As we mark five years since the World Health Organization officially declared the COVID-19 pandemic, the BioSpace editorial team reflects on the health crisis of a generation and how it changed us—and the biopharma industry. While companies like Pfizer, BioNTech and Moderna raked in billions from their vaccines, J&J and Novavax struggled to capture a significant piece of the market. Five years later, much has changed. A substantial number of us now work from the comfort of our homes—though that may be changing for some in the life sciences—and biopharma has a new obsession: obesity. In this space, Novo Nordisk has had a rough week, reporting lower-than-expected results from a second straight trial of its next-gen weight loss drug CagriSema. And in an effort to protect revenues from its blockbuster weight-loss drug Wegovy, Novo jumped into the legal battle between the FDA and compounding pharmacies over the regulator’s decision to declare the shortage of Wegovy over. Viking Therapeutics had a better week, securing “multiple metric tons” of its investigational obesity medication VK2735 in a deal with CordenPharma. Meanwhile, companies continue to tackle adverse events associated with GLP-1s. Another space that has seen its fair share of failures in the past couple of years is depression. The latest flop comes from J&J, which announced it would discontinue its a kappa opioid receptor blocker aticaprant after a disappointing Phase III readout. J&J joins Biogen and Sage Therapeutics, Relmada Therapeutics and Alto Neuroscience, all of whom have suffered regulatory misses or trial flops. Finally, two of Donald Trump’s healthcare nominees, Marty Makary and Jay Bhattacharya, sailed through their confirmation hearings in the Senate last week. Both are up for confirmation on Thursday.
Donald Trump’s tariffs have headlined myriad news stories this week—including at BioSpace, where we reported Pfizer CEO Albert Bourla’s claim that his company is prepared to reshore manufacturing if the president makes good on threats made last month. Eli Lilly also appears to be preparing, commiting $27 billion to boost its U.S. manufacturing capacity. Meanwhile, another regulatory meeting has been canceled under new HHS Secretary Robert F. Kennedy Jr. Reuters revealed last week that an upcoming meeting of the FDA’s external advisers for vaccine policy on March 13 has been canceled—just a week after the CDC Vaccine Advisory Board’s first meeting of 2025 was postponed. Also on the policy front, BioSpace took a deep dive into priority review vouchers (PRVs) after Congress failed to reauthorize the rare pediatric disease PRV program at the end of 2024. Our reporting shows this will be painful for many biopharma companies who rely on funds from the sale of PRVs. Speaking of money, AbbVie and Eli Lilly struck a pair of mid-size deals in hot spaces. AbbVie made a late obesity play this week, inking a licensing deal worth up to $2.2 billion with service provider Gubra to bring a long-acting amylin drug to the market, while Lilly hopped onto the hot molecular glue train, paying more than $1.2 billion in a licensing deal with Magnet Biomedicine. Finally, we examined the somewhat lethargic immuno-oncology space, which has companies, including BMS, Roche, Summit Therapeutics and BeiGene, targeting TIGIT, VEGF, RAS and more in their quest to bring the next Keytruda—which led the way in 2024 as the world’s best-selling drug—to the market.
On the sidelines of this year’s J.P. Morgan Healthcare Conference in San Francisco, BioSpace Senior Editor Annalee Armstrong sat down with Kevin Marks, CEO of Delphia Therapeutics, a member of BioSpace’s NextGen Class of 2025. Their discussion here focused on the company’s novel science of activation lethality, which involves forcing cancer cells to overactivate and thereby overload cell stress pathways, as well as Delphia's relatively smooth path to a $67 million series A raise thanks to contributions from Google Ventures (GV), where Marks was previously employed.This is the second episode in a special series of The Weekly focused on how NextGen companies are navigating the current business environment.HostAnnalee Armstrong, Senior Editor, BioSpaceGuestKevin Marks, President and CEO, Delphia TherapeuticsFor a complete list of NextGen 2025 companies, click here.
