Intensive Hypertension Treatment May Lower Death Risk

pharmanewsonline | May 07, 2019

A new research published in the American Heart Association’s (AHA) journal Hypertension,has shown that people with type 2 diabetes who received intensive treatment to keep blood pressure levels at or below 130/80 mmHg may reduce the risk of death from any cause. Diabetes is one of the most common and costly chronic conditions in Nigeria, with over 5 million people living with diabetes or prediabetes, according to the 2017 report compiled by Journal of Medical Research and Health Education. Diabetes is a disease that occurs when your blood glucose, also called blood sugar, is too high. Blood glucose is your main source of energy and comes from the food you eat. Insulin, a hormone made by the pancreas, helps glucose from food get into your cells to be used for energy.
Hypertension is another name for high blood pressure. It can lead to severe complications and increases the risk of heart disease, stroke, and death. Blood pressure is the force exerted by the blood against the walls of the blood vessels. Unmanaged hypertension can lead to a heart attack, stroke, and other problems.

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West Nile virus can cause severe neurological symptoms and can even result in death. It’s common in horses and birds are natural hosts, but don’t become infected. For horses, there is a vaccine available, but no vaccine to prevent the disease in humans exists. People can get the disease from mosquitoes that carry the disease, and while many patients might not even realize they have it, in others, it causes weakness, flu-like symptoms, nausea and in more serious cases, West Nile fever and West Nile encephalitis. Recently in Greece, there was an outbreak of West Nile.


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BUSINESS INSIGHTS

Model N and Pfizer Innovate Drug Price Transparency Reporting

Model N, Inc. | August 04, 2022

Model N, Inc. the leader in revenue optimization and compliance, announced the launch of Transparency Talks, a new, three-part education series for pharmaceutical companies that tackles the topic of price transparency regulations for prescription drugs. Transparency Talks will bring together leaders from Model N, Pfizer and Global Pricing Innovations (GPI) to explore state drug pricing laws and regulations, as well as facilitate a discussion on trends, best practices and innovative approaches that help pharmaceutical companies meet regulatory compliance goals. First-Ever SaaS Solution for State Price Transparency Mandates Model N has pioneered a technology-driven approach to state price transparency regulations. Its new State Price Transparency Management (SPTM) solution for the Model N Revenue Cloud is the first-ever SaaS solution built specifically to assist pharmaceutical and biotech companies in operationalizing the complete, end-to-end process for meeting State Price Transparency mandates. “Life sciences companies must find an effective way to prepare and respond to fast-moving changes in state price transparency regulations, and we are excited to deliver innovative solutions to help them avoid costly mistakes. t’s been an honor to partner with Pfizer on State Price Transparency Management, creating an innovative solution that helps navigate the fluid state drug price reporting landscape.” Kyle Forcier, Senior Director of Life Sciences Product Marketing at Model N Pfizer and GPI on SPTM The SPTM solution was developed with the collaboration of Pfizer, the world’s largest pharmaceutical company. “Our collaboration with Model N has delivered a tool that helps us better manage complex state reporting requirements,” said Laura Topal, Senior Director, Strategic Pricing, Pfizer. “We’re proud of what we have achieved together, and we’re excited about sharing our learnings with the larger pharma community.” Rachel Jao, Head of Commercial Strategy from GPI, a market leader in innovative solutions for biopharma and market access, will also join Transparency Talks to share the latest in industry best practices. “More than 20 states have drug pricing transparency laws on the books today, and there can be severe financial consequences for non-compliance,” Jao said. “Transparency Talks from Model N is a valuable way for pharma business leaders to learn more about the current regulatory environment and to explore solutions that will help them address this significant challenge.” About Model N Model N is the leader in revenue optimization and compliance for pharmaceutical, medtech and high-tech innovators. Our intelligent platform powers your digital transformation with integrated technology, data, analytics, and expert services that deliver deep insight and control. Our integrated cloud solution is proven to automate pricing, incentive and contract decisions to scale business profitably and grow revenue. Model N is trusted across more than 120 countries by the world’s leading pharmaceutical, medical technology, semiconductor, and high-tech companies, including Johnson & Johnson, AstraZeneca, Stryker, Seagate Technology, Broadcom, and Microchip Technology.

