Making Medicine

What’s moving in biotech policy right now?

In this Headlines episode of Making Medicine, host John Stanford runs through the month’s top stories shaping how medicines are discovered, developed, and delivered in America. Leading the headlines is the Faster Clinical Trials Act, a new bipartisan proposal to modernize clinical trials, reduce regulatory delays, and speed up drug development.

From there, John covers how Most Favored Nation (MFN) drug pricing is changing launch strategies in Europe, the latest on the COINS Act, why Japan is rethinking its approach to drug pricing, and what October’s investment numbers say about the state of American innovation. 

This month’s headlines:
🔹 COINS Act: Where China investment restrictions meet U.S. biotech competitiveness.
🔹 Faster Clinical Trials Act: Five proposed reforms to expand trial access, streamline FDA processes, and support innovation.
🔹 MFN Drug Pricing: Companies reconsider their European launch strategies.
🔹 Japan’s Pricing Reforms: Encouraging signals for innovation and patient access.
🔹 FDA Approvals Corner: Two new treatments approved in October.
🔹 Biotech Venture Capital: About $1.14 billion invested across 50 early-stage deals.
🔹 London Preview: Making Medicine heads to the Jefferies London Healthcare Conference.

Taken together, these stories point to one question: can the U.S. remain the best place in the world for new medicines? Watch the full episode for a quick, clear rundown of the policy and market news you need to know this month.

Timestamps
00:00 Cold Open: Why Faster Clinical Trials Matter
00:30 Introduction: This Week in Biotech Policy
01:19 Election 2026: What's Next for Biotech?
02:22 Faster Clinical Trials Act: Bipartisan FDA Reform
03:28 Five Proposed Clinical Trial Reforms
05:55 How Faster Trials Could Strengthen Biotech Investment
07:09 MFN Drug Pricing and Global Drug Launches
08:06 Roche and Novartis: Rethinking European Markets
09:20 How MFN Could Impact U.S. Innovation
10:30 COINS Act, China, and Global Competition
11:29 Japan's Drug Pricing Reforms
12:51 FDA Approvals Corner
14:07 October Biotech Investment: $1.14 Billion
15:21 Jefferies London Healthcare Conference
16:19 Closing: The Future of American Biotech

Join the Conversation
⬇️ Should Congress prioritize modernizing clinical trials to accelerate drug development and help American patients access new treatments faster?
Could Most Favored Nation (MFN) drug pricing policies discourage pharmaceutical companies from launching new medicines in Europe and ultimately weaken U.S. biotech innovation?
Can the United States remain the global leader in biotechnology while restricting investment in China and facing growing pressure on drug pricing and research funding?
Drop your thoughts in the comments below 👇

👍 Subscribe to the Making Medicine Podcast for conversations about the science, business, investment, and policy shaping the future of medicine.

If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod
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DISCLAIMER: This podcast discusses biotechnology, pharmaceutical policy, and healthcare innovation for informational purposes. It does not provide medical advice. Consult a qualified healthcare professional for personal medical questions

#FasterClinicalTrialsAct #FDAModernization #MakingMedicine #COINSAct #Biotech #Innovation

Could Treasury’s proposed COINS Act rule make it harder for American patients to get promising new medicines?

The proposed regulations would restrict a broad range of transactions with Chinese companies. That could change how U.S. biotech companies partner, invest, and bring new therapies to American patients. But how far does the rule actually reach?

In this Making Medicine Press Pass episode, host John Stanford welcomes Max Bayer, Senior Reporter at Endpoints News, to break down Treasury’s proposed COINS Act rule and what it could mean for drug development in the United States.

Max shares insights from his reporting and his conversations with Treasury officials. That includes why the rule’s broad language leaves that far from settled for co-development partnerships, joint ventures, and other collaborations.

We explore:
🔹 What the proposed rule means for U.S. biotech partnerships and investment involving China.
🔹 Why licensing remains at risk under the rule’s current language.
🔹 How the rule could give China more control over how medicines are developed and who gets access.
🔹 Treasury’s own acknowledgment of potential risks to U.S. public health and American companies.
🔹 Why biotech is not AI or semiconductors: in drug discovery, the promising science U.S. companies want often originates in China.
🔹 How U.S. leadership is holding up, with record U.S. biotech M&A and rising phase 1 trial activity at home.
🔹What policymakers can do instead: target real security risks, make U.S. clinical trials faster and cheaper, and hold China accountable on market access and IP.

