IPP Bureau

AbbVie to acquire Gilgamesh Pharmaceuticals’ bretisilocin for $1.2 billion
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Healthium and C-CAMP launch innovations program for surgical and medical technologies
Healthium and C-CAMP launch innovations program for surgical and medical technologies

By IPP Bureau - August 26, 2025

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