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The Lancet publishes studies showing Roche ’s faricimab improved and maintained vision in two leading causes of vision loss, extending time between treatments up to four months
Two papers in The Lancet highlight one-year results from Roche ’s phase III trials evaluatingfaricimab inneovascular or “wet” age-related macular (nAMD) and diabetic macular edema (DME)Across four studies, about half of eligiblefaricimab patients were able to go four months between treatments, and approximately three-quarters could be treated every three months or longerReductions in central subfield thickness (CST) and resolution ofintraretinal fluid consistentlyfavouredfaricimab overaflibercept in DME, and meaningful and comparable CST reductions were seen innAMD in the first yearBasel, 24 January 2022 - Roche (SIX...
Source: Roche Investor Update - January 24, 2022 Category: Pharmaceuticals Source Type: news

The Lancet publishes studies showing Roche ’s faricimab improved and maintained vision in two leading causes of vision loss, extending time between treatments up to four months
Two papers in The Lancet highlight one-year results from Roche ’s phase III trials evaluatingfaricimab inneovascular or “wet” age-related macular (nAMD) and diabetic macular edema (DME)Across four studies, about half of eligiblefaricimab patients were able to go four months between treatments, and approximately three-quarters could be treated every three months or longerReductions in central subfield thickness (CST) and resolution ofintraretinal fluid consistentlyfavouredfaricimab overaflibercept in DME, and meaningful and comparable CST reductions were seen innAMD in the first yearBasel, 24 January 2022 - Roche (SIX...
Source: Roche Media News - January 24, 2022 Category: Pharmaceuticals Source Type: news

Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant, European Medicines Agency
Results from recently published studies show that vaccine effectiveness against symptomatic disease is lower for Omicron than for other variants and tends to wane over time. As a result, more vaccinated people are likely to develop breakthrough disease due to Omicron. However, these studies also show that vaccination continues to provide a high level of protection against severe disease and hospitalisation linked to the Omicron variant. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - January 14, 2022 Category: Consumer Health News Source Type: news

The future is bright for RWE in pharma approvals
Real-world evidence (RWE) could help pharma achieve many things – including understanding disease burden better and smarter monitoring of newly marketed therapies to make them safer and more effective. But the most promising near-term use case for RWE, according to a Deloitte survey of pharma executives, is in support of regulatory submissions and label expans ion. For industry stakeholders such as Marc Berger, M.D., this advance is a long time coming. The founder of the real-world data (RWD) and analytics group at Pfizer, Berger has been a contributing author on dozens of policy papers on the use of RWE – including ...
Source: EyeForPharma - January 6, 2022 Category: Pharmaceuticals Authors: Brian Eastwood Source Type: news

Janssen Submits Biologics License Application to U.S. FDA Seeking Approval of Teclistamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
RARITAN, N.J., December 29, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of teclistamab for the treatment of patients with relapsed or refractory (R/R) multiple myeloma. Teclistamab is an investigational, off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3.“Despite all the gains that have been made in treating multiple myeloma, the unmet need still remains very high. Our relentless pursuit of treatments ...
Source: Johnson and Johnson - December 29, 2021 Category: Pharmaceuticals Tags: Latest News Source Type: news

EMA Panel Endorses Two Cancer Drugs, One Sickle Cell Drug EMA Panel Endorses Two Cancer Drugs, One Sickle Cell Drug
The recommendations from the European Medicines Agency panel mean the drugs will likely be approved soon.International Approvals (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - December 18, 2021 Category: Cancer & Oncology Tags: Hematology-Oncology News Alert Source Type: news

European Medicines Agency human medicines committee (CHMP) recommends approval of anakinra for treatment of adults with COVID-19 , EMA
Supporting data from study of 606 hospitalised adults with moderate/severe COVID-19 pneumonia, at risk of severe respiratory failure (suPAR ≥6ng/ml), which showed greater clinical symptom improvement over 28-days in anakinra plus standard of care (SOC) arm vs. placebo plus SOC. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - December 17, 2021 Category: Consumer Health News Source Type: news

COVID-19: European Medicines Agency human medicines committee (CHMP) recommends authorisation of monoclonal antibody sotrovimab (Xevudy), EMA (published 16th December 2021)
The Committee recommended authorising sotrovimab for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of the disease becoming severe. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - December 17, 2021 Category: Consumer Health News Source Type: news

Johnson & Johnson Announces Positive CHMP Opinion for a Booster Shot of its COVID-19 Vaccine
NEW BRUNSWICK, N.J., December 15, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a Positive Opinion for use of the Company’s COVID-19 vaccine as a booster for adults aged 18 and older at least two months after primary vaccination with a single-shot of the Johnson & Johnson COVID-19 vaccine, and as a ‘mix and match’ booster following primary vaccination with an approved two-shot mRNA COVID-19 vaccine regimen (known as heterologous boosting). “We are pleased with today’s Positiv...
Source: Johnson and Johnson - December 15, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

New Data from MajesTEC-1 Study Show Continued Deep and Durable Responses of Teclistamab (BCMAxCD3 Bispecific Antibody) in Treatment of Heavily Pretreated Patients with Multiple Myeloma
The objective responsive rate observed in this study suggests a potential benefit for many patients with triple-class exposed disease with an off-the-shelf therapy.”As of September 2021, 165 patients were treated with teclistamab at the SC 1.5 mg/kg dose across both Phase 1 and Phase 2 of MajesTEC-1.1 The primary objectives of the MajesTEC-1 Phase 1 study (NCT03145181) were to identify the recommended SC RP2D (part 1) and characterize the safety and tolerability of teclistamab at the RP2D (part 2). The primary objective of the MajesTEC-1 Phase 2 study (NCT04557098) was to evaluate the efficacy of teclistamab at the RP2D,...
Source: Johnson and Johnson - December 13, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

EMA and ECDC recommendations on heterologous vaccination courses against COVID-19, European Medicines Agency
The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) continue to urge all EU citizens to get fully vaccinated and to adhere to recent recommendations on booster vaccination. Currently available evidence consistently points towards acceptable tolerability and enhanced immune responses with sequential heterologous vaccination vs homologous vaccination. Clinical considerations for heterologous booster vaccine schedules are provided. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - December 10, 2021 Category: Consumer Health 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 Investor Update)
Source: Roche Investor Update - December 7, 2021 Category: Pharmaceuticals 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

CHMP recommends EU approval of Actemra/RoActemra to treat patients with severe COVID-19
Basel, 06 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended extending 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. A final decision regarding the approval of Actemra/RoActemra is expected from the European Commission in the near future. (Source: Roche Media News)
Source: Roche Media News - December 6, 2021 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Actemra/RoActemra to treat patients with severe COVID-19
Basel, 06 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended extending 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. A final decision regarding the approval of Actemra/RoActemra is expected from the European Commission in the near future. (Source: Roche Investor Update)
Source: Roche Investor Update - December 6, 2021 Category: Pharmaceuticals Source Type: news