Roche

Babyscripts Forms Commercial Partnership with Roche to Develop RPM Programs for Pregnancy

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What You Should Know:   – Babyscripts today announced a commercial partnership with Roche Diagnostics, a division of the world’s largest biotech company and a global pioneer in pharmaceuticals and diagnostics.  – Roche will partner with Babyscripts on the development of Babyscripts’ remote patient monitoring (RPM) programs to leverage… Read More »Babyscripts Forms Commercial Partnership with Roche to Develop RPM Programs for Pregnancy

Roche and Prothena to Advance Prasinezumab in P-IIb Study for Patients with Early Parkinson’s Disease

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Shots: The companies will advance the prasinezumab into a P-IIb study in patients with early Parkinson’s disease based on positive signals of efficacy consistent with disease modification in the PASADENA study The study is designed to further assess the efficacy of prasinezumab by expanding upon… Read More »Roche and Prothena to Advance Prasinezumab in P-IIb Study for Patients with Early Parkinson’s Disease

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.

FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies

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Combination therapies involving Roche and AbbVie’s cancer drug Venclexta have been formally approved by the FDA in acute myeloid leukaemia, following supportive data from late-stage studies. The combination therapies had previously been marketed following accelerated approval in November 2018 on the basis of early stage… Read More »FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies

Roche Signs a License Agreement with Dyno to Develop AVV Gene Therapy for ~$1.8B

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Shots: Dyno to receive upfront and is eligible to receive ~$1.8B milestones including development and commercial milestones along with royalties on any product emerges during the collaboration Dyno will be responsible for the design of novel AAV capsids with improved functional properties for gene therapy… Read More »Roche Signs a License Agreement with Dyno to Develop AVV Gene Therapy for ~$1.8B

NICE recommends regular NHS funding for Roche’s lymphoma drug Polivy

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NICE has recommended regular NHS funding for Roche’s Polivy in certain lymphoma patients in final draft guidance, overturning a previous rejection. The new guidance recommends Polivy (polatuzumab vedotin) in combination with rituximab and bendamustine, for adults with diffuse large B-cell lymphoma (DLBCL), in second line… Read More »NICE recommends regular NHS funding for Roche’s lymphoma drug Polivy

Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

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Shots: The approval is based on P-III IMbrave150 study assessing Tecentriq (1200 mg) + bevacizumab (15 mg/kg, q3w, IV) vs sorafenib (400mg, bid) in 501 patients in a ratio (2:1) with unresectable or metastatic HCC, prior not treated with systemic therapies Results: 42% reduction in… Read More »Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

Regeneron Collaborates with Roche to Improve the Global Supply of REGN-COV2 Against COVID-19

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Shots: The two global companies collaborated to develop, manufacture, and distribute REGN-COV2 across the globe. The agreement is expected to increase the supply of REGN-COV2 to at least 3.5 times the current capacity with the potential for expanding it further Regeneron will lead the distribution… Read More »Regeneron Collaborates with Roche to Improve the Global Supply of REGN-COV2 Against COVID-19

Sanofi acquires Principia; FDA’s Nod to Roche’s Enspryng; BMS, Dragonfly’s Licensing Deal

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New strategy, new outlook: Sanofi takes another step, gains full control over the Principia’s MS treatment  Sanofi has inked a definitive agreement with Principia Biopharma to acquire the company, all of its outstanding shares, and its BTK inhibitors in a deal worth USD 3.68 Billion.… Read More »Sanofi acquires Principia; FDA’s Nod to Roche’s Enspryng; BMS, Dragonfly’s Licensing Deal

Roche’s Enspryng (satralizumab-mwge) Receives the US FDA’s Approval for Neuromyelitis Optica Spectrum Disorder

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Shots: The approval is supported by P-III SAkuraStar and SAkuraSky studies involve assessing Enspryng (120mg, SC, q4w) as a monothx. & as an add-on therapy to baseline IST vs PBO in 95 & 83 patients aged 20-70 &  13-73yrs. in a ratio (2:1) & (1:1)… Read More »Roche’s Enspryng (satralizumab-mwge) Receives the US FDA’s Approval for Neuromyelitis Optica Spectrum Disorder

Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

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Shots: The US FDA has accepted the sBLA for a new self-administration option for Xolair across all approved indications in the US. The company anticipates the approval of the therapy in Q1’21 The acceptance is based on the efficacy and safety profile of Xolair in… Read More »Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Roche Collaborates with Celleron Therapeutics for Emactuzumab to Treat Patients with Tenosynovial Giant Cell Tumor

