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All Episodes

BioSpace — 229 episodes

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Title
1

Makary’s out at FDA, Sanofi’s priority voucher issues, top exec pay

2

Fibrosis, IPF and the search for better therapies

3

Pfizer, Lilly, more report Q1, FDA names acting CBER director and an ALS awakening

4

What makes life science angel investment work?

5

Q1 earnings take off, Lilly strikes deals, Regeneron notches historic approval, FDA raises questions

6

The next era of diabetes management

7

Trump’s psychedelics push, Lilly’s up to $7B CAR T deal, Replimune’s saga and Denali’s big win

8

Funding the Future of European Biotech

9

J&J targets $100B revenue, Replimune rebuffed again and a “Revolution” in pancreatic cancer

10

Bonus: Q1 2026 Job Market Update

11

Automation, Collaboration and the Future of Advanced Therapies

12

Lilly’s Foundayo Nod Launches New Battle With Novo, M&A Mania Continues, Tariffs Hit Pharma

13

The Radiotherapeutics Moment: How Isotopes are Changing Cancer Treatment

14

Biopharma M&A Heats Up, Rare Diseases Win Three Approvals, Wave Crashes

15

Beyond Buzzwords in Longevity Investing

16

Gilead’s Ouro Buy, J&J/Protagonist’s Approval, Aurinia’s Revamp, ACIP Confusion, More

17

Inside the Race to Build the Next Generation of AI Drug Discovery Platforms

18

Kennedy’s Vaccine Agenda Stalled, Structure’s ‘Competitive’ Obesity Pill, Novo’s Warning Letter

19

From Two Trials to One, Sponsors Face a Higher Standard

20

Prasad Out at FDA, Lawmaker Takes Action on Rare Disease Rejections and a Spate of Obesity Data

21

Rising Amid Flurry of CAR T Deals, Stylus Proves Cell Therapy Is Not Dead

22

From Grants to Family Offices: Building a Unified Financing Strategy in Biotech

23

UniQure’s Delay, REGENXBIO’s Rejection Explained, Sarepta’s Ingram Steps Down, More

24

ALS Advances Unite Patients and Pharma on Novel Targets, Biomarker Breakthroughs

25

Lilly Bests Novo Again, Rare Disease Week Goes Regulatory, More CDC Leadership Upheaval

26

Corsera Eyes Two-Pronged Approach To Tackle Leading Cardiovascular Killer

27

Redefining Obesity Treatment Beyond GLP-1 Limits

28

Modernagate Fallout, Disc’s Rejection, Compass’ Psilocybin Data, CDC’s Lost Leaders

29

As FDA Moves Away From Animal Testing, AI and Organoids Can Shine

30

Digital Pathology, AI and the Future of ADCs and HER2 Cancer Treatment

31

Weight Loss Drama Compounds on Heels of Novo, Lilly Earnings, Plus Gene Therapy News

32

Programmable RNA 2.0: Beyond the First mRNA Revolution

33

Pfizer’s Metsera Data, 2025 Earnings, the FDA and REGENXBIO, Psychedelics and IPOs

34

Biotech’s New Cycle, JPM Deal Hype and Where Alpha Still Hides

35

Roche Makes Obesity Splash, Moderna Cans Vaccine Trials, Sarepta’s New Data, More

36

From Sound Bites to Signals: Editors Parse Executive and Investor Chatter at JPM

37

JPM26 Recap, Novo’s Oral Wegovy Soars as Lilly’s Orforglipron Is Delayed, IPOs Return

38

Bonus: Q4 2025 Job Market Update

39

Deals Roll at JPM26, Policy Front and Center, IPOs Are Back, FDA Stays Busy

40

From Nuclear Winter to Renewal: Biotech Investing for 2026

41

Novo Launches Oral Obesity Pill, Lilly Targets Lofty Revenue, FDA and M&A in Focus

42

Inside the 2026 Biotech Landscape: Innovation, Investment and Global Momentum

43

Lilly’s Triple Triumph, Prasad’s COVID Error, J&J’s Surprise Voucher, M&A Targets

