Positive topline phase III results show Roche's Vabysmo improved vision for people living with retinal vein occlusion (RVO)
Vabysmo achieved its primary endpoint of non-inferiority toaflibercept in RVO in the BALATON and COMINO clinical trialsVabysmo was generally well tolerated, with a safety profile consistent with previous trialsVabysmo is the first and only treatment that targets and inhibits two disease pathways involving Ang-2 and VEGF-A, linked to a number of vision-threatening retinal conditionsDetailed results will be presented at an upcoming medical meeting and submitted to regulatory authorities around the worldBasel, 27 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from two global phase I...
Source: Roche Investor Update - October 27, 2022 Category: Pharmaceuticals Source Type: news

Positive topline phase III results show Roche's Vabysmo improved vision for people living with retinal vein occlusion (RVO)
Vabysmo achieved its primary endpoint of non-inferiority toaflibercept in RVO in the BALATON and COMINO clinical trialsVabysmo was generally well tolerated, with a safety profile consistent with previous trialsVabysmo is the first and only treatment that targets and inhibits two disease pathways involving Ang-2 and VEGF-A, linked to a number of vision-threatening retinal conditionsDetailed results will be presented at an upcoming medical meeting and submitted to regulatory authorities around the worldBasel, 27 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from two global phase I...
Source: Roche Media News - October 27, 2022 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche records solid results for the first nine months of 2022
Group salesup 2%[1] at constant exchange rates (CER) and 1% in Swiss francs; as expected, significantly lower COVID-19-related sales in both divisions in the third quarterSales in the Pharmaceuticals Divisionat the previous year ’s level with significantly lower sales of COVID-19-related products (Ronapreve and Actemra/RoActemra) and losses to biosimilars, offset by strong growth of newer medicinesSales in the Diagnostics Divisionrise 6%; base business remains strong; as expected, demand for COVID-19 tests sharply down in third quarterHighlights in the third quarter:EU approval forVabysmo (severe eye diseases)US approval...
Source: Roche Investor Update - October 18, 2022 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche records solid results for the first nine months of 2022
Basel, 18 October 2022Group salesup 2%1 at constant exchange rates (CER) and 1% in Swiss francs; as expected, significantly lower COVID-19-related sales in both divisions in the third quarterSales in the Pharmaceuticals Divisionat the previous year ’s level with significantly lower sales of COVID-19-related products (Ronapreve and Actemra/RoActemra) and losses to biosimilars, offset by strong growth of newer medicinesSales in the Diagnostics Divisionrise 6%; base business remains strong; as expected, demand for COVID-19 tests sharply down in third quarterHighlights in the third quarter:EU approval forVabysmo (severe eye ...
Source: Roche Media News - October 18, 2022 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
Phase III data that showed people with nAMD and DME treated with Vabysmo up to every four months achieved similar outcomes compared to receiving treatment every two months with afliberceptIn addition, patients treated with Vabysmo received up to 33% fewer median number of injections compared to afliberceptReducing the number of eye injections over time could offer a less burdensome treatment schedule for individuals, their caregivers and healthcare systemsVabysmo simultaneously targets and inhibits two disease pathways involving Ang-2 and VEGF-A linked to a number of vision-threatening retinal conditionsBasel, 19 September...
Source: Roche Investor Update - September 19, 2022 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
Phase III data that showed people with nAMD and DME treated with Vabysmo up to every four months achieved similar outcomes compared to receiving treatment every two months with afliberceptIn addition, patients treated with Vabysmo received up to 33% fewer median number of injections compared to afliberceptReducing the number of eye injections over time could offer a less burdensome treatment schedule for individuals, their caregivers and healthcare systemsVabysmo simultaneously targets and inhibits two disease pathways involving Ang-2 and VEGF-A linked to a number of vision-threatening retinal conditionsBasel, 19 September...
Source: Roche Media News - September 19, 2022 Category: Pharmaceuticals Source Type: news

Cimerli (Ranibizumab-eqrn Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 12, 2022 Category: Drugs & Pharmacology Source Type: news

Cimerli (Ranibizumab-eqrn Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 11, 2022 Category: Drugs & Pharmacology Source Type: news

