Fidia Pharma USA Inc. Announces Expansion into the Dietary Supplement Market with Launch of CartiJoint.

A world leader in the research, development, and manufacturing of hyaluronic acid (HA)-based products, is introducing CartiJoint™ FORTE, its first product in the dietary supplement category in the USA. CartiJoint™ FORTE is a dietary supplement that supports joint health and mobility with antioxidant activity in a daily dose.*1,2,3 It is uniquely formulated with a bioactive* curcumin extract Bio-Curcumin Curcugreen™ which is 100% natural turmeric along with glucosamine hydrochloride and chondroitin sulfate. Bio-Curcumin Curcugreen™ is from a natural substance with antioxidant activity*. It is a natural extract of Curcuma longa consisting of curcumin, curcuminoids, and oils with high bioavailability compared with standard curcumin and another formula containing curcumin in a pilot study of human volunteers receiving equivalent doses.4 CartiJoint™ FORTE also contains glucosamine hydrochloride and chondroitin sulfate. In the human joint, naturally occurring glucosamine and chondroitin are important structural components that provide support and promote joint mobility and flexibility. 

Spotlight

Fisher Clinical Services

As a leader in clinical supply chain management for over 20 years, Fisher Clinical Services has exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. As clinical trials require increasingly complex supply chain support, our purpose-built integrated facilities provide the global presence, information systems, and flexibility to allow unparalleled visibility and control of GMP activities from protocol design through to the investigator site.

OTHER ARTICLES
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.

Read More
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.

Read More
Pharma Tech

What are the advantages of PCD Pharma Company?

Article | September 29, 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.

Read More

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.

Read More

Spotlight

Fisher Clinical Services

As a leader in clinical supply chain management for over 20 years, Fisher Clinical Services has exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. As clinical trials require increasingly complex supply chain support, our purpose-built integrated facilities provide the global presence, information systems, and flexibility to allow unparalleled visibility and control of GMP activities from protocol design through to the investigator site.

Related News

Pharma Tech

Merck Drives New Innovation & Adds Capacity to Advance Next Generation Antibody-drug Conjugate (ADC) Therapies

Merck | October 29, 2021

Merck, a leading science and technology company, today announced that its Life Science business sector has launched new technology and expanded capacity to advance ADC therapies. These initiatives underscore Merck's continued investment in novel modalities and support the company's efforts to double its ADC and high-potent active pharmaceutical ingredient (HPAPI) capacity in the near future. "ADCs have experienced remarkable growth, with commercially approved ADCs tripling in the past three yearsWe are a pioneer in this space, involved in 50 percent of the commercially approved ADCs on the market today. This latest innovation and additional capacity help bring novel treatments to cancer patients around the world and reinforce our commitment to shaping the future of these novel modalities. Andrew Bulpin, head of Process Solutions, Life Science, at Merck With the launch of its ChetoSensar™ technology, Merck is one of the front runners working to address the hydrophobicity of ADCs, in tandem with its CDMO services. Many ADC candidates have poor aqueous solubility and Merck estimates that more than 20 percent of ADC clinical terminations are caused by this issue. The company's new ChetoSensar™ technology improves ADC solubility, therefore giving hope to ADCs that were previously terminated. The payloads commonly used for ADCs are highly-complex molecules that take many steps to synthesize. Based on Merck's calculations, its new DOLCORE™ platform significantly reduces the development and manufacturing time required, increasing speed-to-market for a novel Dolostatin-based ADC payload by up to a year. In addition, the company will enhance the ADC capabilities of its clinical manufacturing facility in St. Louis, Missouri, USA, in December. This facility will provide larger footprint to enable large-scale production including chromatographic purification for early phase clinical supply. This follows last year's announcement of a €59 million expansion of Merck's facility near Madison, Wisconsin, USA, which will double its HPAPI kilo lab capacity and enable the company to expedite the manufacture of HPAPIs, ADC linker/payloads, and complex APIs. This innovation and additional capacity support the company's ambition to accelerate growth through investments in the "Big Three," including the Process Solutions business unit within the Life Science business sector as a key driver. With 15 years of experience developing and manufacturing ADCs, Merck offers unique CDMO services streamlined with a single, highly experienced provider. The company leverages its global network and deep expertise to tailor each molecule's unique journey, while creating the dynamic client partnerships drug manufacturers need to help reach their critical milestones. Merck integrates contract development and manufacturing with the industry's broadest product offering across multiple modalities. Customers can also seamlessly integrate BioReliance® services from the company's leading biosafety testing portfolio. Merck recently announced expansion projects in Darmstadt, Germany; Cork, Ireland; Buchs, Switzerland; Carlsbad, California, USA; Madison, Wisconsin, USA; Jaffrey, New Hampshire, USA; and Danvers, Massachusetts, USA. These expansions are part of an ambitious, multi-year program to increase the industrial capacity and capabilities of the Life Science business sector to support growing global demand for lifesaving medications and to make significant contributions to public health. About Merck Merck, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2020, Merck generated sales of € 17.5 billion in 66 countries. Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics.

