QIDP

CorMedix Inc. Announces FDA Acceptance of Resubmission of New Drug Application for DefenCath

Retrieved on: 
Monday, March 28, 2022
Company, Private Securities Litigation Reform Act, Cancer, Fast Track, Marketing, Trial of the century, New chemical entity, CMO, Research, SEC, Color, QIDP, CEO, Food, Endpoint security, New Drug Application, Review, General counsel, Goal, Mark (given name), Nasdaq, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, GLOBE, NDA, Agency, Kidney, FDA, Patient, File, Pharmaceutical industry, Coronavirus

The Agency considers the resubmission as a complete, Class 2 response with a six month review cycle.

Key Points: 
  • The Agency considers the resubmission as a complete, Class 2 response with a six month review cycle.
  • Dr. Phoebe Mounts, General Counsel and Head of Technical Operations at CorMedix noted We are pleased to be able to announce the acceptance for filing of the resubmitted NDA.
  • CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations.
  • CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Iterum Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results

Retrieved on: 
Monday, March 28, 2022
CRL, Therapy, Public policy, Finance Secretary (India), Investment, Forward-looking statement, Legislation, GAAP, Compliance, Bacteria, Silicon Valley Bank, ITRM, SEC, QIDP, Research, Conference, U.S. Securities and Exchange Commission, Urinary tract infection, Penem, Senior, Hand, G&A, Net, Maturity, Note, COVID-19, GLOBE, NDA, Phrase, Infection, R, Annual report, FDA, Exchangeable, Corporation, Table, Silicon, Security (finance), IV, Pharmaceutical industry, Lithium, Bank, Nasdaq

DUBLIN, Ireland and CHICAGO, March 28, 2022 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the fourth quarter and year ended December 31, 2021.

Key Points: 
  • The articles can be accessed under Scientific Publications in the Our Science section of the Companys website at www.iterumtx.com .
  • Research and development (R&D) expenses for the fourth quarter and full year 2021 were $3.7 million and $10.7 million, respectively, compared to $2.4 million and $21.1 million for thesame periods in 2020.
  • The increase for the three-month period was primarily due to the non-cash amortization of an intangible asset in 2021.
  • General and administrative (G&A) expenses for the fourth quarter and full year 2021 were $3.1 million and $13.8 million, respectively, compared to $2.3 million and $11.1 million for thesame periods in 2020.

CorMedix Inc. to Report Fourth Quarter and Fiscal Year 2021 Financial Results and Provide a Corporate Update on March 29

Retrieved on: 
Tuesday, March 22, 2022
Company, Cancer, Fast Track, Marketing, Trial of the century, New chemical entity, QIDP, Endpoint security, New Drug Application, Mark (given name), NDA, FDA, Patient, File, Pharmaceutical industry

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases.

Key Points: 
  • CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases.
  • The deficiencies have been addressed in the resubmitted NDA which is being reviewed by FDA for acceptance for filing.
  • CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations.
  • It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with programs in surgical sutures and meshes, and topical hydrogels.

Organon Enters into Global License Agreement to Commercialize Daré Bioscience’s XACIATO™ (clindamycin phosphate vaginal gel, 2%), FDA-Approved Treatment for Females 12 and Older with Bacterial Vaginosis (BV)

Retrieved on: 
Thursday, March 31, 2022
FDA, Health, Consumer, Women, Pharmaceutical, Biotechnology, MSD, Birth, Risk, BV, MRK, NASDAQ, Bacterial vaginosis, Sale, Patent, Investment, Gaps, Form, Forward-looking statement, Fertility, Growth, OGN, Merck & Co., Multimedia, NYSE, Health minister, Bacteria, SEC, QIDP, Woman, Health, U.S. Securities and Exchange Commission, Private Securities Litigation Reform Act, Industry, Review, Twitter, COVID-19, 8-K, Vaginitis, Hart–Scott–Rodino Antitrust Improvements Act, News, Annual report, FDA, Merck, Security (finance), Pharmaceutical industry, Birth control, Online shopping, Risk management, Organon, ORGANON, DARé BIOSCIENCE

XACIATO is an FDA-approved medication for the treatment of bacterial vaginosis (BV) in females 12 years of age and older.

Key Points: 
  • XACIATO is an FDA-approved medication for the treatment of bacterial vaginosis (BV) in females 12 years of age and older.
  • XACIATO received both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA for the treatment of bacterial vaginosis.
  • BV is the most common cause of vaginitis worldwide and is estimated to affect approximately 21 million women in the U.S.
  • Sabrina Martucci Johnson, Dars President and Chief Executive Officer, commented, Organon shares our commitment to advance critically needed innovations in womens health.

