European Medicines Agency (EMA) News 
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This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.Janssen to Highlight Innovation in Retinal Pipeline at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting
Click to Access Audio Press ReleaseRARITAN, N.J., April 21, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that five company-sponsored presentations will be featured during the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting in New Orleans from April 23-27, 2023. Janssen presentations will include updates from the Phase 1/2 MGT009 trial for investigational gene therapy botaretigene sparoparvovec (bota-vec, formerly AAV-RPGR) in patients with the inherited retinal disease (IRD) X-linked retinitis pigmentosa (XLRP) associated with the retinitis pigmentos...
Source: Johnson and Johnson - April 21, 2023 Category: Pharmaceuticals Tags: Innovation Source Type: news
Roche data highlights strength of ophthalmology portfolio and commitment to advancing eye care at ARVO 2023
Vabysmo data suggest rapid and robust drying of retinal fluid in patients withneovascular or ‘wet’ age-related macular degeneration and diabetic macular edemaReal-world studies ofVabysmo demonstrate ability to extend treatment intervals in the first four months while maintaining visual acuityClinical data on an investigational anti-interleukin-6 treatment inuveitic macular edema will be presented for the first timeBasel, 13 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data for its approved and investigational medicines will be highlighted in 30 abstracts at the 2023 Association for Research ...
Source: Roche Media News - April 13, 2023 Category: Pharmaceuticals Source Type: news
Roche data highlights strength of ophthalmology portfolio and commitment to advancing eye care at ARVO 2023
Vabysmo data suggest rapid and robust drying of retinal fluid in patients withneovascular or ‘wet’ age-related macular degeneration and diabetic macular edemaReal-world studies ofVabysmo demonstrate ability to extend treatment intervals in the first four months while maintaining visual acuityClinical data on an investigational anti-interleukin-6 treatment inuveitic macular edema will be presented for the first timeBasel, 13 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data for its approved and investigational medicines will be highlighted in 30 abstracts at the 2023 Association for Research ...
Source: Roche Investor Update - April 13, 2023 Category: Pharmaceuticals Source Type: news
Thoracic Cancer Approvals Differ at FDA, EMA Thoracic Cancer Approvals Differ at FDA, EMA
Compared to the US Food and Drug Administration, the European Medicines Agency had significantly longer approval times, as well as some different perspectives on biomarkers.MDedge News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - April 10, 2023 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news
Moderna Surges On A Key Win For Its Merck-Partnered Cancer Vaccine In Europe
stock climbed Monday after European regulators granted its Merck (MRK)-partnered personalized cancer vaccine a key designation. X Under the prime scheme designation, the European Medicines Agency gives early feedback on test results to speed up the development and evaluation of medicines that may…#merck #keytruda #melanoma #stephenhoge #ericrubin #moderna #marketsmithcom #allisongatlin #ibdagatlin (Source: Reuters: Health)
Source: Reuters: Health - April 10, 2023 Category: Consumer Health News Source Type: news
New four year data for Roche ’s Evrysdi reinforce long-term efficacy and safety profile in some of the most severely affected people with types 2 and 3 spinal muscular atrophy (SMA)
Data from pivotal SUNFISH study showed increases in motor function observed during the first year were maintained through the fourth year, while the overall rate of adverse events continued to decreaseData confirm long-term efficacy and safety profile ofEvrysdi in a broad range of people with Type 2 and non‑ambulant Type 3 SMAMore than 8,500 people —from newborns to the over 60s—have been treated withEvrysdi, which is now approved in more than 90 countries worldwideBasel, 20 March 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new long-term data for Evrysdi ® (risdiplam) in a broad range of people aged 2-...
