Cognizant joins forces with Zenith to digitise pharma manufacturing

pharmaphorum | June 19, 2019

Professional services firm Cognizant has struck a deal to buy Zenith Technologies, a privately-held life sciences manufacturing technology company specialising in digital technologies to manage, control and optimise drug and medical device production. Cognizant, which said it already works with the top 30 largest life science companies in the world, did not reveal the financial details of the deal to buy Zenith, based in Cork, Ireland. Under the new arrangements Zenith Technologies’ more than 800 employees will become part of Cognizant’s Life Sciences business unit. Cognizant said that interconnected “smart factories” have become a strategic priority for pharma, with production systems and processes becoming more complex because of research advances and increased demand for large-molecule biologics. The combined Cognizant-Zenith Technologies expertise will deliver a range of “Industry 4.0” capabilities, the companies said. These include factory design consultation, machine sensor and controller instrumentation, supervisory control, and data acquisition, to manufacturing execution systems, batch automation, enterprise resource planning integration and managed services.

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The Prescription Drug User Fee Act (PDUFA) program is the cornerstone of modern FDA drug review. User fees currently fund about half of new drug review costs. By providing needed funds, PDUFA ended slow and unpredictable review and approval of new drug applications, while keeping FDA’s high standards.


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PHARMA TECH

Babson Diagnostics and Pharmacy Podcast Network Announce Partnership That Will Take Listeners Inside Largest Retail Pharmacy Trade Show

Babson Diagnostics | July 27, 2022

Babson Diagnostics, a science-first, health care technology company, announced a media partnership with the Pharmacy Podcast Network in connection with the 2022 National Association of Chain Drug Stores’ Total Store Expo, the largest gathering of retailers and suppliers in the health and wellness industry. As part of the partnership, the Pharmacy Podcast Network, the most popular and downloaded podcast about the pharmacy industry, will be integrated into Babson Diagnostics’ booth at the Total Store Expo. Todd Eury, founder and chief executive officer of the media company, will host podcasts from the booth featuring industry leaders attending the trade show. In addition, Babson will sponsor two podcasts that will be broadcast prior to the expo, which takes place Aug. 27 through Aug. 29 in Boston. The first of those shows, “Diagnostic Testing in Community Pharmacies,” went live today. “Babson is excited to be collaborating with one of the leading media outlets aimed at community pharmacists, who are the face of neighborhood healthcare. Babson is working with pharmacies to offer medically accurate blood testing that is easier, more convenient and less invasive than traditional methods.” David Stein, CEO of Babson Diagnostics Launched in 2009, the Pharmacy Podcast Network reaches more than 80,000 listeners per month with audio content focused on the critical role pharmacists play in the healthcare industry. “I look forward to bringing exciting new content to my audience through this partnership with Babson Diagnostics,” Eury said. “The Total Store Expo is a one-of-a-kind opportunity to bring insights to pharmacists about new and innovative products and services in health and wellness, such as Babson’s blood-testing ecosystem.” About Babson Diagnostics Babson Diagnostics is a science-first healthcare technology company bringing convenient, medically accurate diagnostic blood testing to the local pharmacy. We are the first and only company to do broad blood panels from a capillary microsample, collected from a finger, at a retail setting. Our core technology was incubated at Siemens Healthineers ​in 2015, and we became Babson Diagnostics in 2017. We have exclusive partnerships with Siemens Healthineers and BD (Becton, Dickinson and Company), two global leaders in healthcare innovation and medical technology. Together we are reimagining the entire blood testing process, helping people get the care they need, when they need it. Babson, based in Austin, Texas, is named in honor of Art Babson, whose legacy of scientific innovation and excellence is the foundation on which the company is built. About Pharmacy Podcast Network Pharmacy Podcast Nation is the flagship show hosting all of the Pharmacy Podcast Network 1400+ episodes. With more than 30 different podcast programs and some 40 different co-hosts helping to develop audio content about the pharmacy sector, its reach includes communities, hospitals, senior-care residences, military and public health settings that meet the information needs of 300,000 pharmacists with more than 100,000 monthly listeners. PPN also delivers a unique publication called Rx Influencer to all healthcare professionals with a specific focus on pharmacy.

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PHARMACY MARKET

Astellas Announces Topline Results from Phase 3 Long-Term Safety Study of Fezolinetant in Mainland China

