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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 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,…
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MSD’s Keytruda Gains EC Approval for First-Line HER2-Positive Gastric Cancer Treatment
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The European Commission (EC) has granted an additional indication to Merck, Sharp & Dohme (MSD; NYSE: MRK) for its blockbuster drug Keytruda (pembrolizumab). The drug is now approved in combination with trastuzumab, originator Roche’s (SWX: ROG) Herceptin, and chemotherapy as a first-line therapy against locally advanced unresectable or metastatic HER2-positive…
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Roche Subsidiary Genentech Addresses Accidental Disclosure of Tiragolumab Trial Data
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Swiss pharmaceutical major Roche (SWX: ROG), through its subsidiary Genentech, has released a statement addressing an accidental disclosure of the second interim analysis from an ongoing Phase III study. The study involves the anti-TIGIT biologic tiragolumab, used with and without the PD-L1 inhibitor Tecentriq (atezolizumab), for patients with PD-L1-high locally…
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GC Biopharma Presents Data Showing Higher Thrombotic Risk with Roche’s Hemlibra
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South Korea’s GC Biopharma (KRX: 006280) has presented evidence suggesting that Roche’s (SWX: ROG) hemophilia therapy, Hemlibra (emicizumab), may display a higher proportion of thrombotic adverse events (AEs) compared to coagulation factor VIII replacements. This finding is based on an analysis of US data reported to the FDA Adverse Event…
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Seagen’s Tukysa Meets Primary Endpoint in Phase III Study for HER2+ Breast Cancer
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Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), has announced an update on an ongoing Phase III oncology study involving a combination therapy that includes the HER2 inhibitor Tukysa (tucatinib), one of Seagen’s four marketed drugs that attracted Pfizer’s interest. The trial successfully met…
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Sino Biopharmaceutical Receives NMPA Approval for Biosimilar Herceptin for HER2+ Cancers
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of Swiss giant Roche’s (SWX: ROG) Herceptin (trastuzumab). This biosimilar drug is intended to treat human epidermal growth factor receptor 2 (HER2) positive early breast cancer,…
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Roche Group’s H1 2023 Financial Report: Pharmaceuticals Grow While Diagnostics Dip
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Swiss pharmaceutical giant Roche Group (SWX: ROG) has released its half-yearly financial report for 2023, showing a -2% year-on-year (YOY) decline in group sales to CHF 29.8 billion (USD 34.5 billion) in constant exchange rate terms. Within the group, Pharmaceuticals saw an 8% YOY increase to CHF 22.7 billion (USD…
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Roche and Alnylam Partner on RNAi Therapeutic Zilebesiran for Hypertension Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG) has signed a deal with US-based RNAi specialist Alnylam (NASDAQ: ALNY), securing rights to co-develop and co-commercialize Alnylam’s zilebesiran, a Phase II stage RNAi therapeutic targeting angiotensinogen (AGT) for the treatment of hypertension. Financial Terms and Collaboration DetailsUnder the agreement, Roche will pay Alnylam…
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Jiangxi Jemincare Group Launches Omalizumab Biosimilar CMAB007 in China for Asthma and Dermatology
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Jiangxi Jemincare Group has overseen the official launch and first prescription of its omalizumab biosimilar, CMAB007, a version of Roche/Genentech’s (SWX: ROG) anti-IgE dermatology and asthma therapy Xolair, in Beijing. The drug’s launch comes less than two months after it received market approval. Therapeutic Applications of OmalizumabOmalizumab is utilized to…
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Biomm Secures Late-Stage Biosimilar Candidate BAT2206 from Bio-Thera Solutions
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Brazil-based biotechnology company Biomm (BVMF: BIOM3) has announced that it has in-licensed the late-stage biosimilar candidate BAT2206 from China’s Bio-Thera Solutions (SHA: 688177). This biosimilar candidate references Johnson & Johnson’s (J&J; NYSE: JNJ) subsidiary Janssen’s immunosuppressant Stelara (ustekinumab). The agreement builds upon a previous licensing and supply deal from 2020…
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Mega Lifesciences Secures Exclusive Rights for Bio-Thera’s Bevacizumab Biosimilar in Indonesia
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Thailand-based Mega Lifesciences (BKK: MEGA) has announced an in-licensing agreement with China-based Bio-Thera Solutions (SHA: 688177) for bevacizumab (BAT1706), a biosimilar version of Roche’s (SWX: ROG) Avastin (bevacizumab). According to the agreement, Mega Lifesciences obtains exclusive distribution and marketing rights to the product in Indonesia, while Bio-Thera will handle the…
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Roche’s Evrysdi Receives NMPA Approval for Wider SMA Patient Age Range
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that its blockbuster nervous system drug Evrysdi (risdiplam) has received market approval from the National Medical Products Administration (NMPA) to treat spinal muscular atrophy (SMA) in patients aged 16 days and above. This marks an expansion of the drug’s indication in China,…
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BioRay Pharmaceutical’s Zuberitamab Approved by NMPA for CD20 Positive DLBCL Treatment
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BioRay Pharmaceutical Co., Ltd has announced that its drug zuberitamab has been approved by the National Medical Products Administration (NMPA) to treat CD20 positive diffuse large B-cell lymphoma, non-specific (DLBCL, NOS) in adults. The approval is for the use of zuberitamab in combination with standard cyclophosphamide, doxorubicin, vincristine, and prednisone…
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Zion Pharma’s ZN-A-1041 Acquired by Roche for Global Development and Commercialization
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China-based Zion Pharma Ltd, a biotechnology company specializing in the development of brain-penetrable compounds, has announced that Roche (SWX: ROG) has acquired the global rights to Zion’s lead program, ZN-A-1041. This orally administered selective tyrosine kinase inhibitor (TKI) targets the human epidermal growth factor receptor 2 (HER2) and is designed…
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Hasten Biopharm Acquires Commercial Rights to Rocephin in China from Roche
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China-based Hasten Biopharmaceutical Co., Ltd has announced the acquisition of the commercial rights in China to Rocephin, a long-acting, broad-spectrum cephalosporin antibiotic, from Swiss pharmaceutical giant Roche (SWX: ROG). This strategic move expands Hasten’s product offerings and strengthens its position in the Chinese market. Comprehensive Agreement Includes Marketing Authorization and…
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Roche’s Q1 2023 Report: 3% Dip in Revenues with Strong Growth in Pharmaceuticals
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Roche (SWX: ROG), the Swiss pharmaceutical and diagnostics giant, reported a 3% year-on-year (YOY) decrease in turnover at constant exchange rates (CER) to CHF 15.3 billion (USD 17.2 billion) in its Q1 2023 report. The decline was attributed to the appreciation of the Swiss franc and a predicted drop in…
