What is Allometric Scaling and How Does it Support Drug Development?

There are many aspects of drug development that must be understood before a drug can be tested in humans. Nonclinical studies are conducted to understand the safety (i.e., toxicity and safety pharmacology) of drug candidates and to provide critical pharmacokinetic (PK) information, including insights into the drug’s absorption, distribution, metabolism, and excretion (ADME) properties.

Spotlight

Pharmacy Podcast Network

In March of 2009, Institutional Pharmacy Technology marketing leader, Todd S. Eury, launched the Pharmacy Podcast Show. Over the years, the Pharmacy Podcast has accumulated over 67,000+ listeners and subscribers and is the most popular and downloaded podcast about the Pharmacy Industry. The Pharmacy Podcast Show transformed into the Pharmacy Podcast Network (PPN) in 2016 and will continue to collect the thought leading interviews with some of the most brilliant minds in Pharmacy with over 25 co-hosts. The PPN is a Digital Health Publication and Content Developing partner to the Pharmaceutical industry focusing on Specialty medications, pharmacy business supportive technologies, and industry trends. The PPN is dedicated to Specialty, Retail, Long-term Care, Micro-Chain, – Pharmacy Businesses, Patients, and Pharmacy Students with special content for each of these specific audiences. The PPN is the nation's largest network of podcasts dedicated to the pharmacy professional and industry in

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Pharmacy Market

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

Article | July 7, 2023

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 | October 6, 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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Spotlight

Pharmacy Podcast Network

In March of 2009, Institutional Pharmacy Technology marketing leader, Todd S. Eury, launched the Pharmacy Podcast Show. Over the years, the Pharmacy Podcast has accumulated over 67,000+ listeners and subscribers and is the most popular and downloaded podcast about the Pharmacy Industry. The Pharmacy Podcast Show transformed into the Pharmacy Podcast Network (PPN) in 2016 and will continue to collect the thought leading interviews with some of the most brilliant minds in Pharmacy with over 25 co-hosts. The PPN is a Digital Health Publication and Content Developing partner to the Pharmaceutical industry focusing on Specialty medications, pharmacy business supportive technologies, and industry trends. The PPN is dedicated to Specialty, Retail, Long-term Care, Micro-Chain, – Pharmacy Businesses, Patients, and Pharmacy Students with special content for each of these specific audiences. The PPN is the nation's largest network of podcasts dedicated to the pharmacy professional and industry in

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Practice Management

Infant Bacterial Therapeutics today announces new patent protection approvals in Brazil and in Hong Kong

Infant Bacterial Therapeutics | December 28, 2021

Infant Bacterial Therapeutics AB announces that the Patent Offices of Brazil and Hong Kong have approved a patent of Lactobacillus reuteri covering IBP-9414. IBT is currently developing its drug candidate IBP-9414 in Phase III for the prevention of necrotizing colitis and improvement of feeding tolerance in preterm infants. The patent covers a novel way to activate the bacteria. Corresponding patent applications are currently pending across several important future markets. This patent reinforces the existing protection of IBT’s drug candidate IBP-9414. Additional market protection, beyond patent exclusivity, is also anticipated in the form of Orphan Drug Exclusivity and biological data protection in the US and EU. The patent provides coverage until 2036. IBP-9414 is intended to be marketed in Brazil and Hong Kong upon marketing authorization. “We are pleased to have strengthened our intellectual property protection for IBP-9414 through the approved patents in Brazil and Hong Kong. Brazil is in particular a substantial market with about 215 million inhabitants, which makes it a very interesting commercial opportunity for our future product", CEO Staffan Strömberg, IBT About Infant Bacterial Therapeutics AB Infant Bacterial Therapeutics AB is a public company domiciled in Stockholm. The company’s Class B shares are listed on Nasdaq Stockholm, Mid-cap. Infant Bacterial Therapeutics AB is a pharmaceutical company with a product in clinical phase III with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting infants. IBT is currently developing the drug candidate IBP-9414. The ambition for IBP-9414 is to become the world’s first approved probiotical drug with the goal to prevent life threatening diseases in premature infants including NEC and sepsis by promoting healthy stomach-and bowel development in premature infants. IBP-9414 contains the active compound Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk. The product portfolio also includes another project, IBP-1016, for the treatment of gastroschisis, a severe and rare disease affecting infants. By developing these drugs, IBT has the potential to fulfill unmet needs for diseases where there are currently no prevention or treatment therapies available.

