Bronchopneumonia

Eagle Pharmaceuticals Announces FDA Acceptance of Investigational New Drug Application for CAL02, a Novel First-in-Class Broad-Spectrum Anti-Virulence Agent for the Adjunct Treatment of Severe Community-Acquired Bacterial Pneumonia

Retrieved on: 
Monday, November 14, 2022
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WOODCLIFF LAKE, N.J., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) announced today that the U.S. Food and Drug Administration (“FDA”) has accepted its investigational new drug (“IND”) application for CAL02, a novel first-in-class broad-spectrum anti-virulence agent for the adjunct treatment of severe community-acquired bacterial pneumonia (“SCABP”).

Key Points: 
  • The Phase 2 study is expected to begin enrollment of approximately 276 patients with severe community-acquired pneumonia at approximately 120 sites worldwide as early as the beginning of 2023.
  • We are pleased that the CAL02 IND has been accepted by FDA and look forward to commencement of the Phase 2 study anticipated early in 2023.
  • In addition, Eagle believes a CAL02 new drug application for the treatment of SCABP may qualify for priority review.
  • Eagle will host an Investor Day on Tuesday, December 6, 2022, at the Lotte New York Palace Hotel, at 8:00am ET.

Nabriva Therapeutics to Report Third Quarter 2022 Financial Results and Recent Corporate Highlights on November 10, 2022

Retrieved on: 
Monday, November 7, 2022
Cuties, Merck, Food, Infection, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, GLOBE, Private Securities Litigation Reform Act, Conference, Pyelonephritis, Tablet, COVID-19, Therapy, Marketing, U.S. Securities and Exchange Commission, NASDAQ, Bronchopneumonia, Fosfomycin, Urinary tract infection, Food and Drug Administration, Pharmaceutical industry

ET to discuss the financial results and recent corporate highlights.

Key Points: 
  • ET to discuss the financial results and recent corporate highlights.
  • Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections.
  • In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics views as of the date of this press release.
  • These forward-looking statements should not be relied upon as representing Nabriva Therapeutics views as of any date subsequent to the date of this press release.

Paratek Announces Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

Retrieved on: 
Tuesday, November 1, 2022
Development, Acne, BARDA, Degenerative disease, Anthrax, ABSSSI, GLOBE, LLC, Nasdaq, Employment, Biomedical Advanced Research and Development Authority, Government, Public health, Office of Inspector General, U.S. Department of Health and Human Services, NASDAQ, U.S. Department of Defense Strategy for Operating in Cyberspace, Company, NTM, Bronchopneumonia, Pharmaceutical industry, Vaccine

The stock options are subject to the terms and conditions of the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, and the terms and conditions of the stock option agreement covering each grant.

Key Points: 
  • The stock options are subject to the terms and conditions of the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, and the terms and conditions of the stock option agreement covering each grant.
  • Paratek is also conducting a Phase 2b Study in a rare disease, nontuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex with NUZYRA.
  • Paratek estimates this opportunity represents a potential $1 billion addressable market in the United States.
  • Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

Paratek Pharmaceuticals to Present at the Credit Suisse 31st Annual Healthcare Conference

Retrieved on: 
Tuesday, November 1, 2022
Security (finance), Annual report, Credit, Development, Risk, Acne, BARDA, Degenerative disease, U.S. Securities and Exchange Commission, Anthrax, ABSSSI, Office of Inspector General, U.S. Department of Health and Human Services, Conference, GLOBE, Credit Suisse, LLC, Nasdaq, Biomedical Advanced Research and Development Authority, Government, Public health, U.S. Department of Defense Strategy for Operating in Cyberspace, Investor, NTM, Bronchopneumonia, Pharmaceutical industry, Vaccine

BOSTON, Nov. 01, 2022 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and military use, announces that Evan Loh, M.D., chief executive officer, will present at the Credit Suisse 31st Annual Healthcare Conference held Nov. 7-10.

Key Points: 
  • BOSTON, Nov. 01, 2022 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and military use, announces that Evan Loh, M.D., chief executive officer, will present at the Credit Suisse 31st Annual Healthcare Conference held Nov. 7-10.
  • Dr. Lohs presentation will be available on-demand beginning Nov. 8 under Presentations & Events" in the Investors section of the company's website.
  • Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
  • Paratek is also conducting a Phase 2b study with NUZYRA in a rare disease, nontuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex.

Paratek Announces First Milestone Towards Creating a U.S. Manufacturing Supply Chain for NUZYRA® (omadacycline) under BARDA Project BioShield Contract

Retrieved on: 
Monday, October 31, 2022
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This milestone follows a successful technology transfer by Paratek and its tablet manufacturing partners in the United States and Europe.

Key Points: 
  • This milestone follows a successful technology transfer by Paratek and its tablet manufacturing partners in the United States and Europe.
  • As supply chain interruptions continue to threaten availability of essential medicines, Paratek is advancing our efforts with BARDA to onshore the manufacturing of NUZYRA to the United States.
  • We are excited to reach this first milestone towards creating a fully integrated manufacturing supply chain for NUZYRA on U.S. soil.
  • In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million.

