PRACTICE MANAGEMENT

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

Citius Pharmaceutical | December 10, 2020

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

During the World Without Lung Cancer Panel at CES Asia on June 14, 2018, Johnson & Johnson Investment Ltd. and Johnson & Johnson Innovation LLC announced the Shanghai Lung Cancer Innovation QuickFire Challenge. Up to three innovators with the best ideas, technologies, or solutions to prevent, intercept or cure lung cancer will be awarded a total of up to $750,000 in grants, a voucher for one year of residency at the new JLABS  Shanghai opening in 2019, and mentorship from Johnson & Johnson Innovation and/or its affiliates.

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RESEARCH

Roivant Grows Computational Drug Discovery Engine with Acquisition of Silicon Therapeutics

Roivant Sciences | March 01, 2021

Silicon Therapeutics has assembled an exclusive industry-driving computational physics platform for the in silico design and optimization of small molecule drugs for testing disease targets. The platform incorporates custom strategies dependent on quantum mechanics, sub-atomic elements and measurable thermodynamics to beat basic bottlenecks in drug disclosure projects, for example, anticipating restricting energies and conformational conduct of molecules. Silicon Therapeutics' computational platform is controlled by a restrictive supercomputing group and custom equipment empowering exact all-molecule reenactments at organically important timescales. This computational platform is firmly incorporated with experimental laboratories equipped for biophysics, medical chemistry and biology to encourage the quick movement of drug applicants by expanding recreations with biophysical data. The organization has utilized these abilities to find numerous drug applicants. The procurement of Silicon Therapeutics supports and supplements Roivant's focused on protein debasement platform. That platform will be fueled by VantAI's high level AI models prepared on restrictive degrader-explicit experimental data and by Silicon Therapeutics' exclusive computational physics abilities, which help address a large number of the methodology explicit difficulties of degrader design and optimization. Coordinating Silicon Therapeutics and VantAI will empower Roivant to particularly catch the force of both computational physics and AI based ways to deal with drug design; for example, by joining exclusive computational physics reproductions as preparing data for VantAI's degrader-explicit profound learning models. "The combination of Silicon Therapeutics' integrated approach, platform and highly capable team with Roivant's technologies and commitment to transforming the pharmaceutical industry represents a new and exciting paradigm in drug discovery and development," said Roger Pomerantz, M.D., F.A.C.P., chairman of the board of directors of Silicon Therapeutics. About Roivant Sciences Roivant's mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. Roivant develops transformative medicines faster by building technologies and developing talent in creative ways, leveraging the Roivant platform to launch Vants – nimble and focused biopharmaceutical and health technology companies.

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PHARMA TECH

TransPerfect Life Sciences Introduces Trial Interactive CTMS Solution

Trial Interactive | November 12, 2021

TransPerfect Life Sciences, a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, announced the release of the Trial Interactive (TI) Clinical Trial Management System (CTMS). This release marks the industry's only mobile-first CTMS, placing important actions and information at the fingertips of study managers and CRAs and supporting a full author-to-archive process. Trial Interactive delivers user-friendly document and trial management solutions to help pharmaceutical, biotechnology, medical device, and contract research organizations (CROs) effectively streamline product development life cycles. The platform improves speed, quality, and compliance across site identification, site feasibility, study start-up, site personnel training, regulated content management, eISF, and eTMF management. The addition of TI CTMS enables a single source of truth across the entire life cycle, providing transparency into Trial Interactive solutions and any sponsor or CRO systems of record. A fully connected solution, Trial Interactive offers fast-to-implement and cost-effective solutions in a secure 21 CFR Part 11-compliant environment. Designed by clinical professionals for clinical professionals, TI CTMS benefits include World-Class User Experience – The time-saving and pain-free mobile-first interface, with full-text and segmented metadata search, flexible filtering and exports, dark mode, and one-click navigation, creates the industry's friendliest user experience. By Clinical, for Clinical – Enjoy greater efficiency without the hassle, and get started quickly with no heavy configuration required and best practices built into the default configuration. True SaaS Solution – TI CTMS is a single-study or enterprise SaaS solution developed by experts. TransPerfect's award-winning service teams support rapid implementation plans with full validation. Enterprise Ready – With the flexibility to align with large-scale operations, TI CTMS enables enterprises with complex study teams to easily update the system to meet unique requirements and have access to a comprehensive web services API supporting third-party integrations. Author-to-Archive Platform – Streamline processes and oversight with content management solutions supporting the workflow of documents across the life cycle from site and study personnel to the eTMF in one seamless process. As clinical operations become more decentralized, TI CTMS continues Trial Interactive's mission of providing practical innovation to improve the efficiency of global clinical processes while reducing costs. "Having consulted with many organizations and colleagues over the years about CTMS, we've recognized common challenges like time-consuming configurations, difficult navigation, and user experiences that are clearly developed without the input of clinical operations experts. The end result is that existing platforms have fallen short of the features that study managers and CRAs really needTI CTMS was built by clinical professionals for clinical professionals and cuts configuration times while delivering powerful capabilities in a clean user experience that perfectly addresses the needs of sponsors and CROs." Michael Smyth, Division President of TransPerfect Life Sciences TransPerfect President and CEO Phil Shawe stated, "The launch of TI CTMS comes at a time when conducting remote and decentralized clinical trials is more important than ever. The CTMS is connected to our eTMF and other platform solutions to deliver a mobile-first experience that ensures study teams can work effectively and at scale from any location." About Trial Interactive TransPerfect's Trial Interactive is an industry leader in practical eClinical innovation that simplifies and automates clinical processes for sponsors, CROs, and sites around the world. The 21 CFR part 11 compliant unified platform delivers an author to archive collaboration experience with solutions for clinical document management, site selection, site activation, eLearning, compliance training, quality, and more with seamless solution interoperability and indexing to the eTMF. Trial Interactive is consistently selected by clinical professionals for providing the most comprehensive yet intuitive experience with the most complete offering of technology and expert TMF services. Trial Interactive helps study teams streamline their operations by cutting unnecessary expenses, expediting timelines, reducing compliance risks, and improving operational excellence. About TransPerfect Life Sciences TransPerfect Life Sciences specializes in supporting global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include eTMF and eClinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact. About TransPerfect TransPerfect is the world's largest provider of language and technology solutions for global business. From offices in over 100+ cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. More than 5,000 global organizations employ TransPerfect's GlobalLink® technology to simplify management of multilingual content. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and ISO 17100 certified. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong.

