Sanofi drives digital transformation with Google Cloud

My conversations with healthcare customers have made it clear that the industry is moving to a more data-centric model, one that can deliver deeper insights to physicians, help them make better-informed decisions, and provide better care for patients. This transformation goes hand in hand with Google's mission to organize the world’s information and make it universally accessible, secure and useful.

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Drug Safety Navigator, LLC

Drug Safety Navigator LLC (DSN) works with drug safety and pharmacovigilance experts from around the world, applying the concept “Experience Matters.”

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Pharma Tech

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

Article | July 15, 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 19, 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 13, 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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Drug Safety Navigator, LLC

Drug Safety Navigator LLC (DSN) works with drug safety and pharmacovigilance experts from around the world, applying the concept “Experience Matters.”

Related News

Sanofi to leverage Aetion’s data analytics platform to get real world evidence of drug efficacy

MedCity News | November 21, 2019

French drugmaker Sanofi announced Wednesday that it is leveraging the data analytics platform of New York-based Aetion to gather real-world evidence that can advance its understanding of the effectiveness, safety, and value of drugs. Specifically, Aetion’s platform will be integrated with Sanofi’s real-world data platform called Darwin. Per the announcement of this collaboration and company-wide integration, Sanofi’s DARWIN compiles and analyzes de-identified data from hundreds of millions of patients who are battling various diseases. Meanwhile, Aetion’s platform analyzes real-world data to answer questions about which drugs are effective, safe and can actually improve outcomes. “Today marks another important step in Sanofi’s digital transformation,” said Bernard Hamelin, Global Head of Medical Evidence Generation, Sanofi, in a news release. “By integrating these platforms we strive to make faster, more informed decisions that will lead to first-in-class and best-in-class treatments that can change the practice of medicine.” In the same announcement, Aetion’s CEO hailed the collaboration as a strong indication of the potential of real-world evidence in the future.

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Sanofi opens digital manufacturing facility in the US

Pharmaceutical Technology | October 15, 2019

French pharmaceutical giant Sanofi has opened a digital manufacturing facility at Framingham in Massachusetts, the US for continuous production of biologics. The facility will use intensified technology to link the production process with research and development. The company expects the approach to improve the commercialisation of drugs. Sanofi notes that the facility will boost its strategy to focus on biologics, supporting the transformation of its R&D pipeline. Sanofi global industrial affairs executive vice-president Philippe Luscan said: “Our Framingham facility leads the way in delivering the next generation of biologics manufacturing, leveraging intensified, continuous processing in a fully integrated digitally powered facility. “This opening demonstrates we are at the leading edge of innovation and manufacturing excellence, helping us to shape the future of both our company and the industry.”

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FDA set to review Sanofi’s isatuximab for multiple myeloma

Pharmatimes | July 11, 2019

The US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for isatuximab for a review, for the indication of relapsed/refractory multiple myeloma (RRMM). The drug’s maker Sanofi has announced that the target action date for the FDA decision is April 30, 2020. The drug is an investigational monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell and its BLA is based on positive results from ICARIA-MM, an open-label pivotal Phase III clinical trial of isatuximab in patients with RRMM. During the trial, isatuximab was administered through an intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with standard doses of pomalidomide and dexamethasone for the duration of treatment, and was found to prolong progression-free survival by five months versus Pomalyst and dexamethasone alone in patients. “We are excited by these results, which represent significant progress in our ambition to extend the lives of multiple myeloma patients,” said John Reed, head of Research and Development at Sanofi. “We look forward to engaging with regulatory authorities with the goal of bringing this potential new treatment to patients as quickly as possible.” The drug is currently being evaluated in multiple ongoing Phase III clinical trials in combination with current standard treatments for people with relapsed/refractory or newly diagnosed multiple myeloma, as well as being under investigation for the treatment of other hematologic malignancies and solid tumours.

Read More

Sanofi to leverage Aetion’s data analytics platform to get real world evidence of drug efficacy

MedCity News | November 21, 2019

French drugmaker Sanofi announced Wednesday that it is leveraging the data analytics platform of New York-based Aetion to gather real-world evidence that can advance its understanding of the effectiveness, safety, and value of drugs. Specifically, Aetion’s platform will be integrated with Sanofi’s real-world data platform called Darwin. Per the announcement of this collaboration and company-wide integration, Sanofi’s DARWIN compiles and analyzes de-identified data from hundreds of millions of patients who are battling various diseases. Meanwhile, Aetion’s platform analyzes real-world data to answer questions about which drugs are effective, safe and can actually improve outcomes. “Today marks another important step in Sanofi’s digital transformation,” said Bernard Hamelin, Global Head of Medical Evidence Generation, Sanofi, in a news release. “By integrating these platforms we strive to make faster, more informed decisions that will lead to first-in-class and best-in-class treatments that can change the practice of medicine.” In the same announcement, Aetion’s CEO hailed the collaboration as a strong indication of the potential of real-world evidence in the future.

Read More

Sanofi opens digital manufacturing facility in the US

Pharmaceutical Technology | October 15, 2019

French pharmaceutical giant Sanofi has opened a digital manufacturing facility at Framingham in Massachusetts, the US for continuous production of biologics. The facility will use intensified technology to link the production process with research and development. The company expects the approach to improve the commercialisation of drugs. Sanofi notes that the facility will boost its strategy to focus on biologics, supporting the transformation of its R&D pipeline. Sanofi global industrial affairs executive vice-president Philippe Luscan said: “Our Framingham facility leads the way in delivering the next generation of biologics manufacturing, leveraging intensified, continuous processing in a fully integrated digitally powered facility. “This opening demonstrates we are at the leading edge of innovation and manufacturing excellence, helping us to shape the future of both our company and the industry.”

Read More

FDA set to review Sanofi’s isatuximab for multiple myeloma

Pharmatimes | July 11, 2019

The US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for isatuximab for a review, for the indication of relapsed/refractory multiple myeloma (RRMM). The drug’s maker Sanofi has announced that the target action date for the FDA decision is April 30, 2020. The drug is an investigational monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell and its BLA is based on positive results from ICARIA-MM, an open-label pivotal Phase III clinical trial of isatuximab in patients with RRMM. During the trial, isatuximab was administered through an intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with standard doses of pomalidomide and dexamethasone for the duration of treatment, and was found to prolong progression-free survival by five months versus Pomalyst and dexamethasone alone in patients. “We are excited by these results, which represent significant progress in our ambition to extend the lives of multiple myeloma patients,” said John Reed, head of Research and Development at Sanofi. “We look forward to engaging with regulatory authorities with the goal of bringing this potential new treatment to patients as quickly as possible.” The drug is currently being evaluated in multiple ongoing Phase III clinical trials in combination with current standard treatments for people with relapsed/refractory or newly diagnosed multiple myeloma, as well as being under investigation for the treatment of other hematologic malignancies and solid tumours.

Read More

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