IPP Bureau

Pembrolizumab + Trastuzumab and chemotherapy met primary endpoint as first line of treatment for GEJ
Pembrolizumab + Trastuzumab and chemotherapy met primary endpoint as first line of treatment for GEJ

By IPP Bureau - June 17, 2023

Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma

Health Ministry to prepare National Action Plan on AMR 2.0
Health Ministry to prepare National Action Plan on AMR 2.0

By IPP Bureau - June 17, 2023

Convergent action on AMR identified as an important area of intervention

MoS Health addresses TB Health Technologies workshop
MoS Health addresses TB Health Technologies workshop

By IPP Bureau - June 17, 2023

Urges Innovators to produce quality products that can be deployed at scale

USFDA completes inspection at Dr Reddy's Laboratories' Bollaram API unit
USFDA completes inspection at Dr Reddy's Laboratories' Bollaram API unit

By IPP Bureau - June 17, 2023

The inspection closed with zero observations

Briefs: Natco Pharma and Panacea Biotec
Briefs: Natco Pharma and Panacea Biotec

By IPP Bureau - June 16, 2023

Panacea Biotec has announced the launch of its new range of high-quality pediatric food & nutritional products

Bliss GVS Pharma updates on inspection by USFDA
Bliss GVS Pharma updates on inspection by USFDA

By IPP Bureau - June 16, 2023

The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection

Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam
Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam

By IPP Bureau - June 16, 2023

The company will submit its comprehensive response on these observations to the US FDA

PrecisionLife announces strategic CNS drug development collaboration with Nanopharmaceutics
PrecisionLife announces strategic CNS drug development collaboration with Nanopharmaceutics

By IPP Bureau - June 16, 2023

Collaboration to accelerate and de-risk clinical development of Nanopharmaceutics CNS portfolio

SMi discloses £6 million seed funding round, bolsters team with new C-suite hire
SMi discloses £6 million seed funding round, bolsters team with new C-suite hire

By IPP Bureau - June 15, 2023

Investment enables development of revolutionary multi-omic platform using super-resolution imaging technology for earlier disease detection and accelerated discovery of therapeutics

Airnov to showcase HDPE bottle range at upcoming CPHI China
Airnov to showcase HDPE bottle range at upcoming CPHI China

By IPP Bureau - June 15, 2023

The new range of HDPE bottles is compliant with US FDA, EU regulations and Chinese DMF registration for use in dry pharmaceutical applications

Philips' direct-to-angio stroke pathway demonstrates improved patient outcomes
Philips' direct-to-angio stroke pathway demonstrates improved patient outcomes

By IPP Bureau - June 15, 2023

Economic analysis of cost of Vall d’Hebron University Hospital Stroke Unit shows direct-to-angio stroke pathway can save more than USD 3,000 per patient

Granules India receives ANDA approval for Levetiracetam Tablets
Granules India receives ANDA approval for Levetiracetam Tablets

By IPP Bureau - June 15, 2023

Granules now has a total of 58 ANDA approvals from US FDA

Baghel inaugurates the World Blood Donor Day at RML Hospital
Baghel inaugurates the World Blood Donor Day at RML Hospital

By IPP Bureau - June 15, 2023

The slogan for this year's World Blood Donor Day campaign is 'Give blood, give plasma, share life, share often'

Euroapi plans initiatives to support production of APIs in France and Europe
Euroapi plans initiatives to support production of APIs in France and Europe

By IPP Bureau - June 15, 2023

Total investments could reach €70 million, of which approximately 15% in R&D and 85% in capex, that would be deployed from 2026

Zydus receives final approval from the USFDA for Diclofenac Sodium and Misoprostol Delayed Release Tablets
Zydus receives final approval from the USFDA for Diclofenac Sodium and Misoprostol Delayed Release Tablets

By IPP Bureau - June 14, 2023

Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States

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