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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

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 Investor Update - July 11, 2022 Category: Pharmaceuticals Source Type: news

Omicron-Specific COVID Shots Could Raise Protection as Boosters Omicron-Specific COVID Shots Could Raise Protection as Boosters
Coronavirus vaccines tweaked to include the Omicron variant strain can improve protection when used as a booster, the European Medicines Agency and other global health regulators said.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 7, 2022 Category: Consumer Health News Tags: Infectious Diseases News Source Type: news

Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Talquetamab for the Treatment of Relapsed or Refractory Multiple Myeloma
June 29, 2022 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for talquetamab for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Talquetamab is an investigational, off-the-shelf, T-cell redirecting bispecific antibody targeting both GPRC5D, a novel drug target, on multiple myeloma cells and CD3 o...
Source: Johnson and Johnson - June 29, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

EU regulator considers clearing smallpox shot for monkeypox
The European Medicines Agency says it will begin reviewing data to decide if a smallpox vaccine made by the pharmaceutical company Bavarian Nordic might also be authorized for monkeypox, amid a growing outbreak of the disease across the continent (Source: ABC News: Health)
Source: ABC News: Health - June 28, 2022 Category: Consumer Health News Tags: Health Source Type: news

European Medicines Agency recommends authorisation of Nuvaxovid Covid-19 vaccine for adolescents aged 12 to 17
The European CHMP has recommended an extension of indication to include use in adolescents aged 12-17 years (currently approved in adults only). This is based on a study which showed the immune response in this age group was comparable to that seen in 18-25 year olds. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - June 27, 2022 Category: Consumer Health News Source Type: news

Janssen Receives Positive CHMP Opinion for IMBRUVICA ® (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)
BEERSE, BELGIUM, June 24, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of a new treatment option with IMBRUVICA® (ibrutinib) in an oral fixed-duration combination with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukaemia (CLL). Outcomes for patients with CLL have improved in the last decade with the advent of oral therapies that target the underlying disease biology.[1] This provides the opportunity...
Source: Johnson and Johnson - June 24, 2022 Category: Pharmaceuticals Source Type: news

EU regulator authorizes COVID shot made by France's Valneva
The European Medicines Agency says it is recommending the authorization of the coronavirus vaccine made by French pharmaceutical Valneva, making it the sixth shot to be given the green light in Europe (Source: ABC News: Health)
Source: ABC News: Health - June 23, 2022 Category: Consumer Health News Tags: Health Source Type: news

European Medicines Agency starts rolling review for adapted Comirnaty COVID-19 vaccine, EMA (published 15th June 2022)
This version of Comirnaty has been adapted to provide better protection against a specific variant/variants of SARS-CoV-2. Review will initially focus on chemistry, manufacturing& control,& then immune response& efficacy against Omicron subvariants as development progresses. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - June 17, 2022 Category: Consumer Health News Source Type: news

New Cancer Drugs Approved Faster in U.S. Than Europe
FDA received licensing applications sooner and had shorter review times, compared to the European Medicines Agency (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - June 14, 2022 Category: Cancer & Oncology Tags: Oncology, Pharmacy, Journal, Source Type: news

Janssen Presents Updated Data at EHA for Teclistamab in Patients with Relapsed or Refractory Multiple Myeloma
June 10, 2022 (VIENNA) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated efficacy and safety results from the teclistamab cohort of the Phase 1b TriMM-2 study (NCT04108195). Teclistamab, an investigational, off-the-shelf, T-cell redirecting bispecific antibody targeting B-cell maturation antigen (BCMA) is being studied in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in patients with relapsed or refractory multiple myeloma (RRMM) who have received three or more prior lines of therapy.1 Patients in the study, including a high proportion with prior anti-CD38 exposur...
Source: Johnson and Johnson - June 10, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news