44

Beyond the Gluten-Free Diet: A New Era in Celiac Disease Treatment

45

Weight Loss Waves, Pazdur’s Exit and FDA Instability, New Neuro Breakthroughs

46

New Approach Methodologies: Redefining Animal Testing Alternatives

47

Prasad’s Leaked FDA Memo, Alzheimer’s Ups and Downs, Next-Gen Obesity Drugs

48

Billions More in M&A, Another Bidding War and More FDA Drama

49

How Biotech Funding is Changing Executive Search and Hiring Processes

50

Pfizer Wins Metsera, Trump Strikes GLP-1 Pricing Deal, FDA Awards More Priority Vouchers

51

Thoughtful Tech: How Removing Technological Burdens Can Improve Clinical Trial Compliance and Patient Experience

52

Pfizer and Novo Battle Over Metsera, Tidmarsh Fights FDA Exit, UniQure and Sarepta Face Setbacks

53

Innovation, Resilience, and the Future of Global Manufacturing

54

Novartis’ Big Buy, Q3 Earnings, Regeneron’s Dropped Cell Therapy, More

55

How Supply Chain Turbulence is Reshaping Biotech Strategy

56

Novo Board Upended, ESMO Excitement, FDA Awards, Replimune’s U-Turn

57

Cost Control to Capability Building: Rethinking Supply and Strategy in Pharma

58

Work Smart, Build Trust: Connecting Technology, Patient Compliance and Data Processing

59

Q3 Earnings Are Here, Novo Ditches Cell Therapy but Buys Akero, Gov’t Shutdown Hits CDC

60

Bonus: Q3 2025 Job Market Update

61

Shutdown Pauses New Drug Reviews, CDC Issues New COVID Guidance, CGT Meets on Mesa

62

Hit Me With Your Best Shot: Understanding Autoinjectors and Combination Drug Delivery Systems

63

M&A Picks Up, Walmsley Moves On, Pfizer’s MFN Deal and Hope for Huntington’s

64

FDA’s Autism Endeavor, Pfizer’s Obesity Comeback Bid, Psychedelics Revival, ACIP Confusion, More

65

What Do AI and Hammers Have in Common?

66

China Crackdown, UK Exit, Novo Layoffs, Adcomm Flip Flop, More

67

Unpacking the Latest MAHA Report, RFK’s Senate Appearance, FDA’s CRL Drop and More

68

The 'Research Safety Net' Saving Scientists from Funding Crisis

69

CDC Faces Critical Meetings Amid COVID Vaccine Uncertainty, Plus Deals, FDA Approvals, More

70

Lilly’s Obesity Pill Heads to the FDA, AbbVie Bets on Psychedelics, HHS Unveils More Change

71

Oral Weight-Loss Race Heats Up as New Data From Lilly, Viking Reset Expectations

72

Why AI Won't Save the 90% of Clinical Trials That Still Fail

73

MAHA Report Emphasizes Vaccines, Safety Vexes Viking’s Obesity Win, Novo Gains Momentum

74

The Hidden Patent Crisis That Could Break Biotech: What Every CEO Needs to Know

75

Prasad Returns, Delany Departs, Lilly’s Weight Loss Pill Disappoints and Sarepta’s Fallout Continues

76

From Chat Bots to World Order: The Race for the 21st Century's Operating System

77

FDA In Flux, Pfizer Talks to Trump on MFN, Merck Cuts 6K Jobs, More

78

We Don't Own Patient Data–We're Just Babysitting It

79

Sarepta Gets Reprieve, RFK Jr.’s New Changes, Roche’s Alzheimer’s Comeback and Q2 Earnings

80

Sarepta’s Wild Week, CDER’s New Leader, FDA Rejections, Manufacturing Billions

81

Why Countries Are Racing to Build mRNA Factories While America Hesitates on Next-Gen Vaccines

82

AI Is Taking Over Drug Safety Monitoring–But There's One Thing It Can't Replace

83

FDA Layoffs, 200 Rejection Letters, User Fees and Priority Vouchers, Bad Week for Rare Disease

84

Bonus Episode: Q2 2025 Job Market Update

85

The mRNA Revolution You Haven't Heard About: From Cystic Fibrosis to Personalized Cancer Vaccines

86

Second Half Milestones, KalVista’s Surprise Approval, Another RFK Jr. Lawsuit, More

