PRACTICE MANAGEMENT

Citius Pharmaceuticals Receives FDA Response and Guidance to Pre-IND Consultation Submission for Mino-Wrap

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."

Spotlight

When it comes to enlisting the cancer-fighting potential of the body’s immune defenses, Amgen believes versatility is a virtue. Dave Reese discusses Amgen’s growing cancer immunotherapy research capabilities. Large numbers of immune cells (T cells in particular) are frequently found within or adjacent to melanoma tumors, indicating that the tumors attract the attention—if not the action—of the immune system. True to its reputation as one of the most ‘immunogenic‘ cancers, melanoma now has more U.S. Food and Drug Administration (FDA)-approved immunotherapy (immune system-targeting) drugs than any other cancer type. As a consequence, metastatic melanoma is no longer the universally fatal disease it was even just 3 or 4 years ago.

Spotlight

When it comes to enlisting the cancer-fighting potential of the body’s immune defenses, Amgen believes versatility is a virtue. Dave Reese discusses Amgen’s growing cancer immunotherapy research capabilities. Large numbers of immune cells (T cells in particular) are frequently found within or adjacent to melanoma tumors, indicating that the tumors attract the attention—if not the action—of the immune system. True to its reputation as one of the most ‘immunogenic‘ cancers, melanoma now has more U.S. Food and Drug Administration (FDA)-approved immunotherapy (immune system-targeting) drugs than any other cancer type. As a consequence, metastatic melanoma is no longer the universally fatal disease it was even just 3 or 4 years ago.

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PHARMACY MARKET

Aizon Launches GxP AI Bioreactor Application for the Pharma Industry

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.” About Aizon 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.

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PHARMA TECH

Gannex Received U.S. FDA Fast Track Designation for Its NASH Drug Candidate ASC42,an FXR Agonist

Gannex | December 14, 2020

Gannex, an entirely claimed organization of Ascletis Pharma Inc. (HKEX:1672) and completely committed to the R&D and commercialization of new medications in the field of NASH, reported today that it got Fast Track assignment from the U.S. Food and Drug Administration (FDA) for its non-alcoholic steatohepatitis (NASH) drug applicant ASC42. The U.S. FDA's Fast Track advancement program is intended to encourage the turn of events and speed up the survey of medications that have capacity to treat genuine or perilous infections or conditions and exhibit the possibility to address neglected clinical necessities with extra clinical advantages to patients. There are no FDA affirmed drugs for NASH sign yet. This Fast Track assignment speaks to FDA's acknowledgment of ASC42's potential in tending to these neglected clinical requirements for NASH patients. Gannex got the investigational new medication application (IND) endorsement for ASC42 from the U.S. FDA in October this year. ASC42 is an in-house developed,novel non-steroidal, specific, intense Farnesoid X Receptor (FXR) agonist with top tier potential. In two NASH creature models, ASC42 showed critical enhancements in liver steatosis, aggravation and fibrosis. The oral tablet plan of ASC42 has been created with the in-house restrictive innovation and is steady at room temperature. "We are excited that the FDA allowed Fast Track assignment for our FXR agonist ASC42 which is found and created by our in-house skilled R&D group," said Dr. Jinzi J. Wu, "This basic acknowledgment by FDA will quicken worldwide advancement of ASC42, a potential top tier FXR agonist."

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BUSINESS INSIGHTS

NovaBay Pharmaceuticals Collaborates with Harrow Health’s ImprimisRx to Promote Prescription Avenova

NovaBay Pharmaceuticals | July 20, 2021

NovaBay Pharmaceuticals, Inc., a pharmaceutical firm focused on commercializing Avenova for the eye care market, has announced a collaboration with ImprimisRx, one of the nation's top ophthalmology-focused pharmaceutical companies, to promote prescription Avenova. ImprimisRx, a wholly-owned subsidiary of Harrow Health, Inc., will offer national sales, marketing, and distribution support for NovaBay's FDA-cleared 0.01% hypochlorous acid Avenova in 40 ml bottles. Avenova is a clinically approved antimicrobial lid and lash solution used to treat various chronic eye conditions. Avenova serves a large and rapidly growing dry eye market, with 30 million Americans suffering from chronic eye diseases such as blepharitis and meibomian gland dysfunction. It is the only lid and lash spray made with NovaBay's patented pure hypochlorous acid and is suitable for daily usage. In addition, Avenova is usually prescribed by ophthalmologists and optometrists before and after cataract and Lasik procedures, making it a complementary therapy for many ImprimisRx's existing products. About ImprimisRx ImprimisRx is one of the nation's top ophthalmology-focused pharmaceutical companies, with 40 proprietary ophthalmic formulations serving thousands of ophthalmologists and optometrists throughout all 50 states. About Harrow Health Harrow Health, Inc. is a healthcare company specializing in ophthalmology. ImprimisRx, the leading ophthalmology-focused pharmaceutical company, and Visionology, a direct-to-consumer eye care subsidiary focusing on chronic eye disease, are owned and operated by the company. Harrow Health also owns stakes in Eton Pharmaceuticals, Surface Ophthalmics, and Melt Pharmaceuticals, all of which began as Harrow Health subsidiaries. Harrow Health also has royalty rights to four clinical-stage drug candidates developed by Surface Ophthalmics and Melt Pharmaceuticals. About NovaBay Pharmaceuticals, Inc. NovaBay Pharmaceuticals, Inc. is a biopharmaceutical company focused on high-quality, differentiated anti-infective consumer products such as Avenova, the top antimicrobial lid and lash spray, CelleRx Clinical Reset, a game-changing product in the beauty category, and NeutroPhase Skin and Wound Cleanser for wound healing. NovaBay products include its patented, pure, stable, pharmaceutical-grade hypochlorous acid, replicating the antimicrobial chemicals used by white blood cells to combat infection. NovaBay's hypochlorous acid products cause no stinging or irritation, are nontoxic, and are non-sensitizing, making them entirely safe for daily usage. In addition, Avenova is the first commercial hypochlorous acid lid and lash spray product that has clinically proven to reduce bacterial load on ocular skin surfaces, effectively addressing the underlying cause of bacterial dry eye.

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