FDA Sent These Warning Letters To Pharma/Device Companies

BARBARA W. UNGER | August 20, 2019 | 167 views

We cover three drug warning letters, one issued to a compounding pharmacy, one device warning letter and one in the food area that is a ‘first of its kind’.  One of the drug warning letters is issued to a firm that recovered solvents that were used in the manufacture of the API of valsartan products that contained the multiple potential carcinogens.  Note that Swiss Medic inspected the firm 6 days before FDA did and issued a report of non-compliance.

Spotlight

Glenmark Generics Ltd

Glenmark Generics Limited aims to be a global integrated Generic and API leader. The Company currently markets finished dose formulations in USA, Europe, and Argentina and has Active Pharmaceutical Ingredients (APIs) presence in over 80 countries through an established group of subsidiaries, marketing front-ends and offices in India and select overseas locations.

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PHARMA TECH

Pharma CRM: Fostering Customer Engagement in the Life Science Industry

Article | September 29, 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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PHARMA TECH

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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BUSINESS INSIGHTS

Tips for Managing Chronic Pain Beyond Prescription Painkillers

Article | June 30, 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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Spotlight

Glenmark Generics Ltd

Glenmark Generics Limited aims to be a global integrated Generic and API leader. The Company currently markets finished dose formulations in USA, Europe, and Argentina and has Active Pharmaceutical Ingredients (APIs) presence in over 80 countries through an established group of subsidiaries, marketing front-ends and offices in India and select overseas locations.

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PHARMACY MARKET

A novel azapeptide editing method provides potential for new drug development, Feinstein Institutes research shows

Feinstein Institutes | November 29, 2022

Peptides, short sections of proteins made up of chains of amino acids, are an important area of new drug development due to their potential for increased specificity and fewer side effects. Their main drawback is the rapid degradation by the body’s own enzymes, which has led to the need to develop longer-lasting peptide alternatives. Azapeptides are one type of peptide alternative that has shown great potential as therapeutics, exemplified by the HIV drug, Atazanavir. A new paper published in the journal Nature Communications by researchers at The Feinstein Institutes for Medical Research details proprietary reagents and methods that can selectively replace only those amino acids known to be targeted by enzymes with more stable versions to create azapeptides. The paper, authored by Yousef Al-Abed, PhD, co-director of the Institute of Bioelectronic Medicine at the Feinstein Institutes, describes the proprietary building blocks and method used to conduct systematic and robust peptide editing, replacing targeted amino acids with aza-amino acids to form more stable and efficient azapeptides. The azapeptides created could expedite the novel therapies to treat many diseases and conditions, including metabolic disease, influenza, pulmonary arterial hypertension, Crohn’s disease, arthritis, and irritable bowel diseases, among others. The paper, titled “Thiocarbazate building blocks enable the construction of azapeptides for rapid development of therapeutic candidates,” provides multiple examples of azapeptide construction, screening, and selection using a known peptide inhibitor of inflammation and bradykinin. “Peptides as drug candidates are easy to discover yet difficult to develop as final drugs because of their fast degradation in our body. A technology that circumvents these problems inherent to native peptides will change the future landscape of drug discovery. Our technology provides a platform of tools that enable minimal modification of any peptide at highly prone degradation sites, thereby increasing its life span in our body, allowing it more time to find its target and neutralize it.” Dr. Al-Abed Through peptide editing, going from peptide to azapeptide, using methods that Dr. Al-Abed and his team detail in the new paper, scientists can create potential therapies that have enhanced characteristics compared to natural peptides, like longer stabilities in a more efficient manner. Dr. Al-Abed and his team have precisely engineered thiocarbazates (a novel functional group) in the proprietary process to achieve an almost universal and more efficient means to selectively replace amino acids in a peptide chain. “Peptide drugs are a crucial resource for patients and the global pharmaceutical industry,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes and Karches Family Distinguished Chair in Medical Research. “Dr. Al-Abed and his team invented a fully automated chemical strategy using novel chemistry to make new peptide drugs which is an important new avenue for peptide drug discovery.” About the Feinstein Institutes The Feinstein Institutes for Medical Research is the research arm of Northwell Health, the largest health care provider and private employer in New York State. Home to 50 research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its five institutes of behavioral science, bioelectronic medicine, cancer, health innovations and outcomes, and molecular medicine. We make breakthroughs in genetics, oncology, brain research, mental health, autoimmunity, and are the global scientific leader in bioelectronic medicine – a new field of science that has the potential to revolutionize medicine.

