Pharma News

Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg, and 300 mg, the generic version of Cleocin®1 Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg, of Pfizer Inc. Glenmark’s Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg, and 300 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

Pfizer Inc and Seagen Inc announced that they have entered into a definitive merger agreement under which Pfizer will acquire Seagen, a global biotechnology company that discovers, develops and commercializes transformative cancer medicines, for 229 USD in cash per Seagen share for a total enterprise value of 43 billion USD. The Boards of Directors of both companies have unanimously approved the transaction.

Sanofi and Provention Bio, Inc., a U.S.-based, publicly traded biopharmaceutical company focused on intercepting and preventing immune-mediated diseases including type 1 diabetes (T1D), have entered into an agreement under which Sanofi has agreed to acquire Provention Bio, Inc., for 25.00 per USD share in cash, representing an equity value of approximately 2.9 billion USD.

Global pharma major Lupin Limited announced that the United States Food and Drug Administration (U.S. FDA) has completed a Pre-Approval and GMP Inspection of its API manufacturing facility located in Visakhapatnam (Vizag), India. The inspection was conducted from March 6 to March 10, 2023 and concluded with no observations.

Researchers have analysed image and genomic data from the UK Biobank to find insights into rare diseases of the human eye. These include retinal dystrophies – a group of inherited disorders affecting the retina – which are also the leading cause of blindness certification in working-age adults.

People with HIV have impaired immune responses to some pathogens and immunizations, and during the COVID-19 pandemic, they often experienced severe symptoms if infected with SARS‐CoV‐2.

Pfizer Inc announced the U.S. Food and Drug Administration (FDA) has approved ZAVZPRET™ (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults. In its pivotal Phase 3 study, ZAVZPRET was statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptom at two hours post-dose.

Indian Pharmacopoeia commission, IPC indicated adverse drug interactions associated with widely used antibiotic cephalosporins and Amikacin.

Cephalosporins are beta-lactam antimicrobials used to manage a wide range of infections from Gram-positive and Gram-negative bacteria.And Amikacin is indicated in the treatment of serious infections due to amikacin sensitive organisms.

Marksans Pharma Limited hereby announces that it has received final approval from US Food & Drugs Administration for its Abbreviated New Drug Application (ANDA) of Famotidine Tablets USP, 10 mg and 20 mg for over-the-counter (OTC) use.

The product is bioequivalent to the reference listed drug (RLD), Pepcid AC® tablets, a registered trademark of Johnson & Johnson Consumer Inc. which has sales of over $ 200 million in the US market.