Merck and Moderna announced success with their jointly developed intismeran autogene (intismeran), a personalized mRNA-based cancer vaccine, in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 immunotherapy, in preventing the remission and spread of melanoma based on positive top-line results from the Phase 3 INTerpath-001 trial. The trial result marks a groundbreaking
Felzartamab, an anti-CD38 monoclonal antibody, developed by MorphoSys now acquired by Novartis has won its first global approval in China for treating multiple myeloma (MM) in combination with lenalidomide and dexamethasone in adults who have received at least one prior line of therapy. Human Immunology Bioscences (HI-Bio) obtained exclusive licensing
Curium has entered a definitive agreement to acquire Lantheus in a deal worth up to $8 billion. Curium develops, manufactures, and supplies of radiopharmaceuticals used in diagnosing and treating cancer. The company holds patents on the compositions, formulations, purification processes, and systems and methods of use of radioactive isotope of
The Federal Circuit vacated a PTAB final written decision on an inter partes review (IPR) in which Dental Monitoring SAS’s (“Dental Monitoring”) patent directed to a method for acquiring and analyzing an image of a dental arch had been invalidated as obvious. Align Technology, Inc. (“Align”) filed a petition
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