Miruna Sasu, CEO of COTA, has been labeled as a disrupter in the industry. In this discussion, she highlights the challenges of investing in the life sciences industry. She also suggests how the investor mindset needs to change as well as offer solutions that benefit both investors and developers seeking investment.HostLori Ellis, Head of Insights, BioSpaceGuestsMiruna Sasu, President and CEO, COTADisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
There was a high point this week for employees riding the rollercoaster that is currently the FDA, as 300 recently fired employees are reportedly being asked to return. This could serve to boost spirits at the agency, which is reeling from unpredictable and seemingly ‘indiscriminate’ layoffs—and low morale as a result. Trump made additional waves over the weekend, threatening to enact tariffs on the largest pharmaceutical companies—unless they relocate their manufacturing operations to the U.S. And the early impacts of the new administration continue to be felt, as the CDC’s vaccine advisory board postponed its first meeting of 2025—just a week after RFK Jr.’s confirmation as HHS secretary. In weight loss news, the Outsourcing Facilities Association (OFA), which represents compounders, is suing the FDA after the agency declared an end to the shortage of semaglutide, marketed by Novo Nordisk as Ozempic and Wegovy. This followed a similar OFA lawsuit last fall, filed after the FDA removed Eli Lilly’s tirzepatide— Zepbound and Mounjaro—from its shortage list. In a possible attempt to protect Zepbound from compounder competition, Lilly announced Tuesday that it will expand single dose vials options of the blockbuster weight loss drug at a reduced price. This all comes as a new study compares physician wishlists with investment in the obesity space—and reveals key indicators for drug developers. And it’s been a good news/bad news kind of week in gene therapy, as Pfizer discontinued hemophilia B drug Beqvez worldwide, Regeneron reported more positive data from its gene therapy for genetic deafness and, facing a cash crunch, bluebird bio elected to go private in an acquisition by global investment firms Carlyle and SK Capital Partners. Finally, let us leave you with a ghost story—the story of so-called “ghost assets” that have found a new home, and a new purpose.
At the 2025 National Biotechnology Conference, gene therapies, bispecific antibodies and other novel modalities—relative newcomers to medicine—will be much discussed. In this curtain raiser, BioSpace speaks with conference chair Prathap Nagaraja Shastri of J&J about these highly anticipated topics. HostJef Akst, Managing Editor, BioSpaceGuestPrathap Nagaraja Shastri, Scientific Director and Group Leader, Clinical Pharmacology and Pharmacometrics, Johnson and JohnsonBioSpace is a media partner of the National Biotechnology Conference.
President Trump has been on a staff cutting rampage since taking office, and this weekend, the hammer came down on an undisclosed number of FDA employees. The firings—which reportedly affected staffers within the FDA’s centers for food, medical devices and tobacco products—came days after Robert F. Kennedy Jr. was confirmed as HHS secretary.One space that could have an ally in RFK Jr. is psychedelic therapies, which the new HHS boss has accused the FDA of “suppressing,” along with stem cell therapies. On the flip side, Kennedy is a well-known vaccine critic, though his confirmation didn’t affect the approvals of a pair of vaccines—one for GSK’s meningococcal shot and another for Bavarian Nordic’s chikungunya jab.One notable vaccine maker, however, is struggling. Moderna reported Q4 and 2024 earnings last week, revealing full-year revenue of just over $3 billion—less than half of the nearly $7 billion the company brought in the year before. Adding insult to financial injury, Moderna is also laying off around 50 employees on its digital team.Moderna isn’t the only company facing challenges. Several biopharmas, including Merck, Regeneron and Bristol Myers Squibb are facing patent headwinds that, according to William Blair, are the strongest they’ve been in nearly 15 years. It’s also a difficult climate in which to stay alive as a biotech, to which the 13 bankruptcies in 2024 can attest.Finally, BioSpace launched a new NextGen podcast series this week, in which senior editor Annalee Armstrong speaks with execs from four of our NextGen Class of 2025 companies—starting with COUR Pharmaceuticals.
On the sidelines of this year’s J.P. Morgan Healthcare Conference in San Francisco, BioSpace Senior Editor Annalee Armstrong sat down with Dannielle Appelhans, CEO of COUR, a member of BioSpace’s NextGen Class of 2025. Their discussion here, focused on the company’s long history leading up to its $105 million in series A funding at the start of 2024 and the possibility of an initial public offering in the future, among other things, represents the first of a special series of The Weekly focused on how NextGen companies are navigating the current business environment. HostAnnalee Armstrong, Senior Editor, BioSpaceGuestDannielle Appelhans, CEO, COURFor a complete list of NextGen 2025 companies, click here. The NextGen Class of 2025 is brought to you by Pliancy.
