IPP Bureau

USFDA concludes inspection of NATCO’s  Pharma Division, Kothur
USFDA concludes inspection of NATCO’s Pharma Division, Kothur

By IPP Bureau - June 20, 2025

The company received seven observations in the Form-483

Sanner commences manufacturing critical injection-molded components in USA
Sanner commences manufacturing critical injection-molded components in USA

By IPP Bureau - June 20, 2025

The GMP-compliant facility with automated environmental monitoring accommodates both white room and class 7 and 8 cleanroom space

UFlex introduces FSSAI compliant single-pellet solution for food packaging
UFlex introduces FSSAI compliant single-pellet solution for food packaging

By IPP Bureau - June 20, 2025

UFlex is the first and only Indian company to receive USFDA approval for its technology and capacity to recycle all three materials

Briefs: Hikal and Sun Pharma
Briefs: Hikal and Sun Pharma

By IPP Bureau - June 17, 2025

Sun Pharma gets 8 observations from USFDA for Halol facility

Lupin and Sino Universal Pharmaceuticals sign license and supply agreement for tiotropium DPI in China
Lupin and Sino Universal Pharmaceuticals sign license and supply agreement for tiotropium DPI in China

By IPP Bureau - June 17, 2025

SUP will obtain regulatory approvals for selling Tiotropium DPI in China

USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad
USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad

By IPP Bureau - June 17, 2025

The company received one observation in the Form-483

USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru
USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru

By IPP Bureau - June 17, 2025

The inspection concluded successfully, with the facility found to be in compliance with the required regulations

Bristol Myers Squibb presents data across targeted protein degradation research at EHA 2025
Bristol Myers Squibb presents data across targeted protein degradation research at EHA 2025

By IPP Bureau - June 16, 2025

Innovative agents highlight growth of targeted protein degradation platform and BMS' leadership in innovative cancer therapies

AstraZeneca collaborates with CSPC Pharmaceuticals focused on AI-enabled research
AstraZeneca collaborates with CSPC Pharmaceuticals focused on AI-enabled research

By IPP Bureau - June 16, 2025

The collaboration furthers AstraZeneca’s presence in China following the $2.5bn investment in Beijing

Roche to advance prasinezumab into Phase III development for early-stage Parkinson's disease
Roche to advance prasinezumab into Phase III development for early-stage Parkinson's disease

By IPP Bureau - June 16, 2025

Prasinezumab is a potential first-in-class anti-alpha-synuclein antibody, targeting a known biological driver of Parkinson’s disease progression

Novo Nordisk to advance subcutaneous and oral amycretin for weight management into phase 3 clinical development
Novo Nordisk to advance subcutaneous and oral amycretin for weight management into phase 3 clinical development

By IPP Bureau - June 16, 2025

The decision to advance subcutaneous and oral amycretin into phase 3 is based on feedback received from regulatory authorities

NVIDIA partners with Novo Nordisk and DCAI to advance drug discovery
NVIDIA partners with Novo Nordisk and DCAI to advance drug discovery

By IPP Bureau - June 13, 2025

The companies aim to create customized AI models and agents that Novo Nordisk can use for early research and clinical development

Bristol Myers Squibb announces positive results from Phase 3 Poetyk PsA-1 and PsA-2 trials of deucravacitinib in psoriatic arthritis
Bristol Myers Squibb announces positive results from Phase 3 Poetyk PsA-1 and PsA-2 trials of deucravacitinib in psoriatic arthritis

By IPP Bureau - June 13, 2025

FDA approves AbbVie’s mavyret as first and only treatment for acute hepatitis C
FDA approves AbbVie’s mavyret as first and only treatment for acute hepatitis C

By IPP Bureau - June 13, 2025

Now approved for both acute and chronic HCV in adults and children aged 3 and above

Mezzion secures $20 million funding to advance Phase 3 clinical development of Udenafil for fontan patients
Mezzion secures $20 million funding to advance Phase 3 clinical development of Udenafil for fontan patients

By IPP Bureau - June 13, 2025

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