Specialty Pharma Journal Specialty, Precision & Technology
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the Phase III KATHERINE study met its primary endpoint, showing Kadcyla® (ado-trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival; iDFS) by 50 percent …
Tag Archives: genentech
December, 2018
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5 December
FDA Grants Priority Review to Genentech’s Tecentriq in Combination with Chemotherapy for Initial Treatment of Extensive-Stage Small Cell Lung Cancer
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the …
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5 December
Genentech’s Hemlibra Provided Sustained Bleed Control in the Largest Pivotal Study to Date of Children With Hemophilia A With Factor VIII Inhibitors
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today data from the primary analysis of the Phase III HAVEN 2 study evaluating Hemlibra® (emicizumab-kxwh) prophylaxis in children younger than 12 years of age with hemophilia A with factor VIII inhibitors, including longer …
November, 2018
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28 November
Genentech Gains Rights to Portfolio of NLRP3 Inhibitors through Acquisition of Jecure Therapeutics
SAN DIEGO–(BUSINESS WIRE)–Jecure Therapeutics Inc., a biotechnology company with novel drug discovery programs targeting serious inflammatory diseases, today announced a definitive agreement by which it will be acquired by Genentech, a member of the Roche Group. With this acquisition, Genentech will obtain full rights to Jecure’s entire preclinical portfolio of …
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28 November
FDA Approves ACTPen for Genentech’s Actemra, a Single-Dose, Prefilled Autoinjector for Treatment of RA, GCA and Two Forms of Juvenile Arthritis
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved ACTPen™ 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra® (tocilizumab) as an additional formulation for adult patients with moderate to severe active …
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21 November
FDA Grants Accelerated Approval to Venclexta for Newly-Diagnosed Acute Myeloid Leukemia or Patients Ineligible for Intensive Induction Chemo
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Venclexta® (venetoclax), in combination with a hypomethylating agent (azacitidine or decitabine), or low-dose cytarabine (LDAC), for the treatment of people …
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20 November
Genentech to Pay $100 Million to Immunocore to Co-Develop Investigational Drug Targeting Tumors Expressing MAGE-A4
(Oxford, UK and Conshohocken, US, 19 November 2018) Immunocore Limited, a leading T Cell Receptor (TCR) biotechnology company focused on delivering first-in-class biological therapies that have the potential to transform lives of people with serious diseases, today announces it has entered into a new partnership with Genentech, a member of …
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14 November
FDA Grants Priority Review to Genentech’s Tecentriq in Combination with Abraxane for PD-L1-Positive Metastatic TNBC
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) for the initial (first-line) treatment of …
October, 2018
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30 October
New Stairway Study Data Shows Potential for Extended Durability with Faricimab in Wet Age-Related Macular Degeneration
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase II STAIRWAY study which explored the extended durability of faricimab (RG7716) in the treatment of wet age-related macular degeneration (AMD), a leading cause of blindness in people …
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24 October
Genentech’s Tecentriq Plus Chemotherapy as Initial Treatment Helped Advanced Non-Squamous NSCLC Patients Live Significantly Longer than Chemotherapy Alone
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase III IMpower130 study of Tecentriq® (atezolizumab) plus chemotherapy (carboplatin and Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) for the initial (first-line) treatment of people with previously untreated metastatic non-squamous non-small cell lung cancer …