BioSpace

Inside Germany’s biotech capital infrastructure and innovation engine

21 May 2026

Contributed by Lukas

In this episode of Denatured, as part of our series of the European life science investment ecosystem, you'll be hearing from Regina Hodits, managing...

FDA’s absent leaders, the millions pharma CEOs make, and pancreatic cancer’s momentum

20 May 2026

Contributed by Lukas

FDA Commissioner Marty Makary officially resigned last week following reports of his ouster. Then, the acting directors for the agency’s two main re...

From MSCs to iPSCs: building the cell therapy future

14 May 2026

Contributed by Lukas

In this episode of Denatured, you'll be hearing from Miguel Forte, president of the International Society for Cell and Gene Therapy (ISCT), and John E...

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

13 May 2026

Contributed by Lukas

Moments after recording this episode of The Weekly, FDA Commissioner Marty Makary announced his resignation. Reports first circulated last Friday that...

Fibrosis, IPF and the search for better therapies

07 May 2026

Contributed by Lukas

In this episode of Denatured, you'll be hearing from Georg Vo Beiske, CEO of Tribune Therapeutics and Jonas Hallén, co-founder & Chief Medical Of...

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

06 May 2026

Contributed by Lukas

First quarter earnings continue to roll in, with Pfizer, Eli Lilly, Amgen and more reporting in the past week. While Pfizer beat consensus estimates, ...

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

06 May 2026

Contributed by Lukas

First quarter earnings continue to roll in, with Pfizer, Eli Lilly, Amgen and more reporting in the past week. While Pfizer beat consensus estimates, ...

What makes life science angel investment work?

30 Apr 2026

Contributed by Lukas

In this episode of Denatured, you'll be hearing from Yaniv Sneor, founder of the Mid Atlantic Bio Angels and Alex Pederson, an investor at Mid Atlanti...

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

29 Apr 2026

Contributed by Lukas

First quarter earnings are coming in at a rapid pace, with Sanofi and Novartis defending patents for Dupixent and Lutathera, respectively, and Sanofi ...

The next era of diabetes management

23 Apr 2026

Contributed by Lukas

In this episode of Denatured, you'll be hearing from Dr. Sarah Howell, CEO at Arecor Therapeutics and Dr. Wendy S. Lane, clinical endocrinologist and ...

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

22 Apr 2026

Contributed by Lukas

After entering the CAR T arena in February, Eli Lilly jumped onto the in vivo bandwagon, penning a deal worth up to $7 billion for Kelonia Therapeutic...

Funding the Future of European Biotech

16 Apr 2026

Contributed by Lukas

In this episode of Denatured, you'll be hearing from Edoardo Negroni, co-founder & managing partner at AurorA-TT and Naveed Siddiqi, senior partne...

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

15 Apr 2026

Contributed by Lukas

Johnson & Johnson kicked off Q1 earnings season with a “modest” beat, raking in $24.1 billion in sales as it targets $100 billion in revenue i...

Bonus: Q1 2026 Job Market Update

14 Apr 2026

Contributed by Lukas

Listen to BioSpace’s Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel discuss 2026 job market performance so far, sh...

Automation, Collaboration and the Future of Advanced Therapies

09 Apr 2026

Contributed by Lukas

In this episode of Denatured, you'll listen to Jason Jones, head of global business development at Cellular Origins and Alexander Seyf, founder & ...

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

08 Apr 2026

Contributed by Lukas

Eli Lilly won FDA approval last week for orforglipron—now Foundayo— officially launching what promises to be a heated battle between Lilly and chi...

The Radiotherapeutics Moment: How Isotopes are Changing Cancer Treatment

02 Apr 2026

Contributed by Lukas

In this episode of Denatured, you'll listen to Dr. Marc Hedrick, President and CEO of Plus Therapeutics and Dr. Phil Kantoff, CEO & Co-founder of ...

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

01 Apr 2026

Contributed by Lukas

Biogen, Eli Lilly and Merck spent more than $20 billion in the past week to swallow biotechs with approved products or promising drug candidates—rep...

Beyond Buzzwords in Longevity Investing

26 Mar 2026

Contributed by Lukas

In this episode, you'll be listening to Sergey Jakimov, managing partner at LongeVC and Artem Trotsyuk, operating partner, US, LongeVC. We discuss how...

