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Genentech and NVIDIA Collaborate to Advance Drug Discovery with AI
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Genentech, a subsidiary of Swiss pharmaceutical giant Roche (SWX: ROG), has entered into a collaboration agreement with semiconductor manufacturer NVIDIA (NASDAQ: NVDA) to expedite drug discovery and development. This partnership aims to harness the power of artificial intelligence (AI) by integrating Genentech’s biological and molecular datasets with NVIDIA’s advanced supercomputing…
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EMA’s CHMP Issues Positive Opinion for Roche’s Tecentriq SC Subcutaneous Formulation
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The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion regarding the approval of Tecentriq SC (atezolizumab), the subcutaneous version of Roche’s (SWX: ROG) PD-L1 inhibitor Tecentriq. This development is a significant step forward for patients with various types of…
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Roche’s Lymphoma Therapy Columvi Receives NMPA Approval for Adult Patients with Relapsed DLBCL
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its novel lymphoma therapy, Columvi (glofitamab). The drug is now approved to treat adult patients with recurrent or refractory diffuse large B-cell lymphoma (DLBCL) who have…
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Roche’s Gene Therapy Elevidys Misses Primary Endpoint in DMD Trial
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Switzerland-headquartered pharmaceutical giant Roche (SWX: ROG) has announced that a Phase III trial for its gene transfer therapy Elevidys (delandistrogene moxeparvovec) did not meet its primary endpoint in Duchenne muscular dystrophy (DMD) ambulatory patients aged 4 to 7 years. The trial aimed to measure the change from baseline in motor…
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CDE Grants Priority Review to LaNova’s LM-302, Roche’s Alectinib, and Alphamab’s KN026
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China’s Center for Drug Evaluation (CDE) has indicated that LaNova Medicines’ LM-302, Roche’s (SWX: ROG) alectinib, and Alphamab Oncology’s HER2-targeted bispecific antibody (BsAb) KN026 (anbenitamab) are set for priority reviews. This designation is a significant step that could expedite the availability of these drugs to patients in need. LM-302: A…
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Roche’s Vabysmo Receives FDA Approval for Macular Edema Treatment Following RVO
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Swiss pharmaceutical giant Roche (SWX: ROG) announced last week that it has received an indication extension approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Vabysmo (faricimab) to treat macular edema following retinal vein occlusion (RVO). This approval broadens the therapeutic applications of Vabysmo, which…
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Roche Agrees to Acquire Telavant for $7.1 Billion to Boost IBD Treatment Portfolio
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Switzerland-headquartered pharmaceutical giant Roche (SWX: ROG) announced this week an agreement to purchase Telavant Holdings, a biotechnology firm co-owned by UK’s Roivant Sciences (NASDAQ: ROIV) and US-based Pfizer (NYSE: PFE). The acquisition will grant Roche rights to RVT-3101, a potential best-in-class and first-in-class anti-TL1A subcutaneous antibody, in the US and…
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Roche’s Q3 2023 Report Shows 1% Global Growth Amid Lower COVID-19 Product Demand
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Swiss pharmaceutical giant Roche (SWX: ROG) released its Q3 2023 report, indicating that a reduced demand for COVID-19 products impacted global growth, resulting in a 1% year-on-year (YOY) increase at constant exchange rates over the first nine months, with total sales amounting to CHF 44.1 billion (USD 49.4 billion). Excluding…
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Alebund Pharmaceuticals Secures Exclusive Rights to Roche’s Mircera in China
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Shanghai-based Alebund Pharmaceuticals has entered into a commercialization agreement with Swiss pharmaceutical giant Roche (SWX: ROG), securing exclusive promotion rights to Mircera (methoxy polyethylene glycol-epoetin beta) in mainland China. The financial terms of the deal remain undisclosed, highlighting the strategic nature of the partnership without revealing specific monetary details. Mircera:…
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Roche’s Alecensa Shows Unprecedented 76% Improvement in Disease-Free Survival in NSCLC Trial
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Roche (SWX: ROG) subsidiary Genentech has revealed preliminary but promising results from a Phase III trial for Alecensa (alectinib) in patients with early-stage resected ALK-positive non-small cell lung cancer (NSCLC). The trial demonstrated that the ALK inhibitor significantly improved disease-free survival (DFS) by an unprecedented 76% compared to chemotherapy, meeting…
