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FDA’s oncology advisors vote against ‘new paradigm’ in AstraZeneca trial

FDA’s oncology advisors vote against ‘new paradigm’ in AstraZeneca trial

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In its first meeting in about nine months, the FDA’s advisory committee of oncology experts voted 6-3 Thursday that a late-stage trial for AstraZeneca’s oral SERD camizestrant didn’t show a “clinically meaningful” benefit.

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STAT+: Hair-raising trial results, and Servier’s M&A wishlist

Why are investors excited about hair loss drugs? Will artificial intelligence make clinical trials run more smoothly? And how does a nonprofit pharma company compete in the M&A arena?

We get into all that and more on this week’s episode of “The Readout LOUD,” STAT’s weekly biotech podcast.

Veradermics CEO Reid Waldman joined us to discuss his company’s data, and why hair loss is such a trendy topic in biotech. Then, Servier Pharmaceuticals CEO David Lee joined us to discuss the company’s acquisition of Day One Biopharmaceuticals. The hosts also discussed the latest news in biotech.

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Why are investors excited about hair loss drugs? Will artificial intelligence make clinical trials run more smoothly? And how does a nonprofit pharma company compete in the M&A arena?

We get into all that and more on this week’s episode of “The Readout LOUD,” STAT’s weekly biotech podcast.

Veradermics CEO Reid Waldman joined us to discuss his company’s data, and why hair loss is such a trendy topic in biotech. Then, Servier Pharmaceuticals CEO David Lee joined us to discuss the company’s acquisition of Day One Biopharmaceuticals. The hosts also discussed the latest news in biotech.

Continue to STAT+ to read the full story…

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Genomics Pioneer and Life Sciences Entrepreneur J. Craig Venter Dies at 79

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J. Craig Venter, PhD, the founder, board chair, and CEO of the J. Craig Venter Institute (JCVI) has died in San Diego following a brief hospitalization for unexpected side effects that arose from the treatment of a recently diagnosed cancer, reported the JCVI in a press statement.

Venter helped define modern genomics and launch the field of synthetic biology. He was skillful in building interdisciplinary teams, pushing for new ideas and faster methods, and insisting that discovery should translate into real-world impact. He was also a major advocate for strong federal science funding and for partnerships that accelerate progress across government, academia, and industry.

“Craig believed that science moves forward when people are willing to think differently, move decisively, and build what doesn’t yet exist,” said Anders Dale, PhD, president of JCVI. “His leadership and vision reshaped genomics and helped ignite synthetic biology. We will honor his legacy by continuing the mission he built—advancing genomic science, championing the public investments that make discovery possible, and partnering broadly to turn knowledge into impact.”

“Venter has been recognized as an essential force in the impetus to evolve genomics from a slow, academic discipline into a fast-moving, data-driven, and commercially relevant enterprise, leaving a lasting imprint on biotechnology, medicine, and synthetic biology,” says John Sterling, GEN’s Editor in Chief, who has known and worked editorially with Venter over the past 35 years.

“Venter was controversial and often challenged the scientific orthodoxy, with critics accusing him of hype and going overboard on privatization. To many, he was a visionary focusing on technological acceleration and blending academic science with the zeal of an entrepreneur. Supporters saw him as a pioneer who sped up genomics by years.”

At the NIH, he played a key role in driving gene discovery using expressed sequence tags (ESTs), enabling rapid identification of large numbers of human genes and accelerating genome mapping efforts. He went on to lead efforts that, along with the NIH, produced the first draft sequences of the human genome, a milestone that helped usher biology into the digital age. He and colleagues later published the first high-quality diploid human genome, demonstrating the importance of capturing genetic variation inherited from both parents.

In synthetic biology, the Venter group constructed the first self-replicating bacterial cell controlled by a chemically synthesized genome—proof that genomes could be designed digitally, built from chemical components, and “booted up” to run a living cell. He also pursued scientific discovery at global scale.

Through the Sorcerer II Global Ocean Sampling Expedition, metagenomics was used to reveal amazing microbial diversity, reporting the discovery of millions of new genes and expanding the known universe of protein families—work that deepened understanding of the ocean microbiome and its impact on planetary systems.

Beyond his scientific achievements, and in addition to founding the JCVI, he also co-founded Synthetic Genomics, Human Longevity, and most recently Diploid Genomics, advancing efforts to translate genomics and synthetic biology into tools for the benefits of human health and environmental sustainability.

 

The post Genomics Pioneer and Life Sciences Entrepreneur J. Craig Venter Dies at 79 appeared first on GEN – Genetic Engineering and Biotechnology News.

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Merck drops early-stage TROP ADC, keeps deal doors open as Keytruda clock ticks

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On the heels of several big buys, Merck still has eyes for M&A—particularly in the oncology, immunology and cardiometabolic spaces—as the quest continues for a candidate that can top Keytruda.

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