FDA approves Coya Therapeutics’ trial of COYA 302 for ALS

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

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

AiMeD noted that proposed GST changes—to either 5% or 18%—both present significant risks requiring carefully nuanced consideration

Remedium Lifecare charts 4X growth strategy

The first pillar is advanced manufacturing, focused on upgrading existing CDMO

Giant antibody in humans acts like a brace against bacterial toxins

Protein L is known as a “superantigen” because it can bind antibodies in unusual ways

India releases first-ever National Guidelines/SOPs for animal blood transfusion and blood banks

Guidelines aim to establish state-regulated veterinary blood banks

Eris Lifesciences receives ANVISA approval for sterile injectable facility

Gland Pharma receives FDA approval for Vasopressin in 5% Dextrose RTU Injection

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited

Roche’s US subsidiary Genentech breaks ground on $700 million manufacturing facility in North Carolina

The $700 million project is part of Roche’s $50 billion investment in US manufacturing, infrastructure and R&D

Enanta files patent infringement suit against Pfizer

The ‘265 Patent is based on Enanta’s July 2020 patent application describing coronavirus protease inhibitors invented by Enanta scientists