The question for policymakers: Can the United States address real national security concerns without slowing the medicines American patients are waiting for?

Watch the full conversation for an in-depth look at the COINS Act, U.S.-China biotech competition, and the choices that will decide whether America stays the best place in the world to discover, develop, and manufacture new medicines.

Timestamps
00:00 Cold Open: Max Bayer Reacts to COINS Act Rules
00:46 Introduction: Treasury’s Proposed China Biotech Restrictions
01:30 FDA Reform and Other Policy Headlines
02:18 Meet Max Bayer of Endpoints News
03:06 Why China Biotech Became a Major Washington Story
04:39 COINS Act and BINSA: Competing Policy Approaches
07:50 Breaking Down Treasury’s Proposed Regulations
08:23 First Reaction: How Tough Are the Biotech Rules?
09:56 Are Pharmaceutical Licensing Deals Exempt?
10:39 What Treasury Told Max About Licensing
12:23 Could Licensing Continue While Collaboration Slows?
15:23 Co-Development and the Future of Biotech Partnerships
18:29 Treasury Acknowledges Potential Public Health Risks
21:38 Regulatory Uncertainty and Investor Decisions
25:20 National Security vs. Medical Innovation
28:22 How Washington Interprets China Biotech Deals
29:11 The $120 Billion Biobucks Debate
33:31 China’s Strategy and International Competition
35:05 Could Europe and Japan Benefit?
39:33 Europe, MFN Pricing, and Global Drug Access
43:46 Could the World Develop Separate Drug Pipelines?
45:28 The Next Generation of Chinese Medicines
46:12 Patient Access and the Ethics of Restrictions
48:50 Can the U.S. Accelerate Its Own Innovation?
51:24 Does America Still Lead in Biotech?
53:00 Closing Thoughts with Max Bayer
53:34 Subscribe to Making Medicine

Join the Conversation ⬇️
Should the U.S. restrict biotech investment in China if it could limit Americans' access to new medicines?
Do the proposed COINS Act regulations strike the right balance between national security and American biotech innovation?
Should pharmaceutical licensing agreements remain exempt from COINS Act restrictions, even when they involve co-development with Chinese companies?
Drop your thoughts in the comments below 👇

👍 Subscribe to the Making Medicine Podcast for conversations about the science, business, investment, and policy shaping the future of medicine.

If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod
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DISCLAIMER: This podcast discusses biotechnology, pharmaceutical policy, and healthcare innovation for informational purposes. It does not provide medical advice. Consult a qualified healthcare professional for personal medical questions.

COINSAct #ChinaBiotech #MakingMedicine #Biotech #DrugDevelopment

Are American biotech companies really sending $120 billion to China? And could restricting U.S. investment weaken America's position in the global biotech industry?

As Washington debates biotechnology investment restrictions and national security, Making Medicine host John Stanford examines five common claims shaping the conversation about China, pharmaceutical innovation, and American competitiveness.

From the economics of biotech licensing agreements to the role of American venture capital, this episode explores what the headlines may be missing, and why the distinction between announced deal values and actual investment matters. 

We explore
🔹 The $120 billion question: Why announced biotech licensing deals don't necessarily represent money actually paid to Chinese companies.
🔹 American innovation: How U.S. biotech companies can develop medicines originally discovered overseas.
🔹 China's biotech ambitions: Why restricting American investment may not stop China's pharmaceutical industry from growing.
🔹 National security: The importance of distinguishing legitimate security threats from investments in therapeutic drug development.
🔹 Winning the biotech race: Why FDA modernization, research funding, intellectual property protection, and venture capital are central to America's competitiveness.

Featuring examples involving Summit Therapeutics and Candid Therapeutics, Stanford examines how international partnerships can influence drug development, economic value, and patient access. The central question: Can America strengthen its biotech leadership by restricting China, or should it focus on making the United States the best place in the world to develop new medicines?

