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

FIDIA PHARMA USA INC. | April 12, 2019 | 124 views

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

QuVa Pharma, Inc

QuVa Pharma, Inc. is a newly-formed national platform for sterile compounding pharmacy services led by two experienced industry executives that has received a majority equity commitment from Bain Capital Private Equity to support the company’s creation and expansion plans. As part of its formation, QuVa Pharma has acquired the assets of the compounding services division of a company leader in the field of parenteral and management services, including its state-of-the-art 503B manufacturing facility in Sugar Land, Texas.

OTHER ARTICLES
VIEWS AND ANALYSIS

Why Is Diversity of Thought Essential for Developing a Winning Strategy?

Article | April 20, 2021

In developing or evolving a strategy, there are key decision moments. Those are the moments where you are deciding where you need to focus, what you need to excel at to win there, and where and how to allocate resources to get to a point in the future. At these moments, it is the contest of ideas that matters. Having choices matters. Having a cross-functional team participating in the development of strategy is one way of ensuring that you are going to be more successful at generating choices before you start making choices. What Is a Cross-functional Team? A cross-functional team is a collection of individuals with varied skillsets from different areas of a business collaborating to achieve a common goal. Why Are Cross-functional Teams Essential for Business Success? Having this diverse set of minds analysing the situation, considering the big picture and the organisation’s capabilities, and the needs of all stakeholders, inspires teams to think about the choices they have differently and more creatively. For example, in a pharmaceutical setting, the medical affairs team brings knowledge of the data, unmet needs, and insight into clinical practice. Access and reimbursement teams identify the right data and take the lead in building that value story to accelerate market access and product uptake. It is incumbent upon commercial to hear their ideas, obtain their perspective and secure their alignment to all strategy decisions. Cross-functional collaboration can help break down silos. Research suggests that working in silos and not sharing data with team members from other departments can cost a company close to $8,000 per day in wasteful expenses. Time is widely recognised as a scarce resource: we need quick access to accurate and real-time insights to make effective business decisions. Real time insight will come from those closest to the customer, so it is important for cross-functional members from different geographies to participate in the development of strategy. Improved insight is a source of sustainable competitive advantage. One single version of the truth is what is required for the right narrative to take place. The right narrative will lead to the right decisions. One single version of the truth is more easily achieved by cross-functional team members working closely together. Better Innovation & Creativity: Individuals with diverse skillsets often explore a problem in different ways. When different people working in different capacities come together, they think outside the box to significantly improve outcomes. It is a great way to come up with concepts that distinguish companies from their competitors. Achieving alignment with strategy across functions and geographies: Today, businesses are moving faster than ever and organisations are seeing possible competitors in areas they never knew existed before. With so much choice about where to focus, you really want your workforce to align around one strategy. Underperformance is inevitable if everybody is off working in ten different directions. Improving the customer experience: Creating an effective customer experience is about more than just ensuring your customers receive the products and services they desire in a timely and efficient manner. It’s also about creating touchpoints with real people who can organically evangelise and grow your brand through their social media and offline interactions with friends and family. Your customers are engaging with multiple communication channels– official websites, social platforms, virtual platforms, medical science liaisons, sales reps, and more. Everyone needs to be aware of, and understand, the moments that matter to your customer and the business along that customer journey and how they contribute to delivering that positive experience. This is more likely to be achieved with a cross-functional approach to strategy development. Business Agility: Cross-functional teams are typically small, adaptable, and flexible. Such teams can move faster as they don’t have to wait and rely on other departments or external sources. They can help in tackling any silo mentality and bridge gaps between team members. They can come together to consider new information and/or changes to adapt the strategy if necessary and/or react to any setbacks immediately. They are better placed to make decisions when problem-solving amidst uncertainty. In summary, the rapidly changing environment and new information requires medical affairs, along with access and reimbursement and commercial, to work together, to ensure that patient’s benefit from the value of new innovative therapies. Companies stand a better chance of creating a winning strategy if it is created by a cross-functional and geographically diverse team. With every team member bringing their abilities and knowledge to the table, the strategy over time can only move from strength to strength. However, if not supported correctly, a cross-functional team working on strategy can be dysfunctional and chaotic, and result in a laborious and time-consuming approach to strategy development. Digital strategy platforms such as Nmblr offer an inclusive and structured process to facilitate a strategy discussion and allow people to bring forward ideas. They do this by: working against silos – the structure provided, levels the playing field. The guidance provided equips people from different disciplines to contribute to the conversation.