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BUSINESS INSIGHTS, PHARMACY MARKET

Innovation Pharmaceuticals Announces BT BeaMedical Technologies Receives FDA Clearance for New Surgical Laser Family

Innovation Pharmaceuticals Inc | November 29, 2022

BT BeaMedical Technologies a private company developing a next-generation laser-based platform for epilepsy and cancer surgery, has notified Innovation Pharmaceuticals that it has received U.S. Food and Drug Administration clearance for its MANTA surgical laser family. The clearance is an important milestone for BeaMed in its development of an advanced laser technology with respect to shaping energy and matching it to patient specific anatomy, a novel concept that BeaMed is proving a reality. Innovation Pharmaceuticals made a strategic investment to acquire a minority stake in BeaMed in June 2022. BeaMed is the inventor and developer of the StingRay Laser System a novel laser-based thermal ablation technology designed for treatment of previously inoperable cases of epilepsy and for improvement of outcomes and enablement of new treatment options for oncology procedures, including those treating brain, prostate, liver, breast, and lung cancers. The StingRay Laser System will utilize the MANTA laser family as its core energy generation devices coupled to new fiber optic technology, allowing a perfect match between the exact structure of tumors and epileptic focal points and the energy delivery, while protecting vital functional areas against thermal damage. The MANTA surgical laser family was cleared by the FDA including five different wavelengths and soft tissue use in a very wide set of clinical specialties, including Neurosurgery, Spinal Surgery, Urology, Thoracic Surgery, Pulmonary Surgery, Gynecology, General Surgery, ENT/Head and Neck, Plastic Surgery, Orthopedics, Arthroscopy, Ophthalmology, Radiology, and Oral Surgery. BeaMed expects to soon make requisite submissions to the FDA for clearance of its fiber optics for use in multiple medical indications. “We are excited with the speed of progress BeaMed is making towards introduction of its new platform product with the potential to help millions of patients globally suffering from epilepsy and cancer in multiple specialties. The execution of this submission and the speed of clearance speaks volumes to the commercialization strategy and the exceptional capabilities of the regulatory team at BeaMed,” Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals “This is an exciting and important milestone for our company. This clearance gives us two key achievements. First, U.S. market access to a wide range of potential laser energy sources, each allowing us different and unique tissue interaction, an achievement which will have wide clinical implications. The second is a very wide set of intended uses covering many key potential markets for our technology. This underscores the clear regulatory strategy of BeaMed, which goes hand in hand with our broad impact business vision of revolutionizing key treatments, including brain tumors, epilepsy, lung cancer, prostate cancer, breast cancer and more,” said Gil Shapira, co-founder of BeaMed. BeaMed was founded by Moshe Eshkol and Gil Shapira, both highly experienced specialists in surgical lasers and medical devices. BeaMed and the development of the StingRay system are also supported by a special prestigious grant from the BIRD Foundation a bi-national organization supporting Israel-US collaboration. Gil Shapira brings forward 26+ years of engineering and product development and management experience, with over 17 years in the surgical laser industry. Gil owns and manages neoLaser, a company he founded in 2012, and led to revenue growth and profitability, with a 43% CAGR on its way to more than 1200 global installations and performing 50,000+ surgeries annually in over 30 countries. Previously, Gil led product development and marketing at OmniGuide, a successful high-growth laser-based medical device spin-off out of the Massachusetts Institute of Technology. About Innovation Pharmaceuticals Innovation Pharmaceuticals Inc. is a clinical stage biopharmaceutical company developing a portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, and infectious diseases. The Company is also active in evaluating other potential investment opportunities that can add value and diversify its portfolio.

