Slapped with the most severe post-inspection classification, the state of Novo Nordisk’s Indiana manufacturing site could pose a problem for clients, including Regeneron and Scholar Rock.
Eli Lilly and Johnson & Johnson are joining fellow Big Pharma peers in upping their investment in AI, with Lilly looking to create the industry’s ‘most powerful supercomputer’ and J&J building a virtual operating room.
As third-quarter earnings continue to roll out, Novartis makes headlines with the second biggest acquisition of the year; Novartis’ CEO also downplayed the impact of Big Pharma pricing deals with the Trump administration; Regeneron continued the trend of dropping cell therapy assets; BioSpace takes a look at how the FDA is functioning mid-shutdown.
Vas Narasimhan confirmed that Novartis is having weekly discussions with the Trump administration on drug pricing, but a deal has not yet been reached.
Phase I/II data for rese-cel point to its therapeutic potential in systemic lupus erythematosus and lupus nephritis, as well as other autoimmune conditions.
BioMarin no longer expects to hit its $4 billion revenue target by 2027, citing various market factors such as impending competition for achondroplasia therapy Voxzogo and the divestment of the gene therapy Roctavian.
Phase III data for dapirolizumab pegol presented at the 2025 conference of the American College of Rheumatology showed quality-of-life benefits in systemic lupus erythematosus that could see Biogen go head-to-head with GSK and AstraZeneca in a blockbuster space.
FEATURED STORIES
BioSpace’s NextGen companies are rising in one of the most confounding biotech markets ever experienced. Executives sounded off on how to keep your head above water during our webinar, Are We There Yet?
BioSpace examines the busiest corporate venture capital arms in the pharmaceutical industry. Novo Holdings, which made headlines last year with its $16.5 billion Catalent buy, topped the list.
The largest Chinese licensing deal behind Pfizer’s is Novartis’ partnership with Shanghai Argo Biopharma, worth potentially more than $4 billion.
The Most Favored Nation order is unlikely to deliver broad, sustained savings without triggering legal challenges, administrative friction and unintended consequences for both the healthcare sector and patient access.
FDA
While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner Marty Makary’s proposal is light on details and raises potential concerns about safety, access and liability.
The FDA and NIH recently announced plans to phase out animal testing requirements for some therapies. While organoid and AI providers celebrate, scientists warn that questions over safety, applicability and implementation remain.
FROM BIOSPACE INSIGHTS
Biotech’s slump may finally be over in 2026. In interviews with BioSpace, Zymeworks’ CEO Ken Galbraith and Zai Lab’s President and COO Josh Smiley explain what’s fueling the comeback.
UPCOMING EVENTS
LATEST PODCASTS
New revelations from the showdown between Novo Nordisk’s CEO and Bernie Sanders’ Senate health committee Tuesday; PhRMA’s legal victory in IRA case; the federal interest rate cut and anticipated approval for schizophrenia.
Infusions of Vertex and CRISPR Therapeutics’ Casgevy and bluebird bio’s Lyfgenia have begun; Moderna targets 10 approvals through 2027; more oral obesity drug data; the latest from ESMO and more.
In this episode, Lori and guests discuss practical approaches regarding artificial intelligence and investor and industry confidence in its current state.
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SPECIAL EDITIONS
In this deep dive, BioSpace investigates China’s rise as a biotech powerhouse.
In this deep dive, BioSpace explores the next big thing in obesity.
BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
DEALS
  1. The Muna partnership will give GSK access to Muna’s MiND-MAP platform, which it will apply to postmortem brain samples to identify potential therapeutic targets for Alzheimer’s disease.
  2. One year after a potential $1.7 billion deal with Hansoh Pharma, GSK goes back to China to forge another alliance with DualityBio for another deal that could be worth up to $1 billion as it continues to build up its ADC portfolio.
  3. The Danish startup, whose lead candidate has parallels to Amgen’s MariTide, launches on the heels of Amgen’s Phase II data release for the drug last week.
  4. Novartis, Gilead, Roche and Takeda commit to new partners in a spate of mid-sized collaborations this week. Meanwhile, Applied Therapeutics’ stock tanks 80% after govorestat is denied approval, Intra-Cellular Therapies seeks to expand Caplyta into major depressive disorder and the FDA investigates the safety of bluebird bio’s Skysona.
  5. The collaboration will see COUR and Roche’s Genentech leverage the biotech’s antigen-specific immune tolerance platform to develop and commercialize therapies for an undisclosed autoimmune disease.
WEIGHT LOSS
  1. From revenue to R&D investment, Novo and Lilly and their mega-blockbuster weight loss drugs Zepbound and Wegovy have moved into a new pharma stratosphere, far eclipsing their rivals.
  2. Compounding pharmacies aren’t the only makers of off-brand versions of Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. The situation is causing the FDA regulatory headaches and, more seriously, posing potential risks to the public.
  3. Novo Nordisk shares tumbled last year when obesity candidate CagriSema failed to clear a weight loss bar of 25%. Now, executives are taking another look at the data but steering clear of making hard bets.
