European Medicines Agency (EMA) News 
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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.Roche ’s subcutaneous formulation of Tecentriq demonstrates positive Phase III results
IMscin001 study showed non-inferior levels of cancer immunotherapyTecentriq in the blood, when injected subcutaneously, compared to intravenous infusion, in people with advanced non-small cell lung cancerAdministered under the skin, the subcutaneous formulation reduces time spent receiving treatment to just minutes, compared with up to an hour for IV infusionData will be submitted to health authorities globally, including the US Food and Drug Administration and European Medicines AgencyBasel, 2 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMscin001 study evaluating a subcutaneous form...
Source: Roche Media News - August 2, 2022 Category: Pharmaceuticals Source Type: news
European Medicines Agency (EMA) response to the monkeypox (MP) public health emergency
EMA has initiated series of actions including recommendation to approve extension of indication for vaccine Imvanex, production of formal list of critical medicines for MP public health emergency& extension of remit of EMA ' s Emergency Task Force to deal with both COVID-19& MP. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - July 29, 2022 Category: Consumer Health News 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
Janssen Receives Positive CHMP Opinion for Novel Bispecific Antibody TECVAYLI ® (teclistamab) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma (RRMM)
BEERSE, Belgium, 22 July 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional marketing authorisation (CMA) for TECVAYLI® (teclistamab) as monotherapy for adult patients with relapsed and refractory multiple myeloma (RRMM), who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. Teclistamab is an off-the-shelf, T-cell r...
Source: Johnson and Johnson - July 22, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news
EU drug regulator recommends clearing vaccine for monkeypox
The European Medicines Agency says the smallpox vaccine made by Bavarian Nordic should also be authorized against monkeypox as an outbreak of the once-rare disease sickens people across Europe (Source: ABC News: Health)
Source: ABC News: Health - July 22, 2022 Category: Consumer Health News Tags: Health 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
Pfizer and BioNTech complete submission to European Medicines Agency for Omicron BA.1 adapted bivalent vaccine candidate
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 sub-lineage, for individuals 12 years of age and older. This application follows guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA) to work towards introducing an Omicron-adapted bivalent vaccine candidate to address the continued evolution of SARS-CoV-2. (Source: World Pharma News)
Source: World Pharma News - July 19, 2022 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news
Towards better prevention of medicine shortages in the EU, EMA (published 15th July 2022)
The European Medicines Agency has published guidance for patients ' and healthcare professionals ' organisations with key principles and examples of good practices to support them in preventing and managing shortages of human medicines. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - July 18, 2022 Category: Consumer Health News Source Type: news
Eight-year data from APHINITY study show Roche ’s Perjeta-based regimen continues to reduce the risk of disease returning for people with HER2-positive early breast cancer
Discussion on the Optimal Primary Breast Cancer Treatment. Breast Care 2019;14:103-10.[11] US Food and Drug Administration. Prescribing information for Phesgo. [Internet; cited June 2022]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf.[12] European Medicines Agency. Phesgo. [Internet; cited June 2022]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/phesgo.[13] World Health Organization. Cancer. [Internet; cited June 2022]. Available from: https://www.who.int/news-room/fact-sheets/detail/cancer.[14] Iqbal N, Iqbal N. Human Epidermal Growth Factor Receptor 2 (H...
Source: Roche Media News - July 14, 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
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 Media News - July 14, 2022 Category: Pharmaceuticals Source Type: news
New data from phase III HAVEN 6 study reinforce favourable safety and efficacy profile of Roche ’s Hemlibra in people with moderate or mild haemophilia A
Hemlibra continues to demonstrate clinically meaningful bleed control, with 66.7% of participants with moderate or mildhaemophilia A experiencing zero treated bleeds at 55.6 weeks median follow-up [1]New data also reinforceHemlibra ’sfavourable safety profile, with no new safety signals observed [1]There is limited information and treatment guidance on moderate and mildhaemophilia A, which can lead to delayed or missed diagnoses of bleeding episodes [2]Hemlibra is approved to treat people of all ages withhaemophilia A with factor VIII inhibitors in more than 110 countries and for people of all ages without factor VIII in...
Source: Roche Media News - July 11, 2022 Category: Pharmaceuticals Source Type: news
E.U. Mounts Urgent Call for COVID-19 Boosters as Cases Rise Again
European regulators are urging second booster doses of COVID-19 vaccines for people over 60 years old as cases and hospitalizations are again rising sharply.
Recommendations from the European Centre for Disease Prevention and Control and the European Medicines Agency also include people with medical conditions that put them at high risk of severe disease, both agencies said in a statement on Monday. Weekly case rates among people age 65 and over increased 32% in 22 of the 24 reporting countries in the week ending July 3 compared to the previous week, according to an ECDC statement.
The new recommendation follows guidance i...
Source: TIME: Health - July 11, 2022 Category: Consumer Health News Authors: Lyubov Pronina / Bloomberg Tags: Uncategorized biztech2030 bloomberg wire COVID-19 europe Londontime Source Type: news
