and US-based Organon & Co have under which Sun will acquire all outstanding shares of Organon for $14 per share in an all-cash transaction with an enterprise valuation of $11.75 billion – a transaction that will be the largest overseas buy for the Indian drugmaker and the domestic pharmaceutical industry.
has received permission to conduct two Phase III clinical trials of Zintrodiazine in patients with uncomplicated malaria due to Plasmodium falciparum (P. falciparum) and uncomplicated Plasmodium vivax malaria in India. The first and second Phase III trials will be multi-centre, randomised, assessor-blind, active-comparator studies to determine the efficacy, safety and tolerability of orally administered Zintrodiazine in patients with uncomplicated malaria due to P. falciparum and uncomplicated P. vivax malaria.
has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fingolimod Capsules, 0.5 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg, of Novartis Pharmaceuticals Corporation (Novartis). Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in patients 10 years of age and older. Refer to the label for a detailed indication. Fingolimod Capsules, 0.5 mg, have an estimated market size of $145 million for the 12 months ending December 2025 according to IQVIA.
The US Food and Drug Administration (USFDA) has conducted an unannounced inspection at Rubicon Research Ltd’s R&D facility located at Concord, Ontario, Canada, from 20 April 2026 to 24 April 2026. The inspection concluded without any Form 483 being issued.