Timestamps
10:53 Understanding the $120 Billion Headline
11:20 How Biotech Licensing Deals Work
13:35 Myth 2: American Investment Must Stay in America
14:29 U.S. Biotech and Chinese Drug Discoveries
17:29 Myth 3: Cutting Off Investment Will Stop China
18:20 China's Long-Term Biotech Strategy
22:07 Myth 4: Every Biotech Investment Is a Security Risk
23:21 Candid Therapeutics Case Study
26:23 Myth 5: Restricting China Is the Best Strategy
27:11 Strengthening American Biotech
29:22 The Five Myths: Final Takeaways

Join the Conversation ⬇️
Should the U.S. restrict investment in Chinese biotech, or prioritize stronger domestic innovation policies?
How should policymakers distinguish national security risks from legitimate pharmaceutical partnerships?
Can international biotech collaboration strengthen American companies while improving patient access to new medicines?
Drop your thoughts in the comments below 👇 

👍 Subscribe to the Making Medicine Podcast for conversations about the science, business, investment, and policy shaping the future of medicine.

If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod
https://www.instagram.com/makingmedicinepod/
https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true

DISCLAIMER: This podcast discusses biotechnology, pharmaceutical policy, and healthcare innovation for informational purposes. It does not provide medical advice. Consult a qualified healthcare professional for personal medical questions.

#ChinaBiotech #Biotechnology #BiotechInvestment #DrugDevelopment #MakingMedicine ​

Japan has many of the ingredients of a world-class biotechnology ecosystem: leading scientific research, Nobel Prize-winning discoveries, and growing investment. Yet many innovative medicines reach Japanese patients later than in other markets, and some never launch at all.

So what explains the gap?

In this special Tokyo episode of the Making Medicine Podcast, host John Stanford is joined by Michael Gutbrod, Principal at Santé Ventures, and Marian Nakada, former Vice President of Venture Investments at Johnson & Johnson Development Innovation, for a conversation about Japan’s innovation paradox.

Following a week of meetings with Japanese policymakers, biotech executives, and investors, the group explores a key question: how can a country with so many advantages in science and innovation still struggle to attract investment, accelerate commercialization, and ensure timely patient access to new medicines?

The discussion examines the strengths that position Japan for success, including government support for biotechnology, growing venture activity, leading academic research, and emerging startup ecosystems. At the same time, John, Michael, and Marian discuss the policies and incentives in Japan that shape investment decisions, product launches, and the future development of innovative medicines.

The group discusses whether Japan can fully realize its ambitions as a global biotechnology leader while addressing longstanding challenges around drug pricing. Along the way, the guests share insights from their meetings across Tokyo and discuss the opportunities ahead for Japan's life sciences sector.

The conversation also explores:
🔹 Japan's growing biotechnology and life sciences investment opportunities
🔹 AMED funding and support for early-stage biotech startups
🔹 The challenges of translating academic research into commercial medicines
🔹 Why accepting failure matters in biotech entrepreneurship
🔹 Collaboration between universities, startups, investors, and pharmaceutical companies
🔹 Drug pricing and delayed access to innovative medicines
🔹 The relationship between pharmaceutical launches and future R&D investment
🔹 Artificial intelligence, healthcare data, and patient awareness
🔹 Regenerative medicine, radiopharmaceuticals, and emerging technologies
🔹 How companies such as Typewriter Therapeutics could help shape Japan's biotech future


The guests also share their experiences meeting Japanese government officials and discuss the opportunities for Japan to build a more connected, internationally competitive biotechnology ecosystem.

Join the Conversation ⬇️
Can Japan turn its scientific strengths into a thriving biotech startup economy? What needs to change to accelerate patient access to innovative medicines?
Drop your thoughts in the comments below 👇

👍 Subscribe to the Making Medicine Podcast for conversations about the science, business, investment, and policy shaping the future of medicine.

If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod
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Timestamps
00:00 Japan's Emerging Biotech Ecosystem
01:10 Inside BioLabs Tokyo 02:54 Why Investors Are Looking at Japan
03:44 Government Funding and AMED
06:39 Japan's Scientific Strengths
07:25 Cultural Challenges for Biotech Startups
10:13 Collaboration, Risk, and Innovation
13:31 Meetings With Japanese Policymakers
14:51 Drug Pricing and Economic Pressures
17:08 Japan's Drug Lag and Patient Access
18:14 How Drug Pricing Affects Biotech Investment
20:27 The Pharma Talent and Innovation Ecosystem
22:14 Policy Predictability and Investment
24:31 U.S. Drug Pricing Policy and Japan
26:18 Japan's Political Culture and the Orchid Index
29:33 Funding Future Pharmaceutical Innovation
31:16 Patient Awareness and Access to Medicines
33:19 AI and Healthcare Information
35:20 The Economic Value of Innovative Medicines
37:13 Healthcare Data and AI Opportunities
38:38 Radiopharmaceuticals and Nuclear Medicine
40:06 Japan's Next Generation of Entrepreneurs
42:23 Typewriter Therapeutics and Startup Success
45:11 A Wish for Japan's Biotech Future
47:50 Final Thoughts

DISCLAIMER: This podcast discusses biotechnology, pharmaceutical policy, and healthcare innovation for informational purposes. It does not provide medical advice. Consult a qualified healthcare professional for personal medical questions.

