Replimune's Tudriqev granted accelerated approval after two setbacks FDA granted accelerated approval to Replimune’s melanoma therapy, Tudriqev (previously known as RP1) in combination with Bristol Myers Squibb’s Opdivo (nivolumab) in adult patients who experienced tumor progression despite prior anti-PD-1 therapy. Tudriqev (vusolimogene oderparepvec-wtpg) is a oncolytic
On June 4, 2026, Justice Jackson wrote for a unanimous Court reversing the Federal Circuit, holding Amarin failed to plausibly allege that Hikma actively induced infringement through its generic. NDA, ANDA, and “Skinny Labels” Pharmaceutical companies usually submit a new drug application (NDA) to the FDA with full data on
USPTO foreign-applicant must be represented by a USPTO registered practioner Effective July 20, 2026, foreign-domiciled applicants and owners must be represented by a registered practitioner. This representation requirement is part of the USPTO’s ongoing efforts to improve efficiency, reduce the backlog, improve quality, and deter fraud and misrepresentation in
10/27 – Kivu Raised $92 Million in Series A Kivu Biosciences, an antibody-drug conjugate biotech startup, has raised $92 million in a Series A funding.1 The company is working with the GlycoConnectTM technology from Synaffix that attaches its proprietary linker-payloads specifically to asparagine-297, a highly conserved native glycan around
10/16 – Wave Achieves First-Ever RNA Editing in Human Wave Life Sciences announced positive proof-of-mechanism data from its ongoing phase 1a/2a study of GalNAc-conjugated RNA editing oligonucleotide (called WVE-006) in treating alpha-1 antitrypsin deficiency (AATD).1 The oligonucleotide recruits the Adenosine deaminases acting on RNA (ADAR) to correct a
10/10 – Nobel Prize in Chemistry Nobel Prize in Chemistry 2024 has been awarded to David Baker “for computational protein design” and Demis Hassabis and John M. Jumper “for protein structure prediction”.1 David Baker developed algorithm called Rosetta for de novo protein structure design that results in the creation
10-7 – Intellia Starts Late-Stage Trial of CRISPR Therapy for Angioedema The company is initiating a second Phase 3 study to assess the efficacy of its in vivo CRISPR-based gene editing therapy as a single-dose treatment for hereditary angioedema (HAE).1 HAE is a rare, autosomal dominant genetic disorder that causes
9/26 – Weight-loss Drug Developer BioAge Labs Went IPO The clinical-stage company held its initial public offering (IPO) raising $198 million.1 The company is developing its oral drug azelaprag, an apelin receptor (APJ) agonist, in combination with current weight-loss medications like Eli Lilly’s Zepbound and Novo Nordisk’s
Basic research – target identification and validation The R in R&D refers to basic research groundwork to discover disease mechanisms and potential drug targets that could be modulated to treat the disease. Key aspects of basic research include investigating disease biology at the molecular and cellular level to identify
Traditional small-molecule drugs have been the dominant modality in drug research over the past century. Ever since the first synthetic drug, chloral hydrate,1 was discovered in 1869, small molecule drugs have played an instrumental role in progressing modern medicine and profoundly impacted the society. Apart from the well-known aspirin
Small molecules (small molecules, peptides of up to 40 amino acids in length and oligonucleotides, approved as new molecular entities, NMEs) have been the dominant type of drug since the beginning of modern medicine, but large molecules (biologics, often protein-based candidates, approved through biologics license applications, BLAs) are quickly gaining
India has sought to become the “pharmacy to the world” by becoming the largest global producer and exporter of affordable medicine (generic drugs). Its pharmaceutical industry is worth over $50 billion with medicines exported to over 200 nations and “the highest number” of U.S. FDA compliant plants producing high-quality
The pharmaceutical industry is an industry that discovers, develops, and manufactures pharmaceutical drugs with its subsidiary industries that register, market and distribute these drugs. Over the past two decades, it has experienced significant growth, with worldwide pharma revenue increasing from 390 billion to 1.6 trillion U.S. dollars by