ABSSSI

MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil

Retrieved on: 
Friday, September 22, 2023
Priority review, Food and Drug Administration Safety and Innovation Act, Innovation Act, IV, Prevalence, Amputation, Diabetes, QIDP, Methicillin, S. aureus, Methicillin-resistant Staphylococcus aureus, Infection, Act, MRSA, NDA, Fast Track, Osteomyelitis, ABSSSI, GAIN, Diabetic foot infection, Patient, Ulcer, Disease, DFI, Mortality, Toxic shock syndrome, Bacteria, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Gram-positive bacteria, Food, Pharmaceutical industry, FDASIA

Oral contezolid and intravenous (IV) contezolid acefosamil are currently being studied in a global Phase 3 clinical trial in treatment of patients with DFI.

Key Points: 
  • Oral contezolid and intravenous (IV) contezolid acefosamil are currently being studied in a global Phase 3 clinical trial in treatment of patients with DFI.
  • Both products were previously granted QIDP designation and Fast Track status in 2018 for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
  • With excellent microbiological activity against common Gram-positive bacteria, contezolid and contezolid acefosamil are well positioned to benefit DFI patients, particularly due to methicillin-resistant Staphylococcus aureus (MRSA).
  • "We believe that MicuRx can offer an important new choice for DFI treatment with flexibility of oral and IV formulations."

Basilea announces submission of a New Drug Application to the US Food and Drug Administration for its antibiotic ceftobiprole

Retrieved on: 
Friday, August 4, 2023
SAB, Infection, ASPR, Priority review, US Foods, Partnership, Biomedical Advanced Research and Development Authority, HHS, QIDP, Bronchopneumonia, Methicillin-resistant Staphylococcus aureus, MRSA, Administration for Strategic Preparedness and Response, LR, NDA, CABP, Fungal infection, Ceftobiprole, ABSSSI, GAIN, Administration, Development, Patient, Disease, Mortality, FDA, Safety, BARDA, TARGET, Food, Pharmaceutical industry, Vaccine, Allschwil, Basel

The additional successfully completed phase 3 studies in ABSSSI and CABP support the broad clinical utility of ceftobiprole.

Key Points: 
  • The additional successfully completed phase 3 studies in ABSSSI and CABP support the broad clinical utility of ceftobiprole.
  • Provided that the NDA submission is accepted, Basilea expects a decision by the FDA on the NDA in the second quarter of 2024.
  • Basilea plans to commercialize ceftobiprole in the US through a partner and intends to enter into such a partnership prior to the FDA’s decision on the NDA.
  • Basilea has been awarded approximately USD 112 million, or approximately 75 percent of the costs related to the SAB and ABSSSI phase 3 studies, regulatory activities and non-clinical work.

Histogen Reports First Quarter 2023 Results and Provides Business Update

Retrieved on: 
Thursday, May 11, 2023
Mouse, CA-MRSA, Emricasan, Infection, COVID-19, Caspase, Enzyme, COVID, Inflammation, Staphylococcus, Staphylococcus aureus, ABSSSI, Doxycycline, Fungal infection, Patient, Risk, SAN, Apoptosis, Immune system, USA300, Toxicology, Safety, Pharmaceutical industry, Vaccine

SAN DIEGO, May 11, 2023 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class clinical and preclinical small molecule pan-caspase and caspase selective inhibitors that protect the body’s natural process to restore immune function, today reported financial results for the first quarter ended March 31, 2023, and provided an update on its pipeline and other corporate developments.

Key Points: 
  • Exclusive Intellectual Property License Agreement with Johns Hopkins – In April 2023, we signed an exclusive license agreement with Johns Hopkins University.
  • Steven J. Mento Ph.D. appointed President and CEO – In March 2023, Dr. Mento was appointed President and CEO.
  • First Quarter 2023 Financial Highlights: Three Months Ended March 31, 2023 and 2022
    Revenues for the three months ended March 31, 2023 and 2022, we recognized license revenue of $5 thousand and $3.8 million, respectively.
  • Research and development expenses for the three months ended March 31, 2023 and 2022 were $1.0 million and $1.9 million, respectively.

Aptorum Group Limited Reports 2022 Fiscal Year End Financial Results and Provides Business Update

Retrieved on: 
Friday, April 28, 2023
Biotechnology, FDA, Health, General Health, Pharmaceutical, Oncology, Other Science, Research, Infectious Diseases, Science, Clinical Trials, Aureus, Neuroblastoma, Menopause, Letter, US Foods, Methicillin-resistant Staphylococcus aureus, Bank statement, Infection, USFDA, CMC, MRSA, NGS, Liquid biopsy, Methicillin, Lead, Staphylococcus, Staphylococcus aureus, ABSSSI, Euronext Paris, Patient, Investment, Transaction, JD, Distell Group Limited, Diagnosis, IND, US FDA, Food, Pharmaceutical industry, Cryptocurrency

Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (“Aptorum Group” or “We”), a clinical stage biopharmaceutical company dedicated to meeting unmet medical needs in oncology, autoimmune diseases and infectious diseases, today announced financial results for the fiscal year ended December 31, 2022, and provided an update on clinical and corporate developments.