Peptilogics’ Presentations at American Academy of Orthopedic Surgeons (AAOS) 2022 Annual Meeting Highlight Peptide Therapeutic PLG0206 for the Treatment of Periprosthetic Joint Infection (PJI)

Retrieved on: 
Tuesday, March 22, 2022
Science, Other Science, Biotechnology, Research, Pharmaceutical, Surgery, Health, Other Health, UPMC, LinkedIn, Engineering, Therapy, World Health Organization, Korea Disease Control and Prevention Agency, ESKAPE, Elective surgery, Cystic fibrosis, Survival, QIDP, Biofilm, Wellcome Trust, Research, Associate, World, Cooperative, Death, Failure, AAOS, Medical director, KNEA, Quality of life, Artificial intelligence, University, Technology, Orthopedic surgery, Annual general meeting, Founders Fund, Twitter, Ageing, Cystic Fibrosis Foundation, American Academy, Physician, Center, Phenotype, Animal, Pittsburgh, Patient, Infection, Algorithm, Pharmaceutical industry, PERIPROSTHETIC JOINT INFECTION (PJI), PEPTILOGICS

Peptilogics, a biotech company engineering peptide therapeutics to improve the treatment landscape for patients with life-threatening diseases, will present three papers at the American Academy of Orthopedic Surgeons (AAOS) 2022 Annual Meeting in Chicago March 24.

Key Points: 
  • Peptilogics, a biotech company engineering peptide therapeutics to improve the treatment landscape for patients with life-threatening diseases, will present three papers at the American Academy of Orthopedic Surgeons (AAOS) 2022 Annual Meeting in Chicago March 24.
  • The paper presentations highlight the potent antimicrobial activity of Peptilogics lead investigational engineered peptide PLG0206.
  • The preclinical data showed that PLG0206 reduced biofilm mass and increased survival of animals infected with multi-drug resistant ESKAPE pathogens for the treatment of periprosthetic joint infection (PJI).
  • PLG0206 is a broad-spectrum, anti-biofilm, anti-infective peptide therapeutic currently in clinical development for the treatment of PJI.

Iterum Therapeutics to Provide Business Update and Report Fourth Quarter and Full Year 2021 Financial Results on March 28, 2022

Retrieved on: 
Monday, March 21, 2022
Company, Therapy, Public policy, Investor, Forward-looking statement, Legislation, Access, Bacteria, ITRM, SEC, QIDP, Nasdaq, U.S. Securities and Exchange Commission, Penem, Hand, COVID-19, GLOBE, Phrase, Infection, Security (finance), IV, Pharmaceutical industry

Management will host a conference call at8:30 a.m. ETthat day to discuss the Companys financial results and provide an update on its business.

Key Points: 
  • Management will host a conference call at8:30 a.m. ETthat day to discuss the Companys financial results and provide an update on its business.
  • To access the call please dial 844-200-6205 (domestic) or 929-526-1599 (international) and refer to Access Code 096194.
  • The audio webcast can be accessed under Financials & Filings in the Investors section of the Companys website at www.iterumtx.com following the call.
  • Iterum is currently advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation.

CorMedix Inc. Announces the Appointment of Chief Executive Officer

Retrieved on: 
Thursday, March 17, 2022
Endo International, Company, Private Securities Litigation Reform Act, Cancer, Business development, Organization, Fast Track, Leadership, Oppenheimer, Marketing, Trial of the century, New chemical entity, Board, Patient, McLennan, Business, CMO, Gabelli School of Business, SEC, Research, Fordham Graduate School of Arts and Sciences, QIDP, Sustainability Accounting Standards Board, Laboratory, CEO, US Market Access Center, Entrepreneurship, Endpoint security, New Drug Application, Oppenheimer Holdings, Georgetown University, Goal, Mark (given name), Nasdaq, MBA, GLOBE, NDA, Marsh McLennan, FDA, File, Pharmaceutical industry, Management, Risk management, Amneal Pharmaceuticals, Ranbaxy Laboratories, Economics, Coronavirus

Myron Kaplan, Chairman of CorMedixs Board of Directors commented, We are delighted to welcome Joe to CorMedix as the new Chief Executive Officer.

Key Points: 
  • Myron Kaplan, Chairman of CorMedixs Board of Directors commented, We are delighted to welcome Joe to CorMedix as the new Chief Executive Officer.
  • CorMedix has a strong late-stage pre-commercial asset in DefenCath with a compelling value proposition for patients in the hemodialysis community, said Mr. Todisco.
  • I join my colleagues in welcoming Joe to CorMedix as Chief Executive Officer.
  • I look forward to working closely with Joe as we seek to transform CorMedix to a commercial stage entity.

