IPP Bureau
AbbVie to acquire Gilgamesh Pharmaceuticals’ bretisilocin for $1.2 billion
By IPP Bureau - August 28, 2025
Lighthouse receives $49.2 million NIA grant to advance phase 2 study of Alzheimer’s disease
By IPP Bureau - August 28, 2025
LHP588 is an oral, brain-penetrant lysine-gingipain (Kgp) inhibitor designed to block the key virulence factor of P. gingivalis
argenx reports positive phase 3 ADAPT SERON results of VYVGART in AChR-Ab seronegative gMG
By IPP Bureau - August 28, 2025
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
FDA expands Repatha indication to adults at risk of major cardiovascular events from uncontrolled LDL-C
By IPP Bureau - August 28, 2025
The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia
Samsung India introduces next-gen mobile CT imaging solutions
By IPP Bureau - August 28, 2025
The new lineup includes CereTom Elite, OmniTom Elite, OmniTom Elite PCD, and BodyTom 32/64
Thermo Fisher opens pipette manufacturing site in North Carolina
By IPP Bureau - August 28, 2025
New manufacturing facility in Mebane to produce at least 40 million laboratory pipette tips per week
Gilead’s Yeytuo approved in EU for HIV prevention
By IPP Bureau - August 28, 2025
This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option
FDA approves Coya Therapeutics’ trial of COYA 302 for ALS
By IPP Bureau - August 28, 2025
As part of its partnership with Dr. Reddy’s Laboratories (DRL), FDA acceptance also triggers a $4.2 million milestone payment to Coya
Indian pharma resilient to US tariffs; Eyes US pricing reform gains: Ind-Ra
By IPP Bureau - August 27, 2025
The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion
GST rejig may impact competitiveness of medical devices: AiMeD
By IPP Bureau - August 27, 2025
AiMeD noted that proposed GST changes—to either 5% or 18%—both present significant risks requiring carefully nuanced consideration
SMS Pharmaceuticals receives EIR from USFDA for Central Laboratory Analytical Services
By IPP Bureau - August 27, 2025
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
India showcases herbal GMP leadership at WHO-SEARO regional workshop in Mumbai
By IPP Bureau - August 26, 2025
Delegates also visited Emami’s WHO-GMP-certified manufacturing plant and Zandu Foundation for Healthcare farms for hands-on exposure to quality practices,
Bristol Myers Squibb to present new cardiovascular data at ESC Congress 2025
By IPP Bureau - August 26, 2025
Merck presents new data on cardiovascular disease at ESC Congress 2025
By IPP Bureau - August 26, 2025
Merck will share two oral presentations on ASCVD treatment patterns and patient burden