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Roche ’s Alecensa delivers unprecedented Phase III results for people with ALK-positive early-stage lung cancer
ALINA data demonstrateAlecensa reduces disease recurrence in the early setting for people with ALK-positive non-small cell lung cancer (NSCLC), building on its long-established benefit in the advanced settingAbout half of people with NSCLC experience disease recurrence following surgery, despite adjuvant chemotherapy, therefore new treatments are urgently needed to provide the best chance for cureThese data will be submitted to health authorities globallyand presented at an upcoming medical meetingBasel, 01 September 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Phase III ALINA study evaluating Alecens...
Source: Roche Media News - September 1, 2023 Category: Pharmaceuticals Source Type: news

Roche ’s Alecensa delivers unprecedented Phase III results for people with ALK-positive early-stage lung cancer
ALINA data demonstrateAlecensa reduces disease recurrence in the early setting for people with ALK-positive non-small cell lung cancer (NSCLC), building on its long-established benefit in the advanced settingAbout half of people with NSCLC experience disease recurrence following surgery, despite adjuvant chemotherapy, therefore new treatments are urgently needed to provide the best chance for cureThese data will be submitted to health authorities globallyand presented at an upcoming medical meetingBasel, 01 September 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Phase III ALINA study evaluating Alecens...
Source: Roche Investor Update - September 1, 2023 Category: Pharmaceuticals Source Type: news

Roche ’s Tecentriq becomes the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain, reducing treatment time to just minutes
Tecentriq subcutaneous (SC) is now approved in Great Britain for all indications of intravenousTecentriq, including certain types of lung, bladder, breast and liver cancer, offering a faster, more convenient option to receive treatmentAdministered under the skin within approx. seven minutes,Tecentriq SC saves time for patients and helps conserve resources in healthcare systems1Evaluations by the FDA, EMA and other health authorities globally are ongoingBasel, 29 August 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Tecentriq ® SC (atezolizumab) has been approved by the Medicines and Healthcare products Reg...
Source: Roche Investor Update - August 29, 2023 Category: Pharmaceuticals Source Type: news

Roche ’s Tecentriq becomes the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain, reducing treatment time to just minutes
Tecentriq subcutaneous (SC) is now approved in Great Britain for all indications of intravenousTecentriq, including certain types of lung, bladder, breast and liver cancer, offering a faster, more convenient option to receive treatmentAdministered under the skin within approx. seven minutes,Tecentriq SC saves time for patients and helps conserve resources in healthcare systems1Evaluations by the FDA, EMA and other health authorities globally are ongoingBasel, 29 August 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Tecentriq ® SC (atezolizumab) has been approved by the Medicines and Healthcare products Reg...
Source: Roche Media News - August 29, 2023 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Evrysdi for babies under two months old with spinal muscular atrophy (SMA)
Evrysdi available to treat people of all ages with SMA in the European Union, including babies from birth1Approval is based on interim data from ongoing RAINBOWFISH trial showing majority ofEvrysdi-treated babies were able to stand and walk within timeframes typical of healthy babies by 12 months ’ treatment2,3Evrysdi is the only non-invasive SMA therapy and is approved in 100 countries with more than 11,000 patients treated globallyBasel, 29 August 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved the extension of the Evrysdi ® (risdiplam) European Union (EU) marketing ...
Source: Roche Media News - August 29, 2023 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Evrysdi for babies under two months old with spinal muscular atrophy (SMA)
Evrysdi available to treat people of all ages with SMA in the European Union, including babies from birth1Approval is based on interim data from ongoing RAINBOWFISH trial showing majority ofEvrysdi-treated babies were able to stand and walk within timeframes typical of healthy babies by 12 months ’ treatment2,3Evrysdi is the only non-invasive SMA therapy and is approved in 100 countries with more than 11,000 patients treated globallyBasel, 29 August 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved the extension of the Evrysdi ® (risdiplam) European Union (EU) marketing ...
Source: Roche Investor Update - August 29, 2023 Category: Pharmaceuticals Source Type: news

CHMP recommends Roche ’s Evrysdi for babies under two months old with spinal muscular atrophy (SMA)
Positive recommendation is based on interim data from ongoing RAINBOWFISH trial which showed majority ofEvrysdi-treated babies were able to stand and walk within timeframes typical of healthy babies by 12 months ’ treatment1,2If approved by the European Commission,Evrysdi will be available to treat people of all ages with SMA in the European Union, including babies from birthEvrysdi is now approved in 100 countries with more than 8,500 patients treated globallyBasel, 21 July 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive o...
Source: Roche Media News - July 21, 2023 Category: Pharmaceuticals Source Type: news

