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Lonza Scales Manufacturing for RION’s Exosome Therapeutics
Lonza and RION have entered a collaboration to scale commercial manufacturing of RION’s Purified Exosome Product (PEP), a platform candidate with immunomodulatory and regenerative properties....
New AI-Powered Tools to Optimize Clinical Trial Protocols from Advarra
Advarra has launched Study Design, an AI-driven and data-based solution designed to optimize clinical trial protocols by analyzing 30,000 historical studies to identify inefficiencies and refine...
FDA Approves Stealth BioTherapeutics’ Barth Syndrome Drug After Previous Setbacks
After earlier regulatory challenges including a complete response letter in May, the FDA has granted accelerated approval to Stealth BioTherapeutics’ elamipretide (Forzinity) for treating Barth...
Pfizer Ramps Up Obesity Pipeline With $4.9B Metsera Acquisition
Pfizer has significantly bolstered its position in the obesity therapeutics market by acquiring Metsera Inc. for an upfront $4.9 billion with contingent value rights potentially raising the deal...
Merck's Keytruda Gains FDA Nod for One-Minute Subcutaneous Injection
Merck & Co. secured FDA approval for Keytruda Qlex, a subcutaneous injection formulation of its blockbuster anti-PD-1 cancer immunotherapy. This SC version can be administered in about one minute,...
Bristol Myers Squibb’s Iberdomide Hits Primary Endpoint in Multiple Myeloma Phase 3 Trial
Bristol Myers Squibb reported that its investigational drug iberdomide in combination with Darzalex and dexamethasone met a key primary endpoint in a Phase 3 trial for relapsed or refractory...
Stealth BioTherapeutics’ Barth Syndrome Drug Secures FDA Approval After Previous Rejection
After a prolonged regulatory pathway including an earlier complete response letter, Stealth BioTherapeutics received accelerated approval from the U.S. FDA for elamipretide (Forzinity) for...
Ionis Pharmaceuticals Advances Alexander Disease Treatment with Positive Phase 3 Results
Ionis Pharmaceuticals announced that its antisense oligonucleotide candidate, zilganersen, demonstrated significant clinical benefits in a pivotal phase 3 trial for Alexander disease, a rare...
Genentech Inks $569M Deal with Starpharma to Expand Dendrimer Technology Use
Starpharma Holdings Ltd. reached a substantial outlicensing agreement with Genentech, valued at over $569 million, lifting Starpharma’s stock by 73%. The deal grants Genentech access to...
VedaBio Secures $25M in Funding and Siemens Healthineers Partnership for CRISPR Diagnostics
VedaBio, a developer of amplification-free CRISPR diagnostics, announced the extension of its Series A funding round and a strategic partnership with Siemens Healthineers totaling up to $25...
Myriad Genetics and Sophia Genetics Collaborate on Global Cancer Liquid Biopsy Companion Diagnostic
Myriad Genetics and Sophia Genetics have entered a strategic collaboration to develop and commercialize a cancer liquid biopsy companion diagnostic (CDx) test. The partnership combines Myriad’s...
MapLight Therapeutics Files IPO to Advance Neuropsychiatric Drug Pipeline
Biotechnology company MapLight Therapeutics has filed for an initial public offering on Nasdaq under the ticker 'MPLT,' positioning itself to raise capital to advance its drug development programs...
Capsida Bio Halts Gene Therapy Trial for Rare Neurological Disease After Patient Death
Capsida Bio has paused its SYNRGY trial evaluating CAP-002, an adeno-associated virus-based gene therapy for STXBP1 encephalopathy, following the death of the first treated pediatric patient. The...
Pfizer Closes $4.9B Metsera Deal to Reenter Obesity Market
Pfizer has acquired Metsera for $4.9 billion upfront with potential payments raising the deal to $7.3 billion, regaining a foothold in the competitive obesity drug space after recent internal...
FDA Clears Injectable Keytruda Qlex for Solid Tumors in One-Minute Dose
Merck's Keytruda Qlex, a subcutaneous formulation of its flagship cancer immunotherapy, has received FDA approval, offering a one-minute injection alternative to the traditional 30-minute...
Scholar Rock’s Spinal Muscular Atrophy Drug Faces FDA Rejection Over Manufacturing Issues
The FDA has issued a complete response letter rejecting Scholar Rock’s apitegromab, a treatment for spinal muscular atrophy (SMA), due to unresolved manufacturing quality problems at a contract...
Ionis Pharmaceuticals’ Antisense Drug Shows Promise in Rare Neurological Disease
Ionis Pharmaceuticals reported positive phase 3 trial results for zilganersen, an antisense oligonucleotide for Alexander disease, a rare neurogenetic disorder. The drug demonstrated significant...
New Diagnostic Advances Targeting Acute Leukemia and Cancer Imaging
OGT’s CytoCell KMT2A Breakapart FISH Probe Kit received FDA de novo authorization as a companion diagnostic to identify acute leukemia patients with KMT2A gene translocations eligible for...
Roche’s Oral SERD Wins Phase 3 Breast Cancer Trial, Eyes Market Approval
Roche announced a successful phase 3 trial for its oral selective estrogen receptor degrader (SERD) in a broad breast cancer patient population. The drug outperformed standard of care, marking a...
Emerging Cancer Therapeutics: MBX Biosciences Posts Positive Phase II Data
MBX Biosciences’ experimental once-weekly therapy canvuparatide achieved primary endpoints in a phase 2 study treating chronic hypoparathyroidism, a rare hormone disorder. While statistically...