#JapanBiotech #Biotechnology #DrugDevelopment #LifeSciences #MakingMedicine

Ohio is emerging as a major U.S. life sciences hub, with growing investment in biotech, gene therapy, biomanufacturing and pharmaceutical innovation. But what does it take to build a competitive biotech ecosystem outside traditional hubs like Boston and San Francisco?

In this episode of the Making Medicine Podcast, host John Stanford sits down with Eddie Pauline, President & CEO of Ohio Life Sciences, to explore how Ohio is building its biotech ecosystem—and how decisions involving research funding, drug pricing and federal policy could shape what happens next.

Eddie explains how research from institutions including The Ohio State University, Cleveland Clinic, Cincinnati Children’s and Nationwide Children’s Hospital is helping fuel the state's growth. Nationwide Children’s alone has been involved in roughly 10% of FDA-approved gene therapies, according to Eddie, helping attract additional gene therapy companies and investment to Ohio.

The conversation also examines how Ohio is working to turn world-class research into companies that start, grow and stay in the state, including targeted investment, innovation districts and a planned $40 million life sciences training center designed to strengthen the workforce pipeline.

We explore
🔹 Why Ohio is becoming a major U.S. biotech hub
🔹 Gene therapy and Ohio’s innovation ecosystem
🔹 NIH and SBIR/STTR funding
🔹 Building and retaining biotech companies
🔹 GLOBE, MFN drug pricing and biotech investment
🔹 China’s growing biotechnology ambitions
🔹 U.S.-China competition in life sciences
🔹 Biomanufacturing and workforce development
🔹 What comes next for Ohio biotech

John also breaks down the newly finalized GLOBE drug pricing model, including its international pricing benchmark, reduced scope and what MFN-style pricing could mean for early-stage biotech investment.

Later, Eddie discusses Ohio's engagement with the National Security Commission on Emerging Biotechnology and competition with China. His message is clear: China’s investment and ambition in biotechnology are real, and the United States cannot take its leadership for granted.

Join the Conversation ⬇️
Can states like Ohio become the next major centers of American biotechnology?
What will determine whether biotech companies build and remain in emerging life sciences hubs?
And what must the U.S. do to remain competitive as China expands its biotechnology capabilities? 
Drop your thoughts in the comments below 👇

👍 Subscribe to the Making Medicine Podcast for conversations about the science, business, policy and innovation shaping how medicines are discovered, developed and delivered to patients.

If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:
https://x.com/MakingMedPod
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Timestamps
00:00 America’s Emerging Biotech Hubs
01:40 GLOBE Drug Pricing & MFN Policy
06:06 Meet Eddie Pauline
10:04 Why Ohio Is Becoming a Biotech Hub
12:32 Gene Therapy & Ohio Innovation
15:22 NIH Funding & Life Sciences Policy
18:07 Building & Funding Ohio Biotech
20:22 Investing in Ohio Life Sciences
22:04 Drug Pricing & Biotech Investment
26:06 U.S.-China Biotech Competition
29:03 Ohio’s Biotech & Biomanufacturing Future 
32:56 Closing

DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

#Biotech #LifeSciences #GeneTherapy #Biotechnology #Ohio

Artificial intelligence could transform drug discovery and biotech, but not necessarily in the ways the biggest AI predictions suggest. Where can AI actually make drug development faster and more efficient, and where does the hype collide with the realities of biology?

In this episode of the Making Medicine Podcast, host John Stanford sits down with Dr. Thomas Kaiser, co-founder and Chief Scientific Officer of Avicenna Biosciences and operating partner at DCVC Bio, for a deep dive into AI, machine learning, drug discovery and the future of biotechnology.

Dr. Kaiser shares how Avicenna used a focused machine-learning approach to design two clinical candidates after making just 11 compounds, compared with the hundreds or thousands of molecules traditionally needed to identify a clinical candidate. He also explains how the company has advanced its ALS program toward first-in-human trials while operating with roughly $25 million in funding.

