European Medicines Agency (EMA) News 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.

FDA approves Roche ’s Evrysdi for use in babies under two months with spinal muscular atrophy (SMA)
Approval based on interim RAINBOWFISH data which show pre-symptomatic babies treated withEvrysdi for at least one year were able to sit, stand and walkPrescribing information updated with FIREFISH data showing the majority of symptomatic babies treated withEvrysdi for at least two years could sit for at least five secondsEvrysdi has proven efficacy in babies, children and adults with more than 5,000 patients treated to dateBasel, 31 May 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under...
Source: Roche Investor Update - May 31, 2022 Category: Pharmaceuticals Source Type: news

New pivotal data demonstrate clinical benefit of Roche ’s glofitamab, a potential first-in-class bispecific antibody for people with aggressive lymphoma
Data to be presented for the first time at ASCO and EHA 2022 show glofitamab induces high and durable complete response rates in people with heavily pre-treated diffuse large B-cell lymphoma ¹ Glofitamab has the potential to offer a readily available, fixed-duration CD20xCD3 bispecific antibody treatment approach for people with aggressive lymphomaGlofitamab is part of Roche ’s industry-leading CD20xCD3 bispecific antibody development programme, which aims to address the diverse needs and preferences of people with blood cancers Basel, 27 May 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new p...
Source: Roche Media News - May 27, 2022 Category: Pharmaceuticals Source Type: news

New pivotal data demonstrate clinical benefit of Roche ’s glofitamab, a potential first-in-class bispecific antibody for people with aggressive lymphoma
Data to be presented for the first time at ASCO and EHA 2022 show glofitamab induces high and durable complete response rates in people with heavily pre-treated diffuse large B-cell lymphoma ¹ Glofitamab has the potential to offer a readily available, fixed-duration CD20xCD3 bispecific antibody treatment approach for people with aggressive lymphomaGlofitamab is part of Roche ’s industry-leading CD20xCD3 bispecific antibody development programme, which aims to address the diverse needs and preferences of people with blood cancers Basel, 27 May 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new p...
Source: Roche Investor Update - May 27, 2022 Category: Pharmaceuticals Source Type: news

New pivotal data demonstrate clinical benefit of Roche ’s glofitamab, a potential first-in-class bispecific antibody for people with aggressive lymphoma
Data to be presented for the first time at ASCO and EHA 2022 showglofitamab induces high and durable complete response rates in people with heavily pre-treated diffuse large B-cell lymphoma1Glofitamab has the potential to offer a readily available, fixed-duration CD20xCD3 bispecific antibody treatment approach for people with aggressive lymphomaGlofitamab is part of Roche ’s industry-leading CD20xCD3 bispecific antibody developmentprogramme, which aims to address the diverse needs and preferences of people with blood cancersBasel, 27 May 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new pivotal data on i...
Source: Roche Investor Update - May 27, 2022 Category: Pharmaceuticals Source Type: news

New pivotal data demonstrate clinical benefit of Roche ’s glofitamab, a potential first-in-class bispecific antibody for people with aggressive lymphoma
Data to be presented for the first time at ASCO and EHA 2022 showglofitamab induces high and durable complete response rates in people with heavily pre-treated diffuse large B-cell lymphoma1Glofitamab has the potential to offer a readily available, fixed-duration CD20xCD3 bispecific antibody treatment approach for people with aggressive lymphomaGlofitamab is part of Roche ’s industry-leading CD20xCD3 bispecific antibody developmentprogramme, which aims to address the diverse needs and preferences of people with blood cancersBasel, 27 May 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new pivotal data on i...
Source: Roche Media News - May 27, 2022 Category: Pharmaceuticals Source Type: news

European Commission Grants Conditional Approval of CARVYKTI ® (Ciltacabtagene Autoleucel), Janssen’s First Cell Therapy, for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
BEERSE, BELGIUM, 26 May 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) granted conditional marketing authorisation of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. In December 2017, Janssen Biotech, Inc. (Janssen) entered into an exclusive worldwide license a...
Source: Johnson and Johnson - May 26, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

Roche ’s Polivy combination approved by European Commission for people with previously untreated diffuse large B-cell lymphoma
First new treatment option in more than 20 years to show a clinically meaningful improvement in progression-free survival is approved for people with previously untreated diffuse large B-cell lymphoma (DLBCL)Approval is based on pivotal data from the phase III POLARIX study, where Polivy plus R-CHP significantly improved progression-free survival with comparable safety versus the standard of care, R-CHOPFirst-line treatment with Polivy plus R-CHP has the potential to reduce the burden on patients and healthcare systems, associated with disease progression ¹Basel, 25 May 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today anno...
Source: Roche Investor Update - May 25, 2022 Category: Pharmaceuticals Source Type: news

Roche ’s Polivy combination approved by European Commission for people with previously untreated diffuse large B-cell lymphoma
First new treatment option in more than 20 years to show a clinically meaningful improvement in progression-free survival is approved for people with previously untreated diffuse large B-cell lymphoma (DLBCL)Approval is based on pivotal data from the phase III POLARIX study, where Polivy plus R-CHP significantly improved progression-free survival with comparable safety versus the standard of care, R-CHOPFirst-line treatment with Polivy plus R-CHP has the potential to reduce the burden on patients and healthcare systems, associated with disease progression ¹Basel, 25 May 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today anno...
Source: Roche Media News - May 25, 2022 Category: Pharmaceuticals Source Type: news

