IPP Bureau

Unichem gets 5 observations from USFDA for Goa formulation facility
Unichem gets 5 observations from USFDA for Goa formulation facility

By IPP Bureau - July 17, 2024

The inspection closed with five observations which were more of procedural changes with none of these related to data integrity

Lupin divests US commercial women's health specialty business to Evofem
Lupin divests US commercial women's health specialty business to Evofem

By IPP Bureau - July 17, 2024

Lupin can receive a potential total consideration of up to USD 84 million based on future contingent milestones

Mankind Pharma signs agreement with Takeda to commercialize Vonoprazan in India
Mankind Pharma signs agreement with Takeda to commercialize Vonoprazan in India

By IPP Bureau - July 17, 2024

Vonoprazan is a potassium-competitive acid blocker (P-CAB) used for the treatment of acid-related disorders

Avallano releases AI-driven ProtocolCopilot
Avallano releases AI-driven ProtocolCopilot

By IPP Bureau - July 17, 2024

ProtocolCopilot leverages advanced artificial intelligence to streamline the process of understanding and adhering to clinical research protocols

Medix Biochemica appoints former Thermo Fisher Scientific Lonnie Shoff to its Board of Directors
Medix Biochemica appoints former Thermo Fisher Scientific Lonnie Shoff to its Board of Directors

By IPP Bureau - July 16, 2024

Shoff brings over 30 years of international experience in in vitro diagnostics, healthcare distribution and veterinary diagnostics

Merck starts commercial production of first GMP-compliant manufacturing line for cell culture media in China
Merck starts commercial production of first GMP-compliant manufacturing line for cell culture media in China

By IPP Bureau - July 16, 2024

€ 6.6 million investment at Nantong site expands production capabilities for cell culture media

Merck completes acquisition of EyeBio
Merck completes acquisition of EyeBio

By IPP Bureau - July 16, 2024

Acquisition strengthens and diversifies Merck’s pipeline with the addition of Restoret

ViiV Healthcare to announce data from largest head-to-head randomised clinical trial for 2-drug regimen Dovato against 3-drug regimen Biktarvy at AIDS 2024
ViiV Healthcare to announce data from largest head-to-head randomised clinical trial for 2-drug regimen Dovato against 3-drug regimen Biktarvy at AIDS 2024

By IPP Bureau - July 16, 2024

Findings from the SEIMC-GeSIDA Foundation (FSG) PASO-DOBLE study will include treatment efficacy, safety, and weight gain

Suven Pharmaceuticals gets Form 483 from with two observations from USFDA for Casper Pharma
Suven Pharmaceuticals gets Form 483 from with two observations from USFDA for Casper Pharma

By IPP Bureau - July 14, 2024

The company will address these observations within the stipulated timeline

Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial
Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial

By IPP Bureau - July 14, 2024

Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension

Veerhealth Care secures export order from US Institutional Supplier
Veerhealth Care secures export order from US Institutional Supplier

By IPP Bureau - July 14, 2024

The company is planning to expand its plant capacity in in Vapi

Thermo Fisher Scientific completes acquisition of proteomics solutions company ‘Olink’
Thermo Fisher Scientific completes acquisition of proteomics solutions company ‘Olink’

By IPP Bureau - July 14, 2024

Protein research is key to advancing our understanding of human biology and delivering on the promise of precision medicine

Piramal Pharma’s Ahmedabad facility completes USFDA PAI
Piramal Pharma’s Ahmedabad facility completes USFDA PAI

By IPP Bureau - July 14, 2024

Health Minister Nadda reviews Ayushman Bharat PMJAY and Ayushman Bharat Digital Mission
Health Minister Nadda reviews Ayushman Bharat PMJAY and Ayushman Bharat Digital Mission

By IPP Bureau - July 14, 2024

Directs officials to ensure that challenges hampering their effective implementation are resolved early in coordination with states

Soumya Swaminathan appointed as the Principle Advisor for the National Tuberculosis Elimination Programme
Soumya Swaminathan appointed as the Principle Advisor for the National Tuberculosis Elimination Programme

By IPP Bureau - July 14, 2024

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