IPP Bureau
Sandoz introduces Act4Biosimilars Action Plan to accelerate patient access to biosimilar medicines
By IPP Bureau - June 19, 2023
Despite nearly 20 years of availability, biosimilars show worldwide adoption rate of only 14% in initiative-tracked countries, while reference medicines still represent 86% of biologic
Nanoform and Celanese demonstrate enhanced drug delivery through smaller implants
By IPP Bureau - June 19, 2023
The increased drug load enabled by the nanoformed particles also allows smaller implants with sustained release properties to be developed.
Astellas and Cullgen enter inks agreement to advance innovative targeted protein degraders
By IPP Bureau - June 19, 2023
Cullgen will have the option during the initial stages of clinical development to participate equally in the costs, profits and losses
Laurus Labs signs MOA with IIT Kanpur for novel gene therapy assets
By IPP Bureau - June 19, 2023
Laurus will also provide funding for the clinical trials and will launch these products in India and emerging markets
Lupin launches Thiamine Hydrochloride Injection USP in the US
By IPP Bureau - June 19, 2023
Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.
Lupin receives EIR from FDA for its API manufacturing facility in Vizag
By IPP Bureau - June 19, 2023
The inspection closed with the facility receiving an inspection classification of NAI
Merck completes acquisition of Prometheus Biosciences
By IPP Bureau - June 17, 2023
Acquisition delivers industry-leading research capability, and strengthens pipeline with a novel candidate for ulcerative colitis, Crohn’s disease and other autoimmune conditions
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
By IPP Bureau - June 17, 2023
Convergent action on AMR identified as an important area of intervention
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
By IPP Bureau - June 17, 2023
The inspection closed with zero observations
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
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
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
By IPP Bureau - June 16, 2023
Collaboration to accelerate and de-risk clinical development of Nanopharmaceutics CNS portfolio
