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With an IPO raise of $625 million, Kailera Therapeutics now holds the new record for the largest public market debut.

As technology becomes more integrated and personalized, experts say the biggest opportunity in diabetes management is reducing everyday burdens.

After receiving the FDA’s greenlight for Hunter syndrome drug Avlayah, Denali Therapeutics CEO Ryan Watts saw the culmination of 20 years of hard work unraveling the mysteries of the blood-brain barrier.

While prominent physicians can provide companies with valuable guidance during development, their perspective is limited when it comes to projecting how well or how readily a new product will be adopted. Here’s how to perform rigorous commercial diligence.

Replimune is axing 144 employees at its Woburn headquarters and 80 at its Framingham manufacturing site. The cuts follow the FDA’s second rejection of the biotech’s advanced melanoma candidate.

With programs from Eisai and Hansoh Pharmaceutical in hand, Tortugas Neuroscience has emerged with hopes of delivering daily oral treatments to patients with central nervous system conditions.

A triplet regimen comprising Merck’s Welireg and PD-1 blockbuster Keytruda and Eisai’s Lenvima flopped in a Phase 3 renal cell carcinoma trial.

Moderna, Revolution Medicines and Zymeworks record wins in melanoma, lung and breast cancers, while BeOne swings and misses at head and neck cancer.

The Phase 3 failure has prompted Gilead Sciences and Arcus Biosciences to terminate a mid-stage study of their TIGIT asset in lung cancer.

At Sarepta Therapeutics, we’ve seen it all. Here are the questions I believe we should be asking to move forward in Duchenne muscular dystrophy.

Viatris, which Pfizer created in 2020, voluntarily withdrew extended-release products made at a plant in Ireland after an analysis revealed an issue that could affect bioavailability.

Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.

VINIA’s leadership position in the market validates its superior arterial dilation and blood flow performance as well as BioHarvest’s Botanical Synthesis platform technology

Leveraging its PharmaPatch™ experience, the Company is introducing PatchPrint™ to support existing microneedle patch programs and expand into on-demand personalized patch solutions, including peptide patches, branded wellness patches, manufacturing systems and commercial partnerships.

Ligand-independent mechanism of action of SignaBlok’s first-in-class TREM-1 inhibitors enables development of cell-unspecific and macrophage-targeted TREM-1 inhibitors · In experimental pancreatic cancer, macrophage-targeted but not cell-unspecific TREM-1 inhibitor: − prevents cancer recurrence, improves complete response rate and survival, when administered in a time window of 7 days after standard-of-care (SOC) chemotherapy − reverses immunosuppression and overcomes cancer resistance to anti-PD-L1 immunotherapy · Timely resolution of acute inflammation induced by SOC cancer treatments (chemotherapy, surgery, radiation, radiopharmaceuticals, etc.) can be a common approach to prevent cancer recurrence, increase response rate and survival for not only pancreatic cancer but also other hard-to-treat tumors