Genentech

Genentech Presents Results of Two-Year Data for Evrysdi (risdiplam) in Infants with Type 1 SMA at AAN2021

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Shots: The 2-year data from Part 2 of P-II/III FIREFISH study involves assessing Evrysdi in 41 infants aged 1-7mos. with symptomatic Type 1 SMA Results: improvement in maintained motor function b/w 12-24mos., babies were able to sit without support for at least 5sec. after 24mos.… Read More »Genentech Presents Results of Two-Year Data for Evrysdi (risdiplam) in Infants with Type 1 SMA at AAN2021

Roche’s Actemra/RoActemra (tocilizumab) Receives the US FDA’s Approval as the First Biologic for Systemic Sclerosis-Associated Interstitial Lung Disease

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Shots: The approval is based on P-III focuSSced trial assessing Actemra (SC, 162mg) vs PBO in a ratio (1:1) in 212 adults with SSc. The data from P-I/II fascinate study also supported the approval The P-III study did not meet its 1EPs i.e. change from… Read More »Roche’s Actemra/RoActemra (tocilizumab) Receives the US FDA’s Approval as the First Biologic for Systemic Sclerosis-Associated Interstitial Lung Disease

Genentech Signs an Exclusive License Agreement with X-Chem to Discover Oncology Targets

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Shots: X-Chem to receive an up front and is eligible to receive research, development and regulatory milestone along with royalties on sales of therapies resulting from the collaboration Genentech will lead further development and commercialization of any potential new therapies and retain exclusive rights to… Read More »Genentech Signs an Exclusive License Agreement with X-Chem to Discover Oncology Targets

Genentech Signs ~$1B Pact with Ribometrix to Develop RNA-Targeted Small Molecule Therapies

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Shots: Ribometrix to receive $25M up front, ~$1B+ as milestones along with royalties on sales of therapies emerges from the collaboration The companies collaborated on the discovery & preclinical development of programs. Genentech will lead further development and commercialization and will have exclusive rights to… Read More »Genentech Signs ~$1B Pact with Ribometrix to Develop RNA-Targeted Small Molecule Therapies

ViewPoints Interview: Genentech’s Ted Omachi Shares Insight on the US FDA’s Approval of Xolair in Nasal polyps

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In a recent interview with PharmaShots, Ted Omachi, Global Development Leader for Xolair, and Senior Medical Director of Product Development for Immunology, Genentech shared his views on the approval of Xolair in the US. Shots: The approval is based on P-III POLYP 1 & 2… Read More »ViewPoints Interview: Genentech’s Ted Omachi Shares Insight on the US FDA’s Approval of Xolair in Nasal polyps

Genentech’s Tiragolumab + Tecentriq Receive the US FDA’s Breakthrough Therapy Designation for PD-L1-High Non-Small Cell Lung Cancer

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Shots: The BTD is based on P-II CITYSCAPE study assessing Tiragolumab + Tecentriq vs Tecentriq + PBO as a 1L treatment of 135 patients in a ratio (1:1) with LA unresectable metastatic NSCLC whose tumors have high PD-L1 expression with no EGFR Result: improvement in… Read More »Genentech’s Tiragolumab + Tecentriq Receive the US FDA’s Breakthrough Therapy Designation for PD-L1-High Non-Small Cell Lung Cancer

Genentech Signs a Worldwide License Agreement with Relay Therapeutics to Develop and Commercialize RLY-1971

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Shots: Relay to receive $75M as upfront, $25M in additional near-term payments, and has the right to opt for 50/50 profit/cost-sharing on RLY-1971 in the US. If Relay exercises the option, it will be eligible to receive 50% profits on US sales & ~$410M as… Read More »Genentech Signs a Worldwide License Agreement with Relay Therapeutics to Develop and Commercialize RLY-1971

Genentech’s Ocrevus Shorter 2-Hour Infusion Receives the US FDA’s Approval for Relapsing & Primary Progressive Multiple Sclerosis

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Shots: The approval is based on ENSEMBLE PLUS study, which demonstrated similar frequency and severity of IRRs for 2hrs. Ocrevus infusion time vs conventional 3.5hrs in patients with RRMS. The initial dose is given as two 300mg infusions given 2wks. apart and a subsequent dose… Read More »Genentech’s Ocrevus Shorter 2-Hour Infusion Receives the US FDA’s Approval for Relapsing & Primary Progressive Multiple Sclerosis

AI drug-discovery firm lands first partnership

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The deal with Roche subsidiary Genentech is likely not the last for Genesis Therapeutics, which is based on AI research undertaken at Stanford. Such partnerships are potentially lucrative for drug-discovery startups.

Genentech Collaborates with Imbio to Develop Imaging Diagnostics for Lung Diseases

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Shots: The agreement leverages Imbio’s technical, regulatory & commercial expertise to build medical imaging AI technology for use in research, clinical trials & clinical practice The focus of the agreement is to develop quantitative imaging diagnostics for lung diseases and to bring unique solutions for… Read More »Genentech Collaborates with Imbio to Develop Imaging Diagnostics for Lung Diseases

FDA’s Ok to Roche’s Oral SMA Therapy; Roche’s Etrolizumab Mixed Results in Ulcerative Colitis; Secura receives rights to Copiktra from Verastem

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Roche Set to Compete With Biogen and Novartis in the SMA Market With its First Oral Therapy  The US FDA has recommended the use of Evrysdi (risdiplam), a candidate of Genentech, a Roche company, for spinal muscular atrophy (SMA), an inherited neuromuscular disease resulting in… Read More »FDA’s Ok to Roche’s Oral SMA Therapy; Roche’s Etrolizumab Mixed Results in Ulcerative Colitis; Secura receives rights to Copiktra from Verastem

Genentech Reports Results of Port Delivery System with Ranibizumab in P-III Archway Study for Neovascular Age-Related Macular Degeneration

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Shots: The P-III Archway study involves assessing of PDS with ranibizumab, refilled @6mos. at fixed intervals, vs ranibizumab (0.5mg, monthly IVT) in 418 patients with nAMD, prior treated with VEGF therapy Results: 98.4% of PDS patients were able to go 6mos. without needing additional treatment… Read More »Genentech Reports Results of Port Delivery System with Ranibizumab in P-III Archway Study for Neovascular Age-Related Macular Degeneration