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PHARMACY MARKET

FogPharma Announces $178 Million Series D Financing to Advance Pipeline of First-in-Class Helicon Polypeptide Therapeutics

FogPharma | November 28, 2022

FogPharma®, a biopharmaceutical company pioneering a new class of precision medicines that could ultimately prove applicable to the vast majority of therapeutic targets, including those previously considered “undruggable,” announced a $178 Million Series D financing. The financing round includes new investors ARCH Venture Partners, Milky Way Investments and Fidelity Management & Research Company and existing investors VenBio Partners, Deerfield Management, GV, Cormorant Asset Management, funds and accounts advised by T. Rowe Price Associates, Inc., Invus, Farallon Capital Management, HBM Healthcare Investments, Casdin Capital, and PagsGroup, also participated. Proceeds from the Series D financing will be used to advance and accelerate FogPharma’s growing pipeline of hyperstabilized α-helical (Helicon™) polypeptide therapeutics, a proprietary new class of drugs designed to overcome the limitations of today’s precision medicines with broad applicability to the vast majority of disease targets and therapeutic areas. FogPharma’s lead Helicon polypeptide development candidate, FOG-001, a first-and-only-in-class direct TCF-blocking β-catenin inhibitor with potential applicability to significant cancer patient populations, is expected to enter clinical development in mid-2023. In addition, FogPharma is advancing other first-in-class programs against important, biologically validated cancer targets that have remained elusive to other approaches including TEAD, NRAS, Pan-KRAS, ERG and Cyclin E1. “FogPharma continues to make rapid progress on our moonshot mission to achieve universal druggability – a world where no targets are off-limits to medicine. We believe that Helicon polypeptides, a compelling new therapeutic modality, represent the future of precision medicine. We are thrilled by the support of our investors and will continue to build our platform capabilities, product pipeline which aims to address a significant percentage of cancer patient populations, and our phenomenal team across all levels as we aim to create one of the most impactful new classes of drugs in history.” Gregory Verdine, Ph.D., founder, chairman and chief executive officer of FogPharma In connection with the Series D Financing, Rick Klausner, M.D., has been appointed to FogPharma’s board of directors. In addition, Dr. Verdine has been appointed as chairman of the board. “The team at FogPharma is building an unprecedented new therapeutic modality and robust pipeline with the potential to make a meaningful difference in the lives of cancer patients,” said Dr. Klausner. “I am excited to join the board of directors and be part of something special particularly at this important time as FogPharma continues to impressively scale its science, team, operations and infrastructure, with the goal of advancing its first Helicon polypeptide therapeutic into the clinic.” Dr. Klausner is currently the founder and chief scientist of Altos Labs and founder and chairman of Lyell Immunopharma. Dr. Klausner was founder and director of Juno Therapeutics and founder and director of GRAIL. He is also the chairman of Sonoma Biotherapeutics and co-founder and chairman of Lifemine Therapeutics. Previously, Dr. Klausner served as senior vice president, chief medical officer and chief opportunity officer of Illumina Corporation and as executive director for global health for the Bill and Melinda Gates Foundation. Dr. Klausner was appointed