Janssen Announces Submission of Two Applications to U.S. FDA Seeking Approval of SIMPONI ARIA ® (golimumab) for the Treatment of Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis
HORSHAM, PA, April 24, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of two supplemental Biologics License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA® (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA), in patients two years of age and older in combination with methotrexate. If approved for these indications, SIMPONI ARIA would be the first anti-tumor necrosis factor (TNF)-alpha biologic agent administered by intravenous infusion available...
Source: Johnson and Johnson - April 24, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
Roche receives FDA approval for cobas HPV test for use on the cobas 6800/8800 Systems to identify women at risk for cervical cancer
Basel, 21 April 2020 - Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced US Food and Drug Administration (FDA) approval for the cobas ® HPV test for use on the fully automated, high-throughput cobas® 6800/8800 Systems. The cobas® HPV test identifies women at risk for cervical cancer by detecting the presence of high-risk human papillomavirus (HPV) DNA in cervical samples. Persistent high-risk HPV infections can develop into pre cancerous lesions and, if left untreated, these lesions can progress to cervical cancer.“The approval of our HPV test for the cobas 6800 and 8800 Systems enables molec...
Source: Roche Media News - April 21, 2020 Category: Pharmaceuticals Source Type: news
FDA accepts Roche ’s New Drug Application for Xofluza (baloxavir marboxil) for the treatment of influenza in children
Basel, 27 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) as well as two supplemental New Drug Applications (sNDA) for Xofluza® (baloxavir marboxil). The FDA accepted a NDA for a new formulation of Xofluza as one-dose granules for oral suspension (2 mg/mL), potentially offering a more convenient option for children and those who have difficulty swallowing. In addition, the application seeks approval of Xofluza for the treatment of acute uncomplicated influenza in otherwise healthy children aged one to l ess than 12 y...
Source: Roche Investor Update - March 27, 2020 Category: Pharmaceuticals Source Type: news
Janssen Announces Health Canada Approval of CABENUVA ™, the First Long-Acting Regimen for the Treatment of HIV
Cork, Ireland, March 20, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that Health Canada has approved CABENUVA™ (cabotegravir and rilpivirine extended release injectable suspensions), the first and only once-monthly, long-acting regimen for the treatment of HIV-1 infection in adults. CABENUVA™ is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]). CABENUVA™, a co-packaged kit with two separate inj...
Source: Johnson and Johnson - March 20, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news
Plagues and People – The Coronavirus in a Historical Perspective
By Jan LundiusSTOCKHOLM / ROME, Mar 19 2020 (IPS) The human factor is intimately involved in the origin, spread, and mitigation of the Coronavirus and we cannot afford to ignore that our future existence depends on compassion and cooperation. Response matters!
Some quarantined Italians might recall Giovanni Boccaccio´s The Decameron from 1353 in which people escaping the plague are secluded in a villa where they tell stories to each other. Boccaccio introduced his collection of short stories with an eyewitness account of horrifying human suffering in Florence, which in 1348 was struck by a ”pestilence” that every day...
Source: IPS Inter Press Service - Health - March 19, 2020 Category: International Medicine & Public Health Authors: Jan Lundius Tags: Global Headlines Health Humanitarian Emergencies TerraViva United Nations Women's Health Source Type: news
Hepatitis B prophylaxis in adolescents who present for examination after alleged sexual assault - Jones ME, Tully JM.
