CHMP recommends Bayer ’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended darolutamide, an oral androgen receptor inhibitor (ARi), plus ADT in combination with docetaxel for marketing authorization in the European Union (EU) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). (Source: World Pharma News)
Source: World Pharma News - January 30, 2023 Category: Pharmaceuticals Tags: Featured Bayer Business and Industry Source Type: news

EMA: No Bivalent-Stroke Link; Presley's Cause of Death 'Deferred'; Handshakes Return
(MedPage Today) -- Note that some links may require subscriptions. The European Medicines Agency said it has not seen any signal of a possible stroke risk related to the Pfizer-BioNTech bivalent COVID-19 vaccine. (Reuters) Funds from pandemic... (Source: MedPage Today Infectious Disease)
Source: MedPage Today Infectious Disease - January 19, 2023 Category: Infectious Diseases Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche ’s Tecentriq plus Avastin is the first treatment combination to reduce the risk of cancer returning in people with certain types of early-stage liver cancer in a Phase III trial
Pivotal Phase III IMbrave050 study investigatingTecentriq plusAvastin in people with early-stage hepatocellular carcinoma (HCC) at high risk of recurrence following surgery met primary endpoint of recurrence-free survivalNew adjuvant treatments are urgently needed as an estimated 70-80% of people with early-stage HCC experience disease recurrence following surgery1Data will be discussed with health authorities globally, including the US Food and Drug Administration and the European Medicines Agency to inform the next regulatory steps, and presented at an upcoming medical meetingBasel, 19 January 2023 - Roche (SIX: RO, ROG;...
Source: Roche Investor Update - January 19, 2023 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche ’s Tecentriq plus Avastin is the first treatment combination to reduce the risk of cancer returning in people with certain types of early-stage liver cancer in a Phase III trial
Pivotal Phase III IMbrave050 study investigatingTecentriq plusAvastin in people with early-stage hepatocellular carcinoma (HCC) at high risk of recurrence following surgery met primary endpoint of recurrence-free survivalNew adjuvant treatments are urgently needed as an estimated 70-80% of people with early-stage HCC experience disease recurrence following surgery1Data will be discussed with health authorities globally, including the US Food and Drug Administration and the European Medicines Agency to inform the next regulatory steps, and presented at an upcoming medical meetingBasel, 19 January 2023 - Roche (SIX: RO, ROG;...
Source: Roche Media News - January 19, 2023 Category: Pharmaceuticals Source Type: news

EMA Seeks to Issue Guidance on Liver Damage From Gene Therapy EMA Seeks to Issue Guidance on Liver Damage From Gene Therapy
The European Medicines Agency said it plans to issue advice for physicians using Novartis AG ' s Zolgensma, calling on them to monitor patients for any liver injury after treatment.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 13, 2023 Category: Consumer Health News Tags: Gastroenterology News Source Type: news

Roche announces the European Commission approval of Xofluza for the treatment and prevention of influenza in children aged one year and above
Xofluza is now approved in the EU for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza in children aged one year and above, and in adolescents and adultsXofluza is the first influenza antiviral with a new mechanism of action in almost 20 years, stopping viral replication faster thanoseltamivirSingle-doseXofluza helps reduce the societal burden of influenza by helping patients recover quickly and by preventing infection in individuals following contact with someone with the virusBasel, 12 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC...
Source: Roche Investor Update - January 12, 2023 Category: Pharmaceuticals Source Type: news

Roche announces the European Commission approval of Xofluza for the treatment and prevention of influenza in children aged one year and above
Xofluza is now approved in the EU for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza in children aged one year and above, and in adolescents and adultsXofluza is the first influenza antiviral with a new mechanism of action in almost 20 years, stopping viral replication faster thanoseltamivirSingle-doseXofluza helps reduce the societal burden of influenza by helping patients recover quickly and by preventing infection in individuals following contact with someone with the virusBasel, 12 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC...
Source: Roche Media News - January 12, 2023 Category: Pharmaceuticals Source Type: news

FDA grants priority review to Roche ’s bispecific antibody glofitamab for people with relapsed or refractory large B-cell lymphoma
If approved,glofitamab would be the first fixed-duration CD20xCD3 T-cell engaging bispecific antibody approved to treat the most aggressive type of non-Hodgkin lymphomaResults from the pivotal phase I/II NP30179 study showedglofitamab induced durable response rates in people with heavily pre-treated large B-cell lymphoma, with 40% achieving a complete responseGlofitamab is part of Roche ’s industry-leading portfolio of T-cell engaging bispecific antibodies, which also includes the newly FDA-approved first-in-classLunsumio to treat follicular lymphomaBasel, 6 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announc...
Source: Roche Investor Update - January 6, 2023 Category: Pharmaceuticals Source Type: news