by Presidents Clinton and Bush as the eleventh director of the U.S. National Cancer Institute between 1995 and 2001. Dr. Klausner served as chief of the Cell Biology and Metabolism Branch of the National Institute of Child Health and Human Development as well as a past president of the American Society of Clinical Investigation. He has served in senior advisory roles to the U.S., Norwegian, Qatari and Indian governments. About FogPharma’s Universal Druggability Platform and Helicon™ Polypeptide Therapeutics Existing drug classes are limited in both reach and applicability, with more than 80% of known human protein disease targets considered “undruggable” because they are beyond the reach of both antibodies and small molecules. FogPharma’s Helicon peptide drug discovery engine integrates directed evolution, proprietary α-helix conformational hyperstabilization chemistry, highly multiplexed drug optimization technology, artificial intelligence including deep learning and machine learning, structure-based drug discovery, cancer genomics and biology, and multiscale manufacturing to rapidly discover Helicon polypeptide therapeutics. This novel therapeutic modality combines the targeting strength and specificity of antibodies with the broad tissue distribution, intracellular target engagement and oral dosing optionality of small molecules to address the limitations of today’s precision medicines and reach the most difficult targets – achieving universal druggability. About FOG-001 FogPharma’s lead Helicon polypeptide development candidate, FOG-001, a first-and-only-in-class direct TCF-blocking β-catenin inhibitor. Dysregulation of the Wnt/β-catenin signaling pathway has been shown to occur in at least 20% of all human cancers. In the U.S. alone, FOG-001 has the potential to become a new treatment option for >1 million patients suffering from a broad range of intractable cancers. In biochemical and cellular studies, FOG-001 has been shown to potently, precisely and selectively disrupt the interaction of β-catenin with its obligate downstream transcription factor, TCF. Preclinical studies have demonstrated the ability of FOG-001 to cause tumor growth inhibition and regression by disrupting β-catenin-dependent signaling. FOG-001 is the inaugural member of FogPharma’s TCF-Catenix family of direct-acting β-catenin antagonists and combines key features that distinguish it from previously reported Wnt/β-catenin pathway modulators: FOG-001 acts inside the cell, where it directly binds the key oncogenic driver β-catenin; and FOG-001 blocks TCF-β-catenin engagement at the most downstream node in the canonical Wnt pathway, thus abrogating the signal transmission mechanism by which most, if not all, known Wnt pathway mutations are believed to drive oncogenesis. About FogPharma FogPharma is a biopharmaceutical company pioneering the discovery and development of Helicon™ polypeptides. Through this novel therapeutic modality, FogPharma aims to address the limitations of existing drug classes and achieve universal druggability – a world where no targets are off-limits to new medicines. Spun out of Harvard University by pioneering academic scientist and successful biotech company builder Dr. Gregory Verdine, FogPharma is advancing a broad pipeline of Helicon polypeptide therapeutics against important and biologically validated cancer targets that have remained elusive to other approaches, with the goal of providing new targeted treatment options for significant cancer patient populations. FogPharma is headquartered in Cambridge, Mass., and has raised more than $360 million to date from leading life sciences investors.

