Johnson & Johnson Innovation Announces Extension Of Innovation Partnering Office at Monash University In Collaboration With Victorian State Government To Accelerate The Life-Sciences Hub
MELBOURNE, Australia, July 15, 2021 -- Johnson & Johnson Innovation announced today the extension of the Johnson & Johnson Innovation Partnering Office at Monash University's Clayton Campus in Melbourne (JJIPO@Monash) in collaboration with the Victorian State Government.This joint initiative between Johnson & Johnson Innovation, the Victorian Government and Monash University will be extended for approximately two years through June 30, 2023. The agreement will allow JJIPO@Monash to continue connecting with the Victorian innovation ecosystem, nurturing and accelerating innovative research, new product developmen...
Source: Johnson and Johnson - July 15, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

STELARA ® (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Rates in Adults with Moderately to Severely Active Ulcerative Colitis at Nearly Three Years in Long-Term Extension of Phase 3 Trial
SPRING HOUSE, PENNSYLVANIA, July 9, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new three-year data from the long-term extension (LTE) of the STELARA® (ustekinumab) Phase 3 UNIFI study. The data demonstrated the majority (55.2 percent) of adult patients with moderately to severely active ulcerative colitis (UC) who initially responded to treatment with STELARA sustained symptomatic remissiona rates at nearly three years (week 152).1 Furthermore, a majority (96.4 percent) of the patients in symptomatic remissiona at week 152 were corticosteroid-free. These data are being pr...
Source: Johnson and Johnson - July 9, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Positive New Data for Johnson & Johnson Single-Shot COVID-19 Vaccine on Activity Against Delta Variant and Long-lasting Durability of Response
NEW BRUNSWICK, N.J., July 1, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants. In addition, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date. The two preprint study summaries have been submitted today to bioRxiv. “Today’s newly announced studies reinforce the ability of the Johnson & Johnson COVID-19 vaccine ...
Source: Johnson and Johnson - July 1, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Pulmonary hypertension disorders result in high costs, disability and mortality in Colombia
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - July 1, 2021 Category: Drugs & Pharmacology Source Type: news

Janssen Submits New Drug Application to U.S. FDA for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
RARITAN, NJ, June 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of XARELTO® (rivaroxaban) in pediatric patients. The NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients aged birth to less than 18 years of age after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis (prevention of blood clots) in patients aged 2 years and older with co...
Source: Johnson and Johnson - June 23, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

New Phase 3 Study Results Show IMBRUVICA ® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia
Raritan, N.J., June 12, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced primary results from the pivotal Phase 3 GLOW study (NCT03462719) evaluating fixed-duration IMBRUVICA® plus venetoclax (I+V) compared to chlorambucil plus obinutuzumab (Clb+O) for first-line treatment of elderly or unfit patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study demonstrated superior progression-free survival (PFS) of a once-daily, all-oral, fixed-duration regimen of I+V versus Clb+O as first-line treatment of CLL; the study also showed improved duratio...
Source: Johnson and Johnson - June 12, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX ® (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible
Raritan, N.J., June 12, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced overall survival (OS) results from the Phase 3 MAIA (NCT02252172) study showing the addition of DARZALEX® (daratumumab) to lenalidomide and dexamethasone (D-Rd) resulted in a statistically significant survival benefit over lenalidomide and dexamethasone (Rd) alone in patients with newly diagnosed multiple myeloma (NDMM) who were ineligible for autologous stem cell transplant (ASCT) and were treated to progression.[1] These data were featured in the European Hematology Association (EHA) 2021 Virtual Press Briefin...
Source: Johnson and Johnson - June 12, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

