Citius Pharmaceutical | December 10, 2020
Citius Pharmaceuticals, Inc. ("Citius" or the "Organization") (Nasdaq: CTXR), a strength drug organization zeroed in on creating and commercializing basic consideration drug items, declared its receipt of a composed reaction and direction from the U.S. Food and Drug Administration (FDA) Division of Anti-Infective Products to the Company's Pre-Investigational New Drug (Pre-IND) meeting demand for its Mino-Wrap preparation bundle. Through its worldwide permit concurrence with The University of Texas MD Anderson Cancer Center, Citius is creating Mino-Wrap, a novel way to deal with lessening post-mastectomy contaminations related with the utilization of a tissue expander. The preparation bundle contained data in regards to pre-clinical information and a clinical improvement plan, alongside inquiries for the FDA with respect to security and adequacy information that would be needed to progress Mino-Wrap into clinical preliminaries.
The FDA conceded a Written Response Only gathering with respect to direction and bearing on the Mino-Wrap advancement plan. The organization showed that bio retention reenactment studies may give data to help the improvement of Mino-Wrap and made recommendations on what should be given comparative with non-clinical help. The FDA gave direction on the plan of the medication elution contemplates and concurred that a huge creature pharmacology study would be fitting. They additionally concurred that a 28-day toxicology study seems suitable and that microbiology uphold through existing information is worthy.
"The FDA furnished us with important direction and affirmed some of our underlying plans on the advancement of Mino-Wrap," said Myron Holubiak, President and CEO of Citius Pharmaceuticals. "We are exceptionally satisfied to have direction uphold from the organization since this is quite an under-perceived issue, and current preventative measures have not yielded entirely worthy outcomes. We think we have a significant development for the prevention of post-employable diseases related with bosom reconstructive medical procedure after mastectomies."
TriMas | December 14, 2021
TriMas announced that it has recently signed agreements to acquire Omega Plastics to be added to TriMas Packaging, and TFI Aerospace to be added to TriMas Aerospace.
Omega, located in Clinton Township, Michigan, specializes in manufacturing custom components and devices for drug delivery, diagnostic and orthopedic medical applications, as well as components for industrial applications. Omega leverages its advanced in-house tool making capabilities, ISO13485-certified injection molding facility and ISO Class 8 clean room to provide its customers a faster product development cycle, from prototype development, testing and validation, to short and medium run production and assembly. Omega is an approved vendor to several leading medical device companies, with a long track record of unparalleled service and quality. Omega currently operates as a private, family-owned company, and is expected to generate approximately $18 million in revenue in fiscal year 2021.
“We are excited to announce the agreement between TriMas and Omega. We look forward to expanding Omega’s production capacity to benefit its customers’ longer-term needs, while also leveraging Omega’s advanced tool making capabilities to add rapid prototyping to enhance TriMas Packaging’s speed-to-market advantage on innovation and new product designs. The addition of Omega further expands our Pharmaceutical & Nutraceutical product offerings into additional medical applications, which we believe is an attractive market for long-term growth.”
Thomas Amato, President and Chief Executive Officer of TriMas
Located near Toronto, Canada, TFI is a leading manufacturer and supplier of specialty fasteners used in a variety of applications, predominantly for the aerospace end market. TFI currently operates as a private, family-owned company, and is expected to generate approximately $6 million in revenue in fiscal year 2021.
“In addition to expanding TriMas Packaging through the acquisition of Omega, we are also pleased to announce the acquisition of TFI,” Amato continued. “This acquisition will further expand TriMas Aerospace’s fastener product lines with the addition of complimentary niche products that have an exciting growth trajectory resulting from TFI’s new program wins and the overall aerospace market recovery. We anticipate TFI’s customers will benefit from the added innovation and manufacturing depth offered by TriMas Aerospace, while TriMas Aerospace’s customers will enjoy additional product offerings.”
Amato continued, “We continue to execute on our core strategy of augmenting our growth through bolt-on acquisitions by leveraging our strong cash generation. After closing these two acquisitions, we expect our net leverage ratio to remain below 2.0x, providing ample capacity to execute on additional bolt-on acquisitions while also returning capital to shareholders through dividends and share buybacks.”
TriMas expects to close on Omega by the end of the year, and closed on TFI simultaneously with signing.
“We look forward to welcoming both Omega and TFI to the TriMas family of businesses,” concluded Amato.
TriMas is a global manufacturer and provider of products for customers primarily in the consumer products, aerospace and industrial markets, with approximately 3,300 dedicated employees in 11 countries. We provide customers with a wide range of innovative and quality product solutions through our market-leading businesses. Our TriMas family of businesses has strong brand names in the markets served, and operates under a common set of values and strategic priorities under the TriMas Business Model. TriMas is publicly traded on the NASDAQ under the ticker symbol “TRS,” and is headquartered in Bloomfield Hills, Michigan.
Aizon | February 02, 2021
Aizon launches its Bioreactor Application, the pharma industry's first predictive analysis and profound knowledge management application. The Aizon Bioreactor Application adds the bioreactor process to the "Smart Manufacturing" transformation that is accelerating across the Pharma and Biotech industry. Aizon is extraordinarily able to achieve GxP compliance and give an audit trail from the start of the process. The turnkey application allows pharmaceutical and biotech companies to leverage rich datasets generated during upstream manufacturing to identify and accurately anticipate deviations and results potentially leading to countless dollars in expense savings, diminished danger, and additional income potential gain.
Intended to work with both persistent and took care of batch bioreactors, the Aizon Bioreactor Application gives a profound understanding of the client's bioprocess manufacturing lifecycle. The application leverages specialized Edge AI and contextualization, which is a prerequisite to make the data actionable. Contextualized data is harnessed, analyzed, and visualized through a persona-based lens for faster root cause analysis (RCA), real-time monitoring, and predictive insight across any number of bioreactor units and manufacturing sites.
AI models for bioreactor analytics are ready for use within the application or can be configured by customers within the GxP cloud-based application. “It is clear that biotech and pharmaceutical companies need an accessible, industry-specific tool that accelerates their path to value. Customers seek a seamless way to analyze complex data sets in real-time and to predict with accuracy the yield from bioreactor units that span multiple sites and global regions,” said Pep Gubau, CTO, Aizon. “Biotech and pharmaceutical companies can now more easily leverage the power of AI/ML in a GxP environment with an end-to-end lifecycle governance of data, models, and applications in order to understand and optimize bioreactor processes in commercial manufacturing.”
Aizon’s CEO, John Vitalie adds, ”Our focus is to empower customers to innovate and rapidly achieve their targeted outcomes without the overhead burden of tracking changes, revalidation, and on-going development to maintain compliance. By building the process knowledge framework, compliance, and scalability into the application, customers benefit significantly from the streamlined industrialization of their digital solutions. We see that this is key for pharma and biotech to realize the vision of smart manufacturing and accelerate their progress toward realizing the promise of the adaptive plant.”
Aizon is an enterprise software provider that transforms manufacturing operations with the use of advanced analytics, artificial intelligence, and other smart factory technologies focused on optimizing production within Pharma and other highly regulated industries. The Aizon AI platform and native GxP based applications seamlessly integrate unlimited sources of structured and unstructured data to deliver actionable, real-time insights across all manufacturing sites. Aizon brings deep domain expertise and works closely with Global System Integrators and technology partners to provide enterprise solutions to customers.