BioSpace

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

    3 DAYS AGO

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

    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. These numbers appear to put CT-388, which Roche acquired in its $2.7 billion Carmot buy, in line with Eli Lilly’s Zepbound, according to William Blair analysts. Roche plans to start a Phase III study of CT-388 in the first half of this year and is also pairing the drug with a therapy from Zealand Pharma, with the aim of offering a weight lossoption with fewer gastrointestinal side effects.   Meanwhile, Baseline Therapeutics debuted to challenge Lilly with a Phase III–ready GLP-1 for alcohol use disorder.   In the vaccines sector, Moderna took perhaps the biggest action to date amid Health Secretary Robert F. Kennedy’s anti-vaccine policies and rhetoric, last week announcing that the company will no longer run late-stage vaccine trials for infectious diseases. “You cannot make a return on investment if you don’t have access to the U.S. market,” CEO Stéphane Bancel saidthe World Economic Forum at Davos, Switzerland. Pfizer CEO Albert Bourla, also speaking at Davos, called RFK Jr.’s rhetoric and policies on vaccines “anti-science.”   Finally, Sarepta released new data on Monday for Elevidys, the company’s embattled gene therapy for neuromuscular disease Duchenne muscular dystrophy. Plus, check out up-and-coming treatments for Alzheimer’s and Parkinson’s.

    17 min
  2. From Sound Bites to Signals: Editors Parse Executive and Investor Chatter at JPM

    22 JAN

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

    In this episode of Denatured, BioSpace editorial team members, Senior Editor, Annalee Armstrong, and News Editor, Dan Samorodnitsky, discuss their post-JPM takeaways and 2026 forecasts after speaking to a range of pharma and biotech executives and investors last week. Hosts⁠ Jennifer Smith-Parker⁠, Director of Insights, BioSpace⁠ Guests ⁠Annalee Armstrong, Senior Editor, BioSpace ⁠Dan Samorodnitsky, News Editor, BioSpace Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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

    21 JAN

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

    The 2026 J.P. Morgan Healthcare Conference concludedlast week without a big M&A deal. But the meeting was anything but boring, with President Donald Trump’sMost Favored Nation drug pricing scheme and the perpetual battle for supremacyin the obesity space between Eli Lilly and Novo Nordisk prime topics of conversation. Meanwhile, other companies like Biohaven refuse tocede the entire weight loss market, stating their intention to carve out apiece of the massive pie.   On the competitive front, Novo took a step forwardMonday with the news that its Wegovy pill reached nearly 3,100 patients since its launch on Jan. 5. Meanwhile, an FDAdecision for Lilly’s own oral offering, orforglipron, has been delayed from March28 to April 10. Orforglipron is being reviewed under the FDA’s new Commissioner’sNational Priority Voucher (CNPV) program, which aims to shorten the reviewperiod from 10–12 months to 1–2 months. Other voucher recipients—includingSanofi and Disc Medicine—have also had their decisions delayed.   While the FDA wasn’t a primary focus at JPM, severalbiotechs sought to make clear during their investor presentations that they hadsecured alignment with the regulator on trial design or pathways to approval. This comesafter a year that has seen many of their peers experience regulatory whiplashas previous FDA guidance was seemingly reversed.   And on the business front, IPOs are back! This week, SpyGlass Pharma and AgomAb Therapeutics joined Veradermicsand Eikon Therapeutics on the rapidly accelerating IPO train. Aktis Oncology,which announced its bid in late 2025, debuted on the Nasdaq earlier this month.   And in BioPharm Executive this week, Annalee Armstrongand Dan Samorodnitsky catch up with execs from Novo Nordisk, Korro Bio, Biohaven and Galapagos.

    21 min

  4. 19 JAN

    Bonus: Q4 2025 Job Market Update

    In this episode, BioSpace’s Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel discuss Q4 2025 job market performance, sharing the latest BioSpace data. They touch on positive signs they saw last quarter and what this year might have in store for those seeking employment.  Want to receive our latest quarterly job market reports as soon as they’re published? ⁠⁠⁠Subscribe⁠⁠⁠ to Career Insider for our job market updates, job trends, career advice and more.

    8 min
  5. Deals Roll at JPM26, Policy Front and Center, IPOs Are Back, FDA Stays Busy