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BUSINESS INSIGHTS

Akorn Announces FDA-approved Generic Cetrorelix Acetate for Injection 0.25 mg

Akorn Pharmaceuticals | August 17, 2022

Akorn Operating Company LLC, a specialty pharmaceutical company, announces that it received FDA approval for a generic version of Cetrorelix Acetate for Injection, 0.25 mg. This is the first approved AP-Rated bioequivalent version of Merck Serono's Cetrotide®.1 "We are pleased to announce the first approved AP-rated generic option for women receiving fertility treatments. As an increasing number of infants are being conceived via the use of ART, Akorn is excited to be able to offer a competitively priced option to support women who undergo this series of treatments. This is a welcome addition to our portfolio of more than 200 specialty and injectable generics." Akorn President and CEO Douglas Boothe Assisted Reproductive Technology (ART) is defined as fertility treatments where eggs or embryos are handled for the purpose of establishing a pregnancy. 2 The FDA granted Akorn a Competitive Generic Therapy (CGT) designation for Cetrorelix, a designation intended to incentivize effective development, efficient review, and timely market entry of drugs for which there is inadequate generic competition. As the first approved applicant with the CGT designation, Akorn's Cetrorelix is eligible for 180 days of CGT market exclusivity, which will begin to run from the commercial launch of Cetrorelix. According to IQVIA, U.S. sales of Cetrorelix through June of 2022 were approximately $63 million with full year U.S. sales projection of approximately $127 million. About Cetrorelix Acetate for Injection 0.25 mg Cetrorelix is used to prevent premature ovulation during controlled ovarian stimulation. Cetrorelix blocks the effects of a natural hormone, called gonadotropin‐releasing hormone (GnRH). GnRH controls the secretion of another hormone, called luteinizing hormone (LH), which induces ovulation during the menstrual cycle. During hormone treatment for ovarian stimulation, premature ovulation may lead to eggs that are not suitable for fertilization. Cetrorelix Acetate for Injection blocks such undesirable premature ovulation. About Akorn Akorn Operating Company LLC, develops, manufactures and markets specialty pharmaceuticals. Since 1971, as an industry leader in generic products in alternate dosage forms such as ophthalmics, injectables, oral liquids, otics, topicals, inhalants and nasal sprays, we focus each day on our mission to improve lives, through the quality, availability and affordability of our products.

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BUSINESS INSIGHTS

Element Materials Technology Announces Completion of its Acquisition by Temasek

Element and Temasek | July 08, 2022

Element Materials Technology a global leader in testing, inspection, and certification services, has completed its acquisition by Temasek, a global investor headquartered in Singapore. Temasek has been a minority shareholder in Element since 2019. Temasek has acquired Element from Bridgepoint, whose successful ownership has been an important part of a more than ten-fold increase in Element’s turnover over the past decade. The acquisition, which was subject to regulatory approvals, was previously announced on 25th January 2022. As a highly differentiated TIC leader with a track record of technical expertise, Element is a trusted partner to customers, supporting them from early R&D, through complex government approvals, and into production, with a focus on laboratory-based testing. Its 7,000+ scientists, engineers, and technologists, based across a global network of more than 200 laboratories in 30 countries, serve technically demanding and highly regulated sectors, ensuring products are safe and sustainable. Element works with customers across a wide spectrum, from developing the next generation of aircraft, spacecraft, and autonomous vehicles, to vaccine component testing in its US pharmaceutical laboratories; and from the certification of smartphones and wearable technologies, to providing 5G carrier approvals and developing connected robots. The Group generates annual revenues of more than $1 billion and has grown at over 20% a year over the last ten years. It is well-positioned to accelerate this growth as it builds deeper leadership positions in critical end-markets including life sciences and connected technologies. Element also benefits from strong global ESG tailwinds - with over 60% of its work directly supporting customers on their sustainability journeys, it will continue to play a critical role in the decarbonization of the global economy. “We are delighted to complete this landmark transaction with Temasek, and to begin work on the next chapter of Element’s story. Their partnership over the last three years has been hugely beneficial to our growth. Today, Element is the partner of choice to companies at the forefront of innovation, from advanced medical science to autonomous cars, and has one of the most talented and highly qualified teams in the TIC space. Jo Wetz, CEO of Element We are excited to build upon that legacy of success and drive Element forward by scaling our business further through strategic investments and acquisitions, with a focus on high growth end-markets such as life sciences and connected technologies. Element will continue to play a crucial role in supporting our customers on their sustainability journeys, and in making tomorrow safer than today.” Allan Leighton, Non-Executive Chairman of Element, said: “Element is a true success story – a talented management team leading an exceptional group of experts across offices and laboratories in more than 30 countries around the world. We’re now entering another exciting chapter of purpose-driven growth, together with our customers and our new owners”. Chris Busby, partner at Bridgepoint, said: “Element has been bold in its ambition, delivered impressive organic growth, and implemented a targeted acquisition strategy. As a result, it has significantly expanded its expertise for over 50,000 customers worldwide and become an undisputed heavyweight in TIC. We are proud of what Element has achieved and wish them continued success in the future.” Element was advised by Bank of America Securities, Goldman Sachs and Rothschild & Co A&O EY BCG DLA, Jamieson and PwC. About Element The Element Materials Technology Group is one of the world’s leading global providers of testing, inspection, and certification services for a diverse range of products, materials, and technologies in advanced industrial supply chains where failure in use is not an option. Headquartered in London, UK, Element’s c.7,000 scientists, engineers, and technologists, working in our global network of over 200+ laboratories, support customers from early R&D, through complex regulatory approvals, and into production ensuring their products are safe and sustainable, and achieve market access. In 2021, Element set out its new, industry leading environmental commitments, adopting science-based targets and committing to net zero emissions across its entire global business by 2035. These environmental commitments follow Element’s achievement of the highest ESG ranking in the testing, inspection and certification industry from Sustainalytics, a global leader in ESG research and data. About Temasek Temasek is a global investment company with a net portfolio value of S$381 billion as at 31 March 2021. Headquartered in Singapore, it has 13 offices in nine countries around the world. The Temasek Charter defines Temasek’s three roles as an Investor, Institution, and Steward, which shape its ethos to do well, do right, and do good. As a provider of catalytic capital, it seeks to enable solutions to key global challenges. With sustainability at the core of all Temasek does, it actively seeks sustainable solutions to address present and future challenges, as it captures investible opportunities to bring about a sustainable future for all.

