Shirin David

Liquidia Corporation Files Response to United Therapeutics Lawsuit and Files Counterclaims

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월요일, 1월 8, 2024

11,826,327 (the ‘327 patent) in association with Liquidia’s New Drug Application (NDA) for YUTREPIA™ (treprostinil) inhalation powder.

Key Points:

11,826,327 (the ‘327 patent) in association with Liquidia’s New Drug Application (NDA) for YUTREPIA™ (treprostinil) inhalation powder.
Simultaneously, Liquidia filed counterclaims against UTHR seeking a declaration that all asserted claims of the ‘327 patent are not infringed, are invalid and are unenforceable.
Furthermore, the counterclaims summarize certain publications, references and information that UTHR failed to submit to the United States Patent and Trademark Office (USPTO) during the prosecution of the ‘327 patent.
Liquidia has also asserted that these same references and information, as set forth in the counterclaims, also render the claims of the ‘327 patent invalid.

FDA Grants Soligenix "Fast Track" Designation for Dusquetide in the Treatment of Oral Lesions of Behçet's Disease

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월요일, 1월 8, 2024

Vasculitis, Disease, Food, FDA, NDA, Doctor of Philosophy, Aphthous stomatitis, Shirin David, Conditional sentence, Patient, Radiation, Fast Track, Skin, Mucositis, Pharmaceutical industry

Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition.

Key Points:

Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition.
Fast track designation is intended to facilitate the development and expedite the review of new drugs and biologics.
"We are very pleased to have SGX945 in Behçet's Disease granted fast track designation from the FDA," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.
"As demonstrated by the granting of the designation, our previous studies with dusquetide in oral mucositis have clearly validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation.

EQS-News: Planned Silumina Anodes plant focusing on nanocoated silicon achieves an increase in annual output capacity from 15 GWh to 120 GWh in terms of equivalent battery capacity

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토요일, 12월 30, 2023

DFS, Bird, Graphite, FRA, News, Shirin David, Kilowatt-hour, Silicon, PFS

With an anode mixing ratio of 10/90 at the battery manufacturer, a battery capacity of approx.

Key Points:

With an anode mixing ratio of 10/90 at the battery manufacturer, a battery capacity of approx.
The plant is now designed for the production of alumina-coated metallurgical silicon with an annual output of 8,000 t/y.
This product will be integrated into the anode graphite by the customers in their battery factories and not in the Altech plant.
This change in production strategy significantly increases the equivalent battery capacity of Altech's active anode material Silumina Anodes from 15 GWh to 120 GWh per year.

SOS Moving Company Announces Plans for Nationwide Expansion

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월요일, 11월 13, 2023

Professional, Growth, Customer service, Shirin David, Modernity, Element, Privacy, Communication, Mouth, Nursing

The aim is to continue to provide the same experiences across the country that brought the SOS Moving Company to this place of growth.

Key Points:

The aim is to continue to provide the same experiences across the country that brought the SOS Moving Company to this place of growth.
As the team grows to accommodate new locations and clients, all work will be focused on the goal of being the best moving company in the United States.
The company ethos through expansion will remain around the values of:
Professionalism - The foundation of company services.
By attempting to hold true to proven outcomes, SOS Moving is leveraging its experience in the California market as a proof of concept to expand nationally.

Pyxis Oncology Announces Appointment of Ken Kobayashi, M.D., F.A.C.P as Chief Medical Officer

Retrieved on:

화요일, 11월 28, 2023

BOSTON, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company focused on developing next-generation therapeutics to target difficult-to-treat cancers, today announced the appointment of Ken Kobayashi, M.D., F.A.C.P, as Chief Medical Officer (CMO), effective November 27, 2023.

Key Points:

BOSTON, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company focused on developing next-generation therapeutics to target difficult-to-treat cancers, today announced the appointment of Ken Kobayashi, M.D., F.A.C.P, as Chief Medical Officer (CMO), effective November 27, 2023.
Dr. Kobayashi brings extensive leadership experience in oncology clinical development and regulatory affairs.
As CMO, Dr. Kobayashi will lead the Company’s clinical and regulatory operations, drive strategic growth, and play a key role in advancing Pyxis Oncology’s clinical pipeline.
“I am thrilled to welcome Ken to the Pyxis Oncology team, and I look forward to working closely with him to advance our clinical programs,” said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology.

FINSIGHT Group Intends to Vote AGAINST Q4 Inc.’s Proposed Acquisition by Sumeru Equity Partners

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목요일, 12월 28, 2023

For these reasons, and as we explain further below, subject to more substantive disclosure, FINSIGHT intends to vote AGAINST the Arrangement.

Key Points:

For these reasons, and as we explain further below, subject to more substantive disclosure, FINSIGHT intends to vote AGAINST the Arrangement.
FINSIGHT acquired its ownership in Q4 because we believe in its long-term growth potential and the strength of its core business.
Instead, the proposed Arrangement threatens to prematurely siphon the Company’s future potential into the pockets of conflicted insiders, the Rolling Shareholders, and Sumeru Equity Partners.
Moreover:
Is any portion of Q4 management’s future compensation tied to the returns to be realized by Sumeru Equity Partner’s investment in Q4?