87

CAR T Expands, M&A Ticks Up, Two Psychedelics Read Out, and the Supreme Court Rules on PrEP

88

Understanding the FDA's AI Guidance in Pharmacovigilance

89

FDA Churn Continues, RFK Faces Congress, Obesity Insights at ADA, BIO2025 Recap

90

Navigating Funding Freezes and AI Frontiers

91

Another Gene Therapy Death; Biopharma M&A Picks Up; a Vaccine Board of Vaccine Skeptics

92

RFK Axes CDC Vaccine Advisors ; Metsera’s Weight Loss Win; FDA Supports CGT

93

AI's Role in Decoding the FDA's New Regulatory Communications

94

M&A Ticks Up, ASCO Excites and Vaccines Cause More Drama

95

COVID-19 Vaccine Overhaul, Rocket Grounded, ‘One Tough Hombre’ on MFN

96

How Target Product Profiles Guide the Industry Through Uncertain Times

97

Pfizer’s $6B China Deal, Drug Pricing and FDA’s New COVID Vaccine Plan

98

Trump’s Drug Pricing Policy, Prasad’s CBER Nod, Bayer’s Layoffs and Galapagos’ Next Chapter

99

Eroding Immunity: Vaccine Hesitancy and Cynicism

100

Trump’s US Manufacturing Push, New Vaccine Policy, Novo’s Weight Loss Pill up for FDA Review

101

Tariffs Continue to Dominate Q1 Earnings, AACR Excites Cancer Space, CEO Pay Gaps, More

102

Economic Challenges, Strategic Investments: Reshaping the Women's Health Landscape

103

Makary’s First Interview, US Manufacturing Push and Lilly vs. Novo in Obesity Pill Race

104

Tariff Turmoil, FDA’s Future, Pfizer’s Obesity Setback and CEO Salaries Revealed

105

Bonus: Q1 2025 Job Market Update

106

Breaking Down Barriers: The Nuanced Approach to Women's Representation in Medical Research

107

Tariff-Triggered Recession Fears, Fallout From HHS Cuts, Knockoff GLP-1s and More

108

FDA on Fire, Novo’s Mixed Bag of Semaglutide Cardio Data, Kisunla’s EU Miss, More

109

Balancing Protection and Inclusion: The Evolution of Women in Clinical Trials

110

Trump’s Pharma Tariffs, Monarez for CDC, Novo’s New Obesity Play, More

111

Sarepta’s Elevidys Death, FDA’s Vaccine Move, Weldon Whiplash, PDUFAs in Cardio

112

A Conversation With Mark McKenna, CEO of Mirador

113

“Perfect Patient” Industry Burdens; Exits and Investment in Women’s Health

114

COVID Reflections, Novo’s Next-Gen Weight Loss Struggles, Another Depression Miss, More

115

Tariff Threat Continues, More Meetings Cancelled, AbbVie Makes Obesity Play, More

116

A Conversation With Kevin Marks, CEO of Delphia

117

Money Meets Medicine: A Disruptor's Guide to Life Sciences Investment

118

Trump’s Pharma Tariffs, Another GLP-1 Compounding Lawsuit, Bluebird’s Bailout, More

119

Examining Gene Therapies, Bispecific Antibodies and Other Novel Modalities

120

Trump’s Hammer Hits FDA, Moderna Falls Further and Patent Cliffs Loom

121

A Conversation With Dannielle Appelhans, CEO of COUR

122

Navigating Patient Journeys with Tom Whitehead

123

New M&A Action, BMS’ Ongoing Cost Cuts and the Insatiable Demand for Weight Loss Drugs

124

RFK Jr. Advances, Q4 Earnings Roll Out and a Non-Opioid Pain Drug Hits the Market

125

The Patient's Perspective with Tom Whitehead

126

RFK Jr. Faces the Senate, Sage Rebuffs Biogen, Obesity Space Expands, More

127

Trump Takes Over, Wegovy Still Trails Zepbound and BioSpace Recaps JPM

128

Bonus: Q4 2024 Job Market Update

129

A Conversation with Peter Marks: Insights into GenScript Biotech Forum 2025

130

Dispatches From JPM, Biogen’s Sage Buyout Offer, Pfizer’s Obesity Play, More

131

A Conversation with Peter Marks and Tom Whitehead: Insights into GenScript Biotech Forum 2025 (Teaser)