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Pharmacy Market

Titan Pharmaceuticals to Explore Strategic Alternatives

Titan Pharmaceuticals, Inc. | December 22, 2021

Titan Pharmaceuticals, Inc. announced that it has commenced a process to explore and evaluate strategic alternatives to enhance shareholder value. Titan has engaged Maxim Group LLC as its exclusive financial advisor to assist in this process. Potential strategic alternatives that may be explored or evaluated as part of this process include an acquisition, merger, reverse merger, other business combination, sales of assets, licensing or other strategic transactions involving the Company. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms. Titan does not expect to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or the board of directors has concluded that disclosure is appropriate or legally required. About Titan Pharmaceuticals Titan Pharmaceuticals, Inc. based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. Ultimate validation of the ProNeura® delivery system has been exemplified by approval of Probuphine in the US, EU and Canada. Key ongoing ProNeura implant programs include IND-enabling, non-clinical assessment of TP-2021, a potent peptide kappa opioid agonist for the long-term treatment of severe, chronic pruritis, and nalmefene, a mu opioid receptor blocker designed to decrease relapse and potential death from overdose in detoxed patients with Opiate Use Disorder.

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Business Insights

TriMas Closes on Acquisition of Omega

TriMas | December 21, 2021

TriMasannounced that it has closed the acquisition of Omega Plastics (“Omega”), a manufacturer of custom components and tooling for medical, as well as industrial applications, adding to TriMas’ Packaging group. Omega leverages its core injection molding capabilities, ISO Class 8 clean room and advanced in-house tool making capabilities, to provide its customers a faster product development cycle, from prototype development, testing and validation, to short and medium run production and assembly. Omega’s medical components are currently used in drug delivery, including consumable intravenous applications, as well as diagnostic testing and orthopedic applications. As of September 30, 2021, TriMas’ Packaging group’s last twelve months sales were approximately $534 million, representing approximately 64% of TriMas’ total sales. TriMas plans to expand Omega’s production capacity, as required in order to benefit its customers’ longer-term needs, while also leveraging Omega’s advanced tool making capabilities to add to TriMas Packaging’s speed-to-market advantage on innovation and new product designs. Omega is expected to generate approximately $18 million in revenue in fiscal year 2021. “We welcome Omega to TriMas’ family of businesses and look forward to working with the Omega leadership team to unleash future growth opportunities. I’d like to thank all the teams from Omega, TriMas and our respective advisors that supported the work to complete this transaction.” Thomas Amato, TriMas President & CEO The addition of Omega further expands TriMas Packaging’s Pharmaceutical & Nutraceutical product offering into supporting medical device contract development manufacturing customers.

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Practice Management

Infant Bacterial Therapeutics today announces new patent protection approvals in Brazil and in Hong Kong

