U.S. FDA Approves CARVYKTI ™ (ciltacabtagene autoleucel), Janssen’s First Cell Therapy, a BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
HORSHAM, Pa., February 28, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has approved CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.1 The approval is based on data from the pivotal CARTITUDE-1 study, which included patients who had received a median of six prior treatment regimens (range, 3-18), and had previously rec...
Source: Johnson and Johnson - March 1, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

WHO grants prequalification of Actemra/RoActemra for patients with severe or critical COVID-19
WHO ’s prequalification adds to several mechanisms already in place to improve access to Actemra/RoActemra for people with COVID-19 in low- and middle-income countriesSince the beginning of the pandemic, more than one million patients with severe COVID-19 have been treated with Actemra/RoActemra, as recommended in global treatment guidelinesTwelfth Roche medicine or test to be prequalified Basel, 11 February 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Actemra ®/RoActemra® (tocilizumab) intravenous (IV) has been granted World Health Organization (WHO) prequalification. Prequalification is a confi...
Source: Roche Media News - February 22, 2022 Category: Pharmaceuticals Source Type: news

WHO grants prequalification of Actemra/RoActemra for patients with severe or critical COVID-19
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that Actemra®/RoActemra® (tocilizumab) intravenous (IV) has been granted World Health Organization (WHO) prequalification. Prequalification is a confirmation by WHO that Actemra/RoActemra meets the WHO standards for quality, safety and efficacy for the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. (Source: World Pharma News)
Source: World Pharma News - February 14, 2022 Category: Pharmaceuticals Tags: Featured Roche Business and Industry Source Type: news

WHO grants prequalification of Actemra/RoActemra for patients with severe or critical COVID-19
WHO ’s prequalification adds to several mechanisms already in place to improve access to Actemra/RoActemra for people with COVID-19 in low- and middle-income countriesSince the beginning of the pandemic, more than one million patients with severe COVID-19 have been treated with Actemra/RoActemra, as recommended in global treatment guidelinesTwelfth Roche medicine or test to be prequalified Basel, 11 February 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Actemra ®/RoActemra® (tocilizumab) intravenous (IV) has been granted World Health Organization (WHO) prequalification. Prequalification is a confi...
Source: Roche Investor Update - February 11, 2022 Category: Pharmaceuticals Source Type: news

WHO grants prequalification of Actemra/RoActemra for patients with severe or critical COVID-19
Basel, 11 February 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Actemra ®/RoActemra® (tocilizumab) intravenous (IV) has been granted World Health Organization (WHO) prequalification. Prequalification is a confirmation by WHO that Actemra/RoActemra meets the WHO standards for quality, safety and efficacy for the treatment of COVID-19 in adults who are receiving systemi c corticosteroids and require supplemental oxygen or mechanical ventilation.1 It helps procurers in low- and middle-income countries identify priority medicines to improve access to care and support better health. (Source: Roche Media News)
Source: Roche Media News - February 11, 2022 Category: Pharmaceuticals Source Type: news

WHO grants prequalification of Actemra/RoActemra for patients with severe or critical COVID-19
Basel, 11 February 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Actemra ®/RoActemra® (tocilizumab) intravenous (IV) has been granted World Health Organization (WHO) prequalification. Prequalification is a confirmation by WHO that Actemra/RoActemra meets the WHO standards for quality, safety and efficacy for the treatment of COVID-19 in adults who are receiving systemi c corticosteroids and require supplemental oxygen or mechanical ventilation.1 It helps procurers in low- and middle-income countries identify priority medicines to improve access to care and support better health. (Source: Roche Investor Update)
Source: Roche Investor Update - February 11, 2022 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good results in 2021
Basel, 3 February 2022Group sales increase 9%1 at constant exchange rates (CER); 8% in Swiss francsPharmaceuticals Divisionsales increase 3%; continued strong demand for newly launched medicines more than offsets impact of biosimilarsDiagnostics Divisionsales grow 29%; strong momentum in base business and continued high demand for COVID-19 testsMajor approvals for medicinessince the last quarter: United States: Susvimo and Vabysmo (age-related blindness)Europe: Gavreto (specific type of advanced lung cancer); Actemra/RoActemra (severe COVID-19); Ronapreve (non-hospitalised COVID-19 patients and prophylaxis)Major appro...
Source: Roche Investor Update - February 3, 2022 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good results in 2021
Basel, 3 February 2022Group sales increase 9%1 at constant exchange rates (CER); 8% in Swiss francsPharmaceuticals Divisionsales increase 3%; continued strong demand for newly launched medicines more than offsets impact of biosimilarsDiagnostics Divisionsales grow 29%; strong momentum in base business and continued high demand for COVID-19 testsMajor approvals for medicinessince the last quarter:United States: Susvimo and Vabysmo (age-related blindness)Europe: Gavreto (specific type of advanced lung cancer); Actemra/RoActemra (severe COVID-19); Ronapreve (non-hospitalised COVID-19 patients and prophylaxis)Major approvals f...
Source: Roche Media News - February 3, 2022 Category: Pharmaceuticals Source Type: news