New Phase 3b Psoriatic Arthritis (PsA) Data Show First-in-Class TREMFYA ® (guselkumab) Achieved Robust Joint Symptom Improvement and Complete Skin Clearance in Patients with Inadequate Response to Tumor Necrosis Factor Inhibition (TNFi-IR)
SPRING HOUSE, PENNSYLVANIA, June 2, 2021 – Today the Janssen Pharmaceutical Companies of Johnson & Johnson announced new efficacy and safety data for first-in-class TREMFYA® (guselkumab), including data from the first study evaluating a selective IL-23 inhibitor in adult patients with active PsA, all of whom had demonstrated inadequate response or intolerance to TNFi.1 In the COSMOS Phase 3b study, significantly higher proportions of patients treated with TREMFYA showed joint symptom improvement and complete skin clearance versus placebo at week 24 in this true TNFi-IRa patient population, which is often more...
Source: Johnson and Johnson - June 2, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Highlights Commitment to Advancing Transformative Innovations in Oncology with Scientific Updates from Deep, Diverse Pipeline and Portfolio at ASCO and EHA Virtual Scientific Programs
June 1, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 30 company-sponsored studies, including six oral presentations, will be featured during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, June 4-8. Janssen presentations will include new data and updates for both approved and investigational therapeutics that are being studied for the treatment of various solid tumors and blood cancers. Immediately following ASCO, additional data will be featured during the European Hematology Association (EHA) Virtual Congress, June 9-17. A ...
Source: Johnson and Johnson - June 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
June 1, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for teclistamab in the treatment of relapsed or refractory multiple myeloma. This distinction for teclistamab, an off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 receptors, follows a PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA) received earlier this year. Today’s BTD marks the 11th received by Janssen’s ...
Source: Johnson and Johnson - June 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Reports New Data for BCMA CAR-T, Cilta-Cel, Showing Deep and Durable Responses in Patients with Relapsed or Refractory Multiple Myeloma
June 1, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed CAR-T therapy, demonstrated sustained efficacy and durable responses in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM). Updated results from the Phase 1b/2 CARTITUDE-1 study (n=97) with a longer-term follow-up at a median of 18 months showed an overall response rate (ORR) of 98 percent, with 80 percent of patients achieving a stringent complete response (sCR), highlight...
Source: Johnson and Johnson - June 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Updated Data Demonstrate Significant Improvement in Hematologic Complete Response with DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
RARITAN, N.J., May 26, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced updated results from the Phase 3 ANDROMEDA study, which evaluated DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of patients with newly diagnosed light chain (AL) amyloidosis, a rare blood cell disorder associated with the deterioration of vital organs, most notably the heart, kidneys and liver.[1] Longer-term results from a median follow-up of 20.3 months showed rates of hematologic complete response (hemCR) remained significantly higher in patients treated with DARZALEX FASPRO®...
Source: Johnson and Johnson - May 26, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Long-Term ERLEADA ® (apalutamide) Patient-Reported Outcomes Data in Metastatic Castration-Sensitive Prostate Cancer Demonstrate Maintenance of Health-Related Quality of Life for Patients
May 26, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced patient-reported outcomes (PRO) data from the pre-specified final analysis of the Phase 3 TITAN study in patients with metastatic castration-sensitive prostate cancer (mCSPC). The TITAN study previously demonstrated statistically significant improvement in overall survival (OS) after a median follow-up of 44 months in patients receiving ERLEADA® plus androgen deprivation therapy (ADT).1 The new PRO data showed that the addition of ERLEADA® to ADT maintained patients’ health-related quality of lif...
Source: Johnson and Johnson - May 26, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Presents Updated Data on First-in-Class Talquetamab at ASCO Suggesting Deep and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma
May 24, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today follow-up data from the MonumenTAL-1 Phase 1 first-in-human dose-escalation study of the investigational product talquetamab, the only off-the-shelf T-cell redirecting bispecific antibody in clinical development to target both GPRC5D, a novel multiple myeloma target, and CD3 on T-cells (NCT03399799).[1],[2],[3] With a median follow-up of more than six months, updated results in 30 patients with relapsed or refractory multiple myeloma treated with talquetamab by subcutaneous (SC) administration at the recommend...
Source: Johnson and Johnson - May 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen ’s Updated Phase 1 Results for Teclistamab Suggest Deep, Durable Responses in Patients with Heavily Pretreated Multiple Myeloma
We reported initial findings for teclistamab at ASCO 2020, and study updates have observed a deepening of responses that have shown to be durable in a significant percentage of patients with relapsed or refractory multiple myeloma,” said Amrita Y. Krishnan, M.D., Director of the Judy and Bernard Briskin Center for Multiple Myeloma Research and Chief, Division of Multiple Myeloma, Department of Hematology and Hematopoietic Cell Transplantation at City of Hope, and study investigator. “Teclistamab exposure was sustained across the dosing interval and exceeded target levels, and consistent T-cell activation was ob...
Source: Johnson and Johnson - May 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

