Post-exposure prophylaxis

Soligenix Announces Recent Accomplishments And First Quarter 2024 Financial Results

Retrieved on: 
Freitag, Mai 10, 2024
Partnership, Disease, Patient, Infection, SUDV, Doctor of Philosophy, Vaccine, COVID-19, Patent, Food, European Medicines Agency, Income tax, CTCL, FDA, Government, Safety, Cutaneous T-cell lymphoma, EMA, Acquisition, Research, Food and Drug Administration, MARV, Post-exposure prophylaxis, Pharmaceutical industry

PRINCETON, N.J., May 10, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the quarter ended March 31, 2024.

Key Points: 
  • PRINCETON, N.J., May 10, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the quarter ended March 31, 2024.
  • This study will enroll approximately 80 patients across the U.S. and Europe, starting before the end of 2024, with top-line results expected in the second half of 2026.
  • Financial Results – Quarter Ended March 31, 2024
    Soligenix's revenues for the quarter ended March 31, 2024 were $0.1 million as compared to $0.3 million for the quarter ended March 31, 2023.
  • As of March 31, 2024, the Company's cash position, exclusive of the approximate $4.3 million in net proceeds from our recent financing, was approximately $7.1 million.

MISTR, Known for its Free Online PrEP and Long-Term HIV Care, is Now Prescribing DoxyPEP

Retrieved on: 
Dienstag, April 16, 2024
Telemedicine, Virtual Medicine, Other Health, Pharmaceutical, Other Consumer, General Health, Philanthropy, Women, Infectious Diseases, Men, LGBTQ+, Other Philanthropy, AIDS, Lifestyle, Consumer, Health, Telehealth, Syphilis, NIH, Post-exposure prophylaxis, STI, ART, Patient, Chlamydia, Doxycycline, HIV, Gonorrhea, Pharmaceutical industry

MISTR, the largest telemedicine provider offering free online PrEP and long-term HIV care in all 50 states, D.C., and Puerto Rico, is now prescribing Doxycycline Post-Exposure Prophylaxis (DoxyPEP), an antibiotic that reduces bacterial STIs, including gonorrhea, chlamydia, and syphilis.

Key Points: 
  • MISTR, the largest telemedicine provider offering free online PrEP and long-term HIV care in all 50 states, D.C., and Puerto Rico, is now prescribing Doxycycline Post-Exposure Prophylaxis (DoxyPEP), an antibiotic that reduces bacterial STIs, including gonorrhea, chlamydia, and syphilis.
  • Beginning today, patients can now use MISTR’s seamless telehealth platform to receive DoxyPEP online for free.
  • “I’m proud that MISTR is democratizing access to PrEP, HIV Care, and now DoxyPEP.”
    DoxyPEP has already shown promising results in reducing the rates of certain STIs.
  • Now MISTR patients can receive DoxyPEP, in addition to their PrEP or HIV care medications.

FDA Grants Soligenix Orphan Drug Designation for the Prevention and Post-Exposure Prophylaxis Against Marburg Marburgvirus Infection

Retrieved on: 
Montag, April 15, 2024
Ricin, FDA, MARV, Food and Drug Administration, Ebola, Risk, Safety, Food, Doctor of Philosophy, Vaccine, Post-exposure prophylaxis, Biologics license application, Disease, Element, BLA, Immune system, Government, COVID-19, Pharmaceutical industry

PRINCETON, N.J., April 15, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in MarVax™, the subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, for "the prevention and post-exposure prophylaxis against MARV infection." 

Key Points: 
  • "Marburg marburgvirus causes Marburg Virus Disease, a highly related disease to the more commonly known Ebola Virus Disease.
  • Although MARV has caused fewer outbreaks, they remain highly fatal and a significant risk in continental Africa, with the most recent outbreak occurring in 2023.
  • There is no approved vaccine for MARV, and the only approved vaccines for filovirus type disease is specific to Zaire ebolavirus.
  • "Elements of this subunit vaccine platform have been utilized in our ricin toxin, filovirus and COVID-19 vaccine candidates, indicating its broad applicability.