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PHARMACY MARKET

A novel azapeptide editing method provides potential for new drug development, Feinstein Institutes research shows

Feinstein Institutes | November 29, 2022

Peptides, short sections of proteins made up of chains of amino acids, are an important area of new drug development due to their potential for increased specificity and fewer side effects. Their main drawback is the rapid degradation by the body’s own enzymes, which has led to the need to develop longer-lasting peptide alternatives. Azapeptides are one type of peptide alternative that has shown great potential as therapeutics, exemplified by the HIV drug, Atazanavir. A new paper published in the journal Nature Communications by researchers at The Feinstein Institutes for Medical Research details proprietary reagents and methods that can selectively replace only those amino acids known to be targeted by enzymes with more stable versions to create azapeptides. The paper, authored by Yousef Al-Abed, PhD, co-director of the Institute of Bioelectronic Medicine at the Feinstein Institutes, describes the proprietary building blocks and method used to conduct systematic and robust peptide editing, replacing targeted amino acids with aza-amino acids to form more stable and efficient azapeptides. The azapeptides created could expedite the novel therapies to treat many diseases and conditions, including metabolic disease, influenza, pulmonary arterial hypertension, Crohn’s disease, arthritis, and irritable bowel diseases, among others. The paper, titled “Thiocarbazate building blocks enable the construction of azapeptides for rapid development of therapeutic candidates,” provides multiple examples of azapeptide construction, screening, and selection using a known peptide inhibitor of inflammation and bradykinin. “Peptides as drug candidates are easy to discover yet difficult to develop as final drugs because of their fast degradation in our body. A technology that circumvents these problems inherent to native peptides will change the future landscape of drug discovery. Our technology provides a platform of tools that enable minimal modification of any peptide at highly prone degradation sites, thereby increasing its life span in our body, allowing it more time to find its target and neutralize it.” Dr. Al-Abed Through peptide editing, going from peptide to azapeptide, using methods that Dr. Al-Abed and his team detail in the new paper, scientists can create potential therapies that have enhanced characteristics compared to natural peptides, like longer stabilities in a more efficient manner. Dr. Al-Abed and his team have precisely engineered thiocarbazates (a novel functional group) in the proprietary process to achieve an almost universal and more efficient means to selectively replace amino acids in a peptide chain. “Peptide drugs are a crucial resource for patients and the global pharmaceutical industry,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes and Karches Family Distinguished Chair in Medical Research. “Dr. Al-Abed and his team invented a fully automated chemical strategy using novel chemistry to make new peptide drugs which is an important new avenue for peptide drug discovery.” About the Feinstein Institutes The Feinstein Institutes for Medical Research is the research arm of Northwell Health, the largest health care provider and private employer in New York State. Home to 50 research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its five institutes of behavioral science, bioelectronic medicine, cancer, health innovations and outcomes, and molecular medicine. We make breakthroughs in genetics, oncology, brain research, mental health, autoimmunity, and are the global scientific leader in bioelectronic medicine – a new field of science that has the potential to revolutionize medicine.

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BUSINESS INSIGHTS, PHARMACY MARKET

Innovation Pharmaceuticals Announces BT BeaMedical Technologies Receives FDA Clearance for New Surgical Laser Family

Innovation Pharmaceuticals Inc | November 29, 2022

