BE's pediatric pneumonia jab gets CDSCO expert panel approval
The BE's pneumococcal conjugate vaccine (PCV) can be administered to infants at 6, 10 and 14 weeks of age. Streptococcus pneumoniae infection continues to be a leading cause of child mortality under 5 years of age in India and in developing countries. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 1, 2022 Category: Pharmaceuticals Source Type: news
U.S. FDA Approves IMBRUVICA ® (ibrutinib) as First and Only BTKi Treatment for Pediatric Patients with Chronic Graft-Versus-Host Disease
August 24, 2022 (HORSHAM, PA) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) for the treatment of pediatric patients one year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy. This milestone marks the first pediatric indication for IMBRUVICA® and the introduction of a new oral suspension formulation for patients ages one to less than 12. IMBRUVICA® is now the first FDA-approved therapy for these younger patients who previously had no approv...
Source: Johnson and Johnson - August 24, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Serotypes Not in Vaccines Results in Pneumococcal Disease Serotypes Not in Vaccines Results in Pneumococcal Disease
Michael E. Pichichero, MD, discusses his group ' s findings examining current pneumococcal stereotypes in children.MDedge (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 24, 2022 Category: Consumer Health News Tags: Pediatrics Commentary Source Type: news
Janssen Marks First Approval Worldwide for TECVAYLI ® (teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma
BEERSE, BELGIUM, August 24, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has granted conditional marketing authorisation (CMA) of TECVAYLI® (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.[1] Today’s milestone marks the first approval worldwide for teclistamab, a first-i...
Source: Johnson and Johnson - August 24, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Pfizer announces positive top-line results from Phase 3 study of 20-valent pneumococcal conjugate vaccine in infants
Pfizer Inc. (NYSE:PFE) announced positive top-line results from its pivotal U.S. Phase 3 study (NCT04382326) in infants evaluating its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine for the pediatric population. (Source: World Pharma News)
Source: World Pharma News - August 15, 2022 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news
What is Ondine ’ s Curse?
Discussion
Congenital central hypoventilation syndrome (CCHS) is an autosomal dominant with variable inheritance genetic disease caused by mutation in the Paired Like Homeobox B2 (PHOX2B) gene on chromosome 4. There are two other genes which may also cause CCHS. CCHS affects the chemoreceptor afferent ventilation pathways and is a neural crest migration problem of the autonomic nervous system. The incidence is unknown but a prevalence of 1 in 200,000 live births has been reported. Obviously it is a rarer phenomenon because of the general lethality of the syndrome.
Patients usually present at birth or soon afterwards, but o...
Source: PediatricEducation.org - August 15, 2022 Category: Pediatrics Authors: Pediatric Education Tags: Uncategorized Source Type: news
ACR Makes Changes to Adult, Pediatric Vaccinations Guidance ACR Makes Changes to Adult, Pediatric Vaccinations Guidance
The pneumococcal, recombinant zoster, and HPV vaccines are among those recommended for patients taking immunosuppressive medications.Medscape Medical News (Source: Medscape Internal Medicine Headlines)
Source: Medscape Internal Medicine Headlines - August 8, 2022 Category: Internal Medicine Tags: Rheumatology News Source Type: news
Pneumococcal Vax Slashed Deadly Sickle-Cell Complication in Kids
(MedPage Today) -- Introduction of the 13-valent pneumococcal conjugate vaccine (PCV13) a decade ago in France was associated with a significant reduction in acute chest syndrome (ACS) for children with sickle cell disease, a cohort study showed... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - August 3, 2022 Category: Hematology Source Type: news
Janssen Announces New Data Supporting Safety and Efficacy of RYBREVANT ® and Lazertinib Combination for Patients with Non-Small Cell Lung Cancer and EGFR Mutations
July 26, 2022 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the Phase 1b/2 CHRYSALIS-2 study (NCT04077463) cohort evaluating the safety and tolerability of the combination of RYBREVANT® (amivantamab-vmjw) with the third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) lazertinib and platinum-based chemotherapy (carboplatin and pemetrexed) in patients with relapsed/refractory non-small cell lung cancer (NSCLC) and EGFR mutations.[1] These findings and additional updates, including data on RYBREVANT® in combination with laze...
