IPP Bureau

Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer
Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer

By IPP Bureau - October 26, 2023

Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients

USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent
USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent

By IPP Bureau - October 26, 2023

The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer

Venus Remedies earns REO Certification from CII for second consecutive year
Venus Remedies earns REO Certification from CII for second consecutive year

By IPP Bureau - October 26, 2023

The Responsible Export Organisation (REO) certification is a distinguished recognition awarded by the Confederation of Indian Industry (CII)

Lilly's Retevmo phase 3 results in RET fusion-positive non-small cell lung cancer
Lilly's Retevmo phase 3 results in RET fusion-positive non-small cell lung cancer

By IPP Bureau - October 26, 2023

In the Phase 3 LIBRETTO-431 study, Retevmo more than doubled progression-free survival (PFS) compared to chemotherapy plus pembrolizumab in patients with advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC)

BASF Pharma Solutions introduces premium services to its VPAs digital services platform
BASF Pharma Solutions introduces premium services to its VPAs digital services platform

By IPP Bureau - October 25, 2023

Additional premium services in RegXcellence will include access to BASF’s Product Carbon Footprint data and direct downloads of audit reports

Innocan Pharma reports discovery regarding its LPD platform and global CBD research
Innocan Pharma reports discovery regarding its LPD platform and global CBD research

By IPP Bureau - October 25, 2023

The company expects that this development could improve the strength of its application to the FDA for new drug approval

Nanoform grant global starmap AI license to AstraZeneca
Nanoform grant global starmap AI license to AstraZeneca

By IPP Bureau - October 25, 2023

Nanoform will receive access to compound libraries and large data sets to undertake STARMAP screening

Sumitomo Pharma announces authorization in Canada of Orgovyx for treatment prostate cancer
Sumitomo Pharma announces authorization in Canada of Orgovyx for treatment prostate cancer

By IPP Bureau - October 25, 2023

Orgovyx is the first and only oral GnRH receptor antagonist approved for advanced prostate cancer in Canada

RPG Life Sciences posts Q2 FY24 PAT at Rs. 25.86 Cr
RPG Life Sciences posts Q2 FY24 PAT at Rs. 25.86 Cr

By IPP Bureau - October 23, 2023

RPG Life Sciences has reported total income of Rs. 155.41 crores during the period ended September 30, 2023

Indoco Remedies posts consolidated Q2FY24 PAT at Rs. 35.08 Cr
Indoco Remedies posts consolidated Q2FY24 PAT at Rs. 35.08 Cr

By IPP Bureau - October 23, 2023

The company has reported total income of Rs. 486.16 crores during the period ended September 30, 2023

Natco Pharma receives 8 observations from USFDA for Pharma Division at Kothur
Natco Pharma receives 8 observations from USFDA for Pharma Division at Kothur

By IPP Bureau - October 23, 2023

The company is confident of addressing all the observations within the stipulated time

Zhimeng Biopharma CB03 receives Orphan Drug Designation from the USFDA
Zhimeng Biopharma CB03 receives Orphan Drug Designation from the USFDA

By IPP Bureau - October 23, 2023

CB03 is a candidate drug for the treatment of ALS and other central nerve system (CNS) diseases

ERS Genomics completes licensing agreement with Syngene International
ERS Genomics completes licensing agreement with Syngene International

By IPP Bureau - October 23, 2023

Syngene gains access to ERS Genomics' foundational CRISPR/Cas9 patent portfolio, ushering in a new era of technical innovation in India for its global partners

India should take global leadership with Holistic Healthcare Approach: Sonowal
India should take global leadership with Holistic Healthcare Approach: Sonowal

By IPP Bureau - October 23, 2023

New Molecular biology lab launched, AIIA increased its work scope in form of MoUs

KKR to invest in life sciences firm Catalio Capital Management
KKR to invest in life sciences firm Catalio Capital Management

By IPP Bureau - October 23, 2023

Investment is additive to KKR’s existing health care growth strategy

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