But this isn't another conversation about AI replacing scientists. Thomas explains why unreliable and irreproducible scientific data can limit AI models, why drug development still requires years of validation, and why claims that AI could deliver “100 years of biotech in the next 10 years” run into enormous scientific and financial constraints. His takeaway is simple: “Good ideas are cheap. Durable ideas are the hard part.”

We explore
🔹 How AI and machine learning are actually being used in drug discovery
🔹 How Avicenna found two clinical candidates after making just 11 compounds
🔹 Why bigger datasets aren't always better for AI drug design 
🔹 The reproducibility problem hiding inside scientific literature
🔹 Why AI can't eliminate the decade-long realities of drug development
🔹 The math behind claims of “100 years of biotech in 10 years”
🔹 Where AI could genuinely transform clinical candidate design
🔹 How electronic health records could unlock new drug discoveries
🔹 Why fragmented U.S. healthcare data could become a competitive disadvantage
🔹 China's growing role in global biotech and drug development
🔹 What the U.S. can learn from faster clinical trial systems abroad
🔹 The pill penalty and investment in small molecule medicines

Thomas also explains where he believes AI can be transformative. When researchers understand the biology and translational pharmacology and can clearly define what a medicine needs to accomplish, AI can become a powerful tool for solving complex drug-design problems.

John and Thomas examine whether fragmented U.S. health data could leave American researchers at a disadvantage to countries with centralized health records, China's growing capabilities in drug development, and how faster clinical trial systems such as Australia's could offer lessons for the United States.

Ultimately, the future of AI in medicine may depend less on making bigger promises and more on understanding exactly where the technology works, where it doesn't, and how scientists can use it to develop better medicines more efficiently.

Read Tom’s op-ed https://www.biospace.com/drug-development/opinion-ai-will-only-revolutionize-drug-discovery-and-development-if-we-play-to-its-strengths

Join the Conversation ⬇️
Where do you think AI will have the biggest impact on drug discovery and development?
Are expectations for AI in biotech moving faster than the science itself?
Could fragmented healthcare data become one of America's biggest disadvantages in the global race for biotechnology innovation?
Drop your thoughts in the comments below 👇

👍 Subscribe to the Making Medicine Podcast for conversations about the science, business, policy and innovation shaping how medicines are discovered, developed and delivered to patients.

If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod
https://www.instagram.com/makingmedicinepod/
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Timestamps
00:00 AI, Biotech & the Future of Drug Discovery
01:41 From Biotech Founder to Biotech Investor
05:38 Avicenna's ALS Drug & First-in-Human Trials
07:41 Building a Biotech With $25 Million 
09:49 How Avicenna Uses AI Differently
11:57 11 Compounds, 2 Clinical Candidates
14:54 What the AI Drug Discovery Hype Gets Wrong
18:03 Why AI Can't Replace Drug Development
23:38 100 Years of Biotech in 10 Years?
26:07 Where AI Can Transform Drug Discovery 
28:19 Is U.S. Healthcare Data a Competitive Disadvantage?
32:48 Can Foreign Health Data Work for U.S. Patients?
35:47 Japan's Biotech Investment Challenge
36:53 China and the Global Biotech Race
40:19 Speed vs. Safety in Clinical Trials 
42:03 Why Australia Can Start Clinical Trials Faster
44:49 Rethinking Risk and Patient Safety
46:15 The Pill Penalty & Small Molecule Innovation

DISCLAIMER: We're reporting on and discussing developments in medicine, biotechnology and healthcare policy, not making medical recommendations. For personal health questions, always consult a qualified healthcare professional. 

#ArtificialIntelligence #DrugDiscovery #Biotech #DrugDevelopment #MakingMedicine

China’s biotech industry is expanding rapidly, reshaping clinical trials, drug development, licensing and the global competition for biomedical innovation. What can the United States learn from what’s happening in China?

In this episode of the Making Medicine Podcast, host John Stanford sits down with Tim Scott, President & CEO of Biocom, following a biotech delegation trip to Shanghai.

Tim shares his firsthand observations of China's life sciences ecosystem, including its approach to clinical trials, patient registries, drug development, biotech investment and pharmaceutical partnerships. 

The conversation examines why major pharmaceutical companies are increasingly looking to China for innovation, how China's investigator-initiated trial system can accelerate development, and what the scale of China's biotech ecosystem could mean for global medicine.

We explore
🔹 Why pharmaceutical companies are increasingly partnering with Chinese biotech
🔹 How China's investigator-initiated clinical trials work
🔹 Patient registries and trial-ready cohorts
🔹 Why China's biotech ecosystem is expanding so quickly
🔹 How drug development and licensing are changing globally
🔹 The role of biosecurity and scientific collaboration
🔹 NIH funding, workforce development and U.S. biotech innovation
🔹 What it takes for the United States to remain competitive in biotechnology
🔹 How AI could reshape the global biotech landscape

One of the episode's central ideas comes from Tim's “playing to win” analogy. Rather than focusing only on limiting competitive threats, he argues that U.S. biotech leadership also depends on continued investment in research, clinical trials, manufacturing, workforce development and scientific innovation.

The discussion also explores the tension between competition and collaboration. Tim describes China and the United States as both competitors and participants in an increasingly interconnected global life sciences ecosystem. His observations offer a firsthand look at how China's biotech capabilities are evolving and what those changes could mean for drug development worldwide.

Join the Conversation⬇️
How significant is China's growing role in global biotech?
What factors will determine the future of U.S. leadership in biomedical innovation?
And where should the balance between international collaboration, competition and protecting sensitive biotechnology research be drawn?
Drop your thoughts in the comments below👇

👍 Subscribe to the Making Medicine Podcast for conversations about the science, business, policy and innovation shaping how medicines are discovered, developed and delivered to patients.

If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod
https://www.instagram.com/makingmedicinepod/
https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true

Timestamps
00:00 China Biotech Competition
01:00 California Life Sciences Leadership
07:45 Pharma Licensing Deals in China
13:10 China Clinical Trials & Investigator-Initiated Trials
20:00 Drug Pricing & Biotech Innovation
23:18 Inside Shanghai’s Biotech Ecosystem
25:28 China’s Biotechnology Growth Strategy
35:28 Biosecurity & U.S.-China Biotech Policy
40:20 Competing in Global Biotech
42:10 The Knicks Analogy: Playing to Win
43:20 NIH Funding & U.S. Biotech Innovation
47:35 AI, China & the Future of Biotechnology
49:58 Closing 

DISCLAIMER: We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

#Biotech #ChinaBiotech #DrugDevelopment #ClinicalTrials #biotechnology

From billion-dollar drug development bets and looming patent cliffs to drug pricing, patient access and the future of U.S. clinical trials, some of the biggest stories in biotech are connected by one question: what will they mean for the medicines patients ultimately receive?

In this episode of the Making Medicine Podcast, host John Stanford breaks down the stories he’s reading and watching across biotechnology, pharmaceuticals and healthcare policy, and explains why they matter beyond the headlines.

We begin with the enormous financial risk behind pharmaceutical R&D, including the fallout from a failed clinical trial following a multibillion-dollar biotech acquisition. It’s a reminder that the risk of developing a new medicine doesn’t disappear when a smaller biotech is acquired by Big Pharma.

John also examines the approaching patent cliff, as major medicines lose exclusivity and pharmaceutical companies look to M&A and new pipelines for future growth. At the same time, generic drugs and biosimilars could bring lower-cost competition and expanded access for patients.

Then, we turn to drug pricing and patient access. What could the latest pricing agreements mean for the proposed GLOBE and GUARD models? And why can an FDA-approved medicine still remain out of reach while insurers determine coverage and prior authorization requirements?

Finally, John looks at the growing cost and complexity of conducting clinical trials in the United States, why more early-stage trials are moving overseas, and what potential regulatory reforms could mean for America's ability to compete in drug development.

We explore
🔹 The high-stakes financial risk behind pharmaceutical R&D
🔹 How failed clinical trials can affect even the largest drugmakers
🔹 The patent cliff reshaping Big Pharma
🔹 M&A and the search for the next generation of medicines
🔹 GLOBE, GUARD and the changing drug pricing landscape
🔹 Why FDA approval doesn't always mean immediate patient access
🔹 Insurance coverage and prior authorization delays
🔹 Why clinical trials are increasingly moving outside the U.S.
🔹 What regulatory reform could mean for American biotech

Join the Conversation ⬇️
Which issue poses the biggest challenge for the future of American medicine: the cost and risk of R&D, drug pricing, patient access or the growing difficulty of conducting clinical trials in the U.S.? What biotech or pharmaceutical story are you watching right now?
Drop your thoughts in the comments below 👇