FDA Grants Soligenix Orphan Drug Designation for the Prevention and Post-Exposure Prophylaxis Against Sudan Ebolavirus Infection

Retrieved on: 
Donnerstag, April 11, 2024
FDA, Food and Drug Administration, Food, Ebolavirus, Primate, Doctor of Philosophy, Vaccine, Post-exposure prophylaxis, Biologics license application, Senior, SUDV, BLA, Government, Immunity, Pharmaceutical industry

PRINCETON, N.J., April 11, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in SuVax™, the subunit protein vaccine of recombinantly expressed Sudan ebolavirus (SUDV) glycoprotein, for "the prevention and post-exposure prophylaxis against SUDV infection."

Key Points: 
  • "The SuVax™ vaccine specifically addresses the potentially lethal Sudan Virus Disease, caused by SUDV.
  • SUDV is a type of ebolavirus for which there is no current treatment or vaccine.
  • With recent outbreaks in 2022 and 2023, developing vaccines for all Ebola type diseases remains an important worldwide priority.
  • The FDA's decision to grant orphan drug designation signifies an important step for Soligenix as we continue to advance the program and adds significantly to the existing patent estate surrounding this novel technology."

Cocrystal Pharma Reports 2023 Financial Results and Provides Updates on its Antiviral Drug-Development Programs

Retrieved on: 
Donnerstag, März 28, 2024
COCP, MERS, Research, SARS, Enzyme, Drug discovery, Influenza, CFO, COVID-19, Lung, Coronavirus, RNA, Gastroenteritis, G&A, Death, SARS-CoV-2, Trial of the century, IND, Disease, World Health Organization, Post-exposure prophylaxis, Clinical trial, CDC, Safety, Pharmacokinetics, Cocrystal, Therapy, FDA, Pharmaceutical industry

Our drug-discovery process focuses on the highly conserved regions of the viral enzymes and inhibitor-enzyme interactions at the atomic level.

Key Points: 
  • Our drug-discovery process focuses on the highly conserved regions of the viral enzymes and inhibitor-enzyme interactions at the atomic level.
  • Cocrystal reported unrestricted cash as of December 31, 2023 of $26.4 million, compared with $37.1 million as of December 31, 2022.
  • Net cash used in operating activities for 2023 was $14.7 million, compared with $21.4 million for 2022.
  • The Company had working capital of $25.0 million and 10.2 million common shares outstanding as of December 31, 2023.

Invivyd Announces FDA Authorization for Emergency Use of PEMGARDA™ (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19

Retrieved on: 
Freitag, März 22, 2024
Diphenhydramine, Anaphylaxis, Hook effect, Pre-exposure prophylaxis, Half-life, Risk, Bone marrow, COVID-19, Patient, Metoprolol, Adrenaline, Epitope, DSM-IV codes, SARS-CoV-2, Death, Adolescence, Bank statement, Post-exposure prophylaxis, Clinical trial, CDC, Antibody, Vaccination, Safety, Immunodeficiency, Vaccine, FDA, Food, Medicine

Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.

Key Points: 
  • Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
  • “The PEMGARDA EUA marks a transformational moment for Invivyd and for the many moderately to severely immunocompromised people who are vulnerable to COVID-19 disease in the U.S.
  • It was developed using INVYMAB™, the company’s platform approach which combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering.
  • The severity of the reactions was generally mild (17/27) or moderate (8/27), but two reactions were life-threatening.

Sanofi Announces Launch of Verorab® (Sanofi Inactivated Rabies Vaccine) in the UK for Pre-exposure and Post-exposure Prophylaxis of Rabies in All Age Groups

Retrieved on: 
Freitag, April 5, 2024
Research, Other Health, Pharmaceutical, Vacation, Other Travel, Infectious Diseases, Destinations, Travel, Clinical Trials, Science, Biotechnology, Health, Other Science, SNY, Rabies, Risk, SAN, Death, Dog, Post-exposure prophylaxis, Licensure, Fox, Vaccine

Sanofi (EURONEXT: SAN and NASDAQ: SNY) has today announced the launch of Verorab® (Sanofi Inactivated Rabies Vaccine) in the UK, an inactivated rabies vaccine indicated for pre-exposure and post-exposure prophylaxis of rabies in all age groups.1