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

25 Mar 2026

Contributed by Lukas

Immunology & inflammation stole the show this week, as Gilead dropped up to $2.1 billion for Ouro Medicines and its T cell engager OM336—an inve...

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

19 Mar 2026

Contributed by Lukas

In this episode, you'll be listening to  Akshay Rai, principal, Healthcare & Biotech Investments at Premji Invest and Viswa Colluru, CEO and foun...

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

18 Mar 2026

Contributed by Lukas

Biopharma’s weight loss warriors have led the news this week, with Structure Therapeutics and Rhythm Pharmaceuticals announcing new data. Structure ...

From Two Trials to One, Sponsors Face a Higher Standard

12 Mar 2026

Contributed by Lukas

In this episode of Denatured, you'll listen to Oxana Iliach, senior director of regulatory strategy at Certara and Vera Pomerantseva, director of ...

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

11 Mar 2026

Contributed by Lukas

After Friday’s news that Center for Biologics Evaluation & Research Chief Vinay Prasad will leave the FDA—again—at the end of April, stocks ...

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

10 Mar 2026

Contributed by Lukas

Stylus Medicine CEO Emile Nuwaysir and Chief Scientific Officer Jason Fontenot speak with BioSpace about the biotech's work on next-generation ...

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

05 Mar 2026

Contributed by Lukas

In this Denatured episode, Jennifer C. Smith-Parker speaks to Ram May-Ron, managing partner at FreeMind Group, and Ravi Kiron, managing director at Bi...

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

04 Mar 2026

Contributed by Lukas

The FDA is dominating the headlines once again thisweek.  Days after FDA Commissioner Marty Makary appeared to question uniQure’s gene therapy cand...

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

26 Feb 2026

Contributed by Lukas

In this episode, you'll be listening to Indu Navar, CEO and founder of EverythingALS and Dr. Olga Uspenskaya, chief medical officer at VectorY The...

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

25 Feb 2026

Contributed by Lukas

Eli Lilly notches another win over Novo Nordisk, as Zepbound bests CagriSema in a head-to-head trial sponsored by Novo; The FDA kicked off Rare Di...

Corsera Eyes Two-Pronged Approach To Tackle Leading Cardiovascular Killer

24 Feb 2026

Contributed by Lukas

Corsera Health’s Chief Operating Officer Rena Denoncourt and CFO Meredith Kaya speak with BioSpace about the biotech’s mission and vision fo...

Redefining Obesity Treatment Beyond GLP-1 Limits

19 Feb 2026

Contributed by Lukas

In this episode, you'll be listening to Jane Hughes, President of R&D and Co Founder of Verdiva Bio, and Jon Rees, CEO and cofounder of MitoRx...

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

18 Feb 2026

Contributed by Lukas

Last week, the FDA declined to review Moderna’s mRNA-based flu vaccine, with Center for Biologics Evaluation and Research Director Vinay Prasad hims...

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

17 Feb 2026

Contributed by Lukas

Last year, the FDA announced it would be phasingout animal testing requirements for some therapies. The NIHfollowed suit. According to Thomas Hartung,...

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

12 Feb 2026

Contributed by Lukas

In this episode of Denatured, Jennifer C. Smith-Parker speaks with Dr. Rob Monroe, Vice President and Chief Scientific Officer of Oncology at Danaher ...

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

11 Feb 2026

Contributed by Lukas

Last Thursday, Hims & Hers launched a compounded versionof Novo’s oral Wegovy, approved just before Christmas and launched in early January. Nov...

Programmable RNA 2.0: Beyond the First mRNA Revolution

05 Feb 2026

Contributed by Lukas

In this episode of Denatured, Jennifer C. Smith-Parker speaks to Erik Digman Wiklud, CEO of Circio and Jacob Becraft, CO-founder and CEO of Strand The...

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

04 Feb 2026

Contributed by Lukas

Pfizer reported the first data from its new obesity pipeline, picked up in the nearly $10 billion acquisition of Metsera last fall. While BMO Capital ...

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

29 Jan 2026

Contributed by Lukas

In this episode of Denatured, Jennifer C. Smith-Parker speaks with RTW’s Rod Wong and Stephanie Sirota how shifting JPM deal timing masks record M&a...