Acurx Pharmaceuticals to Participate in the 2022 Virtual Growth Conference Presented by Maxim Group LLC and hosted by M-Vest on March 28-30, 2022 from 9:00 a.m. - 5:00 p.m. EDT

Retrieved on: 
Wednesday, March 16, 2022
Recurrence, IIIC, MRSA, Patient, Biotechnology, VRE, Private Securities Litigation Reform Act, Chief executive officer, Infection, Plasma, Conference, FDA, Fireside, Infectious Diseases Society of America, Firmicutes, Methicillin-resistant Staphylococcus aureus, Clostridioides difficile infection, Q&A, Primary energy, Health information technology, NASDAQ, EDT, Kepler-86, Tobacco Products Scientific Advisory Committee, Clostridioides, Gram-positive bacteria, Financial services, Company, Got Game Entertainment, DRSP, CEO, Charles M. Vest, Clostridioides difficile (bacteria), QIDP, CDI, DNA, Fireside chats, Gram, Enterococcus, Marketing, Pharmaceutical industry, Health care, Actinobacteria

Mr. Luci will be presenting during the Fireside Chat with Acurx Pharmaceuticals, Inc. at 9:30 am ET on Monday, March 28, 2022.

Key Points: 
  • Mr. Luci will be presenting during the Fireside Chat with Acurx Pharmaceuticals, Inc. at 9:30 am ET on Monday, March 28, 2022.
  • The conference will feature company presentations, fireside chats, roundtable discussions, and live Q&A with CEOs moderated by Maxim Research Analysts.
  • About Acurx Pharmaceuticals, Inc. Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections.
  • However, while we may elect to update these forward- looking statements at some point in the future, we specifically disclaim any obligation to do so.

Microbion Corporation Announces Granting of a US Patent for the Use of Topical Pravibismane for Diabetic Foot Ulcer Infections

Retrieved on: 
Tuesday, March 15, 2022
Bismuth, DFI, NTM, Ulcer, Method, Patent, US, Patient, Intention, FDA, Multimedia, Cystic Fibrosis Foundation, United States Patent and Trademark Office, Safety, Mycobacterium, NIH, Orphan drug, United States Department of Defense, Chronic lung disease, USPTO, Company, Growth, QIDP, United States patent law, Infection, Pharmaceutical industry, BC

11,207,288 to Microbion on December 28, 2021, with claims to the use of Microbion's proprietary pravibismane topical composition for diabetic foot infections ("DFI").

Key Points: 
  • 11,207,288 to Microbion on December 28, 2021, with claims to the use of Microbion's proprietary pravibismane topical composition for diabetic foot infections ("DFI").
  • The patent, entitled "Bismuth-thiol compositions and methods for treating wounds," extends topical pravibismane patent protection through to mid-2039.
  • The granted claims cover the administration and use of topical pravibismane compositions in diabetic foot ulcer infections.
  • This patent further expands Microbion's patent portfolio, comprising granted claims to its pravibismane composition and methods of treating wounds and diabetic foot ulcers.

Phathom Pharmaceuticals Submits Vonoprazan NDA to FDA for the Treatment of Erosive Esophagitis

Retrieved on: 
Monday, March 14, 2022
Esophagus, Nasdaq, Safety, Stomach, Lansoprazole, Twitter, Maintenance, Private Securities Litigation Reform Act, Mortality, Company, Marketing, Research, Helicobacter pylori, U.S. Securities and Exchange Commission, FDA, Gastroesophageal reflux disease, Chest pain, Acid erosion, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cancer, PPI, Angina, QIDP, NDA, Vonoprazan, GLOBE, Amoxicillin, Clarithromycin, Drugs for acid-related disorders, Patient, Security (finance), NDAS, GERD, Standard of care, Heartburn, Degenerative disease, Esophagitis, EE, SEC, Food, Goal, Fast Track, LinkedIn, Pharmaceutical industry, Takeda, NERD

Erosive esophagitis, a major type of gastroesophageal reflux disease (GERD), affects approximately 20 million people in the U.S.

Key Points: 
  • Erosive esophagitis, a major type of gastroesophageal reflux disease (GERD), affects approximately 20 million people in the U.S.
  • We believe there is great interest among patients and healthcare providers for new treatment options to address the shortcomings of current treatment.
  • If approved, vonoprazan has the potential to satisfy the large unmet needs of millions of patients and set a new treatment paradigm in EE.
  • Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders.