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The acquisition gives Johnson & Johnson access to Firefly Bio’s next-gen platform designed to create degrader antibody conjugates that can crack the tricky KRAS cancer target.
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The FDA has expanded the regulatory toolkit during President Donald Trump’s second term, adding new mechanisms for rare diseases while putting the Biden-era platform technology designation into action.
As the FDA tries to clarify its intent for former FDA Commissioner Marty Makary’s plausible mechanism framework for bespoke therapies, experts emphasize the importance of expanding its scope to encompass rare diseases that affect more than just one or a few individuals.
Analysts and investors were unimpressed by Phase 2 data posted in the spring showing that an amylin analog developed by Roche and partner Zealand Pharma elicited 9% weight loss, less than Eli Lilly’s rival candidate. Executives from both companies told BioSpace that premium weight loss is not the point of petrelintide.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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Entrada Therapeutics saw a 2.36% dystrophin increase in patients treated with its oligonucleotide asset—a number that fell short of the company’s prior guidance of a double-digit improvement.
Acting Center for Drug Evaluation and Research Director Tracy Beth Høeg reportedly disagreed with staff who wanted to approve Sanofi’s type 1 diabetes drug. It’s far from the first time a political appointee has allegedly meddled in a recent FDA decision.
Sarepta Therapeutics has put in place several initiatives to help its gene therapy Elevidys return to growth, but recovery will take a long time, according to company executives.
With Siran Biotechnology under its fold, GSK will have access to a long-acting siRNA therapy that could induce weight loss while preserving lean mass, in addition to addressing other weight-related comorbidities.
In this episode of Denatured, you’ll be hearing from Georg Vo Beiske, CEO of Tribune Therapeutics and Jonas Hallén, co-founder and Chief Medical Officer of Calluna Pharma. We dive into IPF and fibrosis challenges, unpacking treatment hurdles, emerging targets, unmet needs and expansion paths beyond the lung.
Panel interviews can play a major role in getting jobs. Two career coaches discuss what to do before and during the interview, including identifying how to differentiate yourself, engaging in true conversations and not overlooking a key panel member.
Biotech R&D job postings live on BioSpace rose for the fourth straight month in April, and a CBRE report shared similar findings for employment. The head of CBRE’s U.S. life sciences practice discusses what’s behind the growth and the current job market.
Opportunities increased by the end of the first quarter, according to BioSpace data.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
Sanofi’s investment will support a Canadian site’s efforts to apply AI to drug production, while Amgen has unveiled the second expansion of its Puerto Rico plant in quick succession.