US FDA

ABVC BioPharma Executes a Global Licensing Definitive Agreement for the Treatment of NSCLC, Expecting Aggregate Income of $13.75M and Royalties of up to $12.50M

Retrieved on: 
Wednesday, April 17, 2024
Combination, Safety, Ophthalmology, Oncology, Dietary supplement, Polysaccharide, Immunotherapy, Partnership, Research, IND, CNS, Non-small-cell lung cancer, MSKCC, Lung cancer, Grifola frondosa, Therapy, Patient, Combination therapy, Edible, Myelodysplastic syndrome, Health, Triple-negative breast cancer, Clinical trial, MDS, Ergosterol, TNBC, US FDA, Investigational New Drug, Virginity, Pharmaceutical industry

The Investigational New Drug (IND) application for ABV-1519 proposed the clinical investigation of BLEX 404 as a Combination Therapy Drug with Chemotherapy.

Key Points: 
  • The Investigational New Drug (IND) application for ABV-1519 proposed the clinical investigation of BLEX 404 as a Combination Therapy Drug with Chemotherapy.
  • We believe that this collaboration leverages the respective strengths of both companies to accelerate the availability of this vital treatment to patients worldwide.
  • This licensing agreement exemplifies ABVC and OncoX's shared dedication to advancing medical science and improving patient care.
  • ABVC urges its shareholders to sign up on the Company's website for the latest news alerts: visit https://abvcpharma.com/?page_id=17707

Nxera Pharma Notes Successful Development Progress of Partnered Schizophrenia Candidate NBI-1117568

Retrieved on: 
Tuesday, April 16, 2024
Neurocrine Biosciences, Safety, EVP, DSM-IV codes, Partnership, Schizophrenia, Patient, US FDA, Pharmaceutical industry

long-term) dosing in future clinical trials.

Key Points: 
  • long-term) dosing in future clinical trials.
  • The achievement of this important safety development milestone triggers a $15 million payment to Nxera from Neurocrine.
  • These candidates have potential to address a range of neurological and neuropsychiatric conditions and include:
    Matt Barnes, EVP, President of Nxera Pharma UK and Head of R&D, commented: “We are delighted that NBI-1117568 has successfully achieved this important safety development milestone.
  • These results will support the safe, long-term use of this novel clinical candidate, which is consistent with a desired product profile for schizophrenia and other neurological diseases where patients often need therapy over many years.

Biomerica Reports Third Quarter 2024 Financial Results

Retrieved on: 
Saturday, April 13, 2024
Use, University, Insurance, Stomach, HP, Bacteria, ELISA, Helicobacter pylori, DDW, Clinical trial, Annual general meeting, US FDA, Growth, IBS

Although our operating expenses for the quarter were $0.1 million higher than the third quarter of 2023, primarily due to the strategic expansion of our sales force in fiscal year 2024, it is noteworthy that our operating expenses remained consistent with the second quarter of 2024.

Key Points: 
  • Although our operating expenses for the quarter were $0.1 million higher than the third quarter of 2023, primarily due to the strategic expansion of our sales force in fiscal year 2024, it is noteworthy that our operating expenses remained consistent with the second quarter of 2024.
  • As of February 29, 2024, the Company maintained a cash and equivalents balance of $5.3 million down from $7.1 million from fiscal second quarter of 2024.
  • Our gross margins improved to 13.7% from 9.9% within the year-to-date 2024 fiscal year compared to same period in 2023.
  • With the aforementioned focused management of operating expenses, net operating loss was 11% better in 2024 fiscal year compared to 2023.

ABVC BioPharma Executes a Global Licensing Term Sheet for Oncology/Hematology Products, Expecting Licensing Income of $55M and Royalties of up to $50M

Retrieved on: 
Wednesday, April 10, 2024
Use, BioLite, Ophthalmology, Polysaccharide, Pancreatic cancer, License, Dietary supplement, Partnership, IND, CNS, Non-small-cell lung cancer, CDMO, Knowledge, Investigational New Drug, Therapy, Royalty payment, Field, Edible, Myelodysplastic syndrome, Triple-negative breast cancer, MDS, Ergosterol, NSCLC, TNBC, US FDA, Pharmaceutical industry

The Investigational New Drug (IND) application proposed the clinical investigation of BLEX 404 as the primary active ingredient.

Key Points: 
  • The Investigational New Drug (IND) application proposed the clinical investigation of BLEX 404 as the primary active ingredient.
  • [1]
    "We are thrilled to announce that the term sheet for a potential groundbreaking licensing deal with OncoX has been successfully executed.
  • This licensing deal marks a significant milestone for ABVC and OncoX, affirming their commitment to excellence and shared vision for the future.
  • ABVC urges its shareholders to sign up on the Company's website for the latest news alerts; visit https://abvcpharma.com/?page_id=17707

Global COVID-19 Vaccines Strategic Research Report 2024 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, April 24, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, FDA, Cancer, Ageing, Vaccination, RNA, Partnership, US FDA, Vaccine, Messenger, COVID-19

The "COVID-19 Vaccines - Global Strategic Business Report" has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "COVID-19 Vaccines - Global Strategic Business Report" has been added to ResearchAndMarkets.com's offering.
  • The global market for COVID-19 Vaccines, estimated at 6.4 Billion Doses in the year 2023, is projected to reach 4.2 Billion Doses by 2025.
  • The COVID-19 Vaccines market in the U.S. is estimated at 285 Million Doses in the year 2023.
  • mRNA vaccines are touted to provide better protection against newer variants, prompting discussions around the need for booster doses.

