Eiger and its COVID treatment are in a state of purgatory after murky FDA guidance suggests its unknown whether the company will nab emergency use authorization. In March, the company said the treatment passed a phase 3 test and slashed the risk of hospitalizations.

Synaffix has landed another antibody-drug conjugate partner. After inking deals with Genmab and MacroGenics this year alone, the Dutch biotech has landed a partnership with Emergence Therapeutics that could be worth $360 million.

Iveric Bio is coming for Apellis Pharmaceuticals. Tuesday, the biotech revealed its second late-phase geographic atrophy clinical trial has hit its primary endpoint and outlined plans to file for FDA approval in the eye disease by the end of the first quarter.

A team of researchers from two French universities has found that the absence of gonadotropin-releasing hormone could be driving olfactory dysfunction and cognitive decline in people with Down syndrome. In a small, pilot study published in Science, the team also showed that restoring GnRH could improve cognitive performance.

In recent years, artificial intelligence developers have changed the face of medicine with algorithms capable of detecting the earliest signs of cancer. Owkin, meanwhile, is taking a slightly different approach with its own cancer-spotting AI.

Virginia’s Advanced Pharma Manufacturing and R&D Cluster is getting a $52.9 million boost. The funding comes as part of a $1 billion federal government competition to address critical manufacturing and supply issues in the U.S.

The Prostate Cancer Foundation is “challenging Americans” to show their support for men impacted by prostate cancer by getting active and eating healthfully during Prostate Cancer Awareness Month this September.

CDMO giant Lonza inked a deal with Touchlight to expand production and distribution of the biotech’s so-called doggybone DNA platform.

CVS Health has won the bidding war for home health and technology services company Signify Health.

Several months after the FDA unveiled a framework to help manufacturers forge risk management plans aimed at combating drug shortages, two trade group heavyweights are sounding their discontent.

How can we predict the ability of a preclinical drug to inadvertently cause or intentionally inhibit cytokine secretion and T cell activation

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TwinRCTs require fewer patients and shorten trial timelines for rare neurodegenerative diseases.

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What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations?

Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

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