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Shots: Celleron will receive an exclusive global right for the clinical development, manufacturing, and commercialization of emactuzumab (formerly RG7155 and RO5509554). The companies expect the closing of an agreement by the end of 2020 86% of TGCT patients treated with emactuzumab responded to the drug,… Read More »Roche Collaborates with Celleron Therapeutics for Emactuzumab to Treat Patients with Tenosynovial Giant Cell Tumor

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

Roche’s ulcerative colitis drug etrolizumab looks shaky after data roll-out

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Roche’s late-stage trial programme for ulcerative colitis candidate etrolizumab has generated some positive and negative results, but leans firmly towards the latter. The Swiss drugmaker has acknowledged that the dual-acting anti-integrin antibody – which is trying to chase down Takeda’s blockbuster Entyvio in UC –… Read More »Roche’s ulcerative colitis drug etrolizumab looks shaky after data roll-out

Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis

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Shots: In the HIBISCUS I induction study, in patients without prior anti-TNF treatment, etrolizumab met its 1EPs while in HIBISCUS II study in the same kind of people, it did not meet its 1EPs. In the HICKORY study, in patients with prior anti-TNF treatment, therapy… Read More »Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis

Roche’s Tecentriq (atezolizumab) + Paclitaxel Fail to Meet the Primary Endpoint in P-III IMpassion131 Study for Patients with Metastatic Triple-Negative Breast Cancer

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Shots: The P-III IMpassion131 study involves assessing of Tecentriq + paclitaxel vs PBO + paclitaxel, in 651 people in a ratio (2:1) with previously untreated, inoperable, LA/ m-TNBC The study did not meet its 1EPs of PFS for 1L treatment of people with m-TNBC) in… Read More »Roche’s Tecentriq (atezolizumab) + Paclitaxel Fail to Meet the Primary Endpoint in P-III IMpassion131 Study for Patients with Metastatic Triple-Negative Breast Cancer

Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC

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Shots: The approval is based on integrated analysis including data from 74 people with LA/ m-NTRK fusion-positive solid tumors (14 tumor types) & 161 people with ROS1+ NSCLC of the pivotal P-II STARTRK-2, P-I STARTRK-1 and P-I ALKA-372-001 trials, and data from the P-I/II STARTRK-NG… Read More »Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC

Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

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Shots: The approval is based on P-III IMspire150 study assessing Tecentriq (atezolizumab) + Cotellic  (cobimetinib) + Zelboraf (vemurafenib) vs  PBO + Cotellic +   Zelboraf in patients with BRAF V600 mutation-positive advanced melanoma Results: mPFS (15.1 vs 10.6mos.); the safety profile of the Tecentriq combination was… Read More »Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

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Shots: The P-III COVACTA study involves assessing of Actemra/RoActemra (IV) + SOC vs PBO + SOC in adult patients hospitalized with severe COVID-19 associated pneumonia. Patients will be followed for 60 days post-randomization The study did not meet its 1EPs i.e. improvement in clinical status… Read More »Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Roche Collaborates with Jnana Therapeutics to Discover Novel Therapies to Treat Immune-Mediated and Neurological Diseases

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Shots: Jnana to receive $40M upfront payment in cash and is eligible to get ~$1B as research funding, preclinical, development, and commercialization milestone along with royalties on sales of the therapies The partners will work on the discovery and preclinical development of therapies targeting key… Read More »Roche Collaborates with Jnana Therapeutics to Discover Novel Therapies to Treat Immune-Mediated and Neurological Diseases

Roche Signs RWD Collaboration with PicnicHealth to Create Personalized Treatment for Patients with Multiple Sclerosis

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Shots: The real-world evidence partnership will allow the Roche to access PicnicHealth’s set of de-identified patient records to gain insights on certain diseases and treatments The collaboration will initially focus on MS and may be extended to support Huntington’s disease (HD), paroxysmal nocturnal hemoglobinuria (PNH),… Read More »Roche Signs RWD Collaboration with PicnicHealth to Create Personalized Treatment for Patients with Multiple Sclerosis

Treating Pharma Data as an Asset: moving from an application centric to an information-centric organization – presented by Dr. Martin Romacker, Roche

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Pharma knows there is a need for clean, reusable, FAIR data to fuel effective machine learning-driven R&D – but driving effective information and knowledge management is a long process, needing a step change where individuals learn their roles in data stewardship and reduce them to… Read More »Treating Pharma Data as an Asset: moving from an application centric to an information-centric organization – presented by Dr. Martin Romacker, Roche