FDA grants priority review to Roche ’s bispecific antibody glofitamab for people with relapsed or refractory large B-cell lymphoma
If approved,glofitamab would be the first fixed-duration CD20xCD3 T-cell engaging bispecific antibody approved to treat the most aggressive type of non-Hodgkin lymphomaResults from the pivotal phase I/II NP30179 study showedglofitamab induced durable response rates in people with heavily pre-treated large B-cell lymphoma, with 40% achieving a complete responseGlofitamab is part of Roche ’s industry-leading portfolio of T-cell engaging bispecific antibodies, which also includes the newly FDA-approved first-in-classLunsumio to treat follicular lymphomaBasel, 6 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announc...
Source: Roche Media News - January 6, 2023 Category: Pharmaceuticals Source Type: news

Pfizer announces FDA and EMA acceptance of etrasimod regulatory submissions for ulcerative colitis
Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for etrasimod for individuals living with moderately-to-severely active ulcerative colitis (UC). The FDA's decision is expected in the second half of 2023. The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for etrasimod in the same patient population with the decision anticipated in the first half of 2024. (Source: World Pharma News)
Source: World Pharma News - December 26, 2022 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

CHMP recommends expansion of EU label for Hemlibra to include people with moderate haemophilia A
Thepositive CHMP opinion is based on the results of the HAVEN 6 study, which demonstrated effective bleed control and afavourable safety profile ofHemlibra in people with moderatehaemophilia A without inhibitors1Given that many people with moderatehaemophilia A may not receive prophylaxis, they may endure a worsened clinical burden with only 15% living a bleed-free life2If approved,Hemlibra, already approved for severehaemophilia A in the EU, will offer an effective and convenient prophylactic treatment option with afavourable safety profile for people with moderatehaemophilia ABasel, 16 December 2022 - Roche (SIX: RO, ROG...
Source: Roche Media News - December 16, 2022 Category: Pharmaceuticals Source Type: news

CHMP recommends expansion of EU label for Hemlibra to include people with moderate haemophilia A
Thepositive CHMP opinion is based on the results of the HAVEN 6 study, which demonstrated effective bleed control and afavourable safety profile ofHemlibra in people with moderatehaemophilia A without inhibitors1Given that many people with moderatehaemophilia A may not receive prophylaxis, they may endure a worsened clinical burden with only 15% living a bleed-free life2If approved,Hemlibra, already approved for severehaemophilia A in the EU, will offer an effective and convenient prophylactic treatment option with afavourable safety profile for people with moderatehaemophilia ABasel, 16 December 2022 - Roche (SIX: RO, ROG...
Source: Roche Investor Update - December 16, 2022 Category: Pharmaceuticals Source Type: news

Roche presents new data demonstrating the potential benefit of glofitamab and Lunsumio as fixed-duration, off-the-shelf treatment options for lymphoma
Data showcase the potential ofglofitamab andLunsumio to address diverse patient needsData presented at ASH 2022 andsimultaneouslypublished in theNew England Journal of Medicine showed thatglofitamab, given as a fixed course, induced early and durable responses in people with heavily pre-treated large B-cell lymphoma1,227-month follow-up data showedLunsumio continued to induce high and durable responses in people with relapsed or refractory follicular lymphoma, with 60% experiencing a complete response3Basel, 12 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that updated clinical data for its CD20xCD3 T-...
Source: Roche Investor Update - December 12, 2022 Category: Pharmaceuticals Source Type: news

Roche presents new data demonstrating the potential benefit of glofitamab and Lunsumio as fixed-duration, off-the-shelf treatment options for lymphoma
Data showcase the potential ofglofitamab andLunsumio to address diverse patient needsData presented at ASH 2022 andsimultaneouslypublished in theNew England Journal of Medicine showed thatglofitamab, given as a fixed course, induced early and durable responses in people with heavily pre-treated large B-cell lymphoma1,227-month follow-up data showedLunsumio continued to induce high and durable responses in people with relapsed or refractory follicular lymphoma, with 60% experiencing a complete response3Basel, 12 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that updated clinical data for its CD20xCD3 T-...
Source: Roche Media News - December 12, 2022 Category: Pharmaceuticals Source Type: news

Sanofi and GSK's next-generation COVID-19 booster vaccine VidPrevtyn ® Beta approved by the European Commission
After the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for VidPrevtyn® Beta, the vaccine was approved by the European Commission, as a booster for the prevention of COVID-19 in adults 18 years of age and older. (Source: World Pharma News)
Source: World Pharma News - November 15, 2022 Category: Pharmaceuticals Tags: Featured Sanofi Business and Industry Source Type: news