FDA OKs First Interchangeable Ranibizumab Biosimilar
(MedPage Today) -- The FDA has approved the first interchangeable biosimilar to the ophthalmologic anti-VEGF agent ranibizumab (Lucentis), Coherus BioSciences announced. The approval of ranibizumab-eqrn (Cimerli) covers all five current FDA-approved... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - August 3, 2022 Category: American Health Source Type: news

FDA Approves Cimerli (ranibizumab-eqrn), an Interchangeable Biosimilar to Lucentis
REDWOOD CITY, Calif., Aug. 02, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or Coherus BioSciences, Nasdaq: CHRS) announced today that the U.S. Food and Drug Administration (FDA) has approved Cimerli (ranibizumab-eqrn) as a biosimilar... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 2, 2022 Category: Drugs & Pharmacology Source Type: news

CHMP recommends EU approval of Roche ’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
Vabysmo (faricimab) simultaneously targets and inhibits two disease pathways that driveneovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME)The CHMP recommendation is based on results across four phase III studies: TENAYA and LUCERNE innAMD at year one, and YOSEMITE and RHINE in DME up to two yearsThe totality of the data across all studies innAMD and DME available to date showed that over 60% of people treated withVabysmo were able to extend treatment to every four months, while improving and maintaining visionIf approved,Vabysmo would offer the first new mechanism of action in ...
Source: Roche Investor Update - July 22, 2022 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
Vabysmo (faricimab) simultaneously targets and inhibits two disease pathways that driveneovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME)The CHMP recommendation is based on results across four phase III studies: TENAYA and LUCERNE innAMD at year one, and YOSEMITE and RHINE in DME up to two yearsThe totality of the data across all studies innAMD and DME available to date showed that over 60% of people treated withVabysmo were able to extend treatment to every four months, while improving and maintaining visionIf approved,Vabysmo would offer the first new mechanism of action in ...
Source: Roche Media News - July 22, 2022 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche achieves good results in the first six months of 2022
Group sales up 5%1 at constant exchange rates (CER) and 5% in Swiss francsPharmaceuticals Divisionsales increase 3%; continued strong demand for new medicines to treat severe diseases; as expected, the impact of biosimilars slows down furtherDiagnostics Divisionsales grow 11%; ongoing strong base business; demand for COVID-19 tests is expected to decline in the second half of the yearIFRSnet income increases by 12% (12% in Swiss francs), whilecore earnings per share are up 11%Highlights in the second quarter:EU approvals ofPolivy (first-line treatment for aggressive form of blood cancer),Lunsumio (follicular lymphoma) andT...
Source: Roche Investor Update - July 21, 2022 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche achieves good results in the first six months of 2022
Basel, 21 July 2022Group sales up 5%1 at constant exchange rates (CER) and 5% in Swiss francsPharmaceuticals Divisionsales increase 3%; continued strong demand for new medicines to treat severe diseases; as expected, the impact of biosimilars slows down furtherDiagnostics Divisionsales grow 11%; ongoing strong base business; demand for COVID-19 tests is expected to decline in the second half of the yearIFRSnet income increases by 12% (12% in Swiss francs), whilecore earnings per share are up 11%Highlights in the second quarter:EU approvals ofPolivy (first-line treatment for aggressive form of blood cancer),Lunsumio (follic...
Source: Roche Media News - July 21, 2022 Category: Pharmaceuticals Source Type: news

New two-year data confirm Roche ’s Vabysmo improves vision with fewer treatments for people with neovascular age-related macular degeneration
In the TENAYA and LUCERNE studies, more than 60% ofVabysmo patientscould be treated every four months at two years. This represents an increase from 45% at year onePatients treated withVabysmo received a median number of 10 injections over the two years versus 15 injections for those treated withaflibercept, potentially decreasing the number of injectionsNo new safety signals were identified andVabysmo continued to be well tolerated, with afavourable benefit-risk profileBasel, 14 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new two-year data from the TENAYA and LUCERNE studies that reinforce the long-term...
Source: Roche Investor Update - July 14, 2022 Category: Pharmaceuticals Source Type: news