New Real-World Observational Analysis of UPTRAVI ® (selexipag) Underscores the Importance of Risk Assessment for Treating Pulmonary Arterial Hypertension (PAH) Patients
SOUTH SAN FRANCISCO, CA – April 6, 2021 – Findings from an analysis of the first 500 patients enrolled in the SPHERE registry (SelexiPag: tHe usErs dRug rEgistry) found more than three-quarters (76%) of pulmonary arterial hypertension (PAH) patients treated with UPTRAVI® (selexipag) either maintained (56%) or reduced (20%) their one-year mortality risk score. The SPHERE results were published in the April issue of the Journal of Heart and Lung Transplantation (JHLT). SPHERE is an ongoing real-world, observational, user registry using two different risk assessment methods that describes the clinical characte...
Source: Johnson and Johnson - April 6, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

United Therapeutics Announces FDA Approval and Launch of Tyvaso(R) for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
First and only approved therapy in the United States for patients with PH-ILD, a serious, life-threatening disease with potentially more than 30,000 patients in need FDA approval based on data from the INCREASE clinical trial PH-ILD is the second FDA... Biopharmaceuticals, FDA, Product Launch United Therapeutics, Tyvaso, treprostinil, pulmonary hypertension (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 1, 2021 Category: Pharmaceuticals Source Type: news

United Therapeutics gets another FDA approval for pulmonary hypertension therapy
United Therapeutics (NASDAQ: UTHR) has received another Food and Drug Administration approval for Tyvaso more than a decade after the agency first approved the therapy for treatment of pulmonary arterial hypertension.   The FDA approved a supplemental new drug application for the use of Tyvaso Inhalation Solution, an inhaled form of the drug trepostinil, to increase exercise ability in patients with pulmonary hypertension resulting from interstitial lung disease (PH-ILD), United Therapeutics said… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - April 1, 2021 Category: Health Management Authors: Rebecca Cooper Source Type: news

United Therapeutics gets another FDA approval for pulmonary hypertension therapy
United Therapeutics (NASDAQ: UTHR) has received another Food and Drug Administration approval for Tyvaso more than a decade after the agency first approved the therapy for treatment of pulmonary arterial hypertension.   The FDA approved a supplemental new drug application for the use of Tyvaso Inhalation Solution, an inhaled form of the drug trepostinil, to increase exercise ability in patients with pulmonary hypertension resulting from interstitial lung disease (PH-ILD), United Therapeutics said… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 1, 2021 Category: Biotechnology Authors: Rebecca Cooper Source Type: news

United Therapeutics gets another FDA approval for pulmonary hypertension therapy
United Therapeutics (NASDAQ: UTHR) has received another Food and Drug Administration approval for Tyvaso more than a decade after the agency first approved the therapy for treatment of pulmonary arterial hypertension.   The FDA approved a supplemental new drug application for the use of Tyvaso Inhalation Solution, an inhaled form of the drug trepostinil, to increase exercise ability in patients with pulmonary hypertension resulting from interstitial lung disease (PH-ILD), United Therapeutics said… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - April 1, 2021 Category: Health Management Authors: Rebecca Cooper Source Type: news

United Therapeutics gets another FDA approval for pulmonary hypertension therapy
United Therapeutics (NASDAQ: UTHR) has received another Food and Drug Administration approval for Tyvaso more than a decade after the agency first approved the therapy for treatment of pulmonary arterial hypertension.   The FDA approved a supplemental new drug application for the use of Tyvaso Inhalation Solution, an inhaled form of the drug trepostinil, to increase exercise ability in patients with pulmonary hypertension resulting from interstitial lung disease (PH-ILD), United Therapeutics said… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 1, 2021 Category: Biotechnology Authors: Rebecca Cooper Source Type: news