Source: Roche Investor Update - March 20, 2023 Category: Pharmaceuticals Source Type: news
New four year data for Roche ’s Evrysdi reinforce long-term efficacy and safety profile in some of the most severely affected people with types 2 and 3 spinal muscular atrophy (SMA)
Data from pivotal SUNFISH study showed increases in motor function observed during the first year were maintained through the fourth year, while the overall rate of adverse events continued to decreaseData confirm long-term efficacy and safety profile ofEvrysdi in a broad range of people with Type 2 and non‑ambulant Type 3 SMAMore than 8,500 people —from newborns to the over 60s—have been treated withEvrysdi, which is now approved in more than 90 countries worldwideBasel, 20 March 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new long-term data for Evrysdi ® (risdiplam) in a broad range of people aged 2-...
Source: Roche Media News - March 20, 2023 Category: Pharmaceuticals Source Type: news
TREMFYA ® (guselkumab) Real-World Data Analyses Show Greater Treatment Persistence Than IL-17s in Both Bio-naïve and Bio-experienced Patients Living With Moderate to Severe Plaque Psoriasis
SPRING HOUSE, PENNSYLVANIA, March 17, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data, showing that initiation of TREMFYA® (guselkumab) was associated with greater treatment persistencea compared to secukinumab or ixekizumab in bio-naïve and bio-experienced patientsb living with moderate to severe plaque psoriasis (PsO), based on pairwise analysesc of real-world data.[1],[2] Additionally, in a post-hoc analysis of Phase 3 VOYAGE 2 clinical trial results, TREMFYA demonstrated durable clinical efficacy, itch relief and quality-of-life improvements in patients living with scal...
Source: Johnson and Johnson - March 17, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
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
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
European committee: Regulators should deny Merck's Lagevrio
A European medical committee says regulators should reject Merck’s COVID-19 treatment Lagevrio for European Union use. The drugmaker said that a European Medicines Agency committee has recommended marketing authorization refusal for the antiviral pill. More than two dozen countries have already…#merck #iv #fda #lagevrio (Source: Reuters: Health)
Source: Reuters: Health - February 24, 2023 Category: Consumer Health 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
New phase III data show Roche ’s Vabysmo rapidly improved vision and reduced retinal fluid in people with retinal vein occlusion (RVO)
Vabysmo met its primary endpoint in two clinical trials, BALATON and COMINO, showing non-inferior visual acuity gains compared toafliberceptMoreVabysmo patients showed an absence of blood vessel leakage in the retina compared toaflibercept in a pre-specified exploratory endpointIf approved, RVO would be the third indication forVabysmo in addition toneovascular or ‘wet’ age-related macular degeneration and diabetic macular edemaBasel, 10 February 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive new data from two global phase III studies, BALATON and COMINO, evaluating Vabysmo ® (faricimab) in macular ...
Source: Roche Investor Update - February 10, 2023 Category: Pharmaceuticals Source Type: news
New phase III data show Roche ’s Vabysmo rapidly improved vision and reduced retinal fluid in people with retinal vein occlusion (RVO)
Vabysmo met its primary endpoint in two clinical trials, BALATON and COMINO, showing non-inferior visual acuity gains compared toafliberceptMoreVabysmo patients showed an absence of blood vessel leakage in the retina compared toaflibercept in a pre-specified exploratory endpointIf approved, RVO would be the third indication forVabysmo in addition toneovascular or ‘wet’ age-related macular degeneration and diabetic macular edemaBasel, 10 February 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive new data from two global phase III studies, BALATON and COMINO, evaluating Vabysmo ® (faricimab) in macular ...
Source: Roche Media News - February 10, 2023 Category: Pharmaceuticals Source Type: news
Janssen Reports Positive Topline Phase 2 Results for Nipocalimab in Pregnant Individuals at High Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
SPRING HOUSE, PENNSYLVANIA, February 6, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive topline results from the proof-of-concept Phase 2 open-label UNITY clinical trial for the treatment of pregnant adults at high risk for severe hemolytic disease of the fetus and newborn (HDFN). HDFN is a serious and rare condition which can cause life-threatening anemia in the fetus. It occurs when the blood types of a pregnant individual and their fetus are incompatible.1 The trial met the primary endpoint, with the majority of pregnant patients who received nipocalimab achieving a live b...
Source: Johnson and Johnson - February 8, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
