Citeline Podcasts

On the heels of Eli Lilly recently committing $3.3bn across two recombinase-focused deals, the question for the field is which gene editing modality, and which delivery system, will get large genetic payloads safely into the right cells. ElevateBio's chief scientific officer Amy Pooler joins In Vivo's David Wild to argue that the answer isn't one technology, but many. In this episode, Pooler walks through ElevateBio's full editing stack: AI-designed large serine recombinases, retrotransposon-based insertion, generative AI-optimized base editors, and an LNP delivery platform that has now shown re-dosing and therapeutically meaningful editing in non-human primates. She also makes the case for epigenetic editing as a potentially underappreciated modality, one that could compete with small molecules in indications where you want potency and specificity without permanently rewriting the genome. And she explains why ElevateBio, with six consecutive years of revenue growth and a 98% manufacturing batch success rate, sees its end-to-end CDMO model as uniquely positioned to turn those tools into medicines partners can actually bring to the clinic.

Generics Bulletin's editorial team discusses the recent Medicines for Europe legal and annual conferences, attended by executive editor Dave Wallace, as well as the Medicines UK conference attended by reporter Anabel Costa-Ferreira.

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the impact of the US Food and Drug Administration clarifying that journal articles written by former commissioner Martin Makary and others were not official guidance (:58). They also discuss the questions an FDA commissioner nominee could field from Senators based on the recent confirmation hearing for President Trump’s US Centers for Disease Control and Prevention and Health and Human Services Assistant Secretary for Preparedness and Response nominees (15:12).

More On These Topics From The Pink Sheet

US FDA Says Two Makary, Prasad Journal Articles And NPV FAQ Were Not Policy Or Guidance: https://insights.citeline.com/pink-sheet/legislation/us-fda-says-two-makary-prasad-journal-articles-and-npv-faq-were-not-policy-or-guidance-6MCDQTKVXFG7TJ7IWOT6YMW4CA/

US CDC, ASPR Nominees’ Confirmations In Question After Contentious Senate Hearing: https://insights.citeline.com/pink-sheet/agency-leadership/us-cdc-aspr-nominees-confirmations-in-question-after-contentious-senate-hearing-3TX2W6HSXRACJELUX2CYY6ICVY/

Eisai's Michael Irizarry talks to Scrip about broadening Leqembi's use with its subcutaneous version, its ongoing Phase III in treating patients before dementia symptoms appear and news from a Phase II study of it tau-targeting asset, etalanetug.

On the July 2026 edition of the Scrip Deals Podcast, Scrip Senior Writer Joseph Haas and Bruce Leuchter, CEO of Neurvati Biosciences and GRIN Therapeutics, discussed the recent trend of biopharma M&A deals valued at $1bn or greater closing quickly. Recent research showed that closing time for such deals is less than half of how long it took to close a billion-dollar acquisition during the span on 2023-2025.. Leuchter offered some insights on why this might be. Haas and Leuchter also discussed M&A activity during the just-ended second quarter of 2026.

Health literacy is a phrase you hear a lot in consumer health at the moment, but it's not always clear what people mean by it, or what a company is actually supposed to do about it. In this episode of Over the Counter, HBW Insight talks to Trevor Gore, a trustee of the Self-Care Forum who spent more than two decades at Reckitt and now looks at healthcare through behavioural science. Gore's argument is that most companies treat health literacy as a readability job, making labels and leaflets easier to follow, when the harder work is changing what people do: helping them recognize symptoms, understand risk and act on it. We discuss the three levels of health literacy, the gap between what people intend to do and what they actually do, the line between educating and promoting, and why awareness on its own buys you almost nothing.

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the implications of potential regulations that would cement the FDA’s presumption that it can release complete response letters (:49) and effectively ban direct-to-consumer advertising (18:45), as well as a potential reorganization to create a senior FDA position in charge of all medical products (29:23).

More On These Topics From The Pink Sheet

US FDA To Clarify, Expand ‘Significant Discretion’ To Publish CRLs: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/us-fda-to-clarify-expand-significant-discretion-to-publish-crls-NYZ2YV2DCFD6HDJ3XTLRZPXSRY/

US FDA Moves To Eliminate ‘Adequate Provision’ For DTC Broadcast Ads: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/us-fda-moves-to-eliminate-adequate-provision-for-dtc-broadcast-ads-5Y32BOH25JEXVLE4ES2JMFHYLQ/

HHS Considering US FDA Reorganization With Medical Products Chief Overseeing Centers: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/hhs-considering-us-fda-reorganization-with-medical-products-chief-overseeing-centers-7DSI2OHYUBHXTO73OBBDJW2QQA/

Lyme disease is spreading, the last US vaccine was withdrawn in 2002, and the most recent attempt at a new one (Pfizer and Valneva's Phase III candidate) missed its primary endpoint earlier this year. Into that gap steps Tonix Pharmaceuticals with a different idea entirely: skip the vaccine and deliver the antibody directly.

In Vivo's David Wild talks to Tonix CEO Seth Lederman about TNX-4800, a fully human monoclonal antibody targeting OspA on the Lyme-causing bacterium Borrelia burgdorferi. Lederman explains why the unusual biology of OspA makes it better suited to a monoclonal approach than a traditional vaccine, how the antibody works inside the tick's midgut to kill the bacteria and block their migration before they can enter a human host, and what the Phase I data tell us about safety, dosing, and the planned two-dose seasonal regimen. He also discusses the adaptive Phase II field study Tonix is preparing for 2027, the lessons (and the lack of information) from the Valor trial, and the long-term questions around who would use this product, how it would be reimbursed, and whether the health economic case can be made for a seasonal preventive in a disease whose chronic form remains medically and politically contested.

In this podcast, Satish Reddy, chairman of Dr. Reddy's Laboratories, talks about deploying generic Revlimid gains strategically, building a diversified growth engine, what India must fix — regulatory science, risk capital and more — to become a serious innovation force, and learnings from China.

A quick update for our listeners: Scrip now has its own dedicated podcast channel on Spotify and Apple Podcasts.​ ​Be sure to subscribe to get all episodes.

In this episode of the China biopharma English-language podcast, Xu Hu talks about China’s drug regulator finalizing trial data protection measures for drugs registered in the country, and some of the impacts these may have on future licensing deals involving the China market and company strategies in managing product lifecycle and market access in China.

Here are links to the stories this episode is based on:

Impact Of China’s New Data Protection On Deals, Corporate Strategies;

China Finalizes Data Protection Periods;

China Plans Clinical Data Protection By Product Category For First Time