Source: Johnson and Johnson - July 26, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news
Why You ’ ll Need to Get COVID-19 Boosters Again and Again
Several highly effective vaccines were developed at an unprecedented speed to combat the COVID-19 pandemic. During the phase 3 clinical trials, mRNA vaccines had vaccine efficacy of 94–95% in preventing symptomatic infections. After the rollout, real-world evidence showed that the mRNA vaccines provided ~90% effectiveness against infection. Then came the variants. The wave after wave of new variants, with ever-increasing transmissibility and capacity to escape existing immunity, challenge the ability of vaccines to prevent infection and transmission. The effectiveness of a primary series of mRNA vaccines (two doses) ...
Source: TIME: Health - July 19, 2022 Category: Consumer Health News Authors: Akiko Iwasaki and Albert Ko Tags: Uncategorized COVID-19 freelance Source Type: news
ACIP Backs 'Enhanced' Flu Vaccine for Seniors
(MedPage Today) -- The CDC's Advisory Committee on Immunization Practices (ACIP) on Wednesday unanimously endorsed a group of influenza vaccines thought to provide better protection for older adults, as well as a new pneumococcal vaccine for children... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - June 23, 2022 Category: American Health Source Type: news
U.S. FDA Approves Merck ’s Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Infants and Children
Clinical data supporting approval demonstrated non-inferior immune responses for all serotypes shared with PCV13 following a four-dose series and superior immune responses for important disease-causing shared serotype 3 and unique serotypes 22F... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 22, 2022 Category: Drugs & Pharmacology Source Type: news
Janssen Presents Updated Data at EHA for Teclistamab in Patients with Relapsed or Refractory Multiple Myeloma
June 10, 2022 (VIENNA) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated efficacy and safety results from the teclistamab cohort of the Phase 1b TriMM-2 study (NCT04108195). Teclistamab, an investigational, off-the-shelf, T-cell redirecting bispecific antibody targeting B-cell maturation antigen (BCMA) is being studied in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in patients with relapsed or refractory multiple myeloma (RRMM) who have received three or more prior lines of therapy.1 Patients in the study, including a high proportion with prior anti-CD38 exposur...
Source: Johnson and Johnson - June 10, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
New IMBRUVICA ® (ibrutinib) Data in Fixed-Duration Combination Regimen Presented at EHA 2022 Shows Deep, Durable Response at Three Years in Untreated Chronic Lymphocytic Leukemia
June 10, 2022 (VIENNA) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new and updated results from the Phase 2 CAPTIVATE study evaluating IMBRUVICA® (ibrutinib) in combination with venetoclax (I+V) as a potential fixed-duration (FD) treatment in adult patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Updated data from the FD cohort with three years of follow-up shows that I+V continues to demonstrate deep and durable responses and clinically meaningful progression-free survival (PFS) and overall survival (OS) in the first-line tre...
Source: Johnson and Johnson - June 10, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Presents Updated Results Evaluating First-in-Class GPRC5D Bispecific Antibody Talquetamab in Heavily Pretreated Patients with Multiple Myeloma
June 10, 2022 (VIENNA) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the Phase 1 MonumenTAL-1 first-in-human dose-escalation study of talquetamab (NCT03399799), an investigational, off-the-shelf, T cell redirecting bispecific antibody targeting both GPRC5D, a novel multiple myeloma target, and CD3 on T cells.1 Results from the study showed encouraging responses in heavily pretreated patients with relapsed or refractory multiple myeloma (RRMM) who received talquetamab at the recommended subcutaneous Phase 2 dose (RP2D) administered weekly (QW) or every two weeks (Q2W).2 The...
Source: Johnson and Johnson - June 10, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