We we are reading
CNBC: https://www.cnbc.com/2026/09/08/novartis-novn-del-desiran-drug-trial.html
Endpoints: https://endpoints.news/mercks-top-dealmaker-signals-more-ma-as-keytrudas-patent-cliff-nears/
STAT: https://www.statnews.com/2026/09/02/trump-most-favored-nation-drug-pricing-industry-analysts-skeptical/
STAT: https://www.statnews.com/2026/08/26/pancreatic-cancer-drug-rasonque-approved/
NYT: https://www.nytimes.com/2026/09/04/opinion/clinical-trials-drugs-science.html

👍 Subscribe to the Making Medicine Podcast for more conversations about the science, business and policies shaping how medicines are discovered, developed and delivered to patients.

If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: https://x.com/MakingMedPod
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Timestamps
00:00 Biotech News: What We’re Reading
00:59 Novartis, Avidity & the Risk of Pharma R&D
04:05 Big Pharma’s Patent Cliff & M&A Strategy
06:49 GLOBE, GUARD & Most Favored Nation Drug Pricing
08:37 FDA Approval vs. Patient Access to Cancer Drugs
11:41 Why U.S. Clinical Trials Are Moving Overseas
14:17 Closing

DISCLAIMER: We're reporting on and discussing developments in medicine, biotechnology and healthcare policy, not making medical recommendations. For personal health questions, always consult a qualified healthcare professional. 

#Biotech #DrugPricing #DrugDevelopment #PatientAccess #MakingMedicine

Why does a small molecule medicine get nine years on the market before Medicare negotiation while a biologic gets 13? And what does that four-year difference mean for the medicines that do get developed?

For 9/13 Day, the Making Medicine Podcast is revisiting some of our most important conversations about the pill penalty and its impact on biotech investment, drug development and patients.

Under the Inflation Reduction Act, small molecule medicines become eligible for Medicare drug price setting after nine years, compared with 13 years for biologics. That difference may sound small, but investors and biotech leaders argue it can significantly change the economics of developing a new medicine.

In this special episode, host John Stanford explains why some small molecule investment continues despite the pill penalty, why 13 years isn't a “magic number,” and why the later years of a medicine's life can be so important to recovering the enormous cost and risk of drug development.

We also revisit conversations with investors, scientists and industry leaders who explain how the 9-versus-13-year distinction factors into real-world decisions about which technologies, companies and medicines receive investment.

Plus, we look at the EPIC Act, legislation supported by Incubate that would eliminate the disparity by giving small molecule medicines and biologics the same 13-year timeline. The concern isn't parity for its own sake, the years between nine and thirteen can be some of the most commercially important in a medicine's lifecycle. Shortening that runway for biologics wouldn't fix the underlying incentive problem; it would just extend it to another class of medicines.

The question isn't simply whether nine years sounds like enough. It's whether public policy is unintentionally encouraging scientists and investors to pursue one type of medicine over another, and what that could ultimately mean for patients.

We explore
🔹 What the “pill penalty” actually means
🔹 Why small molecules receive nine years while biologics receive 13
🔹 Why some investors still fund small molecule medicines
🔹 Why the later years of a drug's commercial life matter
🔹 How the pill penalty can influence biotech investment decisions
🔹 Why small molecules remain important to cancer and other diseases
🔹 What Incubate's Life Science Investment Tracker is finding
🔹 Why investors say policy can influence small molecule vs. biologic development
🔹 How the EPIC Act would address the 9-versus-13-year disparity
🔹 What changing investment incentives could ultimately mean for patients

Join the Conversation ⬇️
Do you think small molecule medicines and biologics should receive the same timeline before Medicare negotiation?
Should policymakers consider how drug pricing policies affect investment decisions years before a medicine reaches patients?
Could the 9-versus-13-year distinction change which medicines ultimately get developed?
Drop your thoughts in the comments below 👇

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Timestamps
00:00 Why Invest for 9 Years When You Can Get 13?
00:21 What Is the Pill Penalty?
03:32 How the Pill Penalty Changes Biotech Investment
07:49 Why Do Biologics Get 13 Years?
09:16 Why Years 9–13 Matter for Drug Revenue
12:22 Why Small Molecule Drugs Still Matter
19:31 9/13 Day and the EPIC Act
21:24 The Data on Declining Small Molecule Investment
24:33 How Price Controls Affect Biotech Investment
34:40 Do Investors Really Favor Biologics?
36:35 Closing

DISCLAIMER: We're reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.

