US FDA

Kane Biotech Announces Second Quarter 2023 Financial Results

Retrieved on: 
Tuesday, August 29, 2023
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WINNIPEG, Manitoba, Aug. 29, 2023 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX- V:KNE; OTCQB:KNBIF) (the “Company” or “Kane Biotech”) today announced its second quarter 2023 financial results.

Key Points: 
  • 68% Increase in Product and Services Revenue; 74% Increase in Royalties Revenue
    WINNIPEG, Manitoba, Aug. 29, 2023 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX- V:KNE; OTCQB:KNBIF) (the “Company” or “Kane Biotech”) today announced its second quarter 2023 financial results.
  • Gross profit for the second quarter of 2023 was $330,505, a decrease of 48% compared to $639,215 for the quarter ended June 30, 2022.
  • Loss for the second quarter of 2023 was ($967,905), an increase of 22% compared to ($794,595) for the quarter ended June 30, 2022.
  • Detailed financial information about Kane Biotech can be found in its June 30, 2023 Financial Statements and Management Discussion and Analysis on SEDAR and the Company’s website.

Filing eCTD (electronic Common Technical Document) Submissions Training Course: Now Mandatory for Submissions in the EU and Global regulatory Agencies

Retrieved on: 
Friday, August 25, 2023
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Mercia Lucouw works as a regulatory affairs associate at Qdossier, a Celegence company.

Key Points: 
  • Mercia Lucouw works as a regulatory affairs associate at Qdossier, a Celegence company.
  • For ten years she worked as a pharmacist in hospital and has routinely been involved in international clinical trials.
  • After joining Qdossier in 2021, she has been involved several regulatory activities covering a variety of products.
  • She is also part of the development team for DosscriberT (MS word eCTD document templates).

Techdow USA and CTTQ Pharma Announce Collaboration Agreement and Launch of Fosaprepitant for Injection

Retrieved on: 
Tuesday, August 22, 2023
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Techdow USA Inc. (“Techdow USA”), a wholly owned subsidiary of Hepalink USA Inc., and Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (“CTTQ”), an integrated company engaged in the Development, Manufacturing and Licensing of pharmaceuticals, are pleased to announce the signing of a Licensing, Supply and Distribution agreement regarding the launch of Fosaprepitant for Injection, the therapeutic generic equivalent of EMEND® (fosaprepitant) for injection in the US market.

Key Points: 
  • Techdow USA Inc. (“Techdow USA”), a wholly owned subsidiary of Hepalink USA Inc., and Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (“CTTQ”), an integrated company engaged in the Development, Manufacturing and Licensing of pharmaceuticals, are pleased to announce the signing of a Licensing, Supply and Distribution agreement regarding the launch of Fosaprepitant for Injection, the therapeutic generic equivalent of EMEND® (fosaprepitant) for injection in the US market.
  • Fosaprepitant for Injection had US brand and generic sales of approximately $35 million, according to IQVIA Health for the 12 months ending June, 2023.
  • Both the API and drug product will be manufactured by CTTQ and the ANDA product will be sold under the Techdow USA Label.
  • Techdow USA continuously explores opportunities to expand their product portfolio and pipeline to better serve patients and customer needs.

MedReg 2023: Annual Medical Device Regulatory Confex - Navigating Regulatory Horizons

Retrieved on: 
Tuesday, August 15, 2023
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DUBLIN, Aug. 15, 2023 /PRNewswire/ -- The "MedReg 2023 - Annual Medical Device Regulatory Confex" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Aug. 15, 2023 /PRNewswire/ -- The "MedReg 2023 - Annual Medical Device Regulatory Confex" training has been added to ResearchAndMarkets.com's offering.
  • Step into the realm of regulatory excellence at MedReg 2023, the Annual Medical Devices Regulatory Confex that promises to revolutionize attendees' understanding of medical device regulations.
  • A compelling picture is painted by envisioning a world where medical device regulations are overlooked - a world that compromises patient safety.
  • MedReg 2023 transcends traditional learning, offering an experience designed to excite, inspire, and invigorate attendees' regulatory spirit.

Essex Bio-Technology Posts Sound 2023 Interim Financial Results, Revenue Up 37.1%, Profit Up 22%

Retrieved on: 
Wednesday, August 16, 2023
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HONG KONG, Aug 16, 2023 - (ACN Newswire) - Essex Bio-Technology Ltd ("Essex" or the "Group", Stock Code: 1061.HK) today announced the interim results for the six months ended 30 June 2023 ("the period under review").

Key Points: 
  • HONG KONG, Aug 16, 2023 - (ACN Newswire) - Essex Bio-Technology Ltd ("Essex" or the "Group", Stock Code: 1061.HK) today announced the interim results for the six months ended 30 June 2023 ("the period under review").
  • The profit of the Group increased by 22.0% to approximately HK$170 million as compared to approximately HK$139.2 million for the same period last year.
  • As of 30 June 2023, the Group had cash and cash equivalents of approximately HK$506 million (31 December 2022: approximately HK$543 million).
  • The Group's revenue is primarily made up of the segments of Ophthalmology and Surgical (wound care and healing).