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RESEARCH

Modern Phenotypic Drug Discovery

Article | September 1, 2021

Nature Reviews Drug Discovery makes these points well. It goes over historical and recent successes of the phenotypic approach, and discusses some areas that it's opening up for discussion and research. One of these is the long-vexed question of polypharmacology: what do you do when your active compound doesn't seem to have a single target, but rather hits a whole list of stuff at varying degrees of potency? Seen from a pure target-based viewpoint, this is a failure, and you'd better start working on something else. But to be honest, there are a lot of drugs out there (and not all of them ancient legacy compounds by any means) that work this way, even if their developers didn't think so at the time. So it's not to be disparaged on principle, but that said, it's still a difficult area to make progress in because of all the variables. A good enough phenotypic hit, though, makes its own case that it's worthy of further investigation and development, even if it's not "clean" by rigorous target-based standards. But as always, your phenotypic screen had better be a good one. That is, it had really better model the human disease in a useful way, and have a good signal/noise. The authors note that you're much better off with assays that involve a gain-of-function/gain-of-signal readout, as opposed to ones that could read out just through cellular stress or cytotoxicity, which is an invitation to chase your tail. Another area the paper brings up is searching lower-molecular-weight compounds than are usually screened, down to fragment-sized. There are quite a few useful drugs out there with really low molecular weights - ibuprofen, aspirin, metformin, dimethyl fumarate, lacosamide and more - and any screening program would be happy to have discovered something as useful as those. As the authors note, hits like these in phenotypic screens might be another case of polypharmacology, or they might be hitting pathways whose "tone" we have not understood well (and for which micromolar inhibitors might work out just fine). At any rate, there might be an opportunity for fragment phenotypic screening, and even of covalent fragments (which will call for even more attention to the validity of the underlying screening model, I'd say). The paper discusses the question of target ID, which for most phenotypic programs feels like a natural progression. Most of us are innately biased towards thinking in terms of drug targets, so when a phenotypic compound emerges we want to know what it's "really" doing. And most of the time, there is such a target in there somewhere, although finding it can be quite a haul. I know of several compounds that have been kicking around for years that are obviously doing something in the assays, but no one has ever been able to pin down quite what that is! This paper makes the case for getting out of a binary mindset for target identification. They point out, correctly, that target ID is a means to an end, and that you do not actually need to identify your target to go on to clinical trials and go to the FDA for approval. I always find it surprising to find how many people are surprised by that, but it's true. You also need to realize that knowing a target may not tell you nearly as much as you would want about a compound's mechanism of action, if your new target lands in the middle of a bunch of not-well-worked-out biology. There's a good case to be made that modern chemical biology and imaging techniques have made it easier to progress things, even if you're not quite sure how they're working. We can extract huge amounts of information about the cellular effects of a given compound, and if you do a good job of matching this against a closely related structure that's phenotypically inactive, you can make a lot of headway. This doesn't mean that you shouldn't bother trying to find the target - as mentioned, this is a great way to expand the knowledge of the underlying disease, and can lead to other new programs spinning off of the phenotypic effort. But it does mean that you shouldn't freeze in fear if you don't have a target to point to. The FDA wants to see safety and efficacy, and that's what we should want to see, too, for starters. But as the paper notes at the end, phenotypic screening is going to advance at the pace of good model development. Many of these same chem-bio tools can be brought to bear on this question as well, along with advances in cell culture, organoids, and other new assay technologies. You're not going to be able (realistically) to recapitulate all the features of a human disease, so you will probably find yourself concentrating on certain features that you can make the case for driving a project on. I was very happy to see this paper reference Jack Scannell's paper on translatability (blogged about here), because its point is crucial to the whole phenotypic screening endeavour. If your underlying assay is flawed, there is nothing you can do in any other part of the project to make up for it. A poorly translatable assay is a sign that you should spend your time trying to fix it, or to go do something entirely different instead. It is not a sign that you should just keep on going, because "it's the best thing we've got". If it isn't good enough, it isn't good enough. I don't get to quote A. E. Houseman much around here, but he's right: "The toil of all that be. Helps not the primal fault; It rains into the sea. And still the sea is salt." If you don't fix your assay up front, you are raining into the sea.

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Tips for Managing Chronic Pain Beyond Prescription Painkillers

Article | April 17, 2020

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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What are the advantages of PCD Pharma Company?

Article | February 17, 2020

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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Spotlight

QuVa Pharma, Inc

QuVa Pharma, Inc. is a newly-formed national platform for sterile compounding pharmacy services led by two experienced industry executives that has received a majority equity commitment from Bain Capital Private Equity to support the company’s creation and expansion plans. As part of its formation, QuVa Pharma has acquired the assets of the compounding services division of a company leader in the field of parenteral and management services, including its state-of-the-art 503B manufacturing facility in Sugar Land, Texas.

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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.

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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.

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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

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