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Follow along as BioSpace tracks job cuts and restructuring initiatives.

The pivotal study of zilganersen in Alexander disease missed a secondary endpoint, but analysts expect the FDA to approve the asset given the unmet need and overall data.

Eli Lilly and Rigel Pharmaceuticals partnered in February 2021 to advance a pair of RIPK1 blockers, but the pharma in October last year pulled the plug on one of these programs for central nervous system indications.

The deals keep rolling in, with Lilly penning a $7 billion pact for gene delivery biotech Kelonia Therapeutics and UCB taking over cell therapy-focused Neurona Therapeutics; President Trump signed a new executive order supporting the development of psychedelic therapies, sparking fanfare and concern alike; and the FDA’s recent Replimune decision has triggered broader debate about the agency’s flexibility.

Two of the biggest insurance providers have expressed reluctance to participate in the government’s BALANCE program that would have made GLP-1 drugs more affordable to patients.

In the U.S., Moderna withdrew its approval application for the combination vaccine in May last year and the timeline for resubmission remains uncertain.

The newly approved HIV drug Idvynso will also help Merck diversify as loss of exclusivity looms over its top-selling product, the mega-blockbuster cancer drug Keytruda.

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.

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