Janssen Submits New Drug Application to the U.S. Food and Drug Administration Seeking Approval of Niraparib and Abiraterone Acetate Dual-Action Tablet, Plus Prednisone, as a First-Line Targeted Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Gene Mutations
RARITAN, N.J., February 28, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of niraparib in combination with abiraterone acetate, in the form of a dual-action tablet (DAT), plus prednisone, for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). If approved, this will be the first DAT formulation available in the U.S. to patients with mCRPC with BRCA mutations, which are a type of homologous recombination repair (HRR) gene alt...
Source: Johnson and Johnson - March 1, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Breast Cancer Genes Raise Risks for Older Women, Too
TUESDAY, Feb. 28, 2023 -- Though BRCA1 or BRCA2 gene mutations are associated with breast and ovarian cancer in younger women, those over 50 continue to have a high risk of breast cancer.
That ’s true even if they didn’t have breast cancer... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - February 28, 2023 Category: General Medicine Source Type: news
Janssen Receives Positive CHMP Opinion for AKEEGA ® (Niraparib and Abiraterone Acetate Dual Action Tablet) Plus Prednisone or Prednisolone for the Treatment of Adult Patients with BRCA1/2 Gene-Mutated Metastatic Castration Resistant Prostate Cancer
BEERSE, Belgium, 24 February 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorisation for AKEEGA® (niraparib and AA), in the form of a DAT, given with P or prednisolone, for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.[1]Niraparib is a highly selective poly adenosine diphosphate-ribose polymerase (PARP) inhibi...
Source: Johnson and Johnson - February 27, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Janssen Presents Updated Data Demonstrating Improved Outcomes from the Use of Niraparib in Combination with Abiraterone Acetate Plus Prednisone as a First-Line Therapy in Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
SAN FRANCISCO, February 16, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced updated results from the Phase 3 MAGNITUDE study evaluating the investigational use of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) with or without specific homologous recombination repair (HRR) gene alterations, including BRCA mutations. Results will be featured today in a Rapid Abstract Session (Abstract #170) at the American Society of Clinica...
Source: Johnson and Johnson - February 16, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
What experts say you should know about ovarian cancer
Ovarian cancer is considered to be the most serious of women's cancers. That's why experts say women should know about their risks and prevention. (Source: CBC | Health)
Source: CBC | Health - February 11, 2023 Category: Consumer Health News Tags: Radio/White Coat, Black Art Source Type: news
Consider Fallopian Tube Removal to Avoid Ovarian Cancer
The new advice replaces the decades old focus on symptom awareness and early detection of ovarian cancer through screening. (Source: WebMD Health)
Source: WebMD Health - February 10, 2023 Category: Consumer Health News Source Type: news
Why It ’ s So Hard to Have Your Fertility Tested
Patients often say the same thing in appointments with Dr. Abey Eapen, an infertility specialist at UT Southwestern Medical Center: “I never learned about this in my high school.”
For many couples, having a baby is far more difficult than it was made out to be in sex ed. While many women in heterosexual couples get pregnant within a few months of trying, studies suggest up to 15% of couples are unable to conceive after a year of having unprotected sex. That means they meet the clinical definition of infertility: not conceiving within a year if the woman is younger than 35, or within six months if she’s 35...
Source: TIME: Health - February 9, 2023 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized healthscienceclimate medicine Wellbeing Source Type: news
Advanced Ovarian Cancer: 20% Disease-Free Survival at 10 Years Advanced Ovarian Cancer: 20% Disease-Free Survival at 10 Years
Maurie Markman, MD, discusses a recent paper on the 10-year survival rate of patients with stage III ovarian cancer.Medscape Oncology (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - February 7, 2023 Category: Cancer & Oncology Tags: Hematology-Oncology Commentary Source Type: news
Renewed Calls for Fallopian Tube Removal to Avoid Ovarian Cancer Renewed Calls for Fallopian Tube Removal to Avoid Ovarian Cancer
Renewed calls for all women to consider having their fallopian tubes removed once they have finished with childbearing come from the Ovarian Cancer Research Alliance.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - February 7, 2023 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news
Court Rejects Johnson & Johnson ’s Bankruptcy Plan for Talc Lawsuits
A federal appeals court last week rejected an LTL Management bankruptcy filing, delivering a blow to the company’s plan to resolve thousands of talc lawsuits. The company is a Johnson & Johnson subsidiary.
The ruling effectively found the company’s bankruptcy was not filed in good faith. J&J said on Feb. 6 that it plans to appeal the U.S. Court of Appeals for the Third Circuit’s ruling.
“LTL initiated this process in good faith and our objective has always been to equitably resolve claims related to the company’s cosmetic talc litigation,” J&J wrote.
If denied on appeal, Joh...
Source: Asbestos and Mesothelioma News - February 7, 2023 Category: Environmental Health Authors: Amy Edel Tags: Asbestos Exposure Legal Mesothelioma Source Type: news
Did talcum powder cause the cancer that killed Maureen? Her widower is in group against manufactures
When Maureen Wright was diagnosed with ovarian cancer, both she and her husband Jeffrey were left reeling in disbelief. (Source: the Mail online | Health)
Source: the Mail online | Health - February 6, 2023 Category: Consumer Health News Source Type: news
Ultra-Processed Food Intake Linked to Cancer Burden, Mortality
MONDAY, Feb. 6, 2023 -- Higher consumption of ultra-processed food (UPF) is associated with increased cancer burden and cancer-related mortality, especially ovarian cancer, according to a study published online Jan. 31 in eClinicalMedicine.
Kiara... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - February 6, 2023 Category: Pharmaceuticals Source Type: news
Women suing J & J speak out after company's failed legal maneuver
In the long legal fight over allegations that talc in Johnson & Johnson baby powder is linked to ovarian cancer, plaintiffs got an incremental victory on Monday: A federal appeals court rejected J&J’s effort to move more than 38,000 lawsuits to bankruptcy court. Plaintiff Deborah Smith’s case was…#johnsonjohnson #deborahsmiths #jjs #ltlmanagement #ltl #chapter11 #twostep #smiths #shower #johnsonsbabypowder (Source: Reuters: Health)
Source: Reuters: Health - February 5, 2023 Category: Consumer Health News Source Type: news
Faking a Cancer Dx? Fallopian Tube Removal; Trodelvy's New Breast Cancer Indication
(MedPage Today) -- A 19-year-old Iowa woman has been arrested after being accused of faking diagnoses of leukemia and pancreatic cancer in order to collect more than $37,000 in online donations. (CBS News)
The Ovarian Cancer Research Alliance... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - February 3, 2023 Category: Hematology Source Type: news
Hormone receptor implicated in ovarian cancer
<img width="100" src="https://factor.niehs.nih.gov/sites/niehs-factor/files/styles/large/public/2020/11/papers/ovarian-cancer/thumb902571.jpg?itok=iczZUMAf" /><br /><p>NIEHS researchers use mice to better understand how ovarian tumors form.</p>
(read more) (Source: Environmental Factor - NIEHS Newsletter)
Source: Environmental Factor - NIEHS Newsletter - February 3, 2023 Category: Environmental Health Source Type: news