Essex Bio-Technology Posts Sound 2023 Annual Financial Results, Revenue Up 29.5%, Profit Up 22.1%

Retrieved on: 
Monday, March 18, 2024
Cloud, Research, SKQ1, Quality control, Weather, NMPA, Therapeutic Goods Administration, Environment, Best, Intelligence, Patent, Patient, Conditional sentence, Ophthalmology, Hospital, POCT, Acquisition, CMC, European Medicines Agency, GMP, City, QMS, Bevacizumab, Chemistry, Yoy, US FDA, Traction, Good, Therapy, Point-of-care testing, VISTA, Pharmaceutical industry

The Group weathered the headwinds and managed to deliver sound performances amidst the challenging trading environment in 2023.

Key Points: 
  • The Group weathered the headwinds and managed to deliver sound performances amidst the challenging trading environment in 2023.
  • As of 31 December 2023, the Group had cash and cash equivalents of approximately HK$509.8 million (2022: approximately HK$543.5 million).
  • Together with the interim dividend of HK$0.045 per ordinary share paid on 13 September 2023, the total dividend for 2023 would be HK$0.09 (2022: HK$0.065) per ordinary share.
  • The Group's turnover is primarily made up of the ophthalmology segment ("Ophthalmology") and surgical (wound care and healing) segment ("Surgical").

Sequana Medical announces 2023 Full Year Results and 2024 Outlook

Retrieved on: 
Thursday, March 28, 2024
Cardiorenal syndrome, Cirrhosis, Partner, Congestion, American Medical Association, Ascites, DSR, Brussels Stock Exchange, Liver disease, RED, Patient, Peritoneal dialysis, 2.0, Mouse, Sheep, Cancer, Heart, Heart failure, PMA, US FDA, Safety, File, CPT9, Overload, Catheter, ISO, THT, FDA, Animal, Pharmaceutical industry

Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “Securing PMA approval is a major value inflection point and the team is navigating through the approval process.

Key Points: 
  • Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “Securing PMA approval is a major value inflection point and the team is navigating through the approval process.
  • Furthermore, the alfapump can benefit from attractive pricing and leverage its FDA breakthrough device designation to enhance its reimbursement position.
  • Following this equity placement, the €3.0 million convertible loan agreement entered in February 2024 by Partners in Equity and Rosetta Capital will be mandatorily converted into new shares.
  • A day-100 meeting is scheduled with the FDA on April 9th 2024.

Kane Biotech Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 26, 2024
Diabetic foot, Financial statement, PIN, Ulcer, Symposium, Sale, KNE, Pivot, Credit, Leg, SAWC, US FDA, Patent, FDA, Government, Food

WINNIPEG, Manitoba, March 26, 2024 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX- V:KNE; OTCQB:KNBIF) (the “Company” or “Kane Biotech”) today announces its fourth quarter and full year 2023 financial results.

Key Points: 
  • WINNIPEG, Manitoba, March 26, 2024 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX- V:KNE; OTCQB:KNBIF) (the “Company” or “Kane Biotech”) today announces its fourth quarter and full year 2023 financial results.
  • On December 20, 2023, Kane Biotech announced that it received a non-binding offer for its interest in STEM Animal Health.
  • Gross profit for the fourth quarter of 2023 was $398,234, an increase of 24% compared to $320,653 for the fourth quarter ended December 31, 2022.
  • Loss for the fourth quarter of 2023 was ($1,611,894), an increase of 92% compared to ($838,150) for the quarter ended December 31, 2022.

SEQUANA MEDICAL SUCCESSFULLY RAISES EUR 11.5 MILLION IN AN EQUITY PLACEMENT

Retrieved on: 
Thursday, March 21, 2024
Cardiorenal syndrome, EUR, Partner, DSR, Offering, Liver disease, Ketel One, KBC, Patient, 2.0, Cancer, Quality management system, AMERICA, Prospectus, Heart failure, EQT, LSP, PMA, US FDA, NASH, Overload, THT, USD, FDA, Security (finance)

This is an exciting time for Sequana Medical as the US FDA's review of our alfapump® PMA filing progresses and we continue our preparations for US commercial launch.

Key Points: 
  • This is an exciting time for Sequana Medical as the US FDA's review of our alfapump® PMA filing progresses and we continue our preparations for US commercial launch.
  • We look forward to continuing our track record of meeting our corporate milestones and driving Sequana Medical forward."
  • (ii)   Finalizing the North American pivotal study in recurrent and refractory liver ascites (POSEIDON) towards secondary endpoint readout planned for Q2 2024.
  • As announced in February 2024, the Company entered into an unsecured and subordinated convertible loan agreement with Partners in Equity and Rosetta Capital for an aggregate principal amount of EUR 3.0 million.

SEQUANA MEDICAL LAUNCHES EQUITY PLACEMENT AND PROVIDES TRADING UPDATE

Retrieved on: 
Wednesday, March 20, 2024
EUR, Partner, Tax, DSR, Offering, Liver disease, FY, Ketel One, KBC, International, Committee, Financial services, 2.0, Cancer, Quality management system, AMERICA, Prospectus, Heart failure, FSMA, Person, European, EQT, LSP, PMA, US FDA, Overload, Stock, Marketing, Transaction, Security (finance)

(ii)   Finalizing the North American pivotal study in recurrent and refractory liver ascites (POSEIDON) towards secondary endpoint readout planned for Q2 2024.

Key Points: 
  • (ii)   Finalizing the North American pivotal study in recurrent and refractory liver ascites (POSEIDON) towards secondary endpoint readout planned for Q2 2024.
  • The Offering shall be structured as a private placement of new shares via an accelerated bookbuilding, which will commence immediately.
  • Trading in Sequana Medical shares on the regulated market of Euronext Brussels will be suspended during the bookbuilding period.
  • Trading in the shares is expected to resume following the publication of the results of the Offering.