Johnson & Johnson Announces Advance Purchase Agreement with the African Vaccine Acquisition Trust for the Company ’s COVID-19 Vaccine Candidate
NEW BRUNSWICK, NJ (March 29, 2021) - Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) (the Company), has entered into an agreement with the African Vaccine Acquisition Trust (AVAT) to make available up to 220 million doses of its single-shot COVID-19 vaccine candidate to African Union’s 55 member states with delivery beginning in the third quarter of 2021. AVAT also has the potential to order an additional 180 million doses, for a combined total of up to 400 million doses through 2022. The availability of the vaccine candidate is subject to its successful appr...
Source: Johnson and Johnson - March 29, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Janssen Receives Positive CHMP Opinion for PONVORY ™ (ponesimod) for the Treatment of Adults With Relapsing Forms of Multiple Sclerosis With Active Disease Defined by Clinical or Imaging Features
BEERSE, BELGIUM, MARCH 26, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for PONVORY™ (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features.[3]“Relapsing forms of multiple sclerosis (MS) have varied and often unpredictable symptoms, posing a unique human, societal and economic burden,” said Catherine T...
Source: Johnson and Johnson - March 26, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Announces U.S. FDA Approval of PONVORY ™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain Lesions
TITUSVILLE, N.J. – (March 19, 2021) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) approved PONVORY™ (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.1,2,3 PONVORY™ offers MS patients superior efficacy in reducing annualized relapse rates compared to an established oral therapy and a proven safety profi...
Source: Johnson and Johnson - March 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

New Phase 3 Data Show First-in-Class TREMFYA ® (guselkumab) Achieved Complete Skin Clearance and Favorable Joint Efficacy in Adult Patients with Active Psoriatic Arthritis (PsA) Through Two Years
SPRING HOUSE, PENNSYLVANIA, March 16, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced long-term data from the Phase 3 DISCOVER-2a study showing that the skin clearance, joint symptom relief, and safety of TREMFYA® (guselkumab) previously demonstrated through 24 weeks and one year (Week 52) in adults with active psoriatic arthritis (PsA) continued through two years (Week 112).1,2 These findings also confirmed that the robust efficacy TREMFYA demonstrated in patients at Week 24 on physical function, physical aspects of health-related quality of life, and resolution of enthesitis...
Source: Johnson and Johnson - March 16, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Emergency Use Listing by the World Health Organization
NEW BRUNSWICK, N.J., March 12, 2021– Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the World Health Organization (WHO) has issued Emergency Use Listing (EUL) for its single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), to prevent COVID-19 in individuals 18 years of age and older.Data from the Phase 3 ENSEMBLE study showed that the Johnson & Johnson COVID-19 vaccine was well tolerated and demonstrated a 67 percent reduction in symptomatic COVID-19 disease in participants who received the vaccine in comparison to participants give...
Source: Johnson and Johnson - March 12, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Conditional Marketing Authorization by European Commission
NEW BRUNSWICK, N.J., March 11, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the European Commission (EC) has granted a Conditional Marketing Authorization (CMA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), to prevent COVID-19 in individuals 18 years of age and older. The CMA follows a Positive Opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).2 The CMA is valid in all 27 member states of the European Union (EU), plus Norway, Iceland and Liechtenstei...
Source: Johnson and Johnson - March 11, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Announces its Single-Shot COVID-19 Vaccine Candidate Receives Positive CHMP Opinion
NEW BRUNSWICK, N.J., March 11, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a Positive Opinion to recommend the Conditional Marketing Authorization (CMA) for its single-dose COVID-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), to prevent COVID-19 in individuals 18 years of age and older. Data from the Phase 3 ENSEMBLE study showed that the Johnson & Johnson COVID-19 vaccine was well tolerated and demonstrated a 67 percen...
Source: Johnson and Johnson - March 11, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Janssen Announces 96-week Results of Phase 3b Study Demonstrating the Continued Safety and Efficacy of Long-acting HIV Treatment of Rilpivirine and Cabotegravir
CORK, IRELAND, March 6, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today presented positive long-term data from the global Phase 3b trial of the first complete, long-acting (LA), two-drug injectable regimen (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The 96-week findings of the Antiretroviral Therapy as Long-Acting Suppression Every 2 Months (ATLAS-2M) trial confirmed the primary endpoint, met at Week 48, and met the secondary endpoint, showing efficacy of both month...
Source: Johnson and Johnson - March 6, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson COVID-19 Vaccine Granted Authorization under Interim Order by Health Canada For Emergency Use
March 5, 2021 - Johnson & Johnson (the Company) announced today that Health Canada has granted an Interim Order (IO) authorization for its single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.This decision was based on scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.Johnson & Johnson anticipa...
Source: Johnson and Johnson - March 5, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Announces U.S. CDC Advisory Committee Recommends First Single-Shot COVID-19 Vaccine for Adults 18 and Older in U.S.
NEW BRUNSWICK, N.J., February 28, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the first single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, for individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. Food and Drug Administration (FDA). “For more than 130 years, Johnson & Johnson has come to the aid of people during times of crisis, and we believe ...
Source: Johnson and Johnson - February 28, 2021 Category: Pharmaceuticals Source Type: news

Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use
NEW BRUNSWICK, N.J., February 27, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection agai...
Source: Johnson and Johnson - February 28, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee
NEW BRUNSWICK, N.J., February 26, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend Emergency Use Authorization (EUA) for the Company’s single-shot COVID-19 vaccine candidate for adults 18 and older, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. The vote was based on a totality of scientific evidence provided by the Company, including efficacy and safety data from the Phase 3 ENSEMBLE trial. “We are e...
Source: Johnson and Johnson - February 26, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA by ViiV Healthcare for Expanded Use of CABENUVA (rilpivirine and cabotegravir) as an HIV Treatment for Use Every Two Months
TITUSVILLE, N.J., February 24, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) by ViiV Healthcare for the expanded use of CABENUVA (consisting of Janssen’s long-acting rilpivirine and ViiV Healthcare’s cabotegravir). The sNDA seeks to expand the CABENUVA label to include administration every two months for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in virologically suppressed adults (HIV-1 RNA less than 50 copies per mL) on a sta...
Source: Johnson and Johnson - February 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
NEW BRUNSWICK, N.J., February 19, 2021– Johnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen-Cilag International N.V. has submitted for Emergency Use Listing (EUL) to the World Health Organization (WHO) for the investigational single-dose Janssen COVID-19 vaccine candidate. The data package delivered today includes interim efficacy and safety results from the Phase 3 ENSEMBLE clinical trial. The Company’s rolling submission of clinical data to WHO is now complete.“Our filing with the World Health Organization marks another important step in our effort to combat COVID-19 and also in our u...
Source: Johnson and Johnson - February 19, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Announces Submission of European Conditional Marketing Authorisation Application to the EMA for its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
NEW BRUNSWICK, N.J., February 16, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that Janssen-Cilag International N.V., has submitted a conditional Marketing Authorisation Application (cMAA) to the European Medicines Agency (EMA) seeking authorisation for its investigational single-dose Janssen COVID-19 vaccine candidate. The submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial.“Throughout Europe, there remains an urgent need for additional COVID-19 vaccines, and today’s submission is a significant step forward in ensuring the European Un...
Source: Johnson and Johnson - February 16, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Janssen Announces Treatment with ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer
RARITAN, N.J., February 8, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the final analysis of the Phase 3 TITAN study, which demonstrated the continued statistically significant benefit of the addition of ERLEADA® (apalutamide) to androgen deprivation therapy (ADT) in overall survival (OS) in patients with metastatic castration-sensitive prostate cancer (mCSPC), regardless of extent of disease, when compared to placebo plus ADT.[1] Results will be featured in an oral presentation at the American Society of Clinical Oncology’s Genitourinary (ASCO GU) Cance...
Source: Johnson and Johnson - February 8, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA® (abiraterone acetate) Combination
RARITAN, N.J., February 8, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the randomized, double-blind, placebo-controlled Phase 3 ACIS study, which met the primary endpoint of radiographic progression-free survival (rPFS) with a 31 percent reduction in the risk of radiographic progression or death in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) receiving androgen deprivation therapy (ADT). Patients in the trial received either a combination of ERLEADA® and ZYTIGA® plus prednisone (combination arm) or placebo a...
Source: Johnson and Johnson - February 8, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

SPRAVATO ® (Esketamine Nasal Spray) Authorised in Europe for the Rapid Reduction of Depressive Symptoms in a Psychiatric Emergency for Patients with Major Depressive Disorder
BEERSE, BELGIUM, February 8, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has authorised the expanded use of SPRAVATO® (esketamine nasal spray), co-administered with oral antidepressant therapy in adults with a moderate to severe episode of MDD, as acute short term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency.7 “Depression is more than just feeling sad, it’s a debilitating combination of symptoms that are different for each person and can prog...
Source: Johnson and Johnson - February 8, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
NEW BRUNSWICK, N.J., February 4, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. The Company’s EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints. The Company expects to have product available to ship immediately followi...
Source: Johnson and Johnson - February 4, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

