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."
Corning Incorporated | November 19, 2021
Corning Incorporated introduced Corning Velocity® Vials, specially engineered Type I borosilicate vials externally coated with the company’s proprietary technology, which are helping industry-leading drugmakers respond to the pandemic at speed. The increased efficiency and throughput enabled by Velocity Vials can drive faster manufacturing of COVID-19 vaccines, helping address industry supply chain challenges and meet global demand.
Velocity Vials can deliver better economics, better quality, and a more environmentally sustainable design compared with traditional borosilicate packaging. Velocity Vials’ protective uniform coating can improve filling line efficiency by 20% to 50% while lowering pharmaceutical production costs and providing a streamlined regulatory process for post-market drugs. Compared with conventional vials, Velocity Vials can also reduce damage that leads to particles, breaks, and cracks.
Catalent, Inc. – a global manufacturing partner to leading drugmakers – supports many of the highest profile COVID-19 vaccine programs and is on track to deliver more than 1 billion doses in 2021. The company recently implemented Velocity Vials in some of its fill-finish lines in Bloomington, Indiana.
“Ensuring consistent production, high quality, and less downtime is essential as we work to keep pharmaceutical supply chains moving, and to this extent, Corning’s Velocity Vials have already shown very promising results. Corning’s Velocity Vials demonstrated a significant improvement in efficiency when compared with traditional borosilicate vials on our fill-finish lines.”
Denis Johnson, vice president and general manager of Catalent’s premiere drug product manufacturing facility in Bloomington
Velocity Vials join Corning Valor® Glass vials and pharmaceutical glass tubing as the company’s newest innovation as Corning builds a comprehensive, end-to-end pharmaceutical packaging portfolio. Corning’s products have enabled the delivery of more than 3 billion doses of COVID-19 vaccines.
Valor Glass, introduced in 2017, is a revolutionary aluminosilicate glass vial that continues to support multiple COVID-19 vaccines, playing a significant role in vaccinating patients across the globe. Domestically, Corning continues building on its agreements with the U.S. government to support the accelerated mass vaccination effort critical to ending the pandemic. With the invention of Velocity Vials, the company extends its longstanding leadership role in the life sciences industry and broadens the reach of Corning’s unique capabilities, significantly expanding its addressable market while strengthening the supply chain for the future.
Adding to the strong position in the industry, Corning’s new high-volume pharmaceutical vial manufacturing facility in Durham, North Carolina, is now operational. The facility will allow the company to produce up to 500 million glass vials per year to improve the domestic supply chain and deliver vital COVID-19 vaccines to the U.S. and abroad.
“Our packaging portfolio and new capacity allow us to expand the vital role we play in supporting critical health care demand globally – both today and tomorrow,” said Brendan Mosher, vice president and general manager, Corning Pharmaceutical Technologies. “We see a future of pharmaceutical manufacturing that has better quality, is more efficient, more sustainable, and has increased capacity for life-saving drugs. Corning now has two leading vial products – Valor Glass and Velocity Vials – giving our customers two innovative technologies to choose from for their different use cases.”
Velocity Vials are the latest example of how Corning is driving transformation across its markets through its leadership in glass and ceramic science and optical physics, as well as through its proprietary manufacturing platforms. For more information about Velocity Vials, visit here.
Caution Concerning Forward-Looking Statements
The statements contained in this release that are not historical facts or information and contain words such as “will,” “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “see,” “would,” and “target” and similar expressions are forward-looking statements. These forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include estimates and assumptions related to economic, competitive and legislative developments. Such statements relate to future events that by their nature address matters that are, to different degrees, uncertain. These estimates are subject to change and uncertainty which are, in many instances, beyond our control. There can be no assurance that future developments will be in accordance with management’s expectations. Actual results could differ materially from those expected by us, depending on the outcome of various factors. We do not undertake to update forward-looking statements.
Although the Company believes that these forward-looking statements are based upon reasonable assumptions regarding, among other things, current estimates and forecasts, general economic conditions, its knowledge of its business, and key performance indicators that impact the Company, actual results could differ materially. The Company does not undertake to update forward-looking statements. Some of the risks, uncertainties and other factors that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements include, but are not limited to: the duration and severity of the COVID-19 pandemic, and its impact across our businesses on demand, operations and our global supply chains; the effects of acquisitions, dispositions and other similar transactions; global business, financial, economic and political conditions; tariffs and import duties; currency fluctuations between the U.S. dollar and other currencies, primarily the Japanese yen, new Taiwan dollar, euro, Chinese yuan and South Korean won; product demand and industry capacity; competitive products and pricing; availability and costs of critical components and materials; new product development and commercialization; order activity and demand from major customers; the amount and timing of our cash flows and earnings and other conditions, which may affect our ability to pay our quarterly dividend at the planned level or to repurchase shares at planned levels; possible disruption in commercial activities due to terrorist activity, cyber-attack, armed conflict, political or financial instability, natural disasters, or major health concerns; loss of intellectual property due to theft, cyber-attack, or disruption to our information technology infrastructure; unanticipated disruption to our supply chain, equipment, facilities, IT systems or operations; effect of regulatory and legal developments; ability to pace capital spending to anticipated levels of customer demand; our ability to increase margins through implementation of operational changes, pricing actions and cost reduction measures; rate of technology change; ability to enforce patents and protect intellectual property and trade secrets; adverse litigation; product and components performance issues; retention of key personnel; customer ability, to maintain profitable operations and obtain financing to fund ongoing operations and manufacturing expansions and pay receivables when due; loss of significant customers; changes in tax laws and regulations; the impacts of audits by taxing authorities; the potential impact of legislation, government regulations, and other government action and investigations; and other risks detailed in Corning’s SEC filings.