BioSpace’s Head of Insights Lori Ellis and Tom Whitehead, co-founder of the Emily Whitehead Foundation discuss the challenges navigated by cancer patients, weaving in their personal experiences with treatment and how they would encourage those undergoing treatment to speak up and advocate for themselves.This episode is presented by the Genscript Biotech Global Forum 2025.HostLori Ellis, Head of Insights, BioSpaceGuestsTom Whitehead, Author, Keynote speaker; Co-Founder, Emily Whitehead FoundationDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
We saw more action on the M&A front this week as Novartisbought back its blood thinner abelacimab and the rest of Anthos Therapeutics for up to $3.1 billion and still ahead, a potential buyout of SpringWorks Therapeutics by Merck KGaA, which confirmed it’s in “advanced discussions” with the biotech. Meanwhile, Eli Lilly signed aglobal licensing deal for a MASH asset with South Korea’s OliX Pharmaceuticals.As Q4 and full-year 2024 earnings continue to roll in, BMS, Eli Lilly,Novo Nordisk, AstraZeneca, Eisai, Vertex and Gilead all reported their results in the past week. Notably, BMS continues to reorganize, now targeting an additional $2 billion in savings through 2027, and AstraZeneca axed two rare disease drugs from its $39 billion acquisition of Alexion. When it comes to revenue growth, Novo’s Wegovy and Lilly’s Zepbound continue to climb at a striking pace—a phenomenon that has at times driven the weight loss drugs into shortage and spawning a controversialshadow market of off-brand versions.Speaking of controversy, Regeneron is suing its Dupixent partner Sanofi, claiming the French pharma has failed to provide it with adequate information regarding sales of the blockbuster anti-inflammatory drug—which missed analyst expectations in Q4.On the clinical side, the pulmonary fibrosis space continues to see positive results, with Boehringer Ingelheim notching its second Phase III win in six months for nerandomilast. It wasn’t all good news, however, as Pliant Therapeutics suspended dosing and enrollment in a Phase IIb/III study of its idiopathic pulmonary fibrosis candidate, causing its stock to crash.Finally, BioSpace released a special edition of ClinicaSpace this week focused on the resurgent cardiovascular space—just in time for Valentine’s Day! Sign uphere to receive your copy.
U.S. political maneuverings are keeping biopharma on its toes. Tuesday, Robert F. Kennedy, Jr. passed a major hurdle as the Senate Finance Committee voted to advance his nomination for HHS secretary to a floor vote of the entire Senate. If confirmed, RFK Jr. could have an impact on myriad regulatory issues, including PDUFA negotiations. In other political news, Donald Trump announced his promised tariffs on Canada, Mexico and China—the last of which could have particular implications for biopharma companies looking to China for promising new drug candidates. Both were subjects of conversation as leading pharma companies—including Pfizer, Merck and Regeneron—reported their Q4 and full-year 2024 earnings. Notably, Pfizer is eyeing deals between $10 billion and $15 billion, while Merck took a 12% stock hit on Gardasil challenges in China and Regeneron issued its first-ever dividends. On the regulatory front, the FDA greenlit Vertex’s Jounavx last week as the first new drug for acute pain in more than two decades. Journavx leads a non-opioid pain space that is seeing significant momentum this year, with Tris Pharma, Algiax Pharamceuticals and SiteOne Therapeutics all announcing positive data in the past month. Meanwhile, in obesity news, the U.K.’s pharmacies regulator rolled out stricter guidelines for online pharmacies selling medicines including Novo Nordisk’s Wegovy and Eli Lilly’s Mounjaro, and an obesity-focused deal inked with Novo last year wasn’t enough to keep Omega Therapeutics afloat as the Massachusetts-based biotech revealed it is heading toward bankruptcy. Finally, a new CEO will be taking the reins at Takeda in 2026—but the selection of Julie Kim is an exception in an industry still struggling for gender parity at the top leadership ranks.