Key Points: 
  • Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (“Aptorum Group” or “We”), a clinical stage biopharmaceutical company dedicated to meeting unmet medical needs in oncology, autoimmune diseases and infectious diseases, today announced financial results for the fiscal year ended December 31, 2022, and provided an update on clinical and corporate developments.
  • Mr. Darren Lui, Chief Executive Officer and Executive Director of Aptorum Group, commented “Aptorum’s operational plans remain on track.
  • Aptorum Group reported a net loss of $11.5 million in 2022, as compared to $27.1 million in 2021.
  • Aptorum Group reported $5.0 million of cash and restricted cash as of December 31, 2022 compared to $8.3 million as of December 31, 2021.

Basilea provides update on New Drug Application to the US Food and Drug Administration for antibiotic ceftobiprole

Retrieved on: 
Tuesday, April 18, 2023
SAB, ASPR, US Foods, Biomedical Advanced Research and Development Authority, HHS, QIDP, Bronchopneumonia, New Drug Application, Administration for Strategic Preparedness and Response, NDA, LR, CMOS, CABP, Staphylococcus, USD, Ceftobiprole, ABSSSI, Administration, Development, Patient, FDA, BARDA, Food, Pharmaceutical industry

53 LR

Key Points: 
  • 53 LR
    Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial or fungal infections, provided an updated timeline for its New Drug Application (NDA) submission for its antibiotic ceftobiprole to the US Food and Drug Administration (FDA).
  • Basilea, therefore, now expects to submit the NDA for the three indications of Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP) in the third quarter of 2023.
  • David Veitch, Basilea’s CEO, said: “We have compiled our NDA dossier and are ready to make a submission to the FDA.
  • However, after completion of the FDA inspection-readiness preparations within our supply chain, it became clear that the quality systems of one of our CMOs need to be adapted prior to an FDA inspection.

Histogen Announces Exclusive Intellectual Property License Agreement with Johns Hopkins University

Retrieved on: 
Monday, April 3, 2023
Human, SARS-CoV-2, Infection, MRSA, ABSSSI, Johns Hopkins University, Patent, Patient, Physician, Risk, SAN, Immune system, Johns Hopkins, WHO, VRSA, World Health Organization, Disease, Pharmaceutical industry

SAN DIEGO, April 03, 2023 (GLOBE NEWSWIRE) -- Histogen Inc. (HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class clinical and preclinical small molecule pan-caspase and caspase selective inhibitors that protect the body’s natural process to restore immune function, today announced that the company has signed an exclusive license agreement with Johns Hopkins University. The intellectual property associated with this license covers the use of emricasan for the treatment of disease in humans resulting from viral or bacterial infections (including, but not limited to, MRSA, VRSA, and SARS-CoV-2). The license agreement with Johns Hopkins is an instrumental addition to Histogen’s intellectual property portfolio. Rights to these patent applications, together with recently issued internal patents, are expected to provide freedom to operate and exclusivity worldwide to the Histogen’s entire caspase inhibitor portfolio.

Key Points: 
  • SAN DIEGO, April 03, 2023 (GLOBE NEWSWIRE) -- Histogen Inc. (HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class clinical and preclinical small molecule pan-caspase and caspase selective inhibitors that protect the body’s natural process to restore immune function, today announced that the company has signed an exclusive license agreement with Johns Hopkins University.
  • The intellectual property associated with this license covers the use of emricasan for the treatment of disease in humans resulting from viral or bacterial infections (including, but not limited to, MRSA, VRSA, and SARS-CoV-2).
  • The license agreement with Johns Hopkins is an instrumental addition to Histogen’s intellectual property portfolio.
  • Patients in the placebo arm who completed the study showed either delay or no symptom resolution for the duration of the study.

