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Following an initial rejection in 2023, Ascendis Pharma on Tuesday said it faces another regulatory bump in the road for TransCon PTH with a three-month delay in the ongoing FDA review.

After missing their initial target in March 2024, Eisai and Biogen have initiated a rolling BLA for a subcutaneous maintenance formulation of Leqembi, which could offer a more convenient dosing schedule for Alzheimer’s disease patients.

Bayer joined BMS in announcing major overhaul; Takeda drops up to $2 billion for an anti-amyloid drug from AC Immune; and BioSpace reflects on last week’s ASGCT meeting—the good, the bad and the ugly.

Learn how to discuss career gaps and how to be a great hiring manager and interviewer.

Dynavax Technologies announced Tuesday that the FDA issued a Complete Response Letter to the company’s sBLA to include a four-dose regimen of Heplisav-B vaccine for adult hemodialysis patients.

Applications of the technology range from data collection to drug design to raising the alarm on product safety, but its adoption is also creating some anxiety.

In Tuesday’s first-quarter 2024 financial results, Bayer reported a slight drop in sales amid its sweeping companywide restructuring that resulted in workforce reductions, while lowering its full-year earnings outlook.

With Monday’s agreement, AbbVie joins the industry’s growing interest in next-generation psychiatric therapies and looks to leverage Gilgamesh Pharmaceuticals’ research platform to discover novel neuroplastogens.

Cytokinetics released data Monday on aficamten, an oral small molecule inhibitor of cardiac myosin, showing it significantly boosted exercise capacity in patients with obstructive hypertrophic cardiomyopathy.

Presented at this week’s European Congress on Obesity, the two studies also demonstrate that Novo Nordisk’s Wegovy (semaglutide) provides cardiovascular benefits irrespective of starting weight and the amount of weight lost.

Crackdowns on drug pricing have forced one major insulin out of the market. Are more to come?

Takeda on Monday said it is paying AC Immune $100 million upfront for an option on a Phase Ib/II Alzheimer’s disease candidate that could activate the immune system to clear amyloid beta plaques.

The company highlights the critical role of unified digital platforms in ensuring compliance, sponsor trust, and clinical readiness.

Highlights ● Insilico published a new study unveiling Target Identification Pro (TargetPro), a superior disease-specific model, and TargetBench 1.0, the first standardized benchmarking framework for target discovery. ● TargetPro achieved 71.6% retrieval of known clinical targets, a 2–3x improvement over large language models (LLMs) such as GPT-4o, Grok3, DeepSeek-R1, Claude-Opus-4, BioGPT, and public platforms like Open Targets. ● TargetPro’s predicted novel targets demonstrated 95.7% structure availability, 86.5% druggability, and 46% repurposing potential, outperforming competing systems on all measures. ● TargetBench’s explainable AI models revealed disease-specific feature importance patterns, emphasizing the value of disease-specific target identification models. ● New gold standard approaches improve accuracy, reliability, and transparency in AI-driven drug discovery.