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Roche’s Prasinezumab Shows Promise in Phase IIb PADOVA Study for Early-Stage Parkinson’s Disease
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Swiss pharmaceutical giant Roche (SWX: ROG) has published results from the Phase IIb PADOVA study for its investigational monoclonal antibody, prasinezumab, in patients with early-stage Parkinson’s disease (PD). The study aimed to assess the drug’s impact on the primary endpoint of time to confirmed motor progression, with a hazard ratio…
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Roche’s cobas 6800/8800 Systems 2.0 Earn CE Certification, Set for US Market Entry
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Global healthcare company Roche (SWX: ROG) has announced that its state-of-the-art cobas 6800/8800 Systems 2.0 has received CE certification. This marks a significant advancement in the Swiss company’s polymerase chain reaction (PCR) technology. Optimizing Laboratory Efficiency with cobas 6800/8800 Systems 2.0The new cobas 6800/8800 Systems 2.0 update represents a major…
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AbbVie Acquires Roche’s Nimble Therapeutics to Boost Immunology Pipeline
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US pharmaceutical company AbbVie (NYSE: ABBV) has reached an agreement to acquire Swiss pharmaceutical giant Roche’s (SWX: ROG) peptide discovery spinout, Nimble Therapeutics, in a deal initially valued at USD 200 million in cash. This strategic acquisition is aimed at strengthening AbbVie’s immunology product pipeline. Acquisition Highlights and Nimble’s Lead…
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Roche’s Columvi Supplemental sBLA Accepted by FDA for Relapsed DLBCL Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that the US Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for its drug Columvi (glofitamab). Roche is seeking FDA approval for the use of Columvi in combination with gemcitabine and oxaliplatin (GemOx) for the…
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Roche’s Evrysdi Receives Patent Term Extension in China, Extending Protection to 2035
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The China National Intellectual Property Administration (CNIPA) has granted Swiss pharmaceutical giant Roche (SWX: ROG) a Patent Term Extension (PTE) for its drug Evrysdi (risdiplam), under patent NO. ZL201580027306.9. This marks the first case of its kind in China, where the SMN2 splicing modifier will now enjoy patent protection until…
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Roche’s SKYSCRAPER-01 Study: Tiragolumab-Tecentriq Combo Misses Primary Endpoint in NSCLC
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Swiss pharmaceutical giant Roche (SWX: ROG) has reported an update on the phase III SKYSCRAPER-01 study, which evaluated the combination of tiragolumab with Tecentriq (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC). SKYSCRAPER-01 Study Details and ResultsThe global, randomized, double-blind…
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Roche to Acquire Poseida Therapeutics in a USD 1.5 Billion Deal
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US-based clinical-stage biopharmaceutical company, Poseida Therapeutics (NASDAQ: PSTX), which specializes in donor-derived CAR-T cell therapies, has announced a definitive merger agreement with Roche (SWX: ROG). The deal, valued at a total equity value of USD 1.5 billion, is anticipated to close in the first quarter of 2025. Expanding Allogeneic Cell…
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Zymeworks and Jazz Pharmaceuticals’ Ziihera Gets Green Light for HER2+ BTC Treatment
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Partners Zymeworks Inc. (NASDAQ: ZYME) and Jazz Pharmaceuticals, Inc. have received accelerated approval from the US Food and Drug Administration (FDA) for Ziihera (zanidatamab), a treatment for adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC). This marks a significant advancement in the treatment options for…
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AbbVie’s Elahere Receives EC Approval for FRα-Positive Ovarian Cancer Treatment
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US-based AbbVie (NYSE: ABBV) has announced the European Commission (EC) approval for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This approval marks Elahere as the first and…
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Flare Therapeutics and Roche Enter Strategic Collaboration for Oncology Drug Discovery
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US-based Flare Therapeutics Inc., a clinical-stage biotech company specializing in cancer therapies through the use of transcription factors, has announced a strategic discovery collaboration agreement with Swiss pharmaceutical giant Roche (SWX: ROG). The partnership will utilize Flare Therapeutics’ expertise in proteomics and mass spectrometry, along with its proprietary library of…
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Roche to Showcase 40+ Abstracts on Blood Disorders at ASH Annual Meeting