BioSpace's Head of Insights Lori Ellis and Tom Whitehead sit down and discuss cell and gene therapies from the perspectives of patients. What do caregivers and patients consider to be risks when lives are on the line? This episode is presented by the Genscript Biotech Global Forum 2025. Host Lori Ellis, Head of Insights, BioSpace Guests Tom Whitehead, Author, Keynote speaker; Co-Founder, Emily Whitehead Foundation Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
In the week since Donald Trump took office, he’s caused quite the stir with healthcare-centered moves that include ordering the Department of Health and Human Services to stop communications, hiring and travel and announcing that he would withdraw the U.S. from the World Health Organization. Wednesday, the U.S. Senate Finance Committee convenes to vote on the controversial nomination of Robert F. Kennedy, Jr. for health secretary—a vote that Jefferies analysts said they expect to be “close.” Biogen continues to grab headlines this month, as the latest chapter in the Sage saga saw the smaller biotech rejecting its neuro partner’s unsolicited buyout offer. Meanwhile, Biogen laid off an undisclosed number of employees from its research unit, just as a higher dose of its Ionis-partnered spinal muscular atrophy therapy Spinraza was accepted for review by both the FDA and EMA. Elsewhere, the weight loss space continues to click on all cylinders, with Versant Ventures debuting its newest obesity biotech Helicore Biopharma on Tuesday with $65 million in series A funds, and two obesity-focused companies, Aardvark Therapeutics and Metsera, seeking entry to the public markets. These up-and-comers will have to compete against the likes of Eli Lilly and Novo Nordisk, the latter of which reported data last week showing that its next-gen obesity drug amycretin could elicit up to 22% weight-loss. And Veru announced that its enobosarm could significantly improve the quality of weight loss in seniors also taking Novo’s Wegovy. Another busy therapeutic space is Duchenne muscular dystrophy, where analysts predict a lot of action in the next couple of years, with a number of data readouts and regulatory submissions. And finally, Annalee Armstrong caught up at JPM with Novavax CEO John Jacobs, who said the vaccine maker is at a pivot point.
Donald Trump was sworn in as the 47th president of the United States on Monday, bringing with him a host of healthcare nominees and potential changes to the FDA, M&A and drug pricing. The new administration was a key focus point at the 2025 J.P. Morgan Healthcare Conference last week, where Annalee Armstrong spoke to executives from several companies about what they’re expecting from a second Trump term. Also at JPM, Mirador Therapeutics CEO Mark McKenna boldly predicted that 2025 would see the return of the megamerger. Speaking of M&A, Annalee spoke with leaders from Biogen, who declined to address the company’s unsolicited takeover bid for Sage Therapeutics. For its part, Sage sued Biogen last week, “seeking preliminary injunctive relief to enforce a standstill agreement.” Meanwhile, Gilead CEO Daniel O’Day addressed the split of Galapagos—a company Gilead has poured more than $5 billion into since 2019. Check out more personal stories from JPM here. In the obesity space, Novo Nordisk reported data from a Phase III trial showing that a high dose of Wegovy elicited more weight loss than the approved regimen—but still fell short of results posted by Eli Lilly’s Zepbound. Relatedly, Wegovy and sister drug Ozempic are both on the list of the next fifteen drugs whose prices could be negotiated under the Inflation Reduction Act. Finally, the FDA on Friday made its first high-profile decision of the year, greenlighting AstraZeneca and Daiichi Sankyo’s Dato-DXd—now Datroway—to treat certain types of advanced breast cancer. The approval is the first for the highly touted antibody-drug conjugate, which is also under FDA review for EGFR-mutated non-small cell lung cacner. Analysts expect 2025 to be a pivotal year for the ADC.
In this bonus episode, BioSpace's vice president of marketing Chantal Dresner and careers editor Angela Gabriel take a look at Q4 job market performance and what we expect to see ahead. We dive into year-on-year data and recent job trends. Want to receive our latest quarterly job market reports? Subscribe to Career Insider for our job market updates, job trends, career advice and more.
