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

FIDIA PHARMA USA INC. | April 12, 2019 | 186 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. 

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TerSera Therapeutics acquires and develops specialty pharmaceutical products with a focus on select therapeutic areas. Our mission is to market products which truly make a difference for patients. Our focus is to bring intelligent solutions to prescribers and patients who need better solutions.

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Pharma CRM: Fostering Customer Engagement in the Life Science Industry

Article | July 7, 2022

Introduction The pharmaceutical industry is becoming more competitive day-by-day with the proliferation of novel technologies and the increasing introduction of new drug-developing companies. As a result, a significant number of pharmaceutical companies are facing difficulties securing solid financial returns. This has left no other choice for life science organizations than to move to digital-AI-based customer-centric systems to stand out. In addition, unexpected circumstances, such as the lack of in-person interaction with customers, have compelled pharma businesses to invest in cutting-edge, conversion-oriented CRM tools. As CRM in pharma provides a centralized platform for managing all the pharmaceutical data and monitoring relationships with customers, it is increasingly being sought in the industry. This strategy is getting a lot of attention in the pharmaceutical industry as a way to build and keep customer loyalty while moving toward supremacy in its respective segment. How Are CRM Solutions Assisting Pharma Companies to Become Customer-Centric? Several pharmaceutical organizations are looking for new strategies to stay competitive and improve their financial returns. The emergence of the pharma CRM trend has presented pharma businesses with a lucrative opportunity to develop new market approaches by transforming into customer-centric organizations. With real-time reports and analytics, any-time data access, and data availability in one place, novel CRM solutions are assisting pharma businesses in developing solid relationships with pharmacies, health care providers, distributors, suppliers, and even end patients. As the trend of improved customer experience and customer relationships spreads throughout the industry, many companies aiming to stay ahead are leveraging pharma CRM solutions to become more customer-centric and improve their financial returns. What are the key pharma CRM features that assist organizations to become customer centric? Let’s find out. Optimizes Products and Services As more and more businesses enter the pharmaceutical market, existing ones are looking for new ways to cut costs without compromising quality in order to survive and thrive in the respective domain. CRM software assists businesses in optimizing their products and services by creating detailed profiles of patients and potential customers, thereby declining costs and adding customer centricity. This also enables them to provide more tailored drugs, faster treatment delivery, and reduce wastage. Enables Integration with Customer Database It is important for drug manufacturing companies to maintain customer databases as they contain crucial information related to customers, such as customer buying behavior, purchasing patterns, usability, and others. Implementing cloud pharma CRM software enables integration with customer data, providing centralized access to organizations and assisting them to become customer-centric. Redefines the Customer Journey Customers and technologies are constantly evolving, and so are customer expectations. Hence, it is becoming crucial for pharma companies to track customers' journeys and analyze if the customer is in the sales cycle. Pharma CRM software assists these firms in determining whether customers are dissatisfied or are interested in an upsell, thereby making them customer-centric and increasing their revenue. Engages Customers in the Marketing Process Engaging customers within their sales and marketing strategies is of great significance for medical aid-providing enterprises to increase their ROI. As CRM for pharma helps in collecting valuable insights on what works and what does not, it assists these firms in constructing innovative marketing and sales campaigns and strategies as per customers’ interests and needs. This results in engaging customers in the marketing process. The Final Word In an intense competitive environment, it is critical for pharmaceutical organizations to engage the customers and build a better brand reputation to improve sales and ROI. As pharma CRM solutions helps in developing customer-centric services by allowing optimization of processes such as production, marketing, and sales, these solutions are ex

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Emergence of CRM in Pharmaceutical: Types & Features