For a complete listing of risks and other factors, please reference the risk factors and forward-looking statements described in our annual reports on Form 10-K and quarterly reports on Form 10-Q.
In accordance with guidance provided by the SEC regarding the use of company websites and social media channels to disclose material information, Corning Incorporated (“Corning”) wishes to notify investors, media, to publish important information about the company, including information that may be deemed material to investors, or supplemental to information contained in this or other press releases. The list of websites and social media channels that the company uses may be updated on Corning’s media and website from time to time. Corning encourages investors, media, and other interested parties to review the information Corning may publish through its website and social media channels as described above, in addition to the company’s SEC filings, press releases, conference calls, and webcasts.
About Corning Incorporated
Corning is one of the world's leading innovators in materials science, with a 170-year track record of life-changing inventions. Corning applies its unparalleled expertise in glass science, ceramic science, and optical physics along with its deep manufacturing and engineering capabilities to develop category-defining products that transform industries and enhance people's lives. Corning succeeds through sustained investment in RD&E, a unique combination of material and process innovation, and deep, trust-based relationships with customers who are global leaders in their industries. Corning's capabilities are versatile and synergistic, which allows the company to evolve to meet changing market needs, while also helping our customers capture new opportunities in dynamic industries. Today, Corning's markets include optical communications, mobile consumer electronics, display, automotive, and life sciences.
LIDDS AB | February 22, 2022
LIDDS AB announced that the next step in the development of NanoZolid®-formulated docetaxel will be to conduct a short clinical study to understand the immunological effects observed in the Phase I clinical study NZ-DTX-001. In the NZ DTX-001 study, activation of systemic inflammatory biomarkers was observed, which can provide improved conditions for treatment with so-called checkpoint inhibitors and result in treatment effect in non-injected tumors.
In the clinical phase I study with nanodotax, which ended in October 2021, an activation of systemic inflammatory biomarkers was observed, which may open up the possibility of a combination therapy with so-called checkpoint inhibitors in cancer immunotherapy. Clinical studies have shown that systemically administered docetaxel significantly improves the response to treatment with checkpoint inhibitors. If LIDDS can show a similar effect with locally administered nanodotax but without systemic side effects, which risk inhibiting the specific immune response against the tumors, both improved efficacy and safety could be achieved. LIDDS has shown in preclinical studies that locally administered nanodotax has as good effect as systemically administered docetaxel but without systemic side effects.
In order to provide a better foundation for decision-making in the clinical development of nanodotax, LIDDS has chosen to take over the sponsorship of the previously approved investigator driven trial on prostate cancer patients. The study provides an important analysis opportunity of the immunological response as the included patients will have their prostate surgically removed, which can be analyzed in detail. The study is planned to be conducted at one clinical site and is expected to include ten patients.
“Based on the exciting activation of immunoregulatory molecules we saw in the Phase I study, it is important to confirm the mechanism of action of nanodotax. The increased understanding of the mechanism will more promptly lead us to the right form of treatment and patient group. The results may possibly also pave the way for more effective combination treatments, which is considered crucial for the commercial positioning of nanodotax and it justifies a further study”
Nina Herne, CEO of LIDDS
In December 2021, LIDDS announced the top-line data of the clinical Phase I study NZ-DTX-001. It was demonstrated that NanoZolid® in combination with docetaxel was safe and well tolerated, reaching the primary endpoint of the trial. The data also showed that the systemic docetaxel exposure was low and that activity in injected lesions was observed. Patients receiving docetaxel showed activation of systemic inflammatory biomarkers that are considered important for efficient recruitment and activation of immune effector cells and for creating a good environment for treatments with immune-modulating drugs such as check-point inhibitors.
The information was submitted for publication, through the agency of the aforementioned contact person, on February 21, 2022 at 16.30 CET.
LIDDS AB (publ) is a Swedish-based pharmaceutical company with a unique drug delivery technology NanoZolid®. NanoZolid® is a clinically validated drug development technology and superior in its ability to provide a controlled and sustained release of active drug substances for up to six months. LIDDS has licensing agreements where NanoZolid is combined with antiandrogens and in-house development projects in clinical and preclinical phase for cytostatics and immunoactive agents. LIDDS (LIDDS) shares are listed on Nasdaq First North Growth Market. Redeye AB, email@example.com, +46 (0)8 121 576 90, is a certified adviser to LIDDS.