132

NextGen Class of 2025, M&A Uptick Predicted Heading Into JPM, FDA Decisions to Watch

133

Trials and Capital: Women’s Health and APAC's Healthcare Revolution

134

Analysis vs Beliefs, CEO Challenges, GLP-1 Investments

135

Biopharma’s Manufacturing Push and Other 2024 Trends

136

Highlights From ASH, Lilly and Novo’s Manufacturing Boon, Momentum in Neuro, More

137

Previous Investment Patterns Set to Repeat in 2025

138

Biopharma’s Shopping Spree, Applied Crashes on Rejection, Skysona’s Safety Concerns, More

139

BridgeBio’s ATTR-CM Approval, Cassava’s Alzheimer’s Failure, Trump’s Cabinet Picks, More

140

51%: The Untapped Market

141

RFK Jr.’s HHS Nomination, Biogen’s Lupus Win and Leqembi Struggles, Neurogene’s Rough Month, More

142

AbbVie’s Surprise Schizophrenia Flop, AstraZeneca’s China Drama, Hope in Huntington’s, More

143

Investing in AI: Benefits, Regulatory Challenges

144

Lilly’s Q3 Miss, Novo’s MASH Win, CAR T’s Autoimmune Pivot, More

145

Pfizer’s Q3 Earnings Win, Deals Galore, Countdown to Election, More

146

Steady But Slow: Future Outlook for Investment

147

Trodelvy’s Bladder Cancer Withdrawal, Sage Therapeutics Layoffs, Sanofi’s Radiopharma Investment, More

148

Q3 Earnings Kick Off With J&J, Bluebird in Tough Spot, Novo-Catalent Deal Under Fire, More

149

How AI Could Ease Tension in Clinical Trials

150

BioSpace at Meeting on the Mesa, WuXi Considers Selling U.S. Facilities, Big Pharma Layoffs, More

151

BMS’ Schizophrenia Approval, Pfizer’s Sudden Sickle Cell Withdrawal and Roche’s Pharma Day

152

AI Return on Investment: Just Because We Can, Should We?

153

Novo Grilled By Senate, PhRMA’s IRA Win and BMS’ KarXT Awaits Approval

154

Sickle Cell Gene Therapies Reach Patients, Moderna Cuts, Obesity Pill Race and ESMO 2024

155

AI Promises: Funding Data Literacy and Reality First

156

BioMarin Fails to Reassure Investors, Terns Moves Forward in Obesity, ESMO Excitement

157

Lilly’s DTC Obesity Push, Layoffs, and an Eye on Ocular Diseases

158

Future-Proofing: Inclusive and Protective Patient Strategies

159

A Tough Ending, New Beginnings and China-U.S. Biopharma Relations

160

New IRA Drug Prices, Lots of Layoffs, Moderna’s Vaccine Opportunity

161

Eyes Wide Open: Gaining Patient Trust in the Face of Evolving Women’s Health Policies in State Legislations

162

Lykos Rejection, Pfizer’s RSV Win, Lilly Vs. Novo and More

163

Pharma Campaign Contributions, Vaccine Hiccups and Lykos’ Moment of Truth

164

The Political Shape of the Future Clinical Trial Space

165

2 Earnings Bonanza, M&A Accelerates and Alzheimer’s Data

166

Layoffs Persist, GLP-1s Launch for Weight Loss in China

167

Who Is Driving The Bus - Drug Developers & Healthcare Providers or AI?