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced plans to present over 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The presentations will feature data on approved medicines Polivy (polatuzumab vedotin), Lunsumio (mosunetuzumab), and Columvi (glofitamab), including long-term follow-up and…
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AstraZeneca’s China President Leon Wang Confirmed to Assist in Investigation Amid Fraud Allegations
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On October 29, 2024, just hours after celebrating a business school anniversary on social media, AstraZeneca’s (AZ, NASDAQ: AZN) Global Executive Vice President and China President, Leon Wang, was confirmed to be cooperating with an investigation. The announcement came less than 48 hours later via AstraZeneca China’s official website. On…
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AstraZeneca China President Leon Wang Involved in Chinese Investigation Amid Industry Probes
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Leon Wang, Executive Vice President International and AstraZeneca (AZ, NASDAQ: AZN) China President, is cooperating with an investigation by Chinese authorities, as stated by the UK pharmaceutical major. During this period, AstraZeneca China General Manager Lai Minglong will ensure business continuity. This development follows a series of media reports about…
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Roche’s Vabysmo Receives NMPA Approval for Macular Edema Treatments in China
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Roche (SWX: ROG), the Swiss pharmaceutical giant, has announced the receipt of another marketing approval from the National Medical Products Administration (NMPA) for its ophthalmology bispecific antibody (BsAb) Vabysmo (faricimab). The new indication is for macular edema secondary to central retinal vein occlusion (CRVO) or hemi-retinal vein occlusion (HRVO). Vabysmo,…
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Roche’s Genentech Scores FDA Approval for Itovebi in Advanced Breast Cancer Treatment, Advancing Personalized Oncology
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Roche (SWX: ROG)’s Genentech, a leader in pharmaceutical innovation, has received approval from the US Food and Drug Administration (FDA) for Itovebi (inavolisib), a potent PI3Kα inhibitor. This marks a significant advancement in the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative,…
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Roche’s VENTANA CLDN18 Assay Receives EU Approval, Enhances Targeted Therapy Options for Gastric Cancer
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Roche (SWX: ROG; OTCMKTS: RHHBY) has secured CE Mark approval in the European Union for its VENTANA CLDN18 (43-14A) RxDx Assay, marking a pivotal advancement in the treatment landscape for gastric cancer. This immunohistochemistry (IHC) companion diagnostic (CDx) test is the first to determine CLDN18 protein expression in tumors of…
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Regor Therapeutics Strikes Deal with Genentech for CDK Inhibitors, Fetching USD 850 Million Upfront
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Regor Therapeutics Group, a US-based biotech with significant ties to China, has entered into a licensing agreement with Genentech, a subsidiary of Swiss pharmaceutical giant Roche (SWX: ROG; OTCMKTS: RHHBY) . Under the agreement, Genentech will acquire the rights to develop, manufacture, and commercialize Regor’s next-generation CDK inhibitors, including the…
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Roche’s Xofluza Receives FDA Approval for Reducing Influenza Transmission in Phase III Study
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Roche (SWX: ROG; OTCMKTS: RHHBY) has announced that its antiviral drug Xofluza (baloxavir marboxil) has received approval from the US Food and Drug Administration (FDA) based on positive results from the Phase III CENTERSTONE study. The study demonstrated that a single dose of Xofluza significantly reduced the transmission of influenza…
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Roche’s Tecentriq Hybreza Becomes First Subcutaneous Anti-PD-(L)1 Immunotherapy in the US
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Roche (SWX: ROG; OTCMKTS: RHHBY) , a leading Swiss pharmaceutical company, has secured US Food and Drug Administration (FDA) approval for its subcutaneous formulation of the programmed death-ligand 1 (PD-L1) inhibitor, Tecentriq Hybreza (atezolizumab, hyaluronidase). This new formulation has been approved for all 12 adult indications of intravenous Tecentriq, covering…
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Roche’s Ocrevus Zunovo Receives FDA Nod as First Twice-Yearly MS Treatment
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Roche Group (SWX: ROG; OTCMKTS: RHHBY) , a Swiss pharmaceutical giant, has announced that the US Food and Drug Administration (FDA) has granted approval for Ocrevus Zunovo (ocrelizumab, hyaluronidase), marking a significant advancement in the treatment of multiple sclerosis (MS). This new formulation is the first and only twice-per-year treatment…