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

28 Jan 2026

Contributed by Lukas

Roche made the biggest splash this week so far, announcing on Tuesday that GLP-1/GIP injectable CT-388 led to 22.5%weight loss in a Phase II trial. Th...

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

22 Jan 2026

Contributed by Lukas

In this episode of Denatured, BioSpace editorial team members, Senior Editor, Annalee Armstrong, and News Editor, Dan Samorodnitsky, discuss their pos...

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

21 Jan 2026

Contributed by Lukas

The 2026 J.P. Morgan Healthcare Conference concludedlast week without a big M&A deal. But the meeting was anything but boring, with President Dona...

Bonus: Q4 2025 Job Market Update

19 Jan 2026

Contributed by Lukas

In this episode, BioSpace’s Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel discuss Q4 2025 job market performance, ...

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

14 Jan 2026

Contributed by Lukas

AbbVie bet nearly $5 billion for the ex-China rights to RemeGen’s PD-1/VEGF bispecific and Novartis struck a $1.5 billion Alzheimer’s-focused deal...

From Nuclear Winter to Renewal: Biotech Investing for 2026

08 Jan 2026

Contributed by Lukas

In this episode of Denatured, Jennifer C. Smith-Parker speaks to Maha Katabi, general partner at Sofinnova Investments and Andrew Lam, managing direct...

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

07 Jan 2026

Contributed by Lukas

Obesity titans Novo Nordisk and Eli Lilly characteristically kicked off 2026 in the headlines. After capping 2025 with the first-ever FDA approval of ...

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

18 Dec 2025

Contributed by Lukas

In this episode of Denatured, Jennifer Smith-Parker speaks to Kenneth Galbraith, CEO at Zymeworks and Josh Smiley, president and COO at Zai Lab, about...

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

17 Dec 2025

Contributed by Lukas

Eli Lilly is wrapping up 2025 with record-breaking weight loss in a late-stage trial for its triple hormone receptor agonist retatrutide. Results from...

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

11 Dec 2025

Contributed by Lukas

In this episode presented by AnaptysBio, Jennifer Smith-Parker speaks to Dr. Joe Murray, professor of medicine, Division of Gastroenterology and Hepa...

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

10 Dec 2025

Contributed by Lukas

Pfizer followed up its winning $10 billion bid forobesity startup Metsera by adding another molecule to its obesity cabinet, thisone from Chinese firm...

New Approach Methodologies: Redefining Animal Testing Alternatives

04 Dec 2025

Contributed by Lukas

Momentum is building behind New Approach Methodologies (NAMs) that offer stronger human relevance than traditional animal testing. The FDA issued on D...

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

03 Dec 2025

Contributed by Lukas

Vinay Prasad’s memo, leaked over the weekend, has sent vaccine makers’ stocks slipping and experts clamoring for more evidence to support the CBER...

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

19 Nov 2025

Contributed by Lukas

Acquisitions have ticked up this month as all eyes were on Pfizer and Novo’s fight over Metsera. The past week saw that deal finalized with Pfizer a...

How Biotech Funding is Changing Executive Search and Hiring Processes

13 Nov 2025

Contributed by Lukas

A lean funding environment has changed how biotechs approach workforce organization and executive hiring. Searches are becoming more targeted and inte...

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

12 Nov 2025

Contributed by Lukas

One of biopharma’s most memorable bidding wars finally came to an end on Friday—with Metsera right back in the arms of its original suitor, but wi...

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

06 Nov 2025

Contributed by Lukas

This conversation features insights from Oliver Eden, senior business unit director at Jabil, and Travis Webb, chief scientific officer at PII. Our gu...

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

05 Nov 2025

Contributed by Lukas

Many of the top stories of 2025 are currently being written. We’re on the edge of our keyboards, watching and waiting as Pfizer and Novo Nordisk duk...

Innovation, Resilience, and the Future of Global Manufacturing

30 Oct 2025

Contributed by Lukas

In this episode of Denatured, guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney discuss how China, historically focused on manufacturing, is increasing...

