-
Roche’s Piasky (Crovalimab) Secures NMPA Approval for Untreated Paroxysmal Nocturnal Hemoglobinuria
•
The National Medical Products Administration (NMPA) has granted marketing approval to Swiss pharmaceutical giant Roche (SWX: ROG) for Piasky (crovalimab) under priority review status. This approval is specifically for the treatment of adult and adolescent patients aged 12 and older with paroxysmal nocturnal hemoglobinuria who have not previously received treatment…
-
Roche Secures NMPA Approval for Rozlytrek to Treat Pediatric NTRK Fusion-Positive Tumors
•
Swiss pharmaceutical giant Roche (SWX: ROG) has received a new indication approval from the National Medical Products Administration (NMPA) for its drug Rozlytrek (entrectinib). The approval allows the treatment of pediatric patients aged at least one month with NTRK fusion-positive solid tumors. Entrectinib is a TRK/ROS1 tyrosine kinase inhibitor known…
-
Roche’s Faricimab Shows Sustained Vision Benefits in Phase III Study for Retinal Vein Occlusion
•
Swiss pharmaceutical giant Roche (SWX: ROG) has released interim Phase III data for its bispecific antibody (BsAb) Vabysmo (faricimab) in the treatment of macular edema resulting from branch and central retinal vein occlusion (BRVO and CRVO). The biologic demonstrated significant vision improvements, with gains of 17 to 19 letters on…
-
Roche Posts Modest 2023 Growth Amid Shifts in Demand for COVID-Related Products
•
Swiss pharmaceutical giant Roche (SWX: ROG) has published its 2023 financial results, showing a modest 1% year-on-year (YOY) increase in global sales at constant exchange rates (CER) to CHF 58.7 billion (USD 68.5 billion). This growth was primarily due to a 6% YOY expansion in the pharmaceutical business to CHF…
-
Roche’s Tecentriq in Combination with Exelixis’s Cabometyx Meets Primary Endpoint in mCRPC Phase III Study
•
Roche (SWX: ROG), the Swiss pharmaceutical giant, has announced positive results from a Phase III study showcasing the efficacy of its anti-PD-L1 drug Tecentriq (atezolizumab) in combination with Exelixis’s (NASDAQ: EXEL) tyrosine kinase inhibitor (TKI) Cabometyx (cabozantinib) for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The study focused on…
-
AstraZeneca’s Imfinzi Meets Primary Endpoint in Hepatocellular Carcinoma Trial
•
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced the successful completion of the primary endpoint in a Phase III trial for its anti-PD-L1 drug Imfinzi (durvalumab). The trial investigated the combination of Imfinzi with bevacizumab, originally developed by Roche (SWX: ROG) as Avastin, and transarterial chemoembolization (TACE) for embolization-eligible hepatocellular…
-
Roche’s Tecentriq SC Receives European Nod as First Subcutaneous PD-(L)1 Therapy
•
Halozyme Therapeutics (NASDAQ: HALO) has announced that the European Commission (EC) has granted marketing authorization to Roche (SWX: ROG) for its anti-PD-L1 drug Tecentriq SC (atezolizumab). This subcutaneous formulation utilizes Halozyme’s proprietary hyaluronidase Enhanze (rHuPH20) and is now approved for the same indications as the original intravenous version of Roche’s…
-
C4 Therapeutics Outlines 2024 Focus Amid 30% Workforce Reduction, Prioritizes Key Oncology Trials
•
C4 Therapeutics (NASDAQ: CCCC), a leader in protein degradation, announced this week its strategic focus for 2024, which includes a significant reduction of 30% in its workforce. The U.S.-based company will prioritize ongoing Phase I/II trials for CFT7455 and CFT1946, targeting relapsed/refractory multiple myeloma (r/rMM) and BRAF V600X-mutant solid tumors,…
-
Merck In-Licenses Inspirna’s Ompenaclid for Advanced Colorectal Cancer, Eyes Market Potential
•
Germany-based Merck (NYSE: MRK) has in-licensed the potential first-in-class candidate ompenaclid from U.S. firm Inspirna, aimed at inhibiting the creatine transport channel SLC6A8. The drug is currently undergoing Phase II trials for RAS-mutated advanced or metastatic colorectal cancer (mCRC). The agreement also encompasses additional follow-on compounds targeting SLC6A8. In return…
-
Roche’s Phesgo and Faricimab Receive NMPA Approvals for Breast Cancer and nAM
•
The National Medical Products Administration (NMPA) has granted separate approvals for two distinct drugs from Swiss pharmaceutical giant Roche (SWX: ROG). The first approval is for Phesgo (trastuzumab, pertuzumab), indicated for the treatment of HER2-positive early and metastatic breast cancer. The second approval is for faricimab, which targets neovascular age-related…