Exro Provides Operational Update in Year-End Shareholder Letter

Retrieved on:

목요일, 12월 21, 2023

CALGARY, AB, Dec. 20, 2023 /PRNewswire/ - Exro Technologies Inc. (TSX: EXRO) (OTCQB: EXROF) (the "Company" or "Exro"), a leading clean-technology company that develops new generation power-control electronics that expand the capabilities of electric motors and batteries, today provided an operational update in a 2023 year-end letter to shareholders.

Key Points:

CALGARY, AB, Dec. 20, 2023 /PRNewswire/ - Exro Technologies Inc. (TSX: EXRO) (OTCQB: EXROF) (the "Company" or "Exro"), a leading clean-technology company that develops new generation power-control electronics that expand the capabilities of electric motors and batteries, today provided an operational update in a 2023 year-end letter to shareholders.
As we reach the end of Q4 2023, in keeping with our commitment to open communication with shareholders, we would like to provide a succinct year-end operational update.
Exro has been diligently working towards UL certification and remains on track to complete testing by December 31st, 2023.
As tradition dictates, in early Q1 2024, Exro shareholders can anticipate a comprehensive letter that revisits the Company's performance in 2023 and details the 2024 roadmap.

AnHeart Therapeutics and Innovent Announce China’s NMPA Has Granted Taletrectinib (ROS1 Inhibitor) Priority Review Designation

Retrieved on:

월요일, 12월 18, 2023

The CDE accepted the NDA in November 2023.

Key Points:

The CDE accepted the NDA in November 2023.
“Taletrectinib’s Priority Review Designation reinforces the urgent need for patients with ROS1-positive NSCLC who were previously treated with ROS1 TKIs in China and the significant clinical advance that taletrectinib may represent for these patients,” said Bing Yan, MD, Chief Medical Officer, AnHeart.
“We look forward to working with the regulatory authorities as they conduct their review of taletrectinib to hopefully bring this breakthrough investigational therapy to patients as soon as possible.”
“Taletrectinib’s potential as a best-in-class precision therapy is further underscored by the Priority Review Designation,” said Dr. Hui Zhou, Senior Vice President of Innovent.
Priority Review Designation allows the CDE to prioritize the review process and evaluation resources for NDAs, which helps accelerate the market access of innovative drugs.

Harrow Announces Third Quarter 2023 Financial Results

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월요일, 11월 13, 2023

Biotechnology, Pharmaceutical, Optical, Medical Supplies, Surgery, Health, FDA, Clinical Trials, Marketing, Investment, Fab Five, New Drug Application, Shirin David, Multimedia, Adjustment, Letter, Pharmaceutical industry

Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, announced results for the third quarter and nine months ended September 30, 2023.

Key Points:

Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, announced results for the third quarter and nine months ended September 30, 2023.
The Company also posted its third quarter Letter to Stockholders and corporate presentation to the “Investors” section of its website, harrow.com .
View the full release here: https://www.businesswire.com/news/home/20231113816178/en/
Commenting on Harrow’s third quarter results, Mark L. Baum, CEO of Harrow, said, “During the third quarter, we produced record revenues, a 50% increase over prior‑year revenues.
In summary, 2023, to date, has been a transformational year – and we believe that, because of the strategic actions that we have taken in 2023, we are positioned well for another record-breaking year in 2024.”
Third quarter 2023 figures of merit:

LexCheck Introduces AI-Powered DealDesk Services to Accelerate Deals

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목요일, 12월 14, 2023

Shirin David, Organization, Risk, Intelligence, Software, Believer, Software as a service, AI, Workload, Overalls, Risk management, Cryptocurrency

NEW YORK, Dec. 14, 2023 /PRNewswire/ -- LexCheck, the leading AI-powered contract acceleration and intelligence platform, today announced an expansion of its offerings with the launch of LexCheck DealDesk services. This offering combines the expertise of contract lawyers with LexCheck's AI-powered contract review solution to provide end-to-end negotiation services at a fraction of the cost. DealDesk expands LexCheck's contract acceleration capabilities to help businesses close deals faster and more reliably.

Key Points:

Combined with the power of LexCheck's contract acceleration software, DealDesk enables businesses to close deals quickly and confidently
NEW YORK, Dec. 14, 2023 /PRNewswire/ -- LexCheck , the leading AI-powered contract acceleration and intelligence platform, today announced an expansion of its offerings with the launch of LexCheck DealDesk services.
DealDesk expands LexCheck's contract acceleration capabilities to help businesses close deals faster and more reliably.
DealDesk allows businesses to accelerate sales velocity and return on investment to stay ahead of the competition.
To help our customers overcome these challenges, we're launching LexCheck DealDesk—a solution designed to finalize deals in days, not weeks."