Key Points: 
  • Sanofi (EURONEXT: SAN and NASDAQ: SNY) has today announced the launch of Verorab® (Sanofi Inactivated Rabies Vaccine) in the UK, an inactivated rabies vaccine indicated for pre-exposure and post-exposure prophylaxis of rabies in all age groups.1
    This launch is based on extensive clinical data from over 13,000 individuals.1 Sanofi Inactivated Rabies Vaccine has been approved and widely used in more than 80 countries.2 It is estimated that between 41 and 70 million individuals have received the vaccine since its first licensure in May 1985, in France.2
    Rabies is nearly always fatal once symptoms appear, but can be preventable with vaccination3
    Each year, an estimated 59,000 people worldwide die from rabies.4 That’s one person every nine minutes of every day3, with approximately 95% of deaths occurring in Asia and Africa.3,4,5 Individuals travelling to these countries should be aware of the risk of rabies and take the appropriate precautionary measures.
  • Rebecca Catterick, UK and Ireland Sanofi Vaccines General Manager, said:
    “Rabies is a fatal, travel-related vaccine-preventable disease.
  • The availability of Verorab® in the UK provides an effective immunisation option for those travelling to high-risk countries, as well as a treatment for post-rabies exposure.”
    Joanna Lowry, Specialist Travel Nurse & Educator, said:
    “I am always surprised by the number of British travellers I meet who are unaware of the risk of rabies.
  • Increasing awareness and sharing education on preventative measures is crucial to help reduce the possibility of this devastating disease.”
    Rabies is primarily transmitted by the bite, scratch, or lick of a rabid animal, 99% of which are by dogs, but can also be other wildlife, such as foxes or bats.6

Paratek Pharmaceuticals Announces Positive Efficacy Data for NUZYRA® as Post-Exposure Prophylaxis of Inhalational Anthrax, Triggering Additional Procurement under BARDA Project BioShield Contract

Retrieved on: 
Dienstag, März 5, 2024
Human services, Anthrax, Soil, FDA, Shanda, NHP, PEP, Survival rate, Administration, Post-exposure prophylaxis, Observation, Death, Bioterrorism, Infection, Tablet, Development, Partnership, Pharmaceutical industry

Anthrax (B. anthracis) is an infectious disease caused by gram-positive, rod-shaped, spore-forming bacteria that can lead to severe illness and death.

Key Points: 
  • Anthrax (B. anthracis) is an infectious disease caused by gram-positive, rod-shaped, spore-forming bacteria that can lead to severe illness and death.
  • Oral NUZYRA tablets associated with this procurement were manufactured in the United States as part of the company’s U.S. onshoring efforts.
  • “This procurement also represents a significant milestone in the company’s onshoring efforts as for the first time Paratek is providing BARDA with NUZYRA tablets produced on U.S. soil.
  • In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million.

Emergent BioSolutions Appoints Industry Leader Joseph C. Papa as New President and CEO

Retrieved on: 
Mittwoch, Februar 21, 2024
EBS, Immunization, Emergent BioSolutions, FDA, Growth, U.S. FDA, Life, Post-exposure prophylaxis, Public, Vaccine

Mr. Papa succeeds Haywood Miller, who will step down from his role as interim CEO, effective February 21, 2024.

Key Points: 
  • Mr. Papa succeeds Haywood Miller, who will step down from his role as interim CEO, effective February 21, 2024.
  • "Following a thorough search process, we are pleased to appoint Joe Papa as president and CEO of Emergent,” said Zsolt Harsanyi, Ph.D., chairman of the Board of Directors.
  • “He is a recognized industry leader with unparalleled experience in all facets of the pharmaceutical and healthcare industry.
  • “I am confident that these important products provide for a bright future ahead as Emergent continues to lead in public health preparedness.

Emergent BioSolutions Receives $75 Million Contract Option from BARDA to Procure Doses of CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted)

Retrieved on: 
Dienstag, November 28, 2023
Post-exposure prophylaxis, Partnership, Licensure, Government, FDA, Acquisition, Administration, Human services, Calendar, Public, Emergent BioSolutions, EBS, Safety, Anthrax, Development, Emergent, Vaccine

Deliveries are expected to begin this calendar year and be complete by the end of the first quarter of 2024.

Key Points: 
  • Deliveries are expected to begin this calendar year and be complete by the end of the first quarter of 2024.
  • Anthrax is considered a high-priority national security threat and has the potential for major public health impact.
  • In April 2022, Emergent submitted the Biologics License Application to the FDA for review, leading to approval and licensure in July 2023.
  • This latest contract option supplements previous contract procurements and supports the U.S. biodefense preparedness efforts.