Category: Chugai

PharmaShots Weekly Snapshots (July 05 – 09, 2021)

Abbisko, alector, Alvotech, Amgen, AstraZeneca, BeiGene, Bharat Biotech, Chugai, Gan & Lee, GSK, Hutchmed, Immunic, Janssen, Jazz, Lilly, Lupin, Lysogene, Mallinckrodt, Merck, NGM, Ocugen, Roche, Sanofi, Sorrento, Spero Therapeutics, Teva, Treos Bio, Verge Genomics, Vor, Weekly Snapshot, Y-mAbs / July 9, 2021 July 9, 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

Biotech, Chugai, Japan, MHLW, NSCLC, Tecentriq / July 8, 2021 July 8, 2021

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 …

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PharmaShots Weekly Snapshots (Mar 22 – 26, 2021)

Astellas and Seagen, AstraZeneca, Bayer, BioMarin, BMS, BridgeBio, Chugai, EirGenix, Fresenius Medical Care, Immunai, Incyte, Insulet, J&J Visions, Janssen, Merck, Novo Nordisk, Pfizer and BioNTech, Pfizer and Myovant, ProQR, Regeneron, Roche, Takeda, Tetra Bio-Pharma, Weekly Snapshot, Zealand / March 26, 2021 March 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

(R/R) Diffuse Large B-Cell Lymphoma, approval, Chugai, MHLW, Polivy, receives, regulatory, Treatment / March 25, 2021 March 25, 2021

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 …

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Why starting an innovation journey isn’t sexy

Chugai, innovation, R&D, Views & Analysis, Views and analysis / February 15, 2021 February 15, 2021

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)

Amgen, Astellas, AstraZeneca, Atara, Bayer, Biogen, BioNTech, Boehringer Ingelheim, Chugai, Elsevier, Gilead, google, Janssen, KaliVir, Kite, Labor Dr. Merk, Lilly, Medtronic, Moderna, MYR, NBE-Therapeutics, Nektar Therapeutics, Novartis, Pfizer, Qiagen, QuantiFERON, RetinAl, Roche, Shadow Health, Weekly Snapshot / December 11, 2020 December 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

Biotech, Casirivimab, Chugai, Commercialization, COVID-19, Development, Imdevimab, In-License Agreement, Japan, Roche, Sign / December 11, 2020 December 11, 2020

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 …

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PharmaShots Weekly Snapshot (Oct 19 – 23, 2020)

111, AbbVie, AstraZenca, Atea Pharmaceuticals, AWS, Bayer, BioSpecifics, Chugai, Daiichi Sankyo, Dicerna, Dinona, Endo, Essex, Genesis, Gilead, GSK, Henlius, Huadong, ImmunoGen, Janssen, Jazz, Lilly, NeuClone, Novartis, Novo Nordisk, Onica, Prothena, Roche, Samsung Biologics, Sanifit, Sanofi, StageBio, TPL Path Labs, UCB, ViiV Healthcare, Weekly Snapshot / October 23, 2020 October 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

Antibody Engineering Technologies, Biotech, Chugai, License Agreement, Novo Nordisk, Signs / October 22, 2020 October 22, 2020

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)

Abbott, AstraZeneca, Bayer, Boehringer, Celltrion, Chugai, Eli Lily, Galapagos, Gilead, Innovent, J&J, Janssen, Linnaeus, Merck, Moderna, Novartis, Pfizer, Prestige, Regeneron, Roche, Sanofi, Servier, Sorrento, Takeda, Translate Bio, Weekly Snapshot / October 16, 2020 October 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

Chugai, drug, First, Japan, MHLW, NDA, Oral, regulatory, Report, Risdiplam, spinal muscular atrophy / October 16, 2020 October 16, 2020

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 …

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

(trastuzumab emtansine), Adjuvant Therapy, approval, Biotech, Chugai, HER2-Positive, Kadcyla, MHLW, receives, regulatory / August 24, 2020 August 24, 2020

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

Biofourmis, Chugai, Collaborate, Develop, DigiHealth, Digitally Measuring, Endometriosis Pain, Latest, Solutions / July 23, 2020 July 23, 2020

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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Chugai, Biofourmis partner on DTx for pain monitoring

Artificial Intelligence, Biofourmis, BioPharma, biopharma nl, Boston, Chugai, Daily, Digital Therapeutics, endometriosis, Health Tech, Massachusetts, pain, Roche, SYN, Top Story, Wearables / July 22, 2020 July 22, 2020

The companies will test Biofourmis’ sensor and artificial intelligence system in a clinical trial of more than 120 women with endometriosis.