New tentative approval for Watson Labs drug dienogest; estradiol valerate

June 9, 2019 | 166 views

This ingredient has seventy-three patent family members in thirty-eight countries. Two suppliers are listed for this compound. There is one tentative approval for this compound.

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EUSA Pharma

EUSA Pharma is a recently formed specialty pharmaceutical company headquartered in the UK which supplies medicines and medical devices across Europe and the US through its own operations, and worldwide through a network of partners in over 40 countries.

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PHARMA TECH

Biomaterials Emerging as a Blessing in the Pharmaceutical Industry

Article | July 7, 2022

Biomaterials are materials (natural or synthetic) that are biologically compatible with the human body and are used to replace, restore, support, or enhance the biological functions of damaged tissues while being in constant contact with body fluids. Over the past couple of decades, biomaterials have made their mark in the rapidly evolving pharmaceutical and medical fields. These materials are designed to interact with living biological tissue and are used for therapeutic and diagnostic purposes. Previously, biomaterials were only used in medical devices to replace or treat tissues or improve organ functions. However, it was later discovered that the term "non-viable" was inappropriate as biomaterials can be used for a variety of medical applications other than implanted devices. Growing Cases of Chronic Wounds Deepen the Penetration of Biomaterials There is a significant rise in the side effects caused due to the use of non-biocompatible materials for the treatment of chronic wounds caused by conditions such as malignant tumors, diabetes, infections, and vasculopathy, among others. Using biodegradable and biocompatible drug carriers is one way to avoid or reduce the side effects that may result from drug delivery to cells with enhanced efficiency and performance during the health rehabilitation process. Also, the use of biomaterials assists in enhancing chronic wound healing through anti-infection and antioxidant effects, immunoregulation, debridement, extracellular matrix remodeling, and angiogenesis, further increasing the adoption of pharmaceutical products made using these materials. Due to their favorable properties, biomaterials are gaining massive traction across the pharmaceutical industry. Here are some of the applications of biomaterials as follows. Dental Injectable Medical Implants Organ Regeneration (Heart, Lungs, Knee, Tracheal graft, others) Drug Delivery Regenerative Medicines Tissue Engineering Wound Healing Disease Treatment The Way Forward Leading manufacturers of biomaterials are aiming at expanding their biomaterial production capacity to strengthen their footprint and gain a competitive edge in the industry. For instance, in 2020, Evonik Industries AG, a German specialty chemicals company, announced the launch of a new biomaterial manufacturing facility in Birmingham, the U.S. to expand the company’s territory across North America. Following the trend, biomaterials are anticipated to create massive investment prospects for pharmaceutical players.

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BUSINESS INSIGHTS

Use of AI: Reshaping the Pharmaceutical Industry

Article | June 30, 2022

For decades, the pharmaceutical industry has counted on state-of-the-art technologies to ensure the market entry of safe and dependable medications. The recent pandemic has shown how important it is for drug companies to get new drugs and vaccines on the market as soon as possible. The incorporation of artificial intelligence and machine learning technologies has greatly benefited the consumer healthcare business and the pharmaceutical industry. These technologies have been indispensable in the field of augmented intelligence, where they are used for applications such as disease detection and diagnosis, research and development, drug manufacturing, and others. How is AI Being Used Across the Pharmaceutical Sector? AI and ML are finding a plethora of applications across the pharmaceutical sector, starting from managing the process of clinical trial databases to drug discovery and disease diagnosis and treatment. These advanced technologies have further gained immense popularity with the advent of the COVID pandemic and the race to discover effective vaccines. The top-level uses of AI across the pharmaceutical sector are as follows Personalized Treatment/ Digital Therapeutics – AI is extensively being used to identify and assist drug developers to provide reliable and accurate insights for developing personalized therapeutics. Disease Identification/ Suggestive Treatment – With robust assessing abilities, AI is finding applications for the diagnosis of diseases ranging from Covid-19 to oncology to degeneration in the eyes. Drug Discovery and Manufacturing – AI assists in screening and comparing the predicted success rate of drug compounds based on biological factors with the results of the initial screening process such as rapid RNA and DNA quantification. Clinical Trials – The technology helps in identifying the most suitable candidate for the clinical trial on the basis of disease conditions, history, and additional attributes covering infection rates, ethnicity, and demographics to study the impact of the drug. The Way Ahead With growing applications in the development of novel therapeutic medications, shifting patient inclination toward personalized medicines, and the introduction of advanced medical fields such as gene therapy, AI is estimated to transform the pharmaceutical

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PHARMA TECH

How Pharma Is Utilizing AI and Analytic Capabilities to Produce Positive Results

Article | August 9, 2022

Applications for AI are as diverse as the industries that employ them, and pharma has identified the particular varieties of AI that are most effective in attaining quicker, more fruitful results across a variety of business activities. In a world where every second counts, pharma and biotech businesses are under pressure to shorten the time to insight and deliver success. As a result, leading organizations quickly realize the potential of artificial intelligence (AI) as a crucial tool for advancing their operations. Leading pharma and biotech firms have realized the potential of AI and are utilizing it to boost productivity and innovation across the board, from production to drug discovery. Their procedures have significantly benefited from the application of machine learning (ML) and natural language processing (NLP), and the results are only becoming better because AI gets stronger and "smarter" the more data it processes. Advantages Pharma Industry Can Leverage Increased effectiveness across the spectrum in the pharmaceutical industry Drug discovery accelerates Superior disease surveillance, detection, and prevention Clinical trials with lower risk Greater insight into the client NLP is used to turn clinical trial data that is text-intensive and highly categorized into the data utilized in machine learning (ML) models, allowing the computer system to apply patterns to the data and generate insights. Clinical trial data is structured and enriched, making it possible to analyze and visualize the data for use in successful plans and strategies for clinical trial design, manufacturing, marketing, and other areas. Faster time to insight and improved business outcomes are the end results. A particularly true principle of machine learning applications is that the outcomes from using AI applications are only as reliable as the data itself. The Pharma Intelligence offering, which combines high-quality, extensive data from the pharmaceutical and biotechnology industries with advanced analytics and AI applications, has assisted customers with high-value products in resolving some of their most difficult key problems, including target prioritization, modalities innovation, competitive benchmarking, clinical trial design and deployment, and more.

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BUSINESS INSIGHTS

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

Article | June 30, 2022

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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EUSA Pharma

EUSA Pharma is a recently formed specialty pharmaceutical company headquartered in the UK which supplies medicines and medical devices across Europe and the US through its own operations, and worldwide through a network of partners in over 40 countries.

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PRACTICE MANAGEMENT

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

Infant Bacterial Therapeutics | December 28, 2021

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

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PHARMACY MARKET

Titan Pharmaceuticals to Explore Strategic Alternatives

Titan Pharmaceuticals, Inc. | December 22, 2021

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

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BUSINESS INSIGHTS

TriMas Closes on Acquisition of Omega

TriMas | December 21, 2021

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

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PRACTICE MANAGEMENT

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

Infant Bacterial Therapeutics | December 28, 2021

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

Read More

PHARMACY MARKET

Titan Pharmaceuticals to Explore Strategic Alternatives

Titan Pharmaceuticals, Inc. | December 22, 2021

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

Read More

BUSINESS INSIGHTS

TriMas Closes on Acquisition of Omega

TriMas | December 21, 2021

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

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