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The ICH M12 guideline has been finalized and global regulatory agencies are already adopting it. Hear DDI expert, Dr. Brian Ogilvie, discuss the important takeaways in this valuable webinar… Register Now > 
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Today’s Big NewsJun 25, 2024 |
| By Gabrielle Masson The Biotechnology Innovation Organization’s CEO John Crowley isn’t shying away from the tough tasks. With only a little more than three months at the helm of the world’s largest biotech advocacy group, the leader has already implemented a wide-scale restructure and taken a firm stance with Congress regarding U.S. biosecurity. |
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By James Waldron An interim analysis has concluded that Merck KGaA's TrilynX study is unlikely to meet its primary objective of prolonging event-free survival. |
By Annalee Armstrong If you're going to be a new biotech in mRNA, it helps to have the type of technology that can draw a big name. That's what Exsilio Therapeutics, which broke cover today with $82 million to create new genomic medicines sprinkled with a side of mRNA, has done. |
Sponsored by Cardinal Health CGT companies should consider developing a market access strategy early in clinical development, ideally more than three years prior to launch. |
By Gabrielle Masson Eli Lilly is teaming up with OpenAI on a quest to develop new treatments that overcome antimicrobial resistance. |
By Helen Floersh Terns Pharmaceuticals’ prediction that its shelved MASH drug TERN-501 could be effective against obesity in a combination treatment appears to be playing out, at least preclinically—apparently without decreasing calorie intake. |
By Gabrielle Masson,Max Bayer We really didn't want to have to create another Layoff Tracker this year. But here we are, launching the third annual iteration tracking biopharma layoffs. |
By Conor Hale Nearly four years after first pitching its multibillion-dollar plan to obtain Grail, Illumina has cut (nearly) all ties with the cancer blood test developer. |
By Fraiser Kansteiner A little over a year after being slapped with an FDA rejection, AbbVie has hit another regulatory wall in its bid to debut a more convenient Parkinson’s disease successor to its established formulation of carbidopa and levodopa. |
By Angus Liu In the U.S. Federal Trade Commission’s latest campaign against what the agency views as “junk” drug patent listings in the FDA’s database, drugmakers have decided not to play ball. A partner at the law firm MBHB explained to Fierce Pharma what could happen next in the fight. |
Fierce podcasts Don’t miss an episode |
| In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker sits down with Bobby Sheng, the CEO of Bora Pharmaceuticals, to discuss the concept of “friend-shoring” in drug manufacturing. |
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On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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