-
Roche to Expand Diagnostics Portfolio with Acquisition of LumiraDx Technology
•
Pharmaceutical giant Roche (SWX: ROG), based in Switzerland, has announced an agreement to acquire innovative diagnostic technology from UK-headquartered LumiraDx (OTCMKTS: LMDXF). The transaction, expected to close in mid-2024, involves an upfront payment of $295 million, complemented by up to an additional $55 million to support LumiraDx’s point-of-care business during…
-
Roche Secures Diagnostics Deal with LumiraDx for $295M
•
Switzerland’s pharmaceutical giant Roche (SWX: ROG) has sealed a deal to acquire innovative diagnostics technology from UK-based LumiraDx. The transaction, valued at $295 million, is anticipated to conclude in mid-2024, with an additional payment of up to $55 million to cover LumiraDx’s point-of-care business expenses until the deal’s closure. The…
-
Medilink Therapeutics Secures Multi-Billion Dollar Deal with Roche for c-MET Targeting ADC
•
Medilink Therapeutics, a Suzhou-based biopharmaceutical company, has entered into a global collaboration and licensing agreement with Swiss pharmaceutical giant Roche concerning YL211, an antibody drug conjugate (ADC) targeting c-Mesenchymal-epithelial transition factor (c-MET) for the development of a treatment for solid tumors. This agreement marks Medilink’s fifth out-license deal for ADC…
-
FDA Prioritizes Roche’s Xolair for Food Allergy Indication Extension Ahead of Q1 Decision
•
The U.S. Food and Drug Administration (FDA) has prioritized Roche’s (SWX: ROG) indication extension filing for Xolair (omalizumab), marking it as the first treatment in the U.S. aimed at reducing allergic reactions associated with accidental food exposure in patients with food allergies. The FDA granted biologic breakthrough therapy designation (BTD)…
-
Roche Diagnostics and Beijing Strong Biotechnologies Deepen Ties to Innovate in Hemostasis Diagnostics
•
Roche Diagnostics (SWX: ROG), the Swiss diagnostics heavyweight, has furthered its collaboration with Beijing Strong Biotechnologies Inc. (SHE: 300406), a Chinese partner, to craft more holistic and pioneering laboratory solutions for hemostasis and thrombotic disorders. Building on their initial partnership established in 2016, which focused on biochemical reagents and resulted…
-
Roche Receives NMPA Approval for Ophthalmology BsAb Vabysmo (Farcimab) for Diabetic Macular Edema
•
Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its ophthalmology bispecific antibody (BsAb) Vabysmo (faricimab), which is indicated for the treatment of diabetic macular edema (DME). Vabysmo targets both vascular endothelial growth factor A (VEGF-A) and…
-
Bio-Thera Secures FDA Approval for Avzivi, a Biosimilar to Roche’s Avastin
•
Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received market approval from the U.S. Food and Drug Administration (FDA) for Avzivi (bevacizumab), a biosimilar version of Roche’s (SWX: ROG) Avastin. The approved indications for Avzivi include non-small cell lung cancer (NSCLC), metastatic colorectal cancer (mCRC), glioblastoma (GBM), renal…
-
Roche Expands Beyond Oncology with USD 2.7 Billion Carmot Therapeutics Acquisition
•
Swiss pharmaceutical giant Roche (SWX: ROG) has entered into an agreement to acquire U.S. biotech firm Carmot Therapeutics, a specialist in anti-obesity and diabetes drugs, in a transaction valued at USD 2.7 billion with potential milestone payments of up to USD 400 million. The acquisition is expected to close in…
-
Roche’s Mosunetuzumab and AnHeart’s Taletrectinib Poised for Priority Review in China
•
The China Center for Drug Evaluation (CDE) website has indicated that Roche’s (SWX: ROG) Lunsumio (mosunetuzumab) and AnHeart Therapeutics’ taletrectinib are on track to receive priority review status. Mosunetuzumab, a bispecific antibody targeting CD20 and CD3, has already been approved for the treatment of adult recurrent refractory follicular lymphoma (FL)…
-
FDA Raises Concerns Over Research Conditions at Roche’s Genentech Trial Site
•
The US Food and Drug Administration (FDA) has voiced concerns regarding the research conditions at a clinical site involved in a Phase III trial evaluating Genentech’s antiviral Xofluza (baloxavir marboxil), a unit of Switzerland-based Roche (SWX: ROG), for the reduction of household transmission of influenza. While the concerns appear to…