Histogen Reports Year-End 2022 Results and Provides Business Update

Retrieved on: 
Thursday, March 9, 2023
Methicillin, Trial of the century, IND, Conatus, Acquisition, HST, Medication, Pfizer, Enzyme, ABSSSI, Knee, SAN, Mortgage assumption, Research, NSF, Patient, Extracellular matrix, CCM, Interim, Staphylococcus aureus, EVP, Apoptosis, Cartilage, CSO, Inflammation, COVID-19, Insurance, Caspase, Toxicology, Sale, MRSA, Safety, Pharmaceutical industry, Cryptocurrency, Allergan

Twelve Months Ended December 31, 2022 and 2021

Key Points: 
  • Twelve Months Ended December 31, 2022 and 2021
    For the years ended December 31, 2022 and 2021, we recognized license revenues of $3.8 million and $27 thousand, respectively.
  • For the years ended December 31, 2022 and 2021, we recognized grant revenue of $0 and $0.1 million, respectively.
  • Research and development expenses for the years ended December 31, 2022 and 2021 were $5.0 million and $8.5 million, respectively.
  • General and administrative expenses for the years ended December 31, 2022 and 2021 were $9.4 million and $7.8 million, respectively.

Aptorum Group Announces Completion of Pre-IND Discussions with US FDA on its ALS-4, a First-in-Class Small Molecule Drug Targeting Methicillin Resistant Staphylococcus Aureus

Retrieved on: 
Friday, March 3, 2023
Biotechnology, FDA, Health, General Health, Pharmaceutical, Oncology, Other Science, Research, Infectious Diseases, Science, Clinical Trials, Aureus, JT Group Limited, Staphylococcus, ABSSSI, US FDA, Infection, Staphylococcus aureus, US Food Sovereignty Alliance, Euronext Paris, MRSA, Methicillin, Pharmaceutical industry, IND

Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (“Aptorum Group” or “Aptorum”), a clinical-stage biopharmaceutical company, announces the completion of the Pre-IND discussions with the US Food and Drug Administration (“US FDA”).

Key Points: 
  • Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (“Aptorum Group” or “Aptorum”), a clinical-stage biopharmaceutical company, announces the completion of the Pre-IND discussions with the US Food and Drug Administration (“US FDA”).
  • ALS-4 is a first-in-class small molecule anti-virulence drug targeting infections caused by Staphylococcus aureus, including but not limited to Methicillin Resistant Staphylococcus Aureus (“MRSA”).
  • The Pre-IND discussions with US FDA focused on overall development plan in preparation for the IND application of ALS-4 targeting Acute Bacterial Skin and Skin Structure Infections (ABSSSI) initially.
  • With the positive feedback on the overall development strategy from the US FDA, Aptorum is now proceeding towards the IND submission of ALS-4.

Zai Lab Announces Inclusion of QINLOCK® (ripretinib) and NUZYRA® (omadacycline) in China’s National Reimbursement Drug List

Retrieved on: 
Wednesday, January 18, 2023
GIST, IV, NRDL, Patient, Bronchopneumonia, National Medical Products Administration, ABSSSI, NMPA, Zai, KIT, Pharmaceutical industry

“NHSA reimbursement will help make QINLOCK and NUZYRA available to many more patients in need across China,” said William Liang, Chief Commercial Officer, Zai Lab.

Key Points: 
  • “NHSA reimbursement will help make QINLOCK and NUZYRA available to many more patients in need across China,” said William Liang, Chief Commercial Officer, Zai Lab.
  • “NRDL inclusion also underscores the clinical value Zai Lab is delivering to the medical community and to patients in China.”
    “A key part of Zai Lab’s mission is to bring transformative medicines to patients with unmet medical needs in China and around the world,” said Josh Smiley, Chief Operating Officer, Zai Lab.
  • “The inclusion of both QINLOCK and NUZYRA in the NRDL is another opportunity for us to achieve that mission.
  • QINLOCK targets the broad spectrum of KIT and PDGFRα mutations known to drive GIST.

Paratek Pharmaceuticals Announces Inclusion of NUZYRA® (omadacycline) in China’s National Reimbursement Drug List (NRDL)

Retrieved on: 
Wednesday, January 18, 2023
Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NRDL, Food, Patient, Bronchopneumonia, ABSSSI, NMPA, Pharmaceutical industry

“The addition of NUZYRA to China’s NRDL means millions of patients now benefit from increased accessibility to this life-saving therapy for serious community-acquired infections, said Evan Loh, M.D., Paratek chief executive officer.

Key Points: 
  • “The addition of NUZYRA to China’s NRDL means millions of patients now benefit from increased accessibility to this life-saving therapy for serious community-acquired infections, said Evan Loh, M.D., Paratek chief executive officer.
  • “This NRDL listing expands China’s antibiotic armamentarium to address antimicrobial resistance, an ever-growing, urgent, global public health crisis.
  • We are grateful to the NHSA for their recognition of the clinical benefit and compelling value proposition that novel, innovative antibiotics such as NUZYRA provide to patients.
  • Paratek’s partner in China, Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), received approval of both IV and oral NUZYRA as a Category 1 innovative drug by the National Medical Products Administration (NMPA) of China for the treatment of CABP and ABSSSI in December 2021.