BioSpace

BioSpace
  • 0.0 (0)
  • LIFE SCIENCES
  • UPDATED WEEKLY

Unravel the business of science with BioSpace. We dive into biopharma's top stories and biggest challenges, whether it’s layoffs, pipeline shake-ups, acquisitions, new FDA approvals or how to regulate AI in drug development.

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

    15 HR AGO

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

    Eli Lilly won FDA approval last week for orforglipron—now Foundayo— officially launching what promises to be a heated battle between Lilly and chief rival Novo Nordisk.   Elsewhere, the M&A space keeps chugging along, with Gilead Sciences gobbling up partner Tubulis for up to $5 billion and Neurocrine Biosciences nabbing Soleno Therapeutics for $2.9 billion. The industry will be on high alert for more deals, as analysts say Amgen, AbbVie and Bristol Myers Squibb all have more money to spend.   At the White House, President Donald Trump levied his long-promised tariffs on the pharma industry, but myriad carveouts mean many companies will be safe from the 100% tax, at least for now. And Trump’s Most Favored National pricing scheme is endangering access to new drugs in Europe as companies forgo launches  in countries that could pull down U.S. prices.   Meanwhile, the Trump administration came out with its proposed 2027 budget on Friday, with several requests for the FDA and Department of Health and Human Services overall. In line with the administration’s efforts to accelerate development of therapies for rare diseases, the FDA proposes is seeking to permanently authorize the rare pediatric disease priority review voucher program. Other proposals include a new clinical trial notification pathway and expanded authority to regulate post approval manufacturing changes. These requests come during a time when the agency is, as always, walking the precarious tightrope of rigor vs. unmet need—with rare disease leaders calling for clarity around topics like externally controlled trials.

    25 min
  2. The Radiotherapeutics Moment: How Isotopes are Changing Cancer Treatment

    6 DAYS AGO

    The Radiotherapeutics Moment: How Isotopes are Changing Cancer Treatment

    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 Convergent Therapeutics. They discuss breakthroughs like alpha-emitting isotopes, supply chain solutions and why radiotherapeutics is biotech's next big frontier. Host   Jennifer C. Smith-Parker, Director of Insights, BioSpace   Guests   Marc Hedrick, President & CEO, Plus Therapeutics   Philip Kantoff, Co-founder & CEO, Convergent Therapeutics Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

    19 min
  3. Biopharma M&A Heats Up, Rare Diseases Win Three Approvals, Wave Crashes

    1 APR

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

    Biogen, Eli Lilly and Merck spent more than $20 billion in the past week to swallow biotechs with approved products or promising drug candidates—representing three of this year’s four biggest takeovers. First, Merck picked up Terns Pharmaceuticals and its mid-stage leukemia drug for $6.7 billion. Then, on Tuesday, Lilly and Biogen struck, acquiring Centessa Pharmaceuticals and Apellis Pharmaceuticals respectively. Those big-ticket deals aren’t the only recent transactions, however. Others include Novartis’ up to $2 billion pick up of Excellergy and Gilead’s $2.1 billion purchase of Ouro Medicines. Meanwhile, Kevin Tang—the newly minted CEO of Aurinia Pharmaceuticals—again has his sights set on Kezar Life Sciences, which he previously targeted in 2024. This time, biopharma’s “clean-up” man is offering $50 million for the chronic disease–focused biotech. Last week also saw nods for Denali Therapeutics’ Avlayah, the first treatment for Hunter syndrome to target the disease’s neurological complications, and Rocket Pharmaceuticals’ Kresladi for leukocyte adhesion deficiency-I. And it’s been a big week for Biogen, which besides moving on Apellis, won approval of a high-dose formulation of spinal muscular atrophy drug Spinraza and scored a Phase 2 win for lupus candidate litifilimab in cutaneous lupus erythematosus. On the weight loss front, Wave Life Sciences’ stock was cut in half after its obesity candidate WVE-007 failed to impress investors in a Phase 1 trial.

    23 min
  4. Beyond Buzzwords in Longevity Investing

    26 MAR

    Beyond Buzzwords in Longevity Investing

    In this episode, you'll be listening to Sergey Jakimov, managing partner at LongeVC and Artem Trotsyuk, operating partner, US, LongeVC. We discuss how developers in the longevity space should stop chasing aging as an abstract target and concentrate on specific mechanisms that can clearly tackle age-related conditions.   Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Sergey Jakimov, Managing Partner, LongeVC Artem Trotsyuk, Operating Partner-US, LongeVC

