Market News & Trends
MedPharm Adds First-to-File Generic Topical Drug to Commercial Manufacturing Portfolio
MedPharm has added a first-to-file generic topical drug product to its commercial manufacturing portfolio under a new supply agreement. Manufacturing will take place at its 110,000-square-foot facility in Durham, North Carolina.
Simtra Adds $250M Sterile Manufacturing Facility to Indiana Campus
Simtra BioPharma Solutions has opened a $250 million, 150,000-square-foot sterile manufacturing facility in Bloomington, Indiana, expanding capacity for sterile injectable drug production and adding approximately 450 jobs.
Eric Cantor Assumes New Role as President and CEO of PhRMA
Eric Cantor assumed his role November 9 as president and CEO of PhRMA, succeeding Stephen J. Ubl. His priorities include patient access, AI in drug discovery, and the biopharmaceutical workforce.
PharmaLogic to Acquire Lantheus Radiopharmaceutical Manufacturing Facility
PharmaLogic Holdings will acquire Lantheus’ CDMO business and Springfield, New Jersey radiopharmaceutical facility. The deal expands Agilera’s U.S. manufacturing for radioligand therapies and includes a long-term supply agreement.
Microneedle Patches Could Improve Stability and Delivery of mRNA Vaccines
Microneedle patches could improve the stability and delivery of mRNA vaccines, according to a review in AAPS Open. Dissolving patches may ease cold-chain requirements and simplify administration.
FDA Clears Bayer’s SUNHARBO for Secondary Stroke Prevention
FDA has approved Bayer’s SUNHARBO (asundexian), the first Factor XIa inhibitor in the U.S., to lower recurrent stroke risk after ischemic stroke or high-risk TIA. In Phase 3, it cut ischemic stroke rate by 26% versus placebo.
iDEL Therapeutics Partners with Daiichi Sankyo to Evaluate Novel Cancer Drug Delivery Platform
iDEL Therapeutics has entered a multi-year research collaboration with Daiichi Sankyo to evaluate a multi-drug conjugate delivered using its synthetic shuttle technology. The preclinical work will compare the candidate against an antibody-drug conjugate and explore ways to overcome cellular uptake and endosomal entrapment.
Daewoong Group Advances Two Drug Delivery Platforms Targeting Injectable Biologics and Microneedle Applications
Daewoong Pharmaceutical, Daewoong Therapeutics and Daewoong Bio are advancing Thermicra, a high-concentration subcutaneous platform, and CLOPAM, a dissolvable microneedle system, toward commercialization.
Eye Drop Candidate Targets Multiple Pathways in Diabetic Macular Edema
Industrial Technology Research Institute is developing a small-molecule eye drop for diabetic macular edema that targets ROCK and PKC pathways and could offer a non-invasive alternative to injections.
GT Biopharma Explores KRAS Inhibitor Combination Following Positive Pancreatic Cancer Study Results
GT Biopharma’s NK cell engager GTB-5550 combined with a KRAS inhibitor showed stronger tumor control in preclinical pancreatic cancer models, and the company is evaluating a Phase 1b combination study.
SK Biopharmaceuticals Launches U.S. Market Entry Platform for Korean Life Sciences Companies
SK Biopharmaceuticals will support 31 Korean life sciences companies entering the U.S. through its SK Life Science LinX platform, offering space, regulatory consulting, and partner introductions.
Microneedle Biosensors Show Potential for Real-Time, Minimally Invasive Diagnostics
A review in Discover Pharmaceutical Sciences finds microneedle-based biosensors could offer less invasive continuous monitoring across diabetes, cancer, neurological disorders and kidney disease.
Abbott and Novo Expand Semaglutide Partnership Across Asia Pacific With New Brand Launch
Abbott and Novo are expanding their collaboration to commercialize Plosbrio (semaglutide) across Singapore and additional Asia Pacific markets. The agreement aims to broaden access to semaglutide treatment for adults with type 2 diabetes.
MediPharm Labs Clears European Regulatory Hurdle for Metered-Dose Cannabis Inhaler
MediPharm Labs has secured a positive regulatory opinion from BSI Group, marking a key step toward bringing its metered-dose cannabis inhaler platform to the UK and selected European markets.
Thermo Fisher Introduces Compact Imaging System for Protein and Nucleic Acid Gels
Thermo Fisher has launched the Invitrogen iGlow Gel Documentation System, a compact imaging platform that streamlines routine protein and nucleic acid gel analysis.
Dipharma Enters UK Market Through Acquisition of Rare Disease Pharmaceutical Partner
Dipharma has acquired UK partner LogixX Pharma, establishing a direct commercial presence in the UK for rare and chronic disease treatments.
T-Therapeutics Secures $133M to Advance Cancer and Autoimmune Disease Therapies Into Clinical Trials
T-Therapeutics has raised $133 million in Series B financing to advance two TCR-based therapies for cancer and autoimmune diseases into clinical trials.
AstraZeneca Eyes $10B Rhythm Pharmaceuticals Acquisition to Expand Rare Disease Portfolio
AstraZeneca has reportedly offered about $10 billion to acquire Rhythm Pharmaceuticals, expanding its rare disease portfolio into specialized obesity therapeutics including Imcivree.
Shilpa CDMO Invests $50 Million to Expand Peptide Manufacturing Capacity in India
Shilpa CDMO is investing $50 million to expand peptide manufacturing capacity in India, adding SPPS reactors and a new commercial production line in Raichur.
Emvena Therapeutics Launches With Funding to Develop Placenta-Targeted Preeclampsia Treatment
Emvena Therapeutics has emerged from stealth to advance a placenta-targeted mRNA approach to treating preeclampsia, a serious pregnancy complication.