    14 JAN

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

    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 with China-based SciNeuro Pharmaceuticals as the 2026 J.P. Morgan Healthcare Conference got underway on Monday. These and other recent tie-ups speak to the therapeutic trends predicted to be hot this year by experts who spoke with BioSpace, who particularly noted that cancer and neuroscience would remain top of the list.   Meanwhile, attendees are still waiting for that “one big M&A deal.” Could it come from Merck? CEO Rob Davis expressed high confidence during the company’s JPM presentation on Monday, revealing that Merck is open to deals in the range of “multi tens of billions of dollars.”   On the weight loss front, Eli Lilly and Novo Nordisk both updated attendees on the state of play, with Lilly expressingconfidence in its supply chain to support the launch of obesity pill orforglipron and Novo continuing to lament the business it is still losing to compounders.   Just in time for JPM, the IPO window cracked open, with Aktis Oncology debuting on the public markets last week and Veradermics and Eikon Therapeutics announcing their bids to follow suit. A similar thaw occurred last year before the window slammed shut again as myriad policy changes frightened investors. How will this year play out?   2025 had its challenges, especially on the policy front. In his annual letter, Flagship CEO Noubar Afeyan cited “growing contempt” in the U.S. for the scientific method and arapidly emerging Chinese biopharma ecosystem among the greatest challenges facing the industry. And while the funding may now be flowing, it still favors later-stage companies. A .J.P. Morgan report released prior to the conference showed VC funding was down across the board last year, but especially for biotechs recruiting early rounds.   Finally, while JPM is the primary focus, the FDA hasn’t taken the week off. Just prior to recording, the regulator requestedthat Lilly and Novo remove the suicide warning from the labels of certain GLP-1 medications after a comprehensive review found no increased risk of suicidal ideation and behavior with these drugs. On the policy front, the FDA continued its quest to accelerate the development of cell and gene therapies with new manufacturing exemptions.   The regulator also took action on two applications this week, approving a rare disease drug developed by Sentynl Therapeutics and Fortress Biotech and denying a cell therapy submitted by Atara Biotherapeutics. To learn about key upcoming FDA action, check out 6 FDA Decisions To Watch in Q1 2026 in ClinicaSpace this week.

    20 min
  6. From Nuclear Winter to Renewal: Biotech Investing for 2026

    8 JAN

    From Nuclear Winter to Renewal: Biotech Investing for 2026

    In this episode of Denatured, Jennifer C. Smith-Parker speaks to Maha Katabi, general partner at Sofinnova Investments and Andrew Lam, managing director, head of Biotech Private Equity at Ally Bridge Group, about how M &A dynamics, dealmaking and global partnerships are reshaping portfolio valuations and paths to growth in 2026. Host Jennifer Smith-Parker, Director of Insights, BioSpace Guests Maha Katabi, General Partner, Sofinnova Investments Andrew Lam, Managing Director, Head of Biotech Private Equity, Ally Bridge Group (ABG) Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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

    7 JAN

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

    Obesity titans Novo Nordisk and Eli Lilly characteristically kicked off 2026 in the headlines. After capping 2025 with the first-ever FDA approval of an oral GLP-1 for obesity, Novo launched its Wegovy pill on Monday, starting at $149 per month out of pocket for the lower doses. Meanwhile, all eyes are on Lilly, which expects a greenlight for orforglipron as early as March. The oral weight loss play is set to be a key aspect of a pivotal year for Lilly, which hopes to more than double its annual revenue in just a few years.     Also pulling a rabbit out of a hat just before Christmas were nine drugmakers—including Amgen, Bristol Myers Squibb, Boehringer Ingelheim—which signed Most Favored Nation drug pricing agreements with the Trump administration, likely securing their businesses against the threat of tariffs. However, drug pricing will continue to be top of mind in 2026, experts told BioSpace, as only about half of Big Pharmas have signed a deal, and small and mid-sized companies haven’t yet begun.     Another area biopharma leaders are watching with bated breath is the FDA. The overwhelming consensus from experts who spoke with BioSpace is that last year was a disaster—particularly from a workforce standpoint. Still, the agency approved 56 novel drugs, down just a tick from 2024’s 59. Advisory committees fell off considerably, in both number and concordance, however, according to a report by Jefferies, as these meetings came under scrutiny by FDA leadership.  In 2026, will the unprecedented leadership turnover—especially at CDER—settle down? Will the new rare disease and cell and gene therapy policies bear first fruits? Also on the regulatory front, the CDC has already been busy this year, axing several childhood vaccines from its recommended schedule with potential implications for biopharma companies including Pfizer and Merck.     And if there’s one area biopharma watchers anticipate even more than regulatory action, it’s M&A action. Last month, analysts shared their top targets with BioSpace, listing names like Summit Therapeutics, Apogee Therapeutics and Axsome Therapeutics. Here at BioSpace, we’ll stick with Viking.     Finally, don’t forget to check out our NextGen Class of 2026—featuring 15 biotech startups whose mission and platforms cut through a challenging environment. And make sure to join us next week when senior editor Annalee Armstrong and news editor Dan Samorodnitsky will provide dispatches from the J.P. Morgan Healthcare Conference.

    23 min
  8. Inside the 2026 Biotech Landscape: Innovation, Investment and Global Momentum

    18/12/2025

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

    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 how renewed confidence is driving biotech entering 2026. As we look towards conversations that will shape this year's J.P. Morgan Healthcare Conference, the biotech industry is fueled by improving market sentiments, visible at recent meetings like Jeffries in London, and reinforced by a wave of partnerships, strategic acquisitions and Chinese collaboration that is recalibrating investor expectations. Host Jennifer Smith-Parker, Director of Insights, BioSpace Guests Kenneth Galbraith, CEO, Zymeworks Josh Smiley, President and Chief Operating Officer, Zai Lab Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

    29 min
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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
    195
  • Rating
    Clean
  • Copyright
    © BioSpace
  • Show Website
    BioSpace

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