168

Pfizer’s Oral GLP-1 Push, Lilly Vs. Novo and PBMs Under Pressure

169

Lilly’s I&I Play, ADC Investment and GLP-1 Momentum Persists

170

FDA Approves Lilly’s Donanemab While Rejections Highlight Manufacturing Issues

171

DE&I: Understanding That We Don’t Understand at Molecular Level

172

Sarepta’s Big DMD Approval, Alnylam’s Clinical Win and ADA Highlights

173

BioSpace at #DIA2024: Workforce Trends, Trial Design, Peter Marks & Recap

174

Challenging Research Models to Improve Health Equity

175

BIOSECURE’s Surprise Absence, the $100+ Billion Future Weight-Loss Market, DIA and More

176

BioSpace at #DIA2024: Convergence and Collaboration

177

Donanemab’s Promise, BIO Wrap and Mass Layoffs

178

BioSpace x DIA: Robust Integrated Regulatory Strategies

179

The ABCs of Biopharma This Week: ASCO, BIO and Cancer

180

BioSpace x DIA: Advanced Therapy Product Regulatory Confusion

181

AstraZeneca’s Ambitious Target, Pharma Layoffs Continue and ASCO

182

BioSpace x DIA: Navigating the Emergence of CGT Combination Products

183

Bayer’s New Strategy, Novo Vs. Lilly and Psychedelics

184

Bayer Layoffs, a Big Alzheimer’s Deal and ASGCT Wrap

185

Women's Health: Where Politics and Science Meet

186

ASGCT, Adcomm for Lilly’s Donanemab, Vertex Vs. Bluebird

187

BioSpace Heads to #ASGCT, Along with Thousands in Cell and Gene Therapy

188

The IRA, BMS’ Big Cuts, First WHIM Approval

189

Where Do We Go From Here? The Future of Women's Health

190

Sanofi Layoffs, CAR-T Warnings and a New GLP-1 Player

191

Amylyx and ALS, Continued ADC Excitement, Dire Drug Shortages

192

It's a Design Problem: Women and Clinical Trials

193

Alphabet Soup: AACR and ACC Dominate Headlines This Week

194

Did WuXi Make a Whoopsie? US-China R&D Relations in Limbo

195

Will the IRA’s Focus on the Pharmaceutical Industry Hurt the World’s Healthcare System Instead of Helping Patients?

196

Bayer’s sweeping executive cuts, Wegovy’s expanding reach

197

Money talk: Salary trends and raises

198

Historic approval for MASH, CAR-Ts in the spotlight

199

The unintended consequences of small molecules

200

The skinny on weight loss, donanemab and the State of the Union

201

The ABCs of ADCs: Why antibody-drug conjugates are so hot right now

202

The gap is where the pain is: Drug pricing and patient costs

203

Sweet succession: Gonzalez, patent thickets and his triumph over biosimilars

204

Iovance wins with Amtagvi and the ADC train chugs on

205

Eyes on the prize: Novo buys Catalent

206

Balancing act: Patient access and innovation

207

Keep calm and CAR-T on?

208

What can biopharma expect from the job market?

209

Grab an umbrella, it's raining ⁠IPOs⁠!

210

Optimistic, but for how long? Our big takeaways from #JPM2024

211

On the ground at #JPM2024 - Day 3 highlights

212

On the ground at #JPM2024 - Day 2 highlights

213

On the ground at #JPM2024 - Day 1 highlights

214

Alternative funding strategies to discuss at JPM with Halia Therapeutics, the ADDF and Triumvira Immunologics

215

The top life sciences startups to watch this year

216

What VCs look for when investing with MPM Capital, Endeavor Venture Fund and Two Bear Capital

217

Every move you make: Biopharma industry under heavy scrutiny

218

What VCs really think of the market right now with MPM Capital, Endeavor Venture Fund and Two Bear Capital

219

Major FDA approvals for Vertex/CRISPR; bluebird gets black box warning and price scrutiny

220

Fast and furious evolution: How to ensure AI is catalyst for positive societal change with Microsoft and IQVIA

221

Integrating AI in life sciences to change employee behavior with Microsoft and IQVIA

222

GLP-1 and ADC rollercoasters pick up speed

223

Artificial Intelligence, Part 3: Improving Communication to Impact Patient Behavior

224

Artificial Intelligence, Part 2: Human Interaction, Liability, and Patient Safety

225

Deals, Dupixent and GLP-1 drug shortages

226

First ever CRISPR gene therapy approval: What happens next?

227

Artificial Intelligence, Part 1: Bias, Access, ROI, Potential Success and Failure

228

Zepbound vs Wegovy: A two horse race

229

Q3 earnings recap: Winners, losers & surprises