Chugai

PharmaShots Weekly Snapshots (July 05 – 09, 2021)

Lysogene Receives the US FDA’s Fast Track Designation for LYS-GM101 Gene Therapy to Treat GM1 Gangliosidosis Published: July 9, 2021 | Tags: Lysogene, US, FDA, Fast Track Designation, LYS-GM101 Gene Therapy, GM1 Gangliosidosis Jazz’s Vyxeos (daunorubicin and cytarabine liposome) for Injection Receives Health Canada Approval for the Treatment of High-risk Acute Myeloid Leukemia Published: July …

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Chugai Files an Application with MHLW for an Additional Indication of Tecentriq as an Adjuvant Treatment for NSCLC in Japan

Shots: The filing is based on the results from the P-III IMpower010 study assessing Tecentriq (1200mg, IV) vs BSC in 1,005 patients in a ratio (1:1) with Stage IB-IIIA NSCLC, following surgical resection and up to 4 cycles of adjuvant cisplatin-based CT Results: 34% reduction in risk of disease recurrence or death in people with …

Chugai Files an Application with MHLW for an Additional Indication of Tecentriq as an Adjuvant Treatment for NSCLC in Japan Read More »

PharmaShots Weekly Snapshots (Mar 22 – 26, 2021)

Pfizer and BioNTech Initiate COVID-19 Vaccine Trial in Children Under 12 Published: Mar 26, 2021 | Tags: Pfizer and BioNTech, Initiate, COVID-19 Vaccine Trial, Children, Under 12 Tetra Bio-Pharma Initiates Additional Studies of ARDS-003 in Neuroinflammation and Antiviral Diseases Published: Mar 26, 2021 | Tags: Tetra Bio-Pharma, Initiates, Additional Studies, ARDS-003,  Neuroinflammation, Antiviral Diseases Immunai …

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Chugai’s Polivy Receives MHLW’s Approval for Relapsed or Refractory Diffuse Large B-cell Lymphoma

Shots: The approval is based on results from P- Ib/II GO29365 study assessing Polivy (IV, 30 & 140mg) + BR vs BR alone in 80 DLBCL patients and P-II JO40762/P-DRIVE study that evaluated Polivy + BR therapy in 35 patients with R/R DLBCL not eligible for ASCT The P-II part of GO29365 study demonstrated CRR …

Chugai’s Polivy Receives MHLW’s Approval for Relapsed or Refractory Diffuse Large B-cell Lymphoma Read More »

Why starting an innovation journey isn’t sexy

Chugai Pharmaceutical’s UK innovation lead, Martin Ellgood explores the challenges pharma companies face when devising innovation strategies. On a hot July morning, our managing director called me aside for a “quick word”. Five minutes later I emerged smugly with a new job title: UK innovation lead. I got ready to update my LinkedIn profile. I …

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PharmaShots Weekly Snapshots (Dec 7-11, 2020)

Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing Published: Dec 11, 2020 | Tags: Antigen, COVID-19, High, Laboratory, Launch, patients, Roche, SARS-CoV-2, Support, Suspected, Test, Testing, Volume Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan Published: Dec 10, 2020 | Tags: Casirivimab, Chugai, Commercialization, COVID-19, Development, Imdevimab, In-License Agreement, Japan, Roche, …

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Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan

Shots: Chugai get an exclusive development and commercialization agreement in Japan for Roche’s Ab cocktail of casirivimab and imdevimab to combat COVID-19 Earlier, Roche & Regeneron collaborated for the development & commercialization of Ab cocktail where Regeneron will distribute the treatment in the US while Roche will be lead manufacturing and distribution activities outside the …

Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan Read More »

PharmaShots Weekly Snapshot (Oct 19 – 23, 2020)

Akebia Presents Results of Vadadustat in P-lll INNO2VATE Program for Anemia Due to CKD at ASN Kidney Week Published: Oct 23, 2020 | Tags: Akebia, Results, Vadadustat, P-lll, INNO2VATE Global Study, Anemia, Chronic Kidney Disease Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020 Published: Oct 22, 2020 …

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Novo Nordisk Signs a License Agreement with Chugai for Antibody Engineering Technologies

Shots: Chugai will receive an upfront, development milestone and royalties if the compound is launch as an approved Ab drug. Additionally, Chugai will receive a fee for technology access Novo Nordisk to get the rights to use several Chugai Ab engineering technologies for their research activities and optional right for the development and marketing of …

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PharmaShots Weekly Snapshot (Oct 12-16, 2020)

Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease Published: Oct 15, 2020 | Tags: approval, Canada, health, Inherited Retinal Disease, Luxturna, Novartis, receives, voretigene neparvovec Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis Published: Oct 15, …

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Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

Shots: The NDA submission is based on FIREFISH study assessing Risdiplam in infants with symptomatic SMA Type 1 & SUNFISH study in children and young adults with SMA Type 2 or 3 FIRESISH study results: improvement in survival and motor milestones in infants. SUNFISH study results: improvement in motor function in people aged 2-25 with …

Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan Read More »

Chugai’s Kadcyla (trastuzumab emtansine) Receives MHLW’s Approval for Adjuvant Therapy of HER2-Positive Early Breast Cancer

Shots: The approval is based on P-III KATHERINE study assessing Kadcyla (100/160mg, IV) adjuvant therapy in 1486 patients with HER2+ early BC who did not have pathologic complete response following neoadjuvant therapy including Herceptin The results showed the superiority of Kadcyla over Herceptin in terms of the 1EPs of invasive disease-free survival. The safety profile …

Chugai’s Kadcyla (trastuzumab emtansine) Receives MHLW’s Approval for Adjuvant Therapy of HER2-Positive Early Breast Cancer Read More »

Chugai and Biofourmis Collaborate to Develop Solutions for Digitally Measuring Endometriosis Pain

Shots: The collaboration will deploy Biofourmis’ Biovitals platform to co-develop a novel digital technology for the objective assessment of pain using biosensors and AI-based algorithms. The solutions will be validated in the global study that enrolls 120+ endometriosis patients The digital solution for managing patients with endometriosis in an ambulatory setting will include a wearable, …

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