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PTSD and psychiatric innovation via neuroplasticity
Otsuka Pharmaceutical moved into experimental psychiatry by announcing a $700 million acquisition of Transcend Therapeutics through its U.S. subsidiary, Otsuka America. The deal could add up to...
Regulatory approval for rare-disease gene therapy
The FDA granted accelerated approval to Rocket Pharmaceuticals’ gene therapy Kresladi for severe leukocyte adhesion deficiency type 1 (LAD-1), clearing a pathway after an earlier rejection tied to...
Immunology dealmaking to refresh Xolair-era allergy pipeline
Novartis agreed to acquire Excellergy in a deal valued at up to $2 billion, targeting next-generation anti-IgE immunology programs that could extend the franchise as Xolair faces biosimilar...
FDA approval expands brain-penetrating protein therapy platform
Denali Therapeutics received FDA approval for Avlayah, a therapy for Hunter syndrome that leverages Denali’s proprietary delivery technology designed to cross the blood-brain barrier. The approval...
CRISPR patent fight heads back into focus after USPTO reaffirmation
Editas Medicine said the USPTO reaffirmed an earlier decision supporting broad inventorship priority for CRISPR/Cas9 genome editing in a dispute involving the Broad Institute and other...
Oncology device-class diagnostics: molecular test improves bile duct cancer detection
Researchers at the University of Pittsburgh School of Medicine and the University of Pittsburgh Medical Center Hillman Cancer Center developed BiliSeq, a 28-gene DNA-based next-generation...
Strategic pipeline reshaping at Innate Pharma
Innate Pharma ended development of its NK cell engager IPH6501 after a Phase 1/2 program for B-cell non-Hodgkin lymphoma, citing strategic pipeline prioritization. The company said the trial has...
Gene therapy company pushes from preclinical into gene-editing platform validation
Beam Therapeutics presented updated clinical proof-of-concept data for BEAM-302, a base editing program for alpha-1 antitrypsin deficiency (AATD), reporting restoration of functional protein...
Funding: oral peptide platform attracts fresh capital
Pinnacle Medicines raised $89 million in a Series B financing to support development of its oral peptide programs, bringing total funding to $134 million. The round was co-led by LAV and Foresite...
Biotech M&A momentum in oncology: Merck buys Terns for $6.7B
Merck agreed to acquire Terns Pharmaceuticals in an all-cash $6.7 billion transaction, aiming to bolster its oncology portfolio as Keytruda approaches the patent cliff. The deal values Terns at...
Patent fight over CRISPR/Cas9 inventorship
Editas Medicine said the USPTO reaffirmed an earlier PTAB decision finding Broad Institute-affiliated inventors were first to conceive CRISPR/Cas9 genome editing in eukaryotic cells, including...
FDA approval of first-ever longer-acting once-weekly insulin
The FDA approved Novo Nordisk’s once-weekly insulin for type 2 diabetes, establishing the first US-authorized longer-acting alternative to daily basal treatment for this indication. The approval...
New FDA clearance for rare immune disorder gene therapy
The FDA cleared Rocket Pharma’s gene therapy Kresladi for severe leukocyte adhesion deficiency type 1 (LAD-1), an ultra-rare disorder that can leave children vulnerable to life-threatening...
Big pharma M&A to build immunology and allergy pipeline
Novartis announced it will acquire Excellergy for up to $2 billion in upfront and milestone payments, aiming to expand its IgE-focused immunology portfolio amid looming competition around Xolair....
Big pharma acquisition to diversify oncology hematology exposure
Merck (MSD outside North America) agreed to acquire Terns Pharmaceuticals for about $6.7 billion in an all-cash deal, adding TERN-701 to its oncology portfolio. Merck will pay $53 per share, and...
FDA accelerated approval for Hunter syndrome drug
The FDA granted accelerated approval to Denali Therapeutics’ Hunter syndrome drug Avlayah (tividenofusp alfa), according to STAT+. The approval follows a period of tougher rare disease scrutiny...
Clinical efficacy and safety update for AstraZeneca’s COPD antibody
AstraZeneca reported Phase 3 wins for its investigational COPD antibody in trials that showed success in broader-than-expected populations, following an earlier mid-stage failure. The company’s...
Oncology diagnostics: FDA review submission for kidney transplant rejection test
Insight Molecular Diagnostics submitted its GraftAssureDx kidney transplant rejection test to the FDA for de novo review, the company said. The digital PCR-based assay measures fractional...
Direct-to-cell delivery innovation and regulatory pathway progress
Idel Therapeutics raised €9 million (about $10.4 million) seed funding to advance cytotoxic intracellular drug delivery technology directly into tumor cell cytosol. The company’s platform targets...
Regulatory path for molecular oncology testing in Europe
Invivoscribe obtained CE-IVDR certification for its IdentiClone Dx IGH assay, a kit designed to detect immunoglobulin heavy chain (IGH) gene rearrangements in patients with suspected...