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

    25 MAR

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

    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 investment it hopes to split with longtime partner Galapagos. Meanwhile, Sanofi also added a T cell engager in a licensing deal with Kali Therapeutics worth $180 million upfront. One I&I partnership that bore fruit last week was that of Johnson & Johnson and Protagonist Therapeutics which got their IL-23 receptor blocker Icotyde across the FDA finish line for plaque psoriasis. Icotyde is the first commercial product for Protagonist. Even the drama this week came from the I&I space, as Kevin Tang took the reins as CEO of Aurinia Pharmaceuticals, which you may remember was the company at the heart of former Center for Drug Evaluation and Research Director George Tidmarsh’s exit from the FDA. Outside of I&I, the CDC’s Advisory Committee on Immunization Practices made headlines once again as Vice Chair Robert Malone posted to social media that the group was being disbanded. The Department of Health and Human Services quickly corrected the record, but Malone posted a few hours later that “dissolving and reforming remains one of options being considered.” In FDA policy news, BioSpace recaps the now nine-month-old Commissioner’s National Priority Voucher pilot program and unpacks new draft guidance on animal testing alternatives. Plus, check out an opinion article on the need for precision ALS drugs and features on gene therapy for hearing loss and Big Pharma’s overall R&D spending in 2025.

    21 min
  6. Inside the Race to Build the Next Generation of AI Drug Discovery Platforms

    19 MAR

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

    In this episode, you'll be listening to  Akshay Rai, principal, Healthcare & Biotech Investments at Premji Invest and Viswa Colluru, CEO and founder, Enveda. They discuss how AI platforms must now prove themselves through data, focused pipelines and clinical readouts and that promises of faster, cheaper drug discovery are not enough to entice strong investor engagement.    Host Jennifer Smith-Parker, Director of Insights, BioSpace Guests Viswa Colluru, CEO & Founder, Enveda Akshay Rai, Principal, Healthcare & Biotech Investments, Premji Invest Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

    20 min
  7. Kennedy’s Vaccine Agenda Stalled, Structure’s ‘Competitive’ Obesity Pill, Novo’s Warning Letter

    18 MAR

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

    Biopharma’s weight loss warriors have led the news this week, with Structure Therapeutics and Rhythm Pharmaceuticals announcing new data. Structure delivered a “competitive profile” for its investigational GLP-1 pill compared to Eli Lilly’s orforglipron and Novo Nordisk’s oral Wegovy, BMO Capital Markets wrote to investors, after the candidate elicited 16.3% weight loss after 44 weeks in a Phase 2 trial. Rhythm was not as successful, announcing that Imcivree failed in a Phase 3 basket trial of various genetically driven obesities.   Meanwhile, Lilly and Novo made headlines outside of the clinical realm, as Lilly warned the public of the potential safety risks of taking compounded versions of tirzepatide—marketed as Zepbound for obesity and Mounjaro for type 2 diabetes. And Novo was hit with an FDA warning letter for failing to investigate reported adverse events—including three deaths—potentially linked to its own diabetes drug Ozempic. The letter only adds to what has been a challenging recent run for Novo, one that led to a 34% drop in total assets under management for its controlling shareholder Novo Holdings.   On the regulatory front, Robert F. Kennedy Jr.’s vaccine agenda is stalled after Massachusetts District Court Judge Brian Murphy found that his efforts to overhaul policies in this area were likely unlawful. Murphy specifically cited Kennedy’s move last June to empty the CDC’s Advisory Committee on Immunization Practices (ACIP). This comes on the heels of a White House crackdown in which officials would like the health secretary to tone down his vaccine skepticism, according to a report by The Wall Street Journal.   At the FDA, tensions continue to escalate, with Sen. Ron Johnson (R-WI) launching an investigation into recent rejections of rare disease drugs. And transparency issues have come to light once again regarding the circumstances around biologics chief Vinay Prasad’s imminent departure and recent request to remain anonymous during a media briefing about uniQure’s gene therapy for Huntington’s disease.

    20 min
  8. From Two Trials to One, Sponsors Face a Higher Standard

    12 MAR

    From Two Trials to One, Sponsors Face a Higher Standard

    In this episode of Denatured, you'll listen to Oxana Iliach, senior director of regulatory strategy at Certara and Vera Pomerantseva, director of product management for risk-based quality management at eClinical Solutions. We speak about how the FDA's latest decision to have one, rather than two pivotal studies, for new drug applications raises the bar for data collection and risk-based management. Host ⁠Jennifer C. Smith-Parker⁠, Director of Insights, BioSpace Guests Oxana Iliach, Senior Director of Regulatory Strategy, Certara Vera Pomerantseva, Director of Product Management for RBQM, eClinical Solutions Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

    21 min
See All (218)

About

Unravel the business of science with BioSpace. We dive into biopharma's top stories and biggest challenges, whether it’s layoffs, pipeline shake-ups, acquisitions, new FDA approvals or how to regulate AI in drug development.

Information

  • Creator
    BioSpace
  • Years Active
    2023 - 2026
  • Episodes
    218
  • Rating
    Clean
  • Copyright
    © 2026 BioSpace
  • Show Website
    BioSpace

You Might Also Like