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

29 Oct 2025

Contributed by Lukas

Novartis started the week early with a Sunday afternoon announcement of the acquisition of neuromuscular drug developer Avidity Biosciences for $12B. ...

How Supply Chain Turbulence is Reshaping Biotech Strategy

23 Oct 2025

Contributed by Lukas

In this episode of Denatured, guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney how in light of economic uncertainty, small biotechs can turn to intern...

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

22 Oct 2025

Contributed by Lukas

Novo Nordisk dominated the news cycle this week, with more leadership changes as the Novo Foundation replaced the company’s board, which will now be...

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

21 Oct 2025

Contributed by Lukas

In this episode of Denatured, guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney will explore how healthcare and pharmaceutical players — from hospita...

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

16 Oct 2025

Contributed by Lukas

This episode continues the discussion with Oliver Eden, senior business unit director at Jabil, and Travis Webb, chief scientific officer at PII, as t...

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

15 Oct 2025

Contributed by Lukas

Johnson & Johnson kicked off Q3 earnings season on Tuesday with the announcement that it is splitting its orthopedics and medtech operations and t...

Bonus: Q3 2025 Job Market Update

14 Oct 2025

Contributed by Lukas

In this discussion, BioSpace’s vice president of marketing ⁠⁠Chantal Dresner⁠⁠ and careers editor ⁠⁠Angela Gabriel⁠⁠ take a look at ...

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

08 Oct 2025

Contributed by Lukas

The U.S. government is now in its second week of a shutdown—with the FDA having paused acceptance of all new drug applications for the duration. But...

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

02 Oct 2025

Contributed by Lukas

Clinical trials can present many challenges for patients–particularly injections.Oliver Eden, senior business unit director at Jabil, and Travis Web...

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

01 Oct 2025

Contributed by Lukas

Genmab closed out a busy third quarter for M&A in biopharma, picking up cancer biotech Merus for $8 billion. This deal—the year’s fifth larges...

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

24 Sep 2025

Contributed by Lukas

The FDA is working to reapprove GSK’s long-dormant drug Wellcovorin (leucovorin) for cerebral folate deficiency, which the agency linked to “devel...

What Do AI and Hammers Have in Common?

18 Sep 2025

Contributed by Lukas

In this episode, Lori Ellis and Colin Zick spend a little time further discussing some of the points brought up in the Bioprocessing Summit last month...

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

17 Sep 2025

Contributed by Lukas

A global shift may be underway in biopharma as the White House prepares legislation that would would place restrictions on drugs brought to the U.S. f...

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

10 Sep 2025

Contributed by Lukas

The Make America Healthy Again Commission released itssecond report Tuesday, recommending, among other efforts, an investigation into a possible link ...

The 'Research Safety Net' Saving Scientists from Funding Crisis

04 Sep 2025

Contributed by Lukas

In this episode, Mike Garrett, CEO of Taconic Biosciences, discusses how preclinical research companies are helping drug developers navigate the curre...

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

03 Sep 2025

Contributed by Lukas

We returned from the Labor Day holiday to a spate of intriguing deals, including two that could surpass $2 billion: Vertex’s new pact with Enlaza fo...

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

27 Aug 2025

Contributed by Lukas

Eli Lilly posted data Tuesday from a second Phase III trial of its oral weight loss therapy orforglipron, providing the company with all it needs to h...

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

26 Aug 2025

Contributed by Lukas

Oral therapies are projected to account for 25% of the anti-obesity medication market by 2030—but first returns have largely disappointed. This mont...

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

21 Aug 2025

Contributed by Lukas

While AI represents a significant advancement in efficiency for early-stage drug discovery, it won't dramatically change the 90% clinical trial fa...

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

20 Aug 2025

Contributed by Lukas

Three months after taking heat over an error-riddled first report, Health Secretary Robert F. Kennedy’s Make America Healthy Again Commission was du...

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

14 Aug 2025

Contributed by Lukas

In this Denatured discussion, the conversation revolves around unpacking the patent policy changes that could make or break biotech companies. Guests ...

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

13 Aug 2025

Contributed by Lukas

Vinay Prasad is back at the FDA as chief of the FDA’s Center for Biologics Evaluation and Research. Prasad’s return—which hit the news wires Sat...

