Tag Archives: Levi Garraway

Roche’s Xolair Nears FDA Approval for Reducing Allergic Reactions to Multiple Foods

(IN BRIEF) Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) under Priority Review. The sBLA is for the reduction of allergic reactions, including anaphylaxis, caused by … Read the full press release

Roche Presents Promising Data on Innovative Lymphoma Treatments at ASH Annual Meeting

(IN BRIEF) Roche, a global pharmaceutical company, has shared compelling data from its CD20xCD3 T-cell engaging bispecific antibody program during the 65th American Society of Hematology (ASH) Annual Meeting & Exposition held in December 2023. The data includes extended follow-up … Read the full press release

Roche’s Kadcyla Demonstrates Long-Term Survival Benefit in HER2-Positive Early Breast Cancer

(IN BRIEF) Roche has released positive long-term follow-up data from the Phase III KATHERINE study, evaluating Kadcyla® (trastuzumab emtansine) as adjuvant therapy for people with HER2-positive early-stage breast cancer (eBC) who have residual invasive disease following neoadjuvant treatment. The study … Read the full press release

Roche to Acquire Carmot Therapeutics for USD 2.7 Billion, Expanding Its Portfolio in Obesity Treatment

(IN BRIEF) Roche, a leading pharmaceutical company, has announced its definitive merger agreement to acquire Carmot Therapeutics, a privately owned US-based company specializing in obesity treatment and related metabolic diseases. The acquisition includes Carmot’s portfolio of clinical stage subcutaneous and … Read the full press release

Roche’s OCREVUS Subcutaneous Injection Shows Promise in Phase III Study for Multiple Sclerosis Treatment

(IN BRIEF) Roche has announced positive late-breaking data from the Phase III OCARINA II study, which demonstrates the effectiveness of OCREVUS as a twice-yearly, 10-minute subcutaneous injection for patients with relapsing or primary progressive multiple sclerosis (RMS or PPMS). The … Read the full press release

Roche’s Evrysdi Shows Promise in Pre-Symptomatic SMA Babies, Potentially Changing the Course of the Disease

(IN BRIEF) Roche has reported positive outcomes from the RAINBOWFISH study, an investigation into the efficacy and safety of Evrysdi® (risdiplam) in babies with pre-symptomatic spinal muscular atrophy (SMA). The study, which included 26 infants aged from birth to six … Read the full press release

Roche’s Xofluza: The Breakthrough Influenza Drug Approved for Children in Europe

(PRESS RELEASE) BASEL, 12-Jan-2023 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY), a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives, has announced that the European Commission has approved Xofluza (baloxavir marboxil), a … Read the full press release

Roche’s announces favourable safety profile and effective bleed control for its Hemlibra in people with moderate or mild haemophilia A without factor VIII inhibitors

People with moderate or mild haemophilia A have significant unmet clinical needs, as this population may not use preventative treatments due to missed or delayed diagnoses of bleeding episodes and a lack of treatment guidelines1,2 New data indicate that Hemlibra has a favourable safety profile in … Read the full press release

Spinal muscular atrophy: New data for Evrysdi will be presented by Roche at the World Muscle Society (WMS) Virtual Congress 20 – 24 September 2021

New data show pre-symptomatic babies with spinal muscular atrophy (SMA) treated with Evrysdi maintained the ability to swallow Evrysdi has demonstrated consistent clinically meaningful efficacy in adults, children, and babies two months and older and is now approved in 58 countries worldwide Further … Read the full press release

Roche on Tecentriq’s US FDA Priority Review grant: New treatment options are urgently needed in early-stage non-small cell lung cancer

Application is being reviewed under the US FDA’s Real-Time Oncology Review pilot programme Based on results of the Phase III IMpower010 study, presented at ASCO, that showed adjuvant Tecentriq improved disease-free survival by more than one-third in PD-L1-positive early-stage lung cancer, compared with … Read the full press release