Article | October 6, 2022

Introduction In the past, the pharmaceutical industry was solely concerned with the development of new drugs and medical devices, along with improving their clinical efficacy, safety, usability, and superiority over alternatives. However, the rapid transformation of the life science industry from product-based to customer-based has presented pharmaceutical companies with various obstacles, driving them to enhance their customer relationship management (CRM). Due to the proliferation of the medical and life-science industries, customer-focused solutions are becoming increasingly crucial for pharmaceutical enterprises to remain afloat. With the increasing complexity of the industry, the emergence of new business models, and the introduction of cutting-edge technologies, the pharmaceutical industry is under intense pressure to deliver superior products and services to stay on edge. In addition, the Internet has made it possible for new technologies to spread rapidly, giving consumers greater freedom to select products and services that match their individual requirements. Thus, rather than emphasizing product differentiation, drug and medical aid manufacturing companies are focusing on embracing innovative customer-centric solutions, such as pharma CRM software, to assist them in analyzing and prioritizing the wants and needs of consumers. Pharma CRM Solution Types: Roads from Product to Customer Experience As the world turns toward the dictum "the customer is king," superior customer service is no longer a luxury. In addition, as a result of increased digitalization, life science organizations are dealing with vast quantities of data. A study shows that the pharmaceutical industry generates twice as much data every five months. This is because of the increased need to capture and store a plethora of information, such as patient data and insights, HCP interests, prescription writing patterns, sensitive patient program information, and segmentation analysis, among others. CRMs assist pharmaceutical companies in accurately collecting and tracking customer information, decreasing marketing costs, increasing sales, improving customer support, and organizing data collection and storage. With all-time high competitiveness in the pharmaceutical industry, every drug and medical equipment provider is investing huge sums of money to explore new audiences before anyone else in order to get a competitive edge. In response to this, pharma CRM solutions are gaining tremendous traction across the life science industry for building solid relationships with High Lifetime Value (LTV)customers. There are different types of pharma CRM solutions available for pharma organizations to collect, store, and analyze data related to customers. Let’s look at a few: Operational Pharma CRM Operational pharma CRM solutions are ideal for assisting teams in gaining a deeper understanding of customers through the acquisition and management of customer relationships and connections, as well as improving the company's perspective on customers and sales. These systems aid pharmaceutical companies with lead generation and contact conversion. By streamlining numerous business activities such as marketing, sales, customer service, and others, they assist in creating the solid service foundation needed to retain customers and improve customer relationships. Operational pharma CRM solutions capture customer details and use them to automate sales, marketing, and other operations for providing services throughout the customer lifecycle. In addition, the system tracks and stores data related to employees, customers, and leads using a centralized platform to support existing and potential customers in an efficient manner. Analytical Pharma CRM With the increasing significance of understanding the needs of patients and customers, analytical pharma CRM systems are gaining massive popularity among mid-sized and large pharmaceutical enterprises. It is increasingly being used to accumulate and analyze large amounts of data, including sales, marketing, and financial data, and filter this data into trends and insights. Throughout the pharmaceutical industry, analytical pharma CRM solutions are making deeper inroads as they aid in the development of strategies to generate new leads, improve customer satisfaction, boost customer retention, and increase sales and marketing department efficiency. Collaborative Pharma CRM Collaborative pharma CRM enables pharmaceutical organizations to create and improve communication between various company divisions involved in customer service. These departments include marketing, sales, customer service, technical support, external customers, vendors, and distributors. The idea of collaboration in the workforce is not new, but it is one that is constantly being redefined in light of new technological innovations. It assists life-science spaces in automating their back-office operations, customer interactions, and business management, resulting in enhanced transparency among the organization’s teams. As the teams often operate independently, particularly in large pharma enterprises, the adoption of collaborative pharma CRM solutions can aid them in breaking down several communication silos to address fast-changing customer needs and effectively manage customer relationships. Pharmaceutical Customer Relationship Management Solutions: The Features List Constantly rising business expenditures and budgets, along with the emergence of new challenges and issues related to generating revenue, are compelling medical product developers to embrace modern solutions, such as pharma CRM software, for increasing sales and improving customer retention. As complexity in the pharma industry increases and competition in fields such as immunology and oncology continues to intensify, enhancing customer experiences is becoming even more important. With the "one size fits all" approach no longer delivering results, the implementation of robust and resilient tech systems for understanding customer needs and supervising medical operations is becoming necessary for pharmaceutical companies. While extensively focusing on the clinical value of the medication or medical equipment, firms operating in the pharmaceutical sector often overlook a prominent driver for success: the customer experience. By addressing critical pain points across patients’ and prescribers’ journeys, pharma CRM technology assists these companies in increasing customer