Read More

MHRA gives Bavencio, Inlyta combo Early Access to Medicines status

Pharmatimes | July 22, 2019

Merck and Pfizer have announced that the UK Medicines and Healthcare Products Regulatory Agency MHRA has issued an Early Access to Medicines Scheme EAMS positive scientific opinion for Bavencio avelumab used in combination with Inlyta axitinib. The opinion is for the combination as first-line treatment of adult patients with advanced renal cell carcinoma (RCC), and is based on information relating to the benefit and risks of the medicines and enables clinicians to prescribe the unlicensed treatment under their own responsibility. The combination was approved by the FDA in May this year based on positive results from the Phase III JAVELIN Renal 101 study (NCT02684006), in which the combination significantly improved median progression-free survival (PFS) compared with sunitinib by more than five months. The study included patients regardless of PD-L1 expression and across IMDC (International Metastatic Renal Cell Carcinoma Database) prognostic risk groups. There is a significant unmet need for RCC first-line treatments that delay progression and have an acceptable safety profile, as approximately 20% to 30% of patients are first diagnosed with RCC at the advanced stage, and 30% of patients treated for an earlier stage go on to develop metastases.

Read More

Is there life beyond Keytruda? Merck makes its case in first investor event in 5 years

fiercepharma | June 20, 2019

Merck CEO Ken Frazier kicked off Thursdays Investor Day presentation by acknowledging that the companys most recently lauded blockbuster, immunooncology drug Keytruda, is also its biggest challenge. “Everywhere I go, the key question I hear from people is ‘What do you have beyond Keytruda?’” Frazier said in his introduction to the investor presentation—the company’s first such event in five years. “But I think what we’re going to be able to show you today is that we do have tremendous growth opportunities beyond Keytruda.” It’s no wonder Frazier finds himself constantly facing the Keytruda question, considering how dominant that one product has been in Merck’s financial reports over the last few years. Even as recently as the first quarter of this year, when Keytruda’s sales leaped 60% to $2.3 billion, the company touted the recent successes that Frazier and his colleagues vowed would drive growth even more, including its new FDA approval for the first-line treatment of non-small cell lung cancer patients who have low levels of the biomarker PD-L1. During Investor Day, Merck’s chief commercial officer, Frank Clyburn, pointed out that Keytruda is just now starting to forge another new market—renal cell carcinoma. He reported that at the recent conference of the American Society of Clinical Oncology (ASCO), clinicians told him the data in kidney cancer would be “practice changing.” Oncologists were also excited about the potential of the drug in adjuvant melanoma, both in the U.S. and overseas, he said. CFO Rob Davis said he is confident that as Merck moves away from selling drugs mostly to a primary-care audience toward more hospital-administered products, the company’s profit margins will expand. Operating expenses will grow at a rate “meaningfully below sales,” he said. And the resulting margin expansion “will translate to accelerated earnings-per-share growth,” he vowed.

Read More

Pharma Tech

Merck Drives New Innovation & Adds Capacity to Advance Next Generation Antibody-drug Conjugate (ADC) Therapies