  4. As Eli Lilly ends the year with Zepbound in good supply, TD Cowen analyst Steve Scala asked CEO David Ricks if the company has taken the GLP-1 supply chain too far.
  5. Wegovy sales increased by more than 100% over 2024. But that wasn’t enough to satiate analysts who want to know why Novo Nordisk can’t access more patients, particularly in the U.S.
POLICY
  1. In a year when eradicated diseases are on the uptick in America, how will American children survive RFK Jr.’s vaccine scrutiny and inconsistency? Two experts call on pharma and regulatory bodies to rebuild trust.
  2. While the Trump administration has painted the jettisoning of staff and regulations as good for business, there are multiple reasons it’s unlikely to work out that way.
  3. At a sometimes-contentious U.S. Senate hearing, the Health and Human Services secretary was evasive on the rationale behind cuts being made to the department and his endorsement of the measles vaccine amid a rapidly growing outbreak.
  4. The third cycle of the drug price negotiations will involve drugs under Medicare Part B. New prices are set to take effect in 2028.
  5. The Most Favored Nation directive would allow drugmakers to directly sell their products to patients at a lower cost, cutting out what President Donald Trump called “the middlemen.”
CAREER HUB
Why are adaptive leaders so useful? And is adaptive leadership a quality that will benefit your life sciences career? Let’s explore this concept and find out.
A life science degree can provide various academic and professional opportunities to you. Here’s an overview of what you can do with a life science degree.
Understanding the difference between talent acquisition and recruitment is vital not only for your hiring process but for the entire organization.
Discover the most common departments that make up a BioPharma company, learn about the responsibilities of each department and figure out which role is the right fit for you.
Like any field, there are upsides and downsides to working in biotech, and educating yourself can help you make an informed decision if you’re considering a career in this industry.
Learn the best tips, tricks, and practices to help yourself to get the first job after college life sciences industry right out of college in our comprehensive guide.
Discover the most in-demand pharma qualifications and how to use them to score your dream job in our comprehensive guide.
HOTBEDS
Where are the Best Places to Work in life sciences? BioSpace’s annual Best Places to Work list demonstrates a company’s desirability in the recruitment marketplace - find out who made the list this year.
IN CASE YOU MISSED IT
“We felt we had a responsibility to explore semaglutide’s potential, despite a low likelihood of success,” Martin Holst Lange, Novo’s R&D chief, said on Monday.
REPORTS
In this Employment Outlook report, BioSpace explores current workforce sentiment, job activity trends and the prospective job and hiring outlook for 2025, particularly as it compares to the previous year.
BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
CANCER
  1. Japan-based Taiho Pharmaceutical has worked with Araris Biotech since 2023 developing antibody-drug conjugates for the oncology space.
  2. Pfizer was studying PF-07820435, an orally available agonist of the STING protein, for solid tumors.
  3. While Houston isn’t yet on the same level as major life sciences hubs, it has plenty to offer and room to grow, according to CNS Pharmaceuticals, RadioMedix and Greater Houston Partnership executives.
  4. Johnson & Johnson and Legend Biotech hope to hit blockbuster status for Carvykti this year.
  5. Vepdegestrant did not improve progression-free survival broadly but saw improvements in one specific patient cohort. Arvinas’ stock took a 43% tumble on the news, and analysts are downcast on the drug’s prospects.
NEUROSCIENCE
  1. Faced with the encroaching threats of patent expirations and generics, biopharma companies in 2024 invested 33% more in licensing deals, on average, than in 2023 with an eye toward enriching their pipelines with novel and potentially more effective therapies.
  2. The Phase IIa results continue a surge of momentum in a treatment space that last week saw the approval of Vertex’s Journavx as the first novel mechanism for acute pain in decades.
  3. In a Phase IIb trial, GH001 elicited significant drops in treatment-resistant depression. The news comes less than two weeks after J&J secured FDA monotherapy approval for its esketamine nasal spray Spravato in the same indication.
  4. After the Phase II failure of its lead asset from Cerevel, AbbVie is resetting expectations and narrowing the clinical program to an adjunct approach—for now.
  5. Analysts were unfazed by the news that Takeda will cease development of soticlestat after Phase III failures, while responding positively to the announcement that Julie Kim will take the helm of the Japanese giant in 2026.
CELL AND GENE THERAPY
  1. By mid-2025, the biotech will split into two entities: a new, as-yet-unnamed innovative medicines specialist and a cell therapy company, the latter of which will inherit the Galapagos name.
  2. BioSpace presents 25 noteworthy biopharma startups in ’25; analysts forecast stronger M&A as the J.P. Morgan Healthcare Conference kicks off next week; GLP-1s continue to expand their reach as Novo, Lilly fight against compounders; and a look ahead to five key FDA decisions in Q1.
  3. From ADCs and radiopharmaceuticals to cell and gene therapies, eager young startups are betting on advances in biopharma’s most competitive therapeutic spaces—and attracting dollars from Big Pharma.
  4. Sangamo is on course to run out of money within months and has now lost access to up to $220 million in milestone payments from Pfizer.
  5. The approval concludes what has been a difficult regulatory path for Ryoncil, which suffered FDA rejections in 2020 and 2023.