satisfaction, improving adherence, and boosting revenues. Apart from this, here are some features of pharma CRM that are vital for organizations’ success Provide Integrated Customer Database Workflow Automation Management of Customers’ Accounts Cycle Activity Planning Customization Real-time data and CRM analytics Sales forecasting Why Are Life Science Companies Leveraging Pharma CRM Solutions? Today, the company's success is predominantly determined by its relationship management with customers and potential leads. With the fast-changing life science landscape and increased competitiveness, the need for pharmaceutical firms to manage customer interactions and improve customer engagement is surfacing at a robust pace to build a better brand reputation. It is crucial in the pharmaceutical industry to acquire patients' trust and maintain a stellar reputation for generating revenue and sustaining in a highly regulated environment. Using customer relationship management solutions is an excellent strategy for accomplishing this objective. According to a survey, a CRM system can enhance customer retention rates by 5%. Depending on the industry, this can then result in a profit gain ranging from 25% to 85%. (Source – PharmaVoice) Let’s see some of the reasons why pharma companies are emphasizing embracing customer relationship management solutions: Creates a Strong Connection with Customers Today, it is imperative for pharmaceutical firms to have a better understanding of their customers and their needs. Deploying pharma CRM software assists these companies in accumulating critical data and insights related to customer and patient behavior to comprehend the past, present, and future of their clients’ relationship with the organization. This aids them in creating a stronger connection with their customers. Promotes Efficiency in the Organization Automated procedures are designed to increase efficiency and enhance productivity without compromising operational accuracy. The use of CRM in pharma companies enables the automation of various consumer-facing business operations such as campaign management, marketing, customer service, and sales, among others. This assists medication manufacturers in enhancing the efficiency of their tasks. These solutions also aid in optimizing communication between the different departments, which in turn results in boosting the productivity of the business as a whole. Enhances Business Accessibility from Anywhere Remote access from anywhere is emerging as one of the essential modern needs for businesses today. For example, pharmaceutical CRM executives need to visit hospitals, chemists, warehouse staff, doctors, and stockists for sales meetings and operations. Cloud pharma CRM systems enable these representatives to access clients' and customers' vital information on the go, thus enhancing business accessibility. Improves Customer Service With the rising importance of improving customer service across the life science industry, it is becoming essential for pharma companies to respond to customer queries within the shortest possible time. Deployment of pharma CRM solutions can provide them with easy access to information stored in the database for resolving the query without causing any inconvenience to the customer or client, thereby offering better customer service. From Lead to Customer: Tracks Complete Journey Based on the current industry conditions and purchasing patterns of customers, the need to identify targeted audiences and potential leads is imperative. To get a complete picture of a customer's purchasing behavior, it is crucial for pharmaceutical firms to follow a customer from their initial interest to being a customer. Pharma CRM software enables these companies to track the complete journey of the customer, starting from being a prospective lead to a lifetime paying client. It can also assist in creating new strategies for future objectives. What Says the Future? With the emergence of new regulations, laws, and policies, the procedures and processes widely employed by pharmaceutical organizations have become more rigorous and rigid in the absence of technological assistance. In addition, intense market competition and rising company expenditures are pushing life-science firms to embrace innovative solutions to boost revenue generation, such as pharma CRM software. As the implementation of customer relationship management solutions assists pharmaceutical businesses in countering these obstacles along with optimizing processes, including customer retention, segmentation, behavior analysis, and many others, these solutions are expected to take center stage in the pharma world over the coming years. FAQ What is Pharma Customer Relationship Management Software? Pharma CRM is a tool that enables life science companies to gain sales and marketing efficiency, complete sales campaigns, adhere to compliance requirements, and efficiently monitor customer relationships. How Does CRM work for Pharma Companies? CRM is used to reduce the workload of pharma companies. Here are the steps showcasing how CRM for the pharmaceutical industry works. Capture the leads Optimize lead management Personalize the pitch Generate more customer value Personalize cross-sell and upsell Help customers help themselves What are the 3 main elements of pharma CRM software? These are the three key elements of pharma CRM solutions. Component #1 – Marketing Automation. Component #2 – Sales Force Automation. Component #3 – Customer Service Solutions.

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Tips for Managing Chronic Pain Beyond Prescription Painkillers

Article | July 12, 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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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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TerSera Therapeutics

TerSera Therapeutics acquires and develops specialty pharmaceutical products with a focus on select therapeutic areas. Our mission is to market products which truly make a difference for patients. Our focus is to bring intelligent solutions to prescribers and patients who need better solutions.

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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.

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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.

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.

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