Astellas Pharma Inc. | September 05, 2022

Astellas Pharma Inc. announced topline results from the Phase 3 MOONLIGHT 3™ clinical trial in women in mainland China evaluating the long-term safety and tolerability of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause. MOONLIGHT 3 is a 52-week single-arm Phase 3 clinical trial investigating the long-term safety and tolerability of fezolinetant 30 mg taken once daily in 150 women in mainland China seeking treatment for relief of VMS associated with menopause. The study's primary endpoint is the frequency and severity of adverse events which were generally consistent with previous Phase 3 studies of fezolinetant. Detailed results will be submitted for publication in the near future. "The topline results from the MOONLIGHT 3 study are very encouraging and, upon initial review, further support the long-term safety of fezolinetant. We are evaluating the full MOONLIGHT data sets and remain committed to developing innovative treatments in this therapeutic area with the hope of delivering a first-in-class, nonhormonal treatment option for women with moderate to severe VMS." Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas Fezolinetant is an investigational selective neurokinin-3 receptor antagonist and is not approved anywhere in the world. In the U.S., a New Drug Application for fezolinetant for the treatment of moderate to severe VMS associated with menopause is under review. The NDA submission is based on results from two pivotal Phase 3 clinical trials, SKYLIGHT 1™ and SKYLIGHT 2™, and the Phase 3 long-term safety study, SKYLIGHT 4™. About the MOONLIGHT Phase 3 Clinical Trials MOONLIGHT 1™ is designed to investigate the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause in women in Asia. The study is double-blinded and placebo-controlled for the first 12 weeks, followed by a 12-week non-controlled extension treatment period. A total of 302 women with moderate to severe VMS associated with menopause were enrolled at nearly 60 sites in mainland China, Korea and Taiwan. MOONLIGHT 3™ is a 52-week single-arm Phase 3 clinical trial designed to investigate the long-term safety and tolerability of fezolinetant in women in mainland China with VMS associated with menopause. A total of 150 women were enrolled at 34 sites in mainland China. About the BRIGHT SKY™ Phase 3 Program The BRIGHT SKY pivotal trials, SKYLIGHT 1™ and SKYLIGHT 2™ enrolled over 1,000 women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4™ is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S., Canada and Europe. About VMS Associated with Menopause VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2 Worldwide, more than 50% of women 40 to 64 years of age experience VMS and, in East Asia, the prevalence of VMS has been estimated to be around 80% of women 40 to 65 years of age, with 55% having moderate to severe VMS.3,4 VMS can have a disruptive impact on women's daily activities and overall quality of life.1 About Fezolinetant Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS associated with menopause.5,6,7 The safety and efficacy of fezolinetant are under investigation and have not been established. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.

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BUSINESS INSIGHTS

DisperSol Appoints Tim Scott New President and CEO; Company Changes Name to AustinPx™, Pharmaceutics and Manufacturing

AustinPx | August 29, 2022

DisperSol Technologies, LLC, a specialty pharmaceutical company announced the appointment of Tim Scott as president and chief executive officer of the company. At the same time, the company announced that it is changing its name to AustinPx™, Pharmaceutics and Manufacturing, to better reflect the company’s new direction as a contract development and manufacturing organization. Mr. Scott also joins the board of directors of AustinPx. The hiring of Mr. Scott and the company name change to AustinPx, Pharmaceutics and Manufacturing, are part of a shift in the focus of the pharmaceutical technology company that first developed KinetiSol® technology, a patented amorphous dispersion technology for improving drug bioavailability. The company will now provide pharmaceutical chemistry services including analytical and formulation development and cGMP manufacturing at its site in Austin, Texas. Mr. Scott was the co-founder and president of Pharmatek Laboratories from 1999 until 2016, when he sold the company to Catalent Pharma Solutions (NYSE: CTLT). He currently serves as board chair of Biocom, a trade organization supporting 2,000 life science companies. Mr. Scott also serves on the Medical Research Advisory Committee for the Conrad Prebys Foundation, providing grants to innovative research in the health sciences. “I can think of no one better to lead the transformation of AustinPx than Tim. He brings a wealth of experience in building a contract development and manufacturing business, and he has strong connections throughout the industry. We are delighted to have his leadership as we build AustinPx into a world class CDMO.” Shaun Kirkpatrick, President at Research Corporation Technologies and board chair of AustinPx “Our goal is to build a client-centric organization that provides drug development and manufacturing services for pharma companies worldwide,” says Scott. “The name AustinPx represents where we come from and what we do. Px stands for Pharmaceutics. To our core, we are a pharmaceutics company. Our approach is data-driven and agnostic, which means our formulation strategy for each drug is based on the unique physiochemistry of that compound. And for poorly soluble compounds, we have one of the most powerful tools available in KinetiSol, a truly next generation technology for rendering active pharmaceutical ingredients amorphous.” KinetiSol is a proprietary technology for improving drug bioavailability. This advanced technology transforms active pharmaceutical ingredients into amorphous solid dispersions, thereby enhancing the physiochemistry and PK of drugs. KinetiSol offers many advantages over other amorphous dispersion technologies. It provides a broader formulation design space and a more efficient scale-up. Additionally, KinetiSol’s significantly smaller ecological footprint makes it a greener technology. About AustinPx AustinPx, Pharmaceutics and Manufacturing is a contract development and manufacturing organization providing analytical and formulation development services and cGMP manufacturing for small molecule drugs. The company specializes in phase-appropriate development strategies, speed to clinic and market strategies, and bioavailability enhancement of poorly soluble molecules – including its next generation amorphous dispersion platform, KinetiSol®. AustinPx’s lead investors include Research Corporation Technologies, Inc. and Acadia Woods.

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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

The Prescription Drug User Fee Act (PDUFA) program is the cornerstone of modern FDA drug review. User fees currently fund about half of new drug review costs. By providing needed funds, PDUFA ended slow and unpredictable review and approval of new drug applications, while keeping FDA’s high standards.

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