European Commission approves PONVORYTM (ponesimod), a Once Daily, Oral Therapy for the Treatment of Adults with Relapsing Forms of Multiple Sclerosis with Active Disease Defined by Clinical or Imaging Features
BEERSE, BELGIUM, May 24, 2021 – Janssen, the Pharmaceutical Companies of Johnson & Johnson, announced today that the European Commission (EC) has approved PONVORY (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features.[4] “Relapsing multiple sclerosis is an unpredictable and complex disease that can present very differently from individual to individual, placing a heavy burden on the patient and their loved ones,” said Professor Gavin Giovannoni, MBBCh, PhD, FCP (Neurol., SA), FRCP, FRCPath, Professor of Neuro...
Source: Johnson and Johnson - May 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Presents Results of First Head-to-Head Study of Biologic Therapies in Patients with Moderate to Severe Crohn ’s Disease
SPRING HOUSE, PENNSYLVANIA, May 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced efficacy and safety data for STELARA® (ustekinumab) in Crohn’s disease (CD) and ulcerative colitis (UC),1-4including data from the SEAVUE study, the first head-to-head study of biologic therapies in patients with CD, presented in a Clinical Science Late-Breaking Abstract Plenary session.1 SEAVUE data showed treatment with STELARA demonstrated high rates of clinical remission, corticosteroid-free remission, clinical response and endoscopic response through one year in biologic-naïve p...
Source: Johnson and Johnson - May 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

RYBREVANTTM (amivantamab-vmjw) Receives FDA Approval as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
May 21, 2021 (HORSHAM, P.A.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has granted the accelerated approval of RYBREVANTTM (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.[1] RYBREVANTTM is the first fully-human, bispecific antibody approved for the treatment of patients with NSCLC t...
Source: Johnson and Johnson - May 21, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

IMBRUVICA ® (ibrutinib)-Based Combination Regimen as a Fixed-Duration, First-Line Treatment for Chronic Lymphocytic Leukemia Demonstrates High Rates of Disease Control
May 19, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the fixed-duration cohort of the investigational Phase 2 CAPTIVATE study, showing that 95 percent of patients treated with combined IMBRUVICA® plus venetoclax were alive and progression-free at two years.[1] Deep remissions were seen across all subgroups, including patients with high-risk chronic lymphocytic leukemia (CLL).1 In addition, long-term data from the RESONATE-2 (PCYC-1115/1116) study will be presented, providing the longest follow-up Phase 3 data for any BTK inhibitor to date. Thes...
Source: Johnson and Johnson - May 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Updated Amivantamab and Lazertinib Combination Data Demonstrate Durable Responses and Clinical Activity for Osimertinib-Relapsed Patients with EGFR-Mutated Non-Small Cell Lung Cancer
May 19, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced updated data from the Phase 1 CHRYSALIS study showing treatment with amivantamab in combination with lazertinib led to a median duration of response (DOR) of 9.6 months in chemotherapy-naïve patients with non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 19 deletion or L858R mutations whose disease had progressed after treatment with osimertinib.[1] These data, which will be presented in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual ...
Source: Johnson and Johnson - May 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Joins World Health Organization in Efforts to Prevent Spread of Ebola in West Africa
Discussions are ongoing with the U.S. Food and Drug Administration regarding the approval of the vaccine regimen in the U.S. WHO Prequalification is often a prerequisite for national registrations of new vaccines and medicines in developing countries. Johnson & Johnson now looks forward to collaborating with the WHO’s African Vaccine Regulatory Forum (AVAREF) to progress national registrations of the Company’s Ebola vaccine regimen. The Company’s Ebola vaccine regimen is designed to be used proactively to induce immunity against Ebola virus disease in adults and children. Johnson & Johnson’s...
Source: Johnson and Johnson - May 13, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Pulmonary endarterectomy achieves excellent results for patients with segmental CTEPH
(American Association for Thoracic Surgery) A new study, presented today at the AATS 101st Annual Meeting, found that patients treated surgically for segmental Chronic Thromboembolic Pulmonary Hypertension (CTEPH) had excellent outcomes with the vast majority doing very well in the long term without any additional treatment other than surgery. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 2, 2021 Category: International Medicine & Public Health Source Type: news

