learning experience.

Read More

Alliance for Regenerative Medicine Published its Response to EU Pharmaceutical Roadmap

Alliance for Regenerative Medicine | July 07, 2020

The Alliance for Regenerative Medicine (ARM), the leading international advocacy organisation dedicated to realising the promise of regenerative medicines and advanced therapies, today published its response to the EU Pharmaceutical Strategy Roadmap which is designed to improve and accelerate patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry. The full response can be found on the European Commission website. While ARM welcomes the Roadmap’s recognition of the wider industry’s contribution to the EU economy and its focus on ensuring patients’ access to safe, state-of-the-art therapies, ARM wants to ensure a continued pathway for the EU to benefit from innovative and life-changing advanced therapy medicinal products (ATMPs).

Read More

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