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

07 Aug 2025

Contributed by Lukas

In this thought-provoking episode, Cresset Group’s CSO, Mark Mackey, and VP of AI, Mutlu Dogruel, dissect the emerging geopolitical battle for AI su...

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

06 Aug 2025

Contributed by Lukas

Center for Drug Evaluation and Research Head George Tidmarsh will oversee the Center for Biologics Evaluation and Research on an acting basis after Vi...

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

31 Jul 2025

Contributed by Lukas

While AI excels at repetitive tasks like triaging medical information calls, document retrieval, and adverse event detection, the industry must addres...

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

30 Jul 2025

Contributed by Lukas

The Sarepta saga continued into another week as the FDA recommended that the voluntary hold on the company’s Duchenne muscular dystrophy gene therap...

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

23 Jul 2025

Contributed by Lukas

Just a few weeks ago, it seemed like Sarepta had weathered a spate of bad news, after two patients died from liver injuries from its Duchenne muscular...

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

22 Jul 2025

Contributed by Lukas

This episode continues the discussion regarding the rapid evolution of mRNA technologies since COVID-19. Guests discuss the improvements that have occ...

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

17 Jul 2025

Contributed by Lukas

This episode focuses on how AI is transforming pharmacovigilance (PV) on a global scale, particularly focusing on the evolving role of local qualified...

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

16 Jul 2025

Contributed by Lukas

Up to 3,500 FDA staffers received their final walking papers Monday after the U.S. Supreme Court found last week that the government is “likely to s...

Bonus Episode: Q2 2025 Job Market Update

15 Jul 2025

Contributed by Lukas

In this discussion, BioSpace’s vice president of marketing ⁠⁠Chantal Dresner⁠⁠ and careers editor ⁠⁠Angela Gabriel⁠⁠ take a look...

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

10 Jul 2025

Contributed by Lukas

This discussion focuses on how mRNA and self-replicating RNA (srRNA) technologies are expanding far beyond COVID vaccines into revolutionary therapeut...

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

09 Jul 2025

Contributed by Lukas

While most of the U.S. was celebrating the 4th of July holiday, President Donald Trump was busy signing the One Big, Beautiful Bill into law. This wid...

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

02 Jul 2025

Contributed by Lukas

The U.S. Supreme Court closed out its session before breaking for summer on Friday, ruling that decisions around coverage of HIV PrEP drugs should be ...

Understanding the FDA's AI Guidance in Pharmacovigilance

01 Jul 2025

Contributed by Lukas

In this episode of Denatured, Archana Hegde from IQVIA discusses the practical challenges faced by pharmacovigilance (PV) professionals as they naviga...

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

25 Jun 2025

Contributed by Lukas

Robert F. Kennedy Jr. testified in front of the House Committee on Energy and Commerce Tuesday, where Democrats confronted the health secretary on hot...

Navigating Funding Freezes and AI Frontiers

19 Jun 2025

Contributed by Lukas

Lori Ellis, head of insights at BioSpace, discusses some of the recent events and topics that are buzzing around BIO and DIA in 2025 with Rich Daly, C...

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

18 Jun 2025

Contributed by Lukas

This week, BioSpace is at 50% power as Heather McKenzie and Jef Akst are off attending this year’s BIO Conference in Boston. The half-team discusses...

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

11 Jun 2025

Contributed by Lukas

This week the BioSpace team was sent into an after-hours scramble by the news that Health and Human Services Secretary Robert F. Kennedy Jr. had fired...

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

05 Jun 2025

Contributed by Lukas

In a dynamic regulatory environment, IQVIA’s Michelle Gyzen suggests that AI may be the best and only way to keep with changes that are happening da...

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

04 Jun 2025

Contributed by Lukas

The words of the week so far in biopharma are “deals” and “cancer”—or, more specifically, money being invested in cancer and other key thera...

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

28 May 2025

Contributed by Lukas

The name of the biopharma game this season is vaccines—and RFK Jr. wasted no time returning from Memorial Day Weekend before making news on this fro...

How Target Product Profiles Guide the Industry Through Uncertain Times

22 May 2025

Contributed by Lukas

Lori Ellis, head of insights and Ian Fisher, head of development of analytics at IQVIA, discusses the critical importance of Target Product Profiles (...