Infant Bacterial Therapeutics | December 28, 2021

Infant Bacterial Therapeutics AB announces that the Patent Offices of Brazil and Hong Kong have approved a patent of Lactobacillus reuteri covering IBP-9414. IBT is currently developing its drug candidate IBP-9414 in Phase III for the prevention of necrotizing colitis and improvement of feeding tolerance in preterm infants. The patent covers a novel way to activate the bacteria. Corresponding patent applications are currently pending across several important future markets. This patent reinforces the existing protection of IBT’s drug candidate IBP-9414. Additional market protection, beyond patent exclusivity, is also anticipated in the form of Orphan Drug Exclusivity and biological data protection in the US and EU. The patent provides coverage until 2036. IBP-9414 is intended to be marketed in Brazil and Hong Kong upon marketing authorization. “We are pleased to have strengthened our intellectual property protection for IBP-9414 through the approved patents in Brazil and Hong Kong. Brazil is in particular a substantial market with about 215 million inhabitants, which makes it a very interesting commercial opportunity for our future product", CEO Staffan Strömberg, IBT About Infant Bacterial Therapeutics AB Infant Bacterial Therapeutics AB is a public company domiciled in Stockholm. The company’s Class B shares are listed on Nasdaq Stockholm, Mid-cap. Infant Bacterial Therapeutics AB is a pharmaceutical company with a product in clinical phase III with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting infants. IBT is currently developing the drug candidate IBP-9414. The ambition for IBP-9414 is to become the world’s first approved probiotical drug with the goal to prevent life threatening diseases in premature infants including NEC and sepsis by promoting healthy stomach-and bowel development in premature infants. IBP-9414 contains the active compound Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk. The product portfolio also includes another project, IBP-1016, for the treatment of gastroschisis, a severe and rare disease affecting infants. By developing these drugs, IBT has the potential to fulfill unmet needs for diseases where there are currently no prevention or treatment therapies available.

Read More

Pharmacy Market

Titan Pharmaceuticals to Explore Strategic Alternatives

Titan Pharmaceuticals, Inc. | December 22, 2021

Titan Pharmaceuticals, Inc. announced that it has commenced a process to explore and evaluate strategic alternatives to enhance shareholder value. Titan has engaged Maxim Group LLC as its exclusive financial advisor to assist in this process. Potential strategic alternatives that may be explored or evaluated as part of this process include an acquisition, merger, reverse merger, other business combination, sales of assets, licensing or other strategic transactions involving the Company. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms. Titan does not expect to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or the board of directors has concluded that disclosure is appropriate or legally required. About Titan Pharmaceuticals Titan Pharmaceuticals, Inc. based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. Ultimate validation of the ProNeura® delivery system has been exemplified by approval of Probuphine in the US, EU and Canada. Key ongoing ProNeura implant programs include IND-enabling, non-clinical assessment of TP-2021, a potent peptide kappa opioid agonist for the long-term treatment of severe, chronic pruritis, and nalmefene, a mu opioid receptor blocker designed to decrease relapse and potential death from overdose in detoxed patients with Opiate Use Disorder.

Read More

Business Insights

TriMas Closes on Acquisition of Omega

TriMas | December 21, 2021

TriMasannounced that it has closed the acquisition of Omega Plastics (“Omega”), a manufacturer of custom components and tooling for medical, as well as industrial applications, adding to TriMas’ Packaging group. Omega leverages its core injection molding capabilities, ISO Class 8 clean room and advanced in-house tool making capabilities, to provide its customers a faster product development cycle, from prototype development, testing and validation, to short and medium run production and assembly. Omega’s medical components are currently used in drug delivery, including consumable intravenous applications, as well as diagnostic testing and orthopedic applications. As of September 30, 2021, TriMas’ Packaging group’s last twelve months sales were approximately $534 million, representing approximately 64% of TriMas’ total sales. TriMas plans to expand Omega’s production capacity, as required in order to benefit its customers’ longer-term needs, while also leveraging Omega’s advanced tool making capabilities to add to TriMas Packaging’s speed-to-market advantage on innovation and new product designs. Omega is expected to generate approximately $18 million in revenue in fiscal year 2021. “We welcome Omega to TriMas’ family of businesses and look forward to working with the Omega leadership team to unleash future growth opportunities. I’d like to thank all the teams from Omega, TriMas and our respective advisors that supported the work to complete this transaction.” Thomas Amato, TriMas President & CEO The addition of Omega further expands TriMas Packaging’s Pharmaceutical & Nutraceutical product offering into supporting medical device contract development manufacturing customers.

Read More

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