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We explain what types of agency meetings can be sought in the EU, US, Japan, China, and Canada, and provide details to guide requesting and preparing for agency interactions. Learn more.
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Today’s Big NewsAug 10, 2023 |
| By Nick Paul Taylor Novo Nordisk is keeping its foot on the gas as it strives to carve out a strong position in the exploding obesity market, inking a deal worth up to $1.1 billion to buy a biotech that is dusting off an old approach to triggering weight loss. |
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By Annalee Armstrong And just like that, we have a crowded race to be the first approved NASH treatment—a market that could grow to $108.4 billion globally by 2030. |
By James Waldron Galera Therapeutics has slammed the emergency button in the wake of a complete response letter from the FDA for a radiotherapy complication drug, jettisoning 70% of its employees as the biotech’s stock sinks. |
By Nick Paul Taylor Inovio is making its third round of layoffs in 13 months. Facing a long path to approval, the biotech has stopped its cervical lesion program to focus on its most promising, closest-to-market programs, putting 58 people out of work in the process. |
By Gabrielle Masson Part of EQRx’s implosion earlier this year included cutting ties with China-based Lynk Pharmaceuticals. However, Lynk seems to have safely removed itself from EQRx’s wreckage, as its eczema asset improved area and severity in a phase 2 clinical trial. |
By Max Bayer Some six months removed from laying off a quarter of its staff, Surrozen has once again found itself in cash preservation mode, culling two research programs to save money. |
By Gabrielle Masson American Gene Technologies (AGT) may be a little bit dizzy with all this spinning. The biotech has inked a blank-check deal for subsidiary Addimmune, signing off the HIV-focused unit to special purpose acquisition company 10X Capital Venture Acquisition Corp. III. |
By Helen Floersh Scientists and clinicians studying COVID-19 have long suspected that the disease doesn’t just affect the lungs, but many other organ systems too. Now, researchers have identified a mechanism that could explain why and reveal new pathways to find treatments for long COVID. |
By Angus Liu Johnson & Johnson is digging its multiple myeloma moat deeper. The FDA has signed off on the company's Talvey, a first-in-class bispecific antibody targeting GPRC5D. |
By Andrea Park Kim Kardashian took to Instagram on Tuesday to boost the (already high) profile of scanning service provider Prenuvo. |
By Nick Paul Taylor The self-regulatory body of the German communications industry has accused BioNTech of trying to pull out of a public debate about vaccine patents. BioNTech received the warning after it asked Twitter to “hide” its account ahead of an online campaign that targeted developers of COVID-19 vaccines in 2020. |
By Dave Muoio A new analysis of hospitals' posted prices finds major differences in charged prices by plan, even when the hospital, insurer and service are all equivalent. |
By Conor Hale Glympse Bio, developer of an injectable diagnostic platform, has been acquired by Sunbird Bio, which plans to point the companies’ resources toward a new blood test for Alzheimer’s disease. |
Fierce podcastsDon’t miss an episode |
| | This week on "Podnosis," we take a closer look at intersectionality and a group that has been ignored: intersex individuals. |
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