HanchorBio Announces Taiwan FDA IND Approval for the Multi-Regional Clinical Trial of HCB101 to Treat Solid and Hematological Malignancies

Retrieved on: 
Monday, July 24, 2023
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"HCB101 is our first program in our pipeline which recently received IND clearance by US FDA and now obtained IND approval from TFDA of this multi-regional, multi-center clinical trial.

Key Points: 
  • "HCB101 is our first program in our pipeline which recently received IND clearance by US FDA and now obtained IND approval from TFDA of this multi-regional, multi-center clinical trial.
  • HCB101 project was initiated in December 2021, and the U.S. IND was submitted in March 2023; the 2.3 year from inception to IND was a record for a biotech company of our size.
  • "IND approval from TFDA within 23 working days (a speed record) is a testament to our in-house drug development capabilities and strong clinical operations through our partnership with global CRO companies.
  • Our team already initiated this clinical trial in the US, and I look forward to enrolling the first subject soon," said Dora Weng, R.N., M.B.A., Clinical Operations Head of HanchorBio.

MedReg 2023: Annual Medical Device Regulatory Confex - Where Regulatory Excellence Meets Virtual Engagement - ResearchAndMarkets.com

Retrieved on: 
Friday, August 11, 2023
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The "MedReg 2023 - Annual Medical Device Regulatory Confex" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "MedReg 2023 - Annual Medical Device Regulatory Confex" training has been added to ResearchAndMarkets.com's offering.
  • Step into the realm of regulatory excellence at MedReg 2023, the Annual Medical Devices Regulatory Confex that will revolutionize your understanding of medical device regulations.
  • Why should you make MedReg 2023 a priority on your virtual event calendar?
  • Imagine a world where medical device regulations are disregarded-a world where patient safety is compromised.

Aptose Reports Results for the Second Quarter 2023

Retrieved on: 
Thursday, August 10, 2023
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Among fifteen (15) patients dosed with TUS/VEN as of August 1, 2023, ten (10) patients have reached an efficacy evaluable stage.

Key Points: 
  • Among fifteen (15) patients dosed with TUS/VEN as of August 1, 2023, ten (10) patients have reached an efficacy evaluable stage.
  • Equity Investments in Aptose – Today, Aptose announced that it has entered into a binding term sheet with Hanmi Pharmaceutical, Inc. (“Hanmi Pharmaceutical”) of Seoul, South Korea, for an investment of up to $7 million or 19.99 percent ownership interest in Aptose, in two tranches.
  • A monotherapy recommended Phase 2 dose of 80 mg daily was selected and all tuspetinib development paths remain open, including the single arm accelerated path.
  • Plan to discuss strategies for potential future monotherapy accelerated development, doublet phase 2 development, and triplet pilot development (4Q 2023)

Applied Therapeutics Reports Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 10, 2023
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NEW YORK, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • “In the second quarter we continued to advance our programs across Galactosemia, SORD Deficiency and Diabetic Cardiomyopathy,” said Shoshana Shendelman, PhD, Founder, Chief Executive Officer, and Chair of the Board.
  • In June 2023, the Company presented baseline data at the 2023 Annual Meeting of the ADA from the ongoing Phase 3 ARISE-HF study of AT-001 (caficrestat) in Diabetic Cardiomyopathy (DbCM).
  • The Company expects topline data from the study in the fourth quarter of 2023.
  • Net loss for the second quarter of 2023 was $29.6 million, or $0.37 per basic and diluted common share, compared to a net loss of $25.9 million, or $0.96 per basic and diluted common share, for the second quarter 2022.

PaxMedica, Inc. Announces Second Quarter 2023 Financial Results and Business Update

Retrieved on: 
Wednesday, August 9, 2023
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TARRYTOWN, NY, Aug. 09, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – PaxMedica, Inc. (Nasdaq: PXMD), a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic drug therapies (“APT”) for the treatment of disorders with intractable neurologic symptoms, today provided a business update and reported financial results for the second quarter 2023, ended June 30, 2023.

Key Points: 
  • TARRYTOWN, NY, Aug. 09, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – PaxMedica, Inc. (Nasdaq: PXMD), a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic drug therapies (“APT”) for the treatment of disorders with intractable neurologic symptoms, today provided a business update and reported financial results for the second quarter 2023, ended June 30, 2023.
  • Importantly, this positive topline data from our retrospective HAT-301 study, demonstrated both statistically significant and clinically meaningful results.
  • Subsequent to quarter end, the Company received proceeds of approximately $0.8 million from the issuance of approximately 1.0 million shares of the Company’s common stock.
  • For PaxMedica’s complete financial results for the three-month period ended June 30, 2023, see the Company’s Quarterly Form 10-Q that will be filed with the Securities and Exchange Commission on August 9, 2023.