BT BeaMedical Technologies a private company developing a next-generation laser-based platform for epilepsy and cancer surgery, has notified Innovation Pharmaceuticals that it has received U.S. Food and Drug Administration clearance for its MANTA surgical laser family. The clearance is an important milestone for BeaMed in its development of an advanced laser technology with respect to shaping energy and matching it to patient specific anatomy, a novel concept that BeaMed is proving a reality. Innovation Pharmaceuticals made a strategic investment to acquire a minority stake in BeaMed in June 2022. BeaMed is the inventor and developer of the StingRay Laser System a novel laser-based thermal ablation technology designed for treatment of previously inoperable cases of epilepsy and for improvement of outcomes and enablement of new treatment options for oncology procedures, including those treating brain, prostate, liver, breast, and lung cancers. The StingRay Laser System will utilize the MANTA laser family as its core energy generation devices coupled to new fiber optic technology, allowing a perfect match between the exact structure of tumors and epileptic focal points and the energy delivery, while protecting vital functional areas against thermal damage. The MANTA surgical laser family was cleared by the FDA including five different wavelengths and soft tissue use in a very wide set of clinical specialties, including Neurosurgery, Spinal Surgery, Urology, Thoracic Surgery, Pulmonary Surgery, Gynecology, General Surgery, ENT/Head and Neck, Plastic Surgery, Orthopedics, Arthroscopy, Ophthalmology, Radiology, and Oral Surgery. BeaMed expects to soon make requisite submissions to the FDA for clearance of its fiber optics for use in multiple medical indications. “We are excited with the speed of progress BeaMed is making towards introduction of its new platform product with the potential to help millions of patients globally suffering from epilepsy and cancer in multiple specialties. The execution of this submission and the speed of clearance speaks volumes to the commercialization strategy and the exceptional capabilities of the regulatory team at BeaMed,” Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals “This is an exciting and important milestone for our company. This clearance gives us two key achievements. First, U.S. market access to a wide range of potential laser energy sources, each allowing us different and unique tissue interaction, an achievement which will have wide clinical implications. The second is a very wide set of intended uses covering many key potential markets for our technology. This underscores the clear regulatory strategy of BeaMed, which goes hand in hand with our broad impact business vision of revolutionizing key treatments, including brain tumors, epilepsy, lung cancer, prostate cancer, breast cancer and more,” said Gil Shapira, co-founder of BeaMed. BeaMed was founded by Moshe Eshkol and Gil Shapira, both highly experienced specialists in surgical lasers and medical devices. BeaMed and the development of the StingRay system are also supported by a special prestigious grant from the BIRD Foundation a bi-national organization supporting Israel-US collaboration. Gil Shapira brings forward 26+ years of engineering and product development and management experience, with over 17 years in the surgical laser industry. Gil owns and manages neoLaser, a company he founded in 2012, and led to revenue growth and profitability, with a 43% CAGR on its way to more than 1200 global installations and performing 50,000+ surgeries annually in over 30 countries. Previously, Gil led product development and marketing at OmniGuide, a successful high-growth laser-based medical device spin-off out of the Massachusetts Institute of Technology. About Innovation Pharmaceuticals Innovation Pharmaceuticals Inc. is a clinical stage biopharmaceutical company developing a portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, and infectious diseases. The Company is also active in evaluating other potential investment opportunities that can add value and diversify its portfolio.