AIM: In Australia, the risk of hepatitis B virus (HBV) transmission from single sexual contact is low. This, combined with assumed widespread immunity from vaccination, has resulted in a lack of clarity surrounding the necessity for hepatitis B post-exposu... (Source: SafetyLit)
Source: SafetyLit - March 17, 2020 Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news
Licensure of a New Hexavalent Vaccine for Use in Infants Licensure of a New Hexavalent Vaccine for Use in Infants
A new hexavalent vaccine for use in children aged 6 weeks through 4 years has been approved by the FDA to prevent diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, and hepatitis B.Morbidity & Mortality Weekly Report (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - March 2, 2020 Category: Allergy & Immunology Tags: Public Health & Prevention Journal Article Source Type: news
Hexavalent Vaccine Included in Vaccines for Children Program
FRIDAY, Feb. 7, 2020 -- The hexavalent combined diphtheria and tetanus toxoids and acellular pertussis (DTaP) adsorbed, inactivated poliovirus (IPV), Haemophilus influenza type b (Hib) conjugate (meningococcal protein conjugate), and hepatitis B... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - February 7, 2020 Category: Pharmaceuticals Source Type: news
Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus influenzae Type b Conjugate, and Hepatitis B Vaccine, and Guidance for Use in Infants
A new combination vaccine to prevent diphtheria, tetanus, whooping cough, polio, Haemphilus influenzae type b disease, and hepatitis B has been licensed, but won ' t be available before 2021. (Source: CDC Morbidity and Mortality Weekly Report)
Source: CDC Morbidity and Mortality Weekly Report - February 6, 2020 Category: American Health Tags: Diphtheria Vaccination Hepatitis B Vaccination MMWR Morbidity & Mortality Weekly Report Pertussis Vaccination Tetanus Vaccination Vaccine-Preventable Diseases and Specific Vaccines Whooping cough Source Type: news
ACIP Releases 2020 Child and Adolescent Vaccine Schedule ACIP Releases 2020 Child and Adolescent Vaccine Schedule
Changes include a recommendation for a hepatitis A catch-up vaccination for anyone who wasn ' t vaccinated as a child.News Alerts (Source: Medscape Infectious Diseases Headlines)
Source: Medscape Infectious Diseases Headlines - February 4, 2020 Category: Infectious Diseases Tags: Infectious Diseases News Alert Source Type: news
Bharat Biotech keen to revive Rs 600 crore TN vaccine complex
With a planned annual capacity of 585 million, the project proposed to make pentavalent, or five-in-one, combination vaccine, BCG vaccine, and vaccines to prevent measles, hepatitis B, human rabies, Hib (haemophilus influenzae type b) and Japanese encephalitis (JE) in the first phase, which was to be commissioned by 2010. (Source: The Economic Times)
Source: The Economic Times - January 2, 2020 Category: Consumer Health News Source Type: news
Panacea Biotec bags orders worth USD 24 mn from UN agencies
The vaccine protects children against five deadly diseases, including diphtheria, tetanus and hepatitis B. "Panacea Biotec... has received awards worth USD 24.32 million from U N agencies (Unicef and PAHO) for supply of its Easyfive-TT, a fully liquid WHO prequalified wP-based Pentavalent vaccine (DTwPHepB-Hib)," the company said in a filing to BSE. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 18, 2019 Category: Pharmaceuticals Source Type: news
Strong Data, Local Relationships: The Future of HIV Care in Tanzania Starts Here
By Margarite Nathe,
Principal Editor/Writer, IntraHealth International ; Lucy Mphuru,
Country Director& Project Director, Tohara Plus Project
Lucy Mphuru (center left) talks with health workers and clients at an IntraHealth-supported mobile clinic in Shinyanga that provides voluntary male circumcision services. Photo by Trevor Snapp for IntraHealth International.November 26, 2019Lucy Mphuru has a big job.Every day, she and her team at IntraHealth International in Tanzania work with frontline health workers and government partners to improve health services in a country of 58 million—1.6 million of whom li...
Source: IntraHealth International - November 26, 2019 Category: International Medicine & Public Health Authors: mnathe Tags: HIV & AIDS Community Engagement Leadership and Governance World AIDS Day Health Workforce Systems Source Type: news
Predictors of Immune Response to Hep B Shot ID'd in Lymphoma
MONDAY, Oct. 28, 2019 -- For patients with lymphoma, the dose and frequency of hepatitis B vaccination, sex, Ann Arbor stage, and ibrutinib as part of the chemotherapy regimen are independent factors that affect the impact of the vaccine, according... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - October 28, 2019 Category: Pharmaceuticals Source Type: news
Hepatitis C Vaccine Blighted, Another in the Works Hepatitis C Vaccine Blighted, Another in the Works
The second-generation vaccine is being developed by one of the members of the research team that first discovered hepatitis C.Medscape Medical News (Source: Medscape Gastroenterology Headlines)
Source: Medscape Gastroenterology Headlines - September 10, 2019 Category: Gastroenterology Tags: Gastroenterology News Source Type: news