Interleukin-6 inhibitors (tocilizumab or sarilumab) for adult patients hospitalised due to COVID-19, DHSC (published/updated 31st January 2022)
Updated policy reflects tocilizumab is now licensed in the treatment of patients receiving systemic corticosteroids and require supplemental oxygen/mechanical ventilation. Sarilumab (off-label) should continue to be considered where tocilizumab is not available/cannot be used. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - February 1, 2022 Category: Consumer Health News Source Type: news

COVID antiviral Molnupiravir to be tested in RECOVERY trial on hospitalised patients
The RECOVERY Trial was launched as an emergency response in March 2020 and has so far discovered three effective treatments for COVID-19 - the inexpensive steroid dexamethasone; the arthritis drug tocilizumab; and an artificial antibody treatment, now known as Ronapreve. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 24, 2022 Category: Pharmaceuticals Source Type: news

Which medicine works best for Covid-19 treatment? WHO answers
For those infected, it is important to know your best treatment options -- the right medicines and drugs that have been effective in reducing mortality, hospitalisation, and ventilation. Baricitinib, Ruxolitinib, tofacitinib, Sotrovimab, Casirivimab-imdevimab, Tocilizumab or sarilumab can be used for Covid-19 treatment, as per WHO. (Source: The Economic Times)
Source: The Economic Times - January 17, 2022 Category: Consumer Health News Source Type: news

Roche COVID-19 At-Home Test granted FDA Emergency Use Authorization to expand access to rapid self-testing solutions in the United States
Rapid test to support the American public ’s fight against the COVID-19 pandemic, with availability to purchase over-the-counter (OTC) at pharmacies and retailers nationwideThe COVID-19 At-Home Test uses a simple nasal swab sample to enable individuals to self-test at home and receive accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron.EUA granted through Roche ’s participation in the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Independent Test Assessment Program to bring rapid tests to the OTC marketBasel, 24 ...
Source: Roche Media News - December 24, 2021 Category: Pharmaceuticals Source Type: news

Remdesivir to be used in patients with moderate to severe COVID-19: Health ministry
The Tocilizumab drug may be considered for use in the presence of severe disease (preferably within 24 to 48 hours of onset of severe disease/ICU admission), according to the guidelines. (Source: The Economic Times)
Source: The Economic Times - December 24, 2021 Category: Consumer Health News Source Type: news

EU Regulator Backs Tocilizumab for Treating Severe COVID-19 EU Regulator Backs Tocilizumab for Treating Severe COVID-19
The EU ' s drug regulator has recommended extending the use of Roche ' s RoActemra arthritis drug for adult COVID-19 patients.Reuters Health Information (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - December 7, 2021 Category: Intensive Care Tags: Infectious Diseases News Source Type: news

Actemra/RoActemra approved by the European Commission to treat patients with severe COVID-19
Basel, 07 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has extended the marketing authorisation for Actemra ®/RoActemra® (tocilizumab) to include the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.1 This decision comes just hours after the recommendation by the European Medicines Agency ' s (EMA) Committee for Medicinal Products for Human Use (CHMP), reflecting the urgent need for Actemra/RoActemra as a potential treatment option during the COVID-19 public health emergency. (Source: Roche Media News)
Source: Roche Media News - December 7, 2021 Category: Pharmaceuticals Source Type: news