Roche ’s Polivy combination approved by European Commission for people with previously untreated diffuse large B-cell lymphoma
First new treatment option in more than 20 years to show a clinically meaningful improvement in progression-free survival is approved for people with previously untreated diffuse large B-cell lymphoma (DLBCL)Approval is based on pivotal data from the phase III POLARIX study, wherePolivy plus R-CHP significantly improved progression-free survival with comparable safety versus the standard of care, R-CHOPFirst-line treatment withPolivy plus R-CHP has the potential to reduce the burden on patients and healthcare systems, associated with disease progression1Basel, 25 May 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announce...
Source: Roche Investor Update - May 25, 2022 Category: Pharmaceuticals Source Type: news

Janssen Presents Study Results Showing Clinical Efficacy for TREMFYA ® (guselkumab) and Long-Term Safety Profile for STELARA® (ustekinumab) for Patients Living with Inflammatory Bowel Disease at Digestive Disease Week® 2022
SPRING HOUSE, PENNSYLVANIA, May 24, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the Phase 2 GALAXI 1 clinical trial of TREMFYA® (guselkumab) in adult patients with moderately to severely active Crohn’s disease (CD), and from three separate long-term pooled analyses of adult patients with ulcerative colitis (UC) and CD treated with STELARA® (ustekinumab).1,2,3,4 These data are being presented as oral and poster presentations and are among 29 Janssen abstracts presented during the Digestive Disease Week® (DDW) meeting taking place in person and virtually in San Di...
Source: Johnson and Johnson - May 24, 2022 Category: Pharmaceuticals Source Type: news

Roche Pharma launches drug to treat breast cancer
PHESGO was first approved by the US FDA in June 2020 during the peak of the Covid pandemic, by the European Medicines Agency (EMA) in December 2020. In India, PHESGO was approved by the DCGI in October 2021 and the import license was granted in January 2022. Globally, over 17,000 breast cancer patients have benefitted from PHESGO as on December 2021, the drug firm stated. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 12, 2022 Category: Pharmaceuticals Source Type: news

New three-year data for Roche ’s Evrysdi (risdiplam) show long-term improvements in survival and motor milestones in babies with Type 1 spinal muscular atrophy (SMA)
91% of infants treated withEvrysdi in the FIREFISH study were still alive at three yearsInfants treated withEvrysdi maintained or continued to improve in measures of motor function, including their ability to sit without support for 5 and 30 secondsEvrysdi has proven efficacy in infants and adults, with over 5,000 patients treated to dateBasel, 29 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new three-year data from the FIREFISH study, including one-year data from the open label extension, reinforcing the long-term efficacy and safety of Evrysdi ® (risdiplam) in infants with symptomatic Type 1 spinal mu...
Source: Roche Media News - April 29, 2022 Category: Pharmaceuticals Source Type: news

New three-year data for Roche ’s Evrysdi (risdiplam) show long-term improvements in survival and motor milestones in babies with Type 1 spinal muscular atrophy (SMA)
91% of infants treated withEvrysdi in the FIREFISH study were still alive at three yearsInfants treated withEvrysdi maintained or continued to improve in measures of motor function, including their ability to sit without support for 5 and 30 secondsEvrysdi has proven efficacy in infants and adults, with over 5,000 patients treated to dateBasel, 29 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new three-year data from the FIREFISH study, including one-year data from the open label extension, reinforcing the long-term efficacy and safety of Evrysdi ® (risdiplam) in infants with symptomatic Type 1 spinal mu...
Source: Roche Investor Update - April 29, 2022 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good sales growth in the first quarter of 2022
Basel, 25 April 2022Group sales increase 11%1 at constant exchange rates (CER) and 10% in Swiss francsPharmaceuticals Divisionsales up 6%; continued strong sales of new medicines for severe diseases. Impact of biosimilars decreases as expected.Diagnostics Divisionsales grow 24% due to good momentum in base business and continued high demand for COVID-19 tests. After a strong first quarter, significant decline in COVID-19-related testing expected.Highlights in the first quarter:FDA approval of Vabysmo (severe eye diseases); CHMP recommends EU approval of Polivy combination (aggressive form of blood cancer), Tecentriq (early...
Source: Roche Media News - April 25, 2022 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good sales growth in the first quarter of 2022
Group sales increase 11%1 at constant exchange rates (CER) and 10% in Swiss francsPharmaceuticals Divisionsales up 6%; continued strong sales of new medicines for severe diseases. Impact of biosimilars decreases as expected.Diagnostics Divisionsales grow 24% due to good momentum in base business and continued high demand for COVID-19 tests. After a strong first quarter, significant decline in COVID-19-related testing expected.Highlights in the first quarter:FDA approval of Vabysmo (severe eye diseases); CHMP recommends EU approval of Polivy combination (aggressive form of blood cancer), Tecentriq (early-stage non-small cel...
Source: Roche Investor Update - April 25, 2022 Category: Pharmaceuticals Source Type: news