Paratek Pharmaceuticals to Report Third-Quarter 2022 Financial Results on Nov. 3

Retrieved on: 
Tuesday, October 25, 2022
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BOSTON, Oct. 25, 2022 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK) today announced that the company will host a conference call and live audio webcast on Thursday, Nov. 3 at 4:30 p.m.

Key Points: 
  • BOSTON, Oct. 25, 2022 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK) today announced that the company will host a conference call and live audio webcast on Thursday, Nov. 3 at 4:30 p.m.
  • ET to report its financial results for the third quarter of 2022.
  • Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.
  • Paratek is also conducting a Phase 2b study with NUZYRA in a rare disease, nontuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex.

Paratek Pharmaceuticals Presenting New Data for NUZYRA® (omadacycline) at IDWeek 2022

Retrieved on: 
Thursday, October 13, 2022
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BOSTON, Oct. 13, 2022 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announces that new data from the NUZYRA® (omadacycline) non-clinical and investigator-initiated research programs will be presented at IDWeek 2022.

Key Points: 
  • The hybrid conference will be held from Oct. 19-23 at the Walter E. Washington Convention Center in Washington, D.C.
  • Posters will be available for registrants on the IDWeek Interactive Program and the IDWeek Mobile App starting on Oct. 19, 8 a.m.
  • Onsite attendees can view posters from Oct. 20-22 from 8 a.m. to 6 p.m.
  • Paratek is also conducting a Phase 2b study with NUZYRA in a rare disease, non-tuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex.

Eagle Pharmaceuticals Announces Submission of Investigational New Drug Application to U.S. Food and Drug Administration for CAL02, a Novel First-in-Class Broad-Spectrum Anti-Virulence Agent for the Treatment of Severe Community-Acquired Bacterial Pneumoni

Retrieved on: 
Wednesday, October 12, 2022
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WOODCLIFF LAKE, N.J., Oct. 12, 2022 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) announced today that it has submitted an investigational new drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for CAL02, a novel first-in-class broad-spectrum anti-virulence agent for the treatment of severe community-acquired bacterial pneumonia (“SCABP”).

Key Points: 
  • CAL02 is a very interesting agent with a unique mechanism of action.
  • CAL02 has the potential to shift the treatment paradigm for patients with severe community-acquired pneumonia, a leading cause of death worldwide.
  • In addition, Eagle believes a CAL02 new drug application for the treatment of SCABP may qualify for priority review.
  • 2 Jain, S., Self, W. H., Wunderink, R. G., Fakhran, S., Balk, R., Bramley, A. M., ... & Finelli, L. (2015).

Clarametyx Announces FDA Acceptance of Investigational New Drug (IND) Application for Phase 1 Study of Immune-Enabling Antibody Therapy CMTX-101

Retrieved on: 
Wednesday, October 5, 2022
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(Clarametyx), a biotechnology company developing targeted, immune-enabling biologic therapies to counter serious infections associated with biofilms, today announced that the U.S. Food and Drug Administration (FDA) has accepted the companys Investigational New Drug (IND) application to initiate a first-in-human Phase 1 safety study followed by a Phase 1b trial of CMTX-101, a novel immune-enabling antibody therapy.

Key Points: 
  • (Clarametyx), a biotechnology company developing targeted, immune-enabling biologic therapies to counter serious infections associated with biofilms, today announced that the U.S. Food and Drug Administration (FDA) has accepted the companys Investigational New Drug (IND) application to initiate a first-in-human Phase 1 safety study followed by a Phase 1b trial of CMTX-101, a novel immune-enabling antibody therapy.
  • Weve made tremendous progress with the early development of this potentially game-changing technology to specifically address bacterial biofilms, which is a major driver of resistance in bacterial infections, said David Richards, Chief Executive Officer, Clarametyx.
  • Collectively, these infections contribute substantial costs to the healthcare system due to significantly increased hospitalization rates and lengths of stay, as well as increased morbidity and mortality.
  • CMTX-101 is intended to be administered concomitantly with a wide range of standard-of-care antibiotics that target both Gram-negative and Gram-positive bacteria.

Paratek Announces Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

Retrieved on: 
Monday, October 3, 2022
Anthrax, ABSSSI, GLOBE, Degenerative disease, Government, NASDAQ, LinkedIn, Nasdaq, Biomedical Advanced Research and Development Authority, Public health, NTM, Twitter, U.S. Department of Defense Strategy for Operating in Cyberspace, BARDA, Bronchopneumonia, LLC, Acne, Development, Employment, Office of Inspector General, U.S. Department of Health and Human Services, Company, Pharmaceutical industry, Vaccine

Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

Key Points: 
  • Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
  • Paratek is also conducting a Phase 2b Study in a rare disease, nontuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex with NUZYRA.
  • Paratek estimates this opportunity represents a potential $1 billion addressable market in the United States.
  • Paratek retains the development and commercialization rights for sarecycline in the rest of the world.