Merck | October 29, 2021

Merck, a leading science and technology company, today announced that its Life Science business sector has launched new technology and expanded capacity to advance ADC therapies. These initiatives underscore Merck's continued investment in novel modalities and support the company's efforts to double its ADC and high-potent active pharmaceutical ingredient (HPAPI) capacity in the near future. "ADCs have experienced remarkable growth, with commercially approved ADCs tripling in the past three yearsWe are a pioneer in this space, involved in 50 percent of the commercially approved ADCs on the market today. This latest innovation and additional capacity help bring novel treatments to cancer patients around the world and reinforce our commitment to shaping the future of these novel modalities. Andrew Bulpin, head of Process Solutions, Life Science, at Merck With the launch of its ChetoSensar™ technology, Merck is one of the front runners working to address the hydrophobicity of ADCs, in tandem with its CDMO services. Many ADC candidates have poor aqueous solubility and Merck estimates that more than 20 percent of ADC clinical terminations are caused by this issue. The company's new ChetoSensar™ technology improves ADC solubility, therefore giving hope to ADCs that were previously terminated. The payloads commonly used for ADCs are highly-complex molecules that take many steps to synthesize. Based on Merck's calculations, its new DOLCORE™ platform significantly reduces the development and manufacturing time required, increasing speed-to-market for a novel Dolostatin-based ADC payload by up to a year. In addition, the company will enhance the ADC capabilities of its clinical manufacturing facility in St. Louis, Missouri, USA, in December. This facility will provide larger footprint to enable large-scale production including chromatographic purification for early phase clinical supply. This follows last year's announcement of a €59 million expansion of Merck's facility near Madison, Wisconsin, USA, which will double its HPAPI kilo lab capacity and enable the company to expedite the manufacture of HPAPIs, ADC linker/payloads, and complex APIs. This innovation and additional capacity support the company's ambition to accelerate growth through investments in the "Big Three," including the Process Solutions business unit within the Life Science business sector as a key driver. With 15 years of experience developing and manufacturing ADCs, Merck offers unique CDMO services streamlined with a single, highly experienced provider. The company leverages its global network and deep expertise to tailor each molecule's unique journey, while creating the dynamic client partnerships drug manufacturers need to help reach their critical milestones. Merck integrates contract development and manufacturing with the industry's broadest product offering across multiple modalities. Customers can also seamlessly integrate BioReliance® services from the company's leading biosafety testing portfolio. Merck recently announced expansion projects in Darmstadt, Germany; Cork, Ireland; Buchs, Switzerland; Carlsbad, California, USA; Madison, Wisconsin, USA; Jaffrey, New Hampshire, USA; and Danvers, Massachusetts, USA. These expansions are part of an ambitious, multi-year program to increase the industrial capacity and capabilities of the Life Science business sector to support growing global demand for lifesaving medications and to make significant contributions to public health. About Merck Merck, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2020, Merck generated sales of € 17.5 billion in 66 countries. Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics.

Read More

MHRA gives Bavencio, Inlyta combo Early Access to Medicines status

Pharmatimes | July 22, 2019

Merck and Pfizer have announced that the UK Medicines and Healthcare Products Regulatory Agency MHRA has issued an Early Access to Medicines Scheme EAMS positive scientific opinion for Bavencio avelumab used in combination with Inlyta axitinib. The opinion is for the combination as first-line treatment of adult patients with advanced renal cell carcinoma (RCC), and is based on information relating to the benefit and risks of the medicines and enables clinicians to prescribe the unlicensed treatment under their own responsibility. The combination was approved by the FDA in May this year based on positive results from the Phase III JAVELIN Renal 101 study (NCT02684006), in which the combination significantly improved median progression-free survival (PFS) compared with sunitinib by more than five months. The study included patients regardless of PD-L1 expression and across IMDC (International Metastatic Renal Cell Carcinoma Database) prognostic risk groups. There is a significant unmet need for RCC first-line treatments that delay progression and have an acceptable safety profile, as approximately 20% to 30% of patients are first diagnosed with RCC at the advanced stage, and 30% of patients treated for an earlier stage go on to develop metastases.

Read More

Is there life beyond Keytruda? Merck makes its case in first investor event in 5 years

fiercepharma | June 20, 2019

Merck CEO Ken Frazier kicked off Thursdays Investor Day presentation by acknowledging that the companys most recently lauded blockbuster, immunooncology drug Keytruda, is also its biggest challenge. “Everywhere I go, the key question I hear from people is ‘What do you have beyond Keytruda?’” Frazier said in his introduction to the investor presentation—the company’s first such event in five years. “But I think what we’re going to be able to show you today is that we do have tremendous growth opportunities beyond Keytruda.” It’s no wonder Frazier finds himself constantly facing the Keytruda question, considering how dominant that one product has been in Merck’s financial reports over the last few years. Even as recently as the first quarter of this year, when Keytruda’s sales leaped 60% to $2.3 billion, the company touted the recent successes that Frazier and his colleagues vowed would drive growth even more, including its new FDA approval for the first-line treatment of non-small cell lung cancer patients who have low levels of the biomarker PD-L1. During Investor Day, Merck’s chief commercial officer, Frank Clyburn, pointed out that Keytruda is just now starting to forge another new market—renal cell carcinoma. He reported that at the recent conference of the American Society of Clinical Oncology (ASCO), clinicians told him the data in kidney cancer would be “practice changing.” Oncologists were also excited about the potential of the drug in adjuvant melanoma, both in the U.S. and overseas, he said. CFO Rob Davis said he is confident that as Merck moves away from selling drugs mostly to a primary-care audience toward more hospital-administered products, the company’s profit margins will expand. Operating expenses will grow at a rate “meaningfully below sales,” he said. And the resulting margin expansion “will translate to accelerated earnings-per-share growth,” he vowed.

Read More

Events