REVEAL Lite 2 Risk Calculator Offers Simplified Model to Assess One-Year Mortality Risk Status in Patients with Pulmonary Arterial Hypertension (PAH)
SOUTH SAN FRANCISCO, CA – February 3, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from an analysis determining the validity of the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2 risk calculator, an abridged version of the REVEAL 2.0 risk calculator, in patients with pulmonary arterial hypertension (PAH), a rapidly progressive disease with no known cure.[1],[2],[3] The analysis showed that REVEAL Lite 2 offers a simplified method of risk assessment using six non-invasive and modifiable variables that may be implemented routinely in...
Source: Johnson and Johnson - February 3, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Janssen to Highlight Robust Solid Tumor Portfolio and Pipeline at 2021 ASCO GU
February 2, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it will highlight the depth of its solid tumor portfolio at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium with 12 data presentations, including three company-sponsored oral presentations from the ERLEADA® (apalutamide) clinical development program. The virtual meeting will take place February 11-13, 2021. “We are committed to the development of innovative therapies for patients with genitourinary cancers for whom there remains a high unmet need,” said C...
Source: Johnson and Johnson - February 2, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial
NEW BRUNSWICK, N.J., January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19. The Phase 3 ENSEMBLE study is designed to evaluate the efficacy and safety of the Janssen COVID-19 vaccine candidate in protecting moderate to severe CO...
Source: Johnson and Johnson - January 29, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial
NEW BRUNSWICK, N.J., January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19. The Phase 3 ENSEMBLE study is designed to evaluate the efficacy and safety of the Janssen COVID-19 vaccine candidate in protecting moderate to severe COVID-19, wit...
Source: Johnson and Johnson - January 29, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

New Amivantamab Data from CHRYSALIS Study Show Robust Clinical Activity and Durable Responses in Patients with Metastatic or Unresectable Non-Small Cell Lung Cancer and EGFR Exon 20 Insertion Mutations
January 28, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the Phase 1 CHRYSALIS study, which evaluated amivantamab in patients with metastatic or unresectable non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy.1 These data were presented for the first time in an oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2020 World Conference on Lung Cancer (WCLC) Singapore. The key findings sho...
Source: Johnson and Johnson - January 29, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV
TITUSVILLE, N.J., January 21, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen’s 25-year commitment to make HIV history. In the U.S., ViiV Healthcare is the marketing authorization holde...
Source: Johnson and Johnson - January 22, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] DARZALEX FASPRO® is the first and only FDA-approved treatment for patients with this blood cell disorder that is associated with the production of an abnormal protein, which leads to th...
Source: Johnson and Johnson - January 16, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Inhaled Treprostinil Beneficial in Pulmonary Hypertension
Exercise capacity improved, clinical worsening reduced for patients with pulmonary HTN due to interstitial lung disease (Source: Pulmonary Medicine News - Doctors Lounge)
Source: Pulmonary Medicine News - Doctors Lounge - January 14, 2021 Category: Respiratory Medicine Tags: Cardiology, Pharmacy, Pulmonology, Journal, Source Type: news

Inhaled Treprostinil Beneficial in Pulmonary Hypertension
THURSDAY, Jan. 14, 2021 -- Inhaled treprostinil improves exercise capacity in patients with pulmonary hypertension due to interstitial lung disease, according to a study published online Jan. 13 in the New England Journal of Medicine. Aaron Waxman,... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 14, 2021 Category: Pharmaceuticals Source Type: news

Janssen to Highlight Commitment to Lung Cancer Science and Innovation with Eight Data Presentations at the International Association for the Study of Lung Cancer ’s 2020 World Conference on Lung Cancer
January 12, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that eight company-sponsored presentations, including two oral presentations, will be featured at the International Association for the Study of Lung Cancer’s (IASLC) 2020 World Conference on Lung Cancer (WCLC) Singapore taking place virtually January 28-31, 2021. The presentations include updated data from the Phase 1 CHRYSALIS study (NCT02609776) evaluating amivantamab in patients with NSCLC and EGFR exon 20 insertion mutations and two studies that characterize the high unmet need and lack of stand...
Source: Johnson and Johnson - January 13, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Janssen Initiates Rolling Submission of a Biologics License Application to U.S. FDA for BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed and/or Refractory Multiple Myeloma
December 21, 2020 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the initiation of a rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adults with relapsed and/or refractory multiple myeloma.“We are committed to innovation in cell therapy and advancing the science of multiple myeloma to improve patients’ lives,” said Pete...
Source: Johnson and Johnson - December 21, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