Johnson & Johnson Single-Shot COVID-19 Vaccinations to Resume in the U.S. for All Adults Aged 18 and Older Following CDC and FDA Decision
NEW BRUNSWICK, N.J., April 23, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that vaccinations with the Company’s COVID-19 single-shot vaccine will resume for all adults aged 18 years and older in the U.S., under Emergency Use Authorization (EUA), following a decision from the United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA).The decision was based on a recommendation from the U.S. CDC Advisory Committee on Immunization Practices (ACIP), which followed a rigorous evaluation of data relating to a very rare adverse event involving blood clots in combin...
Source: Johnson and Johnson - April 23, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

New Phase 3 Data Showed First-in-Class TREMFYA ® (guselkumab) Provided Durable Complete Skin Clearance Through Five Years in Moderate to Severe Plaque Psoriasis (PsO) and Robust Joint Symptom Improvement Through 52 Weeks in Active Psoriatic Arthritis (PsA)
SPRING HOUSE, PENNSYLVANIA, April 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new Phase 3 data which showed TREMFYA® (guselkumab) sustained durable, complete skin clearance rates in a majority of adults with moderate to severe plaque psoriasis (PsO) through five years (252 weeks), a and improved disease activity and axial symptoms in adults with active psoriatic arthritis (PsA) through one year (52 weeks).1,2,3 These data are being presented at the American Academy of Dermatology Virtual Meeting Experience 2021, where Janssen will present a total of 22 abstracts. TREMF...
Source: Johnson and Johnson - April 23, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Cardiac Failure, Pulmonary Hypertension Secondary to Renal AVM Cardiac Failure, Pulmonary Hypertension Secondary to Renal AVM
Systemic AVM is a rare, but potentially reversible cause of high-output heart failure. This case emphasizes the importance of a detailed workup in a patient with heart failure symptoms.Journal of Medical Case Reports (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - April 22, 2021 Category: Intensive Care Tags: Family Medicine/Primary Care Journal Article Source Type: news

Johnson & Johnson Single-Shot COVID-19 Vaccine Phase 3 Data Published in New England Journal of Medicine
NEW BRUNSWICK, N.J., April 21, 2021 – Johnson & Johnson (the Company) today announced publication in the New England Journal of Medicine of primary data from the Phase 3 ENSEMBLE clinical trial for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). The publication of the primary analysis follows the topline efficacy and safety data announced in January, showing the trial met all primary and key secondary endpoints, and found that the Johnson & Johnson single-dose COVID-19 vaccine prevented hospitalization and death across all study participa...
Source: Johnson and Johnson - April 21, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson COVID-19 Vaccine Roll-out to Resume in Europe Following European Medicines Agency (EMA) ReviewEMA Confirms Overall Benefit-Risk Profile Remains Positive
NEW BRUNSWICK, N.J., April 20, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has provided updated guidance for use of the Company’s COVID-19 vaccine and confirmed the overall benefit-risk profile remains positive. The guidance follows PRAC review of a small number of cases of a very rare adverse event involving blood clots in combination with low platelet counts that can occur within approximately one to three weeks following injection with the Company’s COVID-19 vaccine. As a resul...
Source: Johnson and Johnson - April 20, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Janssen Provides Update on Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA® (abiraterone acetate) Plus Prednisone Combination
RARITAN, N.J., April 19, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that regulatory submissions based on the Phase 3 ACIS study, which evaluated the combination of ERLEADA® (apalutamide) and ZYTIGA® (abiraterone acetate) plus prednisone in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC), will not be pursued. As presented at the American Society of Clinical Oncology’s Genitourinary (ASCO GU) Cancers Symposium in February 2021, the ACIS study met its primary endpoint of radiographic progression-free survival (rPFS); ho...
Source: Johnson and Johnson - April 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

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