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Biotech IPOs Are Back: First Four For Fall Hit The Road

 
• By Stacy Lawrence

After a slow August and early September, Wall Street is preparing for four biotech IPOs. Biotech IPOs have been on fire, outperforming even the vigorous biotech indices. But the question remains – can public investors get too much of a good thing?

Companies, bankers and venture capital firms are taking advantage of a wide-open initial public offering window this fall. At least four biotech companies are currently on IPO road shows with offerings slated to price during the week of Sept. 16. This signals the beginning of what’s expected to be an onslaught of IPO fundraising over at least the next few months. And investors have seen solid gains on roughly four out of five biotech IPOs on U.S. markets this year.

But, as always, some are starting to wonder when the flood of supply will start to overwhelm investor demand. At...

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Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 
• By Eliza Slawther

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

Future Of US FDA’s Diversity Action Plan Guidance ‘Up In The Air’ As Statutory Deadline Looms

 
• By Sue Sutter

A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.

Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
• By Kate Rawson

Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.

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Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
• By Kate Rawson

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UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
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LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
• By Brian Bossetta

The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.