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Lead Product(s): Olaparib,Bevacizumab
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co. Inc.
Deal Size: Not Available Upfront Cash: Not Available
Deal Type: Not Available November 05, 2020
Details:
Patients treated with Lynparza and bevacizumab lived without disease progression for a median of 37.2 months vs. 17.7 months with bevacizumab alone.
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Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 29, 2020
Details:
Zejula is the first PARP inhibitor approved as monotherapy in the European Union for patients with platinum-responsive advanced ovarian cancer, regardless of biomarker status.
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Lead Product(s): Trastuzumab Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Daiichi Sankyo Co Ltd
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2020
Details:
Enhertu (trastuzumab deruxtecan) has received acceptance for its supplemental biologics licence application from the FDA, in addition to the priority review, for the treatment of HER2-positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
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Lead Product(s): Trastuzumab Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Daiichi Sankyo Co Ltd
Deal Size: Not Available Upfront Cash: Not Available
Deal Type: Not Available October 28, 2020
Details:
The sBLA is based on results from the DESTINY-Gastric01 randomized Phase II trial, which showed significant and clinically meaningful improvement in objective response rate, the primary endpoint, and overall survival in patients treated with ENHERTU versus chemotherapy.
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Lead Product(s): Osimertinib Mesylate
Therapeutic Area: Oncology Product Name: Tagrisso
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2020
Details:
Unprecedented results show treatment with Tagrisso reduced the risk of disease recurrence or death by 80% in ADAURA Phase III trial.
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Lead Product(s): Acalabrutinib
Therapeutic Area: Oncology Product Name: Calquence
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 16, 2020
Details:
AstraZeneca Pharma India will launch Calquence (acalabrutinib) in India. Calquence (Acalabrutinib), intended for the treatment of chronic lymphocytic leukaemia (CLL).
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Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2020
Details:
ZEJULA (niraparib) is now approved in Canada for the monotherapy maintenance treatment of female adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
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Lead Product(s): Trastuzumab
Therapeutic Area: Oncology Product Name: Zercepac
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Shanghai Henlius Biotech
Deal Size: $565.0 million Upfront Cash: $27.0 million
Deal Type: Licensing Agreement September 30, 2020
Details:
Henlius will grant an exclusive license to Accord US to develop and commercialise HLX02 (trastuzumab biosimilar, Chinese brand name: 汉曲优®, EU brand name: Zercepac®) in the United States of America and Canada.
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Lead Product(s): Bevacizumab
Therapeutic Area: Oncology Product Name: Equidacent
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2020
Details:
The authorization follows the adoption of a positive opinion by the CHMP, which concluded that the development program including analytical, functional, clinical, and immunogenicity data demonstrated biosimilarity with the reference product, Avastin®.
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Lead Product(s): Olaparib
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co. Inc.
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2020
Details:
In the PROfound trial, Lynparza provided a significant clinical benefit to men with BRCA-mutated metastatic castration-resistant prostate cancer.
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