IPP Bureau

Zydus and Synthon ink licensing and supply agreement for Ozanimod Capsules for US market
Zydus and Synthon ink licensing and supply agreement for Ozanimod Capsules for US market

By IPP Bureau - September 05, 2025

Under the terms of this agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product

Edwards Lifesciences launches next-gen transcatheter heart valve in India
Edwards Lifesciences launches next-gen transcatheter heart valve in India

By IPP Bureau - September 05, 2025

Edwards’ latest-generation balloon-expandable transcatheter heart valve incorporates a proprietary calcification-resistant tissue technology

FDA completes inspection at Biocon Biologics' facility in Bengaluru
FDA completes inspection at Biocon Biologics' facility in Bengaluru

By IPP Bureau - September 05, 2025

The U.S. FDA issued a Form 483 with five observations

AstraZeneca’s Baxdrostat proves effective in in Phase III trial for hard-to-control hypertension
AstraZeneca’s Baxdrostat proves effective in in Phase III trial for hard-to-control hypertension

By IPP Bureau - September 05, 2025

The medicine was well tolerated, with no unexpected safety issue

CapVest to acquire majority stake in STADA
CapVest to acquire majority stake in STADA

By IPP Bureau - September 05, 2025

Bain Capital and Cinven will each retain a minority stake, reflecting their ongoing confidence in STADA’s future growth

Resolution Therapeutics doses first patient in phase I/II Emerald study of RTX001 for end-stage liver disease
Resolution Therapeutics doses first patient in phase I/II Emerald study of RTX001 for end-stage liver disease

By IPP Bureau - September 05, 2025

RTX001 represents a groundbreaking advance in the treatment of end-stage liver disease, offering new hope for patients with limited options

Quotient Sciences and CPI join forces to accelerate RNA drug development
Quotient Sciences and CPI join forces to accelerate RNA drug development

By IPP Bureau - September 05, 2025

The partnership will create a first-of-its-kind, fully integrated offering for the development of mRNA drug products

FDA expands medtronic MiniMed 780G system
FDA expands medtronic MiniMed 780G system

By IPP Bureau - September 05, 2025

Now integrates with Abbott’s instinct sensor and approved for type 2 diabetes

Sanofi’s amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic dermatitis
Sanofi’s amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic dermatitis

By IPP Bureau - September 05, 2025

Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity
Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity

By IPP Bureau - September 04, 2025

This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity

Aarti Pharmalabs inaugurates phase 1 of greenfield manufacturing facility
Aarti Pharmalabs inaugurates phase 1 of greenfield manufacturing facility

By IPP Bureau - September 04, 2025

Phase 1 has a total reactor capacity of 440 kL with 63 reactors

Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA
Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA

By IPP Bureau - September 04, 2025

Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure

Cupid’s B2B export order book stands at Rs. 100 Cr+
Cupid’s B2B export order book stands at Rs. 100 Cr+

By IPP Bureau - September 04, 2025

These orders are from international government tenders in South Africa, Tanzania, and Kenya, as well as from international agencies WHO/UNFPA, NGOs like MSI and PSI

Syntegon reports H1 2025 EBITDA higher by 41% to €127 million
Syntegon reports H1 2025 EBITDA higher by 41% to €127 million

By IPP Bureau - September 04, 2025

Free cash flow also reached €63 million, representing an 11 percent increase compared to the high benchmark set in 2024

Brenntag Specialties selected European distributor for Kerry’s pharmaceutical-grade acetates
Brenntag Specialties selected European distributor for Kerry’s pharmaceutical-grade acetates

By IPP Bureau - September 04, 2025

Brenntag Specialties will provide pharmaceutical manufacturers and biopharmaceutical companies with a reliable supply of high-purity, GMP-compliant acetates

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