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VIEWS AND ANALYSIS

Enteris BioPharma Publishes White Paper Examining Factors to Consider While Evaluating Oral Administration of Peptides

Enteris BioPharma | September 13, 2022

Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation announced the publication of a new white paper in Drug Development & Delivery entitled, "Key Considerations in Oral Delivery of Peptides – Factors to Consider While Evaluating Oral Administration." The paper, authored by John Vrettos, PhD, Director of Formulation Development for Enteris BioPharma, and Kalpana Ramakrishnan, PhD, Manager of Business Development for Enteris BioPharma, explores the barriers to developing oral delivery of peptides and how pharmaceutical companies can overcome them. Oral administration of peptides offers several advantages while treating chronic conditions such as diabetes and obesity as they are less invasive and more cost effective compared to injections. "Molecule size, potency, and solubility are some of the key physicochemical properties that determine a peptide's suitability for oral delivery. The healthcare industry is in need of enabling drug delivery technologies with the capability to overcome barriers in oral delivery of peptides. Importantly, orally delivered medications may encourage patient compliance compared with more invasive approaches to administering drugs. Approximately 75% of peptides are delivered by injective routes, including subcutaneous injections which can be painful and difficult to incorporate into a daily routine." Dr. Vrettos Dr. Vrettos continued, "Enteris' Peptelligence® platform offers a 'triple-action' solution comprised of our enteric coating, protease inhibitor, and permeation enhancer. When combined, these technologies have demonstrated an ability to improve the solubility and permeation of orally delivered peptides. These properties can potentially enable oral delivery of some peptide drugs for the first time, and we are excited to share our knowledge on oral delivery of peptides through this informative whitepaper." Peptelligence is a novel formulation technology designed to enhance the oral delivery and bioavailability of selected drugs by enhancing the permeation of such compounds that are typically injected, including peptides and BCS class III and IV small molecules, and preventing their breakdown in the digestive tract. About Enteris BioPharma Enteris BioPharma, Inc. is a wholly-owned subsidiary of SWK Holdings Corporation offering total integrated contract development and manufacturing services for innovative formulation solutions utilizing its proprietary drug delivery technologies, Peptelligence® and ProPerma®, and contract manufacturing (CMO) services using non-proprietary technologies. The company's proprietary technologies have been the subject of numerous feasibility studies and active development programs, some of which are in clinical development. Additionally, Enteris BioPharma is advancing an innovative internal product pipeline of drug products that address significant unmet clinical needs for which there is no satisfactory treatment option.

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Spotlight

West Nile virus can cause severe neurological symptoms and can even result in death. It’s common in horses and birds are natural hosts, but don’t become infected. For horses, there is a vaccine available, but no vaccine to prevent the disease in humans exists. People can get the disease from mosquitoes that carry the disease, and while many patients might not even realize they have it, in others, it causes weakness, flu-like symptoms, nausea and in more serious cases, West Nile fever and West Nile encephalitis. Recently in Greece, there was an outbreak of West Nile.

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