Merck announces pivotal phase 3 ZENITH trial evaluating WINREVAIR

WINREVAIR met primary endpoint of time to first morbidity or mortality event for the treatment of patients with pulmonary arterial hypertension (PAH) functional class III or IV at high risk of mortality

Merck recommends rejection of TRC Capital’s “Mini-Tender” Offer

The offer price is approximately 4.32% below the closing price of the Merck common stock on November 11, 2024

Lupin receives USFDA approval for mixed salts of a single-entity amphetamine ER capsules

The product will be manufactured at Lupin’s Somerset facility in the US

Lupin launches Bumetanide Injection USP in US

Bumetanide Injection USP (RLD Bumex) had an estimated annual sale of USD 20 million in the US

USFDA approves first gene therapy for treatment of aromatic L-amino acid decarboxylase deficiency

Aromatic L-amino acid decarboxylase deficiency is a rare genetic disorder that affects the production of some neurotransmitters

USFDA classifies Biocon Biologics’ Biocon Park in Bengaluru as VAI

The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants

Orchid Pharma Q2 FY25 PAT up 26% YoY driven by strategic initiatives for market expansion

Granules India’s Unit V facility secures USFDA EIR with NAI status

The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit

Lupin receives tentative approval from USFDA for Raltegravir Tablets

This product will be manufactured at Lupin’s Nagpur facility in India

Biocon reports Q2 FY25 net loss at Rs. 16 Cr

Revenue at Rs 3,623 crore, EBITDA at Rs 718 crore