CHMP recommends Roche ’s Evrysdi for babies under two months old with spinal muscular atrophy (SMA)
Positive recommendation is based on interim data from ongoing RAINBOWFISH trial which showed majority ofEvrysdi-treated babies were able to stand and walk within timeframes typical of healthy babies by 12 months ’ treatment1,2If approved by the European Commission,Evrysdi will be available to treat people of all ages with SMA in the European Union, including babies from birthEvrysdi is now approved in 100 countries with more than 8,500 patients treated globallyBasel, 21 July 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive o...
Source: Roche Investor Update - July 21, 2023 Category: Pharmaceuticals Source Type: news

New clinical and real-world data for Roche ’s Vabysmo at ASRS reveal improved outcomes for people with two leading causes of vision loss
Late-breaking post-hoc data indicateVabysmo leads to less fibrosis, which may negatively impact vision, thanaflibercept in people with diabetic macular edema (DME)Real-world data reinforce that first-lineVabysmo use improves outcomes and extends treatment intervals rapidly during the first four months for people withneovascular or ‘wet’ age-related macular degeneration (nAMD) and DMEClinical data reiterateVabysmo ’s positive anatomical outcomes, including reduced blood vessel leakage in the macula and greater and faster retinal fluid controlVabysmo is currently approved in over 70 countries to treatnAMD and DME, with...
Source: Roche Media News - July 20, 2023 Category: Pharmaceuticals Source Type: news

New clinical and real-world data for Roche ’s Vabysmo at ASRS reveal improved outcomes for people with two leading causes of vision loss
Late-breaking post-hoc data indicateVabysmo leads to less fibrosis, which may negatively impact vision, thanaflibercept in people with diabetic macular edema (DME)Real-world data reinforce that first-lineVabysmo use improves outcomes and extends treatment intervals rapidly during the first four months for people withneovascular or ‘wet’ age-related macular degeneration (nAMD) and DMEClinical data reiterateVabysmo ’s positive anatomical outcomes, including reduced blood vessel leakage in the macula and greater and faster retinal fluid controlVabysmo is currently approved in over 70 countries to treatnAMD and DME, with...
Source: Roche Investor Update - July 20, 2023 Category: Pharmaceuticals Source Type: news

European Regulators Investigating Risk for Suicidal Thoughts With Popular Weight-Loss Drugs
TUESDAY, July 11, 2023 -- The European Medicines Agency is investigating concerns that popular weight-loss drugs like Ozempic and Saxenda may be linked to suicidal thoughts and thoughts of self-harm. Three case reports from Iceland spurred the... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 11, 2023 Category: Pharmaceuticals Source Type: news

Risk of Suicidal Thoughts With Popular Weight-Loss Drugs Being Investigated by European Regulators
TUESDAY, July 11, 2023 -- The European Medicines Agency is investigating concerns that popular weight-loss drugs like Ozempic and Saxenda may be linked to suicidal thoughts and thoughts of self-harm. Three case reports from Iceland spurred the... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - July 11, 2023 Category: General Medicine Source Type: news

European Commission approves Roche ’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
Columvi is the first CD20xCD3 T-cell-engaging bispecific antibody available in Europe to treat the most common and aggressive form of lymphomaApproval is based on results from the phase I/II NP30179 study, where Columvi given as a fixed course induced early and long-lasting complete responses in people with heavily pre-treated or refractory diffuse large B-cell lymphoma1Columvi is given for a fixed period of time and made to be readily available, providing patients with a treatment end date and treatment-free periodBasel, 11 July 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) ha...
Source: Roche Media News - July 11, 2023 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
Columvi is the first CD20xCD3 T-cell-engaging bispecific antibody available in Europe to treat the most common and aggressive form of lymphomaApproval is based on results from the phase I/II NP30179 study, where Columvi given as a fixed course induced early and long-lasting complete responses in people with heavily pre-treated or refractory diffuse large B-cell lymphoma1Columvi is given for a fixed period of time and made to be readily available, providing patients with a treatment end date and treatment-free periodBasel, 11 July 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) ha...
Source: Roche Investor Update - July 11, 2023 Category: Pharmaceuticals Source Type: news

Weight Loss Drugs and Suicide; Air Monitor Detects COVID; Fecal Bacteria at Beaches
(MedPage Today) -- Note that some links may require subscriptions. The European Medicines Agency is investigating weight loss and diabetes drugs semaglutide (Ozempic) and liraglutide (Saxenda) over reports of suicidal thoughts. (NBC News) Pharmacy... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - July 11, 2023 Category: American Health Source Type: news