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Roche’s Ocrevus Demonstrates Long-Term Efficacy in Multiple Sclerosis Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG) has presented compelling long-term efficacy data for its selective immunosuppressant Ocrevus (ocrelizumab) in the treatment of multiple sclerosis (MS). The 10-year results from a Phase III extension study provide significant insights into the drug’s sustained impact on patients with relapsing and primary progressive forms…
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Roche’s Forimtamig Receives Tacit Approval for Multiple Myeloma Clinical Trials
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The Center for Drug Evaluation (CDE) has indicated that Swiss pharmaceutical giant Roche (SWX: ROG) has secured tacit clinical trial approval for its Category 1 biologic product, forimtamig (RG6234), in the treatment of multiple myeloma (MM). Promising Efficacy in Phase I Trials Forimtamig is a bispecific antibody (BsAb) designed to…
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Bio-Thera Solutions’ BAT1806 Receives US FDA Approval as Biosimilar to Actemra/RoActemra
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Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, announced that its biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab), known as BAT1806, has passed review by the US FDA. This milestone marks the approval of BAT1806 for use in the US market to treat a range of…
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Roche Secures Global Rights to Ionis Pharmaceuticals’ Alzheimer’s and Huntington’s Disease Candidates
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced the acquisition of global rights to develop, manufacture, and commercialize two early-stage drug candidates for Alzheimer’s disease (AD) and Huntington’s disease (HD) from Ionis Pharmaceuticals (NASDAQ: IONS). This strategic move is set to bolster Roche’s pipeline in central nervous system (CNS) disorders…
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Roche’s Genentech Partners with Orionis Biosciences for Molecular Glue Therapies
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Genentech, a subsidiary of Swiss pharmaceutical giant Roche (SWX: ROG), has announced a partnership with Belgium-based Orionis Biosciences to discover molecular glue-class small-molecule treatments in oncology and neurodegeneration. This strategic collaboration aims to leverage Orionis’s proprietary platform for high-throughput discovery, rational design, and optimization of candidates that modulate intermolecular interactions,…
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Roche’s Genentech Partners with Peptidream for First-in-Class PDCs in Radioisotope Therapy
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Swiss pharmaceutical giant Roche’s subsidiary, Genentech (SWX: ROG), has announced a partnership with Japan’s peptide-based therapeutics and diagnostics specialist, Peptidream (TYO: 4587). The collaboration aims to discover and develop potential first-in-class peptide-drug conjugates (PDCs) for the targeted delivery of radioisotopes against specific disease targets. Details of the PartnershipUnder the terms…
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Roche and Alnylam’s Zilebesiran Achieves Primary Endpoint in Hypertension Phase II Trial
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Roche (SWX: ROG) and Alnylam (NASDAQ: ALNY) have announced that a Phase II trial for their RNAi therapeutic, zilebesiran, has successfully met its primary endpoint of significantly reducing 24-hour mean systolic blood pressure (SBP) at month three in patients with mild-to-moderate hypertension. The results also demonstrated reductions in SBP and…
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Genentech Files for FDA Approval of Crovalimab for PNH, Challenging Soliris
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Swiss pharmaceutical giant Roche’s subsidiary, Genentech (SWX: ROG), has submitted its anti-C5 investigational drug, crovalimab, to the US Food and Drug Administration (FDA) for the treatment of the rare disease paroxysmal nocturnal hemoglobinuria (PNH). The filing is bolstered by Phase III clinical data that demonstrates crovalimab’s non-inferiority and a similar…
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Roche’s Alecensa Achieves Milestone in Adjuvant Therapy Trial for Early-Stage NSCLC
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Switzerland-based pharmaceutical giant Roche (SWX: ROG) has released an update from an interim analysis of a late-stage trial for its ALK inhibitor Alecensa (alectinib) as adjuvant therapy in the early setting for resected non-small cell lung cancer (NSCLC) with ALK mutations. These mutations are present in approximately 5% of NSCLC…
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Roche’s Evrysdi Receives EC Approval for Expanded Indication in Infants with SMA
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Swiss pharmaceutical giant Roche (SWX: ROG) has received regulatory approval from the European Commission (EC) for an indication extension of its SMN2 splicing modifier Evrysdi (risdiplam). The drug is now approved for infants up to 2 months of age with a clinical diagnosis of spinal muscular atrophy (SMA) type 1,…