New Data Demonstrate Long-Term Benefit of IMBRUVICA ® (ibrutinib) as First-Line Treatment for High-Risk Chronic Lymphocytic Leukemia
This study highlighted the need for cytogenetic/molecular testing before CIT treatment, consistent with clinical treatment guidelines.[8],[9]Real-World Prognostic Biomarker Testing, Treatment Patterns, And Dosing Among Patients With CLL/SLL From the informCLL™ Prospective Observational Registry (Abstract #547)An oral presentation on Monday, December 7, will feature results from the informCLL™ real-world prospective observational registry assessing treatment patterns in the era of novel agents.4 Key Study Findings:· The most common index treatment was IMBRUVICA®; the majority of patients treated with ...
Source: Johnson and Johnson - December 6, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Presents First Data from the Phase 1 Study of the GPRC5DxCD3 Bispecific Talquetamab in Patients with Relapsed or Refractory Multiple Myeloma
December 5, 2020 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today initial data for the Phase 1 first-in-human dose escalation study of talquetamab (JNJ-64407564) for the treatment of relapsed or refractory multiple myeloma (NCT03399799). Talquetamab is a first-in-class, and the only investigational bispecific antibody that targets both GPRC5D, a novel multiple myeloma target, and CD3 on T-cells. Initial results for both the subcutaneous (SC) and intravenous (IV) formulations show encouraging clinical activity against the GPRC5D target, which is highly expressed on multip...
Source: Johnson and Johnson - December 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Updated Results from the Phase 1 Study of the BCMAxCD3 Bispecific Teclistamab Show Preliminary Efficacy in Patients with Heavily Pretreated Relapsed or Refractory Multiple Myeloma
This study evaluated the ability of teclistamab to induce cytotoxicity and T-cell activation.About TeclistamabTeclistamab is an investigational bispecific antibody targeting both BCMA and CD3. BCMA, B-cell maturation antigen, is expressed at high levels on multiple myeloma cells.[3],[4],[5],[6],[7] Teclistamab redirects CD3-positive T-cells to BCMA-expressing myeloma cells to induce cytotoxicity of the targeted cells.5,6 Results from preclinical studies demonstrate that teclistamab kills myeloma cell lines and bone marrow-derived myeloma cells from heavily pretreated patients.6 Teclistamab is currently being evaluated in a...
Source: Johnson and Johnson - December 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Early, Deep, Durable Responses of Ciltacabtagene Autoleucel (cilta-cel) Observed in Phase 1b/2 CARTITUDE-1 Study Show Potential of BCMA CAR-T in Treatment of Heavily Pretreated Patients with Multiple Myeloma
December 5, 2020 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today longer-term results from the combined Phase 1b/2 CARTITUDE-1 study (NCT03548207) evaluating the efficacy and safety of ciltacabtagene autoleucel (cilta-cel), an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients with relapsed and/or refractory multiple myeloma. These data, presented as an oral presentation at the American Society of Hematology (ASH) 2020 Annual Meeting (Abstract #177), continued to demonstrate a very hig...
Source: Johnson and Johnson - December 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Disease-Free Survival Data from CAPTIVATE Study Demonstrate Benefit of IMBRUVICA ® (ibrutinib)-Based Regimen as Fixed Duration, First-Line Treatment for Patients with Chronic Lymphocytic Leukemia
December 5, 2020 (RARITAN, N.J.) – New data from the Phase 2 CAPTIVATE study were presented today during an oral session at the 2020 American Society of Hematology (ASH) Annual Meeting (Abstract #123). The study evaluated the efficacy and safety of IMBRUVICA® (ibrutinib) plus venetoclax in the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and showed that, after achieving undetectable minimal residual disease (uMRD) in both the blood and bone marrow with the IMBRUVICA® combination regimen, the one-year disease-free survival (DFS) of patients randomized ...
Source: Johnson and Johnson - December 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
RARITAN, N.J., December 3, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. The application marks the first-ever regulatory submission for the treatment of patients with NSCLC with EGFR exon 20 insertion mutations.[1] The Company...
Source: Johnson and Johnson - December 3, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Acquires Rights to Novel Gene Therapy, Pioneering Treatment Solutions for Late-Stage Age-Related Macular Degeneration
RARITAN, NJ, December 2, 2020 – Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, today announced the acquisition of rights to Hemera Biosciences, LLC’s investigational gene therapy HMR59, administered as a one-time, outpatient, intravitreal injection to help preserve vision in patients with geographic atrophy, a late-stage and severe form of age-related macular degeneration (AMD). Financial terms of the transaction with Hemera Biosciences, a privately-owned biotechnology company, are not being disclosed. Patients with AMD often have low levels of CD59, a prote...
Source: Johnson and Johnson - December 2, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson and U.S. Department of Health & Human Services Expand Agreement to Support Next Phase of COVID-19 Vaccine Candidate Research and Development
NEW BRUNSWICK, N.J., November 14, 2020 – Johnson & Johnson (the Company) announced the expansion to the partnership between its Janssen Pharmaceutical Companies (Janssen) and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services for the ongoing development of Janssen’s investigational COVID-19 vaccine candidate.Under the amendment, Janssen will commit approximately $604 million and BARDA will commit approximately $454 million to support the ongoing Pha...
Source: Johnson and Johnson - November 14, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

