Post-exposure prophylaxis

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

Retrieved on: 
Thursday, March 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: 
Friday, March 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: 
Friday, 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: 
Tuesday, March 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: 
Wednesday, February 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: 
Tuesday, 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.

60 Degrees Pharmaceuticals Suspends Phase IIB Study of Tafenoquine for COVID-19, Pivots to Refocus on Commercialization of Treatments for Malaria and Tick-Borne Diseases

Retrieved on: 
Thursday, October 12, 2023
Incidence, Infection, Post-exposure prophylaxis, COVID-19, HIV disease progression rates, Lyme disease, United, Letter, Parasitism, Cough, Clinical research associate, Risk, Hospital, Therapy, IND, Death, Smell, FDA, Tafenoquine, IIA, IIB, Malaria, Fever, Literature, Babesiosis, Deer, Patient, Pharmaceutical industry, Medical device

Tafenoquine is the active molecule in ARAKODA®, the Company’s U.S. Food and Drug Administration (FDA)-approved regimen for malaria prevention.

Key Points: 
  • Tafenoquine is the active molecule in ARAKODA®, the Company’s U.S. Food and Drug Administration (FDA)-approved regimen for malaria prevention.
  • However, the FDA has explicitly not authorized the use of those products in patients with low risk of COVID-19 disease progression.
  • Current literature on COVID-19 shows that low risk patients have a very low risk of hospitalization.
  • However, such a combination approach may not make clinical sense in a low-risk population or be Phase III enabling.

Pfizer Presents New Data at IDWeek 2023 Highlighting Advances in Prevention and Treatment of Certain Respiratory Illnesses and Other Infectious Diseases

Retrieved on: 
Thursday, October 5, 2023
Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, COVID-19, Clinical Trials, Pain, Shenzhen Kangtai Biological Products, Food, Gram-negative bacteria, Preterm birth, Act, Death, Ritonavir, Plasma, Treatment, Myalgia, Stevens–Johnson syndrome, EUA, Risk, Hospital, Jaundice, Emergency Use Authorization, Nausea, Allergy, Microsome, Headache, Fatigue, CYP3A, Immune system, Safety, History, Regulation of tobacco by the U.S. Food and Drug Administration, Gestational age, Post-exposure prophylaxis, Anaphylaxis, Patient, Medicine, Vaccine, Pharmaceutical industry, Birth control

PAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

Key Points: 
  • PAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19.
  • There are certain other drugs for which concomitant use with PAXLOVID should be avoided and/or dose adjustment, interruption, or therapeutic monitoring is recommended.
  • Drugs listed here are a guide and not considered a comprehensive list of all drugs that may be contraindicated with PAXLOVID.
  • Drugs that are primarily metabolized by CYP3A for which elevated concentrations are associated with serious and/or life-threatening reactions:
    Microsomal triglyceride transfer protein inhibitor: lomitapide

60 Degrees Pharma Withdraws COVID Phase IIB IND, Will Resubmit Pending Assessment of Ability to Meet FDA Requirements

Retrieved on: 
Monday, September 18, 2023
Acceleration, IIB, Lyme disease, Babesiosis, Marketing, COVID-19, Infection, Incidence, Post-exposure prophylaxis, Patient, Clinical research associate, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Malaria, Pharmaceutical industry, Medical device

The Company’s decision to withdraw the IND is in response to recent comments from the U.S. Food and Drug Administration (FDA).

Key Points: 
  • The Company’s decision to withdraw the IND is in response to recent comments from the U.S. Food and Drug Administration (FDA).
  • In the interim, pending additional interaction with FDA, 60P has paused further start-up activities for its Phase IIB trial (ACLR8-LR), thereby decreasing the Company’s burn rate and improving its cash position in the short term.
  • Estimates are that 10 percent of Lyme disease patients are co-infected with babesiosis.
  • In Q2 2023, sales of ARAKODA increased by 150 percent relative to the same period of 2022.

SAB Biotherapeutics Provides Company Update for Q2 2023 Financial Results

Retrieved on: 
Monday, August 21, 2023
SAB, Post-exposure prophylaxis, GLP, JDRF, Serum sickness, New Animal Drug Application, LLP, BIO, Omicron, Higgs, KOL, University, FDA Center for Devices and Radiological Health, Partnership, Diabetes, Blas, T1D, Type A and Type B personality theory, Safety, Pediatric endocrinology, COVID-19, Center for Biologics Evaluation and Research, BTD, G&A, Immunotherapy, Antibody, Breakthrough therapy, Professor, Federation, HIV disease progression rates, Patient, NADA, Administration, International Society, ATG, Endocrinology, Entrepreneurship, Research and development, Blaine Higgs, Federation of Clinical Immunology Societies, FDA, Private law, R, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, US Foods, NIH, Treatment, Type 1 diabetes, Food, Vaccine, Pharmaceutical industry, Medical device, Cryptocurrency, Research

SIOUX FALLS, S.D., Aug. 21, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics ( Nasdaq: SABS ), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human immunoglobulins (hIgG), also known as fully-human polyclonal antibodies, without the need for human donors, today reported financial results for the second quarter ended June 30, 2023, and provided a company update.

Key Points: 
  • SIOUX FALLS, S.D., Aug. 21, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics ( Nasdaq: SABS ), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human immunoglobulins (hIgG), also known as fully-human polyclonal antibodies, without the need for human donors, today reported financial results for the second quarter ended June 30, 2023, and provided a company update.
  • "We are pleased to share the significant progress achieved during the second quarter of 2023.
  • On August 21, 2023, we announced that EisnerAmper LLP was appointed as our independent registered public accounting firm for the fiscal year ending December 31, 2023, effective August 22, 2023.
  • The decrease was primarily due to discretionary cost reduction measures and increased efficiencies as we continue to mature as a publicly traded company.