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The upcoming FDA decision for Replimune’s advanced melanoma drug could be a litmus test for the agency’s future regulatory decision-making, analysts say, with implications stretching well beyond one company.

While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external controls—the application of this flexibility appears to be inconsistent. One former regulator says the situation is more nuanced.

Nobel laureate Sir Michael Houghton and colleagues at Applied Pharmaceutical Innovation (API) outline how rigorous early testing, smart IP and regulatory planning, and scalable CMC choices can help founders reach first-in-human faster.

Follow along as BioSpace tracks job cuts and restructuring initiatives.

BioNTech envisioned the site making hundreds of millions of vaccines a year, but has since shifted its pipeline to other modalities while mRNA technology continues to face headwinds in the U.S.

While some large companies could start paying the full tariff in 120 days, many products, including orphan drugs, cell and gene therapies, and antibody-drug conjugates, will enjoy exemptions that waive or greatly reduce the levies.

After a flurry of deals over the past week from Eli Lilly, Merck and Biogen, analysts predict more M&A action from other big names, including Novartis, Amgen and AbbVie.

After Eli Lilly achieved the milestone approval of the weight loss pill Foundayo, Novo Nordisk launched a full-court press to defend oral Wegovy, which has been enjoying a record-breaking launch since January.

With CBER director Vinay Prasad set to depart the agency at the end of the month, a coalition of patient groups and biotech executives penned a letter imploring the Trump administration to “restore regulatory clarity” for rare disease therapies. Experts on a BioSpace panel last week also acknowledged the challenges faced by a more stringent FDA.

As Big Pharma companies consider foregoing European drug launches to avoid reducing drug prices in the U.S. in alignment with Trump’s Most Favored Nation policy, patients will suffer.

COVID-19 partners Pfizer and BioNTech have been unable to recruit healthy adults aged 50 to 64 fast enough to deliver relevant post-marketing data. Moderna is apparently also facing enrollment challenges.

In this episode of Denatured, you’ll listen to Dr. Marc Hedrick, President and CEO of Plus Therapeutics and Dr. Phil Kantoff, CEO & Co-founder of Convergent Therapeutics. They discuss breakthroughs like alpha-emitting isotopes, supply chain solutions and why radiotherapeutics is biotech’s next big frontier.

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