#PillPenalty #biotech #drugdevelopment #drugpricing #MakingMedicine

A new pancreatic cancer medicine could double survival time. Its annual list price? $480,000. That number is getting lots of attention, but the economics of bringing breakthrough medicines to patients are more complex than a single price tag can convey.

After more than a decade of development and billions of dollars invested, Revolution Medicines has brought a new treatment to patients with metastatic pancreatic cancer, one of the deadliest forms of cancer. Yet much of the public discourse has focused on its $480,000 annual list price. In this episode of the Making Medicine Podcast, host John Stanford examines what that price actually represents and what it can tell us about the costs, risks, and economics of medical innovation.

What does it really cost to develop a breakthrough cancer medicine? How much of a drug's list price does the manufacturer actually receive? What role do insurers, rebates and payer negotiations play? And when a medicine clearly works, who should ultimately be responsible for ensuring patients can access it?

John examines the economics behind the headline, including Revolution Medicines' reported billions in accumulated losses, the enormous cost and risk of oncology drug development, and the complicated insurance system standing between an approved medicine and the patients who need it.

Plus, we break down a packed month of biotech and pharmaceutical policy news in Washington: new Most Favored Nation drug pricing agreements, the CMS GLOBE and GUARD models, U.S. biotech deals involving China, the fight over America's biotechnology competitiveness, and the nomination of Dr. Heidi Overton to lead the FDA.

We also look ahead to the next FDA user fee agreement and what changes could mean for smaller, venture-backed biotechnology companies before closing with our FDA Approvals Roundup and the latest medicines reaching patients.
 
We explore
🔹 Why a new pancreatic cancer drug carries a $480,000 list price
🔹 What Revolution Medicines invested before reaching its first approval
🔹 Why drug list prices don't necessarily reflect what manufacturers receive
🔹 Insurance, rebates, and patient access
🔹 The economics and risks behind developing new cancer medicines
🔹 Most Favored Nation drug pricing and new White House agreements
🔹 CMS GLOBE and GUARD drug pricing models
🔹 U.S. biotech investment, China and national security
🔹 The nomination of Dr. Heidi Overton to lead the FDA
🔹 What the next FDA user fee agreement could mean for biotech
🔹 New FDA approvals across cancer, rare disease and other conditions

Join the Conversation ⬇️
When a new medicine costs billions of dollars and more than a decade to develop, how should we determine what a fair price looks like?
Should the debate over a $480,000 cancer drug focus more on the manufacturer’s list price or what patients and insurers ultimately pay?
How can America make breakthrough medicines accessible to patients while still encouraging investment in the next generation of treatments?
Drop your thoughts in the comments below👇

Read Incubate's comments on GLOBE and GUARDhttps://www.incubatecoalition.org/post/incubate-submits-comments-on-globe-guard-comments

👍 Subscribe to the Making Medicine Podcast for more conversations about the science, policy, investment and innovation shaping the future of American medicine.

If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more: 
https://x.com/MakingMedPod
https://www.instagram.com/makingmedicinepod/
https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=true

Timestamps
00:00 Why Does a Cancer Drug Cost $480,000?
00:24 Welcome to Making Medicine
01:08 New White House Drug Pricing Deals
03:04 $20 Billion in U.S. Pharmaceutical Investment
03:55 What Drug Price Controls Could Mean for Biotech
06:15 CMS GLOBE and GUARD Explained
08:17 Congress Takes Aim at Biotech Deals With China
10:09 Is China Becoming a Biotech Superpower?
11:03 The Truth Behind the $136 Billion China Biotech Number
13:20 U.S. Biotech, China and National Security
15:36 Who Will Lead the FDA?
17:18 What's Next for FDA and Biotech?
20:00 A Breakthrough in Pancreatic Cancer
22:49 The Economics Behind Revolution Medicines
26:32 What Does the $480,000 Drug Price Really Mean?
27:51 Will Insurers Cover a Drug That Works?
30:21 Why the List Price Isn't the Whole Story
31:23 FDA Approvals Roundup
34:36 Closing

DISCLAIMER: We're reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.
 
#biotech #drugpricing #pancreaticcancer #pharmaceuticals #fda #MakingMedicine