Late-Breaking 12-Month Data of Investigational RPGR Gene Therapy Shows Statistically Significant and Continued Vision Improvement in Patients with X-Linked Retinitis Pigmentosa
RARITAN, N.J., November 13, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new 12-month data from the ongoing Phase 1/2 trial (NCT03252847) of its investigational gene therapy for inherited retinal disease X-linked retinitis pigmentosa (XLRP). The data showed that low and intermediate doses were well-tolerated and continued to demonstrate statistically significant sustained or increased vision improvement across multiple metrics (mean sensitivity, volumetric and pointwise) and modalities (full-field static perimetry and microperimetry). Data on the novel adeno-associated virus re...
Source: Johnson and Johnson - November 13, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

New XARELTO ® (rivaroxaban) Peripheral Artery Disease (PAD) Data from EXPLORER Clinical Research Program to be Unveiled at American Heart Association (AHA) Scientific Sessions 2020
RARITAN, N.J., November 9, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that 10 data presentations will be shared at the virtual American Heart Association (AHA) Scientific Sessions 2020 from November 13-17. Most notably, four new sub-analyses of XARELTO® (rivaroxaban) from the landmark VOYAGER PAD trial, part of the EXPLORER global cardiovascular research program, will be presented, including two live, featured science oral presentations. “We're pleased VOYAGER PAD was selected to be front and center once again at a major medical congress, as there's an urgent need f...
Source: Johnson and Johnson - November 9, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Headlines American Society of Hematology Annual Meeting With More Than 35 Presentations Highlighting Deep, Diverse Oncology Pipeline and Portfolio
RARITAN, N.J., November 5, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today more than 35 company-sponsored studies, including 10 oral presentations, will be featured at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition taking place virtually December 5-8, 2020.In multiple myeloma, highlights include Phase 1b/2 results for the B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor T-cell (CAR-T) therapy ciltacabtagene autoleucel (cilta-cel); new and updated data for the anti-CD38 monoclonal antibody DARZALEX® (daratumumab) and the subcutane...
Source: Johnson and Johnson - November 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Nanox to integrate Ambra Health's medical image management software; ACTO acquires CoHealth's content delivery app; and more digital health deals
Also: Vocalis Health and Mayo Clinic seek new  pulmonary hypertension biomarkers; Sensyne Health and Microsoft's strategic partnership focuses on clinical AI co-development. (Source: mobihealthnews)
Source: mobihealthnews - October 29, 2020 Category: Information Technology Source Type: news

Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO ® (rivaroxaban) in Patients with Peripheral Artery Disease
RARITAN, NJ, October 26, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO® (rivaroxaban) in patients with peripheral artery disease (PAD). If approved, this new indication for the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include reducing the risk of major thrombotic vascular events such as heart attack, stroke and amputation in patients after recent lower-extremity revasculariz...
Source: Johnson and Johnson - October 26, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Prepares to Resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 Vaccine Candidate in the U.S.
Discussions with other regulators around the world to resume the clinical trial program are progressing. After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified. There are many possible factors that could have caused the event. Based on the information gathered to date and the input of independent experts, the Company has found no evidence that the vaccine candidate caused the event.At Johnson & Johnson, there is no greater priority than the health and safety of the people we serve every day around the world. Our primary goal is to ensure the safet...
Source: Johnson and Johnson - October 23, 2020 Category: Pharmaceuticals Source Type: news