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BUSINESS INSIGHTS

Hikma strengthens US Injectables business through acquisition of Custopharm

Hikma Pharmaceuticals USA Inc. | September 27, 2021

Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company and one of the largest suppliers of generic injectable medicines in the US, today announces that it has agreed to acquire Custopharm Inc. ('Custopharm') from Water Street Healthcare Partners ('Water Street'). Hikma will pay an initial cash consideration of $375 million on a debt and cash-free basis, with a further $50 million in contingent consideration payable upon the achievement of certain commercial milestones. Custopharm, a US-based generic sterile injectables company with a differentiated product portfolio and R&D pipeline, currently markets its products in the US through its commercial arm Leucadia Pharmaceuticals. Since partnering with Water Street in 2015, Custopharm has received 13 US FDA approvals, with four first-to-market Abbreviated New Drug Application (ANDA) approvals - including one with Competitive Generic Therapy (CGT) designation - and one novel 505(b)(2) NDA approval. Based in Carlsbad, California, Custopharm has 39 employees. With this acquisition, Hikma will have a differentiated US portfolio of close to 130 injectable medicines a more than fivefold increase over the last decade. Through this broad portfolio and by combining Custopharm's strong R&D capabilities with our high-quality and extensive manufacturing footprint, we will be in an excellent position to better serve the growing needs of hospitals, doctors and patients. I look forward to welcoming the team at Custopharm and Leucadia to Hikma as we continue to grow and strengthen our Injectables business. - Riad Mishlawi, President of Hikma Injectables We're excited to become part of Hikma, a global leader that shares our deep commitment to bringing generic products to market and into the hands of patients who need them. Water Street has been an outstanding partner in working with us to build an exemplary portfolio of complex generic products. We're looking forward to building on this success. - William C. Larkins, Ph.D., CEO of Custopharm and Leucadia Terms of the transaction and financial impact: The up-front consideration of $375 million is on a cash-free, debt-free basis and is being funded from Hikma's existing cash resources. The acquisition constitutes a Class 2 transaction pursuant to the UK Listing Rules.The gross assets of Custopharm at 31 December 2020 were $43 million. Losses before tax in the year to 31 December 2020 were $7.5 million. About Hikma Hikma helps put better health within reach every day for millions of people around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. About Custopharm Custopharm is a leader in the generic injectables market. Its goal is to provide important new generic injectable products to the acute and specialty markets and to reach people and communities with underserved conditions. Custopharm invests significantly in developing and acquiring new products, including through strategic partnerships. It also launches newly approved products through its nationally recognized commercial organization, Leucadia Pharmaceuticals. Custopharm features a portfolio of highly differentiated generic products, including four first-to-market products: Calcitonin Salmon Injection, USP, Synthetic, Dihydroergotamine Mesylate Nasal Spray, Sodium Tetradecyl Sulfate (STS) Injection, 3%, and Valrubicin Intravesical Solution, USP. Headquartered in Carlsbad, California, Custopharm is a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry. About Water Street Water Street is a strategic investor focused exclusively on health care. The firm has a strong record of building market-leading companies across key growth sectors in health care. It has worked with some of the world's leading companies on its investments including Humana, Johnson & Johnson, Medtronic and Walgreen Co. Water Street's team is comprised of industry executives and investment professionals with decades of experience investing in and operating global health care businesses. The firm is headquartered in Chicago.

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Spotlight

During the World Without Lung Cancer Panel at CES Asia on June 14, 2018, Johnson & Johnson Investment Ltd. and Johnson & Johnson Innovation LLC announced the Shanghai Lung Cancer Innovation QuickFire Challenge. Up to three innovators with the best ideas, technologies, or solutions to prevent, intercept or cure lung cancer will be awarded a total of up to $750,000 in grants, a voucher for one year of residency at the new JLABS  Shanghai opening in 2019, and mentorship from Johnson & Johnson Innovation and/or its affiliates.