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FogPharma Announces $178 Million Series D Financing to Advance Pipeline of First-in-Class Helicon Polypeptide Therapeutics

FogPharma | November 28, 2022

FogPharma®, a biopharmaceutical company pioneering a new class of precision medicines that could ultimately prove applicable to the vast majority of therapeutic targets, including those previously considered “undruggable,” announced a $178 Million Series D financing. The financing round includes new investors ARCH Venture Partners, Milky Way Investments and Fidelity Management & Research Company and existing investors VenBio Partners, Deerfield Management, GV, Cormorant Asset Management, funds and accounts advised by T. Rowe Price Associates, Inc., Invus, Farallon Capital Management, HBM Healthcare Investments, Casdin Capital, and PagsGroup, also participated. Proceeds from the Series D financing will be used to advance and accelerate FogPharma’s growing pipeline of hyperstabilized α-helical (Helicon™) polypeptide therapeutics, a proprietary new class of drugs designed to overcome the limitations of today’s precision medicines with broad applicability to the vast majority of disease targets and therapeutic areas. FogPharma’s lead Helicon polypeptide development candidate, FOG-001, a first-and-only-in-class direct TCF-blocking β-catenin inhibitor with potential applicability to significant cancer patient populations, is expected to enter clinical development in mid-2023. In addition, FogPharma is advancing other first-in-class programs against important, biologically validated cancer targets that have remained elusive to other approaches including TEAD, NRAS, Pan-KRAS, ERG and Cyclin E1. “FogPharma continues to make rapid progress on our moonshot mission to achieve universal druggability – a world where no targets are off-limits to medicine. We believe that Helicon polypeptides, a compelling new therapeutic modality, represent the future of precision medicine. We are thrilled by the support of our investors and will continue to build our platform capabilities, product pipeline which aims to address a significant percentage of cancer patient populations, and our phenomenal team across all levels as we aim to create one of the most impactful new classes of drugs in history.” Gregory Verdine, Ph.D., founder, chairman and chief executive officer of FogPharma In connection with the Series D Financing, Rick Klausner, M.D., has been appointed to FogPharma’s board of directors. In addition, Dr. Verdine has been appointed as chairman of the board. “The team at FogPharma is building an unprecedented new therapeutic modality and robust pipeline with the potential to make a meaningful difference in the lives of cancer patients,” said Dr. Klausner. “I am excited to join the board of directors and be part of something special particularly at this important time as FogPharma continues to impressively scale its science, team, operations and infrastructure, with the goal of advancing its first Helicon polypeptide therapeutic into the clinic.” Dr. Klausner is currently the founder and chief scientist of Altos Labs and founder and chairman of Lyell Immunopharma. Dr. Klausner was founder and director of Juno Therapeutics and founder and director of GRAIL. He is also the chairman of Sonoma Biotherapeutics and co-founder and chairman of Lifemine Therapeutics. Previously, Dr. Klausner served as senior vice president, chief medical officer and chief opportunity officer of Illumina Corporation and as executive director for global health for the Bill and Melinda Gates Foundation. Dr. Klausner was appointed by Presidents Clinton and Bush as the eleventh director of the U.S. National Cancer Institute between 1995 and 2001. Dr. Klausner served as chief of the Cell Biology and Metabolism Branch of the National Institute of Child Health and Human Development as well as a past president of the American Society of Clinical Investigation. He has served in senior advisory roles to the U.S., Norwegian, Qatari and Indian governments. About FogPharma’s Universal Druggability Platform and Helicon™ Polypeptide Therapeutics Existing drug classes are limited in both reach and applicability, with more than 80% of known human protein disease targets considered “undruggable” because they are beyond the reach of both antibodies and small molecules. FogPharma’s Helicon peptide drug discovery engine integrates directed evolution, proprietary α-helix conformational hyperstabilization chemistry, highly multiplexed drug optimization technology, artificial intelligence including deep learning and machine learning, structure-based drug discovery, cancer genomics and biology, and multiscale manufacturing to rapidly discover Helicon polypeptide therapeutics. This novel therapeutic modality combines the targeting strength and specificity of antibodies with the broad tissue distribution, intracellular target engagement and oral dosing optionality of small molecules to address the limitations of today’s precision medicines and reach the most difficult targets – achieving universal druggability. About FOG-001 FogPharma’s lead Helicon polypeptide development candidate, FOG-001, a first-and-only-in-class direct TCF-blocking β-catenin inhibitor. Dysregulation of the Wnt/β-catenin signaling pathway has been shown to occur in at least 20% of all human cancers. In the U.S. alone, FOG-001 has the potential to become a new treatment option for >1 million patients suffering from a broad range of intractable cancers. In biochemical and cellular studies, FOG-001 has been shown to potently, precisely and selectively disrupt the interaction of β-catenin with its obligate downstream transcription factor, TCF. Preclinical studies have demonstrated the ability of FOG-001 to cause tumor growth inhibition and regression by disrupting β-catenin-dependent signaling. FOG-001 is the inaugural member of FogPharma’s TCF-Catenix family of direct-acting β-catenin antagonists and combines key features that distinguish it from previously reported Wnt/β-catenin pathway modulators: FOG-001 acts inside the cell, where it directly binds the key oncogenic driver β-catenin; and FOG-001 blocks TCF-β-catenin engagement at the most downstream node in the canonical Wnt pathway, thus abrogating the signal transmission mechanism by which most, if not all, known Wnt pathway mutations are believed to drive oncogenesis. About FogPharma FogPharma is a biopharmaceutical company pioneering the discovery and development of Helicon™ polypeptides. Through this novel therapeutic modality, FogPharma aims to address the limitations of existing drug classes and achieve universal druggability – a world where no targets are off-limits to new medicines. Spun out of Harvard University by pioneering academic scientist and successful biotech company builder Dr. Gregory Verdine, FogPharma is advancing a broad pipeline of Helicon polypeptide therapeutics against important and biologically validated cancer targets that have remained elusive to other approaches, with the goal of providing new targeted treatment options for significant cancer patient populations. FogPharma is headquartered in Cambridge, Mass., and has raised more than $360 million to date from leading life sciences investors.

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