Citeline Podcasts

Pink Sheet reporters and editor discuss the problems that emerged for the US FDA from just the threat of a government shutdown (:38), take-aways on the FDA advisory committee process based on the complete response letter issued for Alnylam’s Onpattro (10:25), and incentives that the FDA could offer for ARPA-H projects that reach the application stage (20:16).

More On These Topics From The Pink Sheet

Shutdown Threat Forced US FDA To Cancel Some Travel: https://pink.citeline.com/PS149003/Shutdown-Threat-Forced-US-FDA-To-Cancel-Some-Travel

Alnylam’s Complete Response Is Classic Example Of FDA-Advisory Committee Disagreement: https://pink.citeline.com/PS149000/Alnylams-Complete-Response-Is-Classic-Example-Of-FDA-Advisory-Committee-Disagreement

US FDA Rejects Onpattro Label Expansion: History Repeats In Reverse?: https://pink.citeline.com/PS149004/US-FDA-Rejects-Onpattro-Label-Expansion-History-Repeats-In-Reverse

ARPA-H, US FDA Discuss Incentives For Game-Changing Health Projects: https://pink.citeline.com/PS148944/ARPAH-US-FDA-Discuss-Incentives-For-GameChanging-Health-Projects

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Lilly’s radiopharmaceutical buy; strong third quarter for biotech financing; Novartis’s nephropathy results; US ICER runs cost analysis on first batch of drugs; and the outlook for US FTC oversight of biopharma M&A.

https://scrip.citeline.com/SC149170/Quick-Listen-Scrips-Five-MustKnow-Things

릴리, 다케다, 아스트라제네카에 이어 MSD, 아스텔라스도 아일랜드에 대규모 투자 동참

https://scrip.citeline.com/SC149047/Pharma-Cash-Keeps-Flowing-Into-Ireland

In this episode, HBW Insight speaks to its own OTC expert, managing editor Malcom Spicer, about recent controversy in the US surrounding oral nasal decongestant active ingredient phenylephrine. Used widely and safely by US consumers for around a half century, the efficacy of oral phenylephrine has come under question following a 2015 citizen petition by University of Florida pharmaceutical researchers, which asked the FDA to remove the ingredient from the final OTC CCABA monograph. Only recently addressing this petition, prompted Spicer points out by reforms to the US OTC monograph system, an FDA advisory panel has unanimously voted that research the FDA presented during a two-day meeting in September didn’t support oral phenylephrine’s efficacy for nasal decongestion at the CCABA monograph dose of 10mg. Drawing on his extensive experience and writing on this topic, Spicer takes us beyond the headlines to the key points you need to know about this crucial development, which may or may not have wider implications beyond the US.

In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to Washington Analysis vice president and senior healthcare analyst John Leppard about the Center for Medicare and Medicaid’s Transitional Coverage Of Emerging Technologies pathway, or TCET. He breaks down the pathway and discusses its pros and cons, as well as potential next steps for the agency. We also explore the history of breakthrough device coverage as well as the challenges for coverage of digital health devices.

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: major Q4 catalysts; Verona’s COPD contender; Alfasigma acquires Intercept; more setbacks for Keytruda/Lenvima combo; and new pressures on China IPOs.

https://scrip.citeline.com/SC149131/Quick-Listen-Scrips-Five-MustKnow-Things

Scrip writers Joseph Haas and Jessica Merrill discuss US FTC overview of biopharma mergers like Amgen/Horizon and Pfizer/Seagen with Leerink Partners' analyst Dan Lepanto and ZS Associates partner Cody Powers.

Pink Sheet reporters and editors consider the fallout from Brainstorm Cell Therapeutics Inc.’s negative US FDA advisory committee decision on its ALS drug (:43), the impact of a government shutdown on the agency (10:00), and a study showing only a limited possibility for significant savings in the first round of Medicare price negotiations (22:58).

More On These Topics From The Pink Sheet

BrainStorm’s NurOwn Gets Many, Many Thumbs Down From US FDA Panel: https://pink.citeline.com/PS148915/BrainStorms-NurOwn-Gets-Many-Many-Thumbs-Down-From-US-FDA-Panel

Preparing For A Shutdown: US FDA To Retain 81% Of Workforce, Thanks Mostly To User Fees: https://pink.citeline.com/PS148923/Preparing-For-A-Shutdown-US-FDA-To-Retain-81-Of-Workforce-Thanks-Mostly-To-User-Fees

Republican Lawmaker Takes Unusual Step Of Attacking FDA Salaries Over Abortion Pill Decisions: https://pink.citeline.com/PS148917/Republican-Lawmaker-Takes-Unusual-Step-Of-Attacking-FDA-Salaries-Over-Abortion-Pill-Decisions

Imbruvica, Enbrel, Stelara Offer Best Chance Of Savings From Medicare Negotiation In First Round: https://pink.citeline.com/PS148916/Imbruvica-Enbrel-Stelara-Offer-Best-Chance-Of-Savings-From-Medicare-Negotiation-In-First-Round

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Novartis gives back Beigene PD-1; BMS revs R&D engine; Anthos changes course for Factor XI asset; the non-incretin pipeline for obesity; and a look at Q2’s top-selling drugs.

https://scrip.citeline.com/SC149111/Quick-Listen-Scrips-Five-MustKnow-Things

In this episode, HBW Insight catches up with UK switch specialists Maxwellia to find out what’s next for the company that gave to the UK one of the first OTC daily contraceptive pills. Now a disruptive consumer health player in its own right, the company is looking for investors to take it to the next level and help launch two new women’s health products in the pipeline for next year, CEO Anna Maxwell reveals in this exclusive interview.