In this episode of Denatured, Dr. Peter Marks M.D., PhD. gives his thoughts on the future of cell and gene therapies. He speaks candidly about opportunities and realities, manufacturing and its role in efficacy and the CGT runway. Dr. Marks was keynote speaker at the GenScript Biotech Forum in San Francisco this week. Host Lori Ellis, Head of Insights, BioSpace Guest Peter Marks M.D., PhD., Director, Center for Biologics Evaluation and Research (CBER)
The J.P. Morgan Healthcare Conference kicked off Monday with a flood of high-value deals, reinvigorating sentiment across the biopharma industry. Johnson & Johnson made the biggest splash, acquiring neurology leader Intra-Cellular Therapies for $14.6 billion, while GSK picked up precision therapy specialist IDRx for $1B upfront and Eli Lilly laid down up to $2.5 billion for Scorpion’s PI3Kα inhibitor program. Meanwhile, the immunology and inflammation space continues to fire on all cylinders as Gilead invests up to $1.7 billion for LEO Pharma’s preclinical oral small molecule STAT6 program. And those are only the deals accepted by both parties. Prior to the conference, Biogen offered to acquire its struggling neuro partner Sage Therapeutics for around $469M. The proposal follows a catastrophic run for Sage, which has seen its shares fall more than 90% in the past two years. 2024 sales and earnings forecasts have also generated attention this week, with Sarepta reporting that Duchenne muscular dystrophy gene therapy Elevidys beat analysts’ expectations in the fourth quarter, and Eli Lilly projecting a full-year revenue miss driven largely by lower-than-expected sales of GLP-1 blockbusters Zepbound and Mounjaro. As expected, obesity has been a hot topic at JPM, with Pfizer CEO Albert Bourla announcing that his company is going “all in” in the space. This follows new FDA guidance revealed last week recommending a minimum weight loss threshold for drug developers. Among the many companies taking notice is newcomer Verdiva Bio, which launched last week with more than $410 million in opening funds. Also debuting last week was Kardigan, which raised $300 million to tackle heart disease. Kadigan joins a resurgent cardiovascular space, where several companies—including those developing gene therapies—are targeting myriad diseases. Finally, BioSpace senior editor Annalee Armstrong caught up with Daphne Zohar, CEO of BioSpace NextGen 2025 company Seaport Therapeutics Daphne Zohar, who offered her thoughts on the current state of the neuropsychiatric space.
TEASER: This episode is little sneak peak into upcoming podcasts as well as topics that will be discussed at the 2025 GenScript Biotech Global Forum on January 15 in San Francisco. Listen in as Peter Marks and Tom Whitehead share their thoughts on the CGT space for 2025. Register for the event here. Host Lori Ellis, Head of Insights, BioSpace Guests Peter Marks M.D., PhD., Director, Center for Biologics Evaluation and Research (CBER) Tom Whitehead, Author, Keynote speaker; Co-Founder, Emily Whitehead Foundation
Happy New Year! BioSpace released our NextGen: Class of 2025 this week, highlighting 25 biopharma startups to watch this year. The companies on this list are not afraid of a challenge, wading into some of biopharma’s most competitive therapeutic spaces. As analysts predict an uptick in M&A in ’25, could some of them be potential targets? One NextGen 2025 company that could already be fielding calls is Metsera, which reported promising Phase II data for its investigational subcutaneous GLP-1 therapy on Tuesday. The GLP-1 space continues to garner significant attention, with both Eli Lilly and Novo Nordisk seeking to protect their drugs against competition from compounders. This strategy makes a lot of sense as the sizzling class continues to expand into heart disease, sleep apnea and metabolic dysfunction-associated steatohepatitis, among other indications. On the regulatory side, the FDA approved 55 novel medicines in 2024—including a few inaugural company approvals—and is looking ahead to several key PDUFA dates in Q1, 2025. Meanwhile, the agency released three new guidance documents seeking to provide clarity around confirmatory trials supporting accelerated approvals, the use of AI in drug development and the use of tissue biopsies in clinical trials. Finally, BioSpace senior editor Annalee Armstrong heads to the J.P. Morgan Healthcare Conference next week as biopharma seeks an M&A spark to improve the currently a gloomy sentiment. Stay with us for all the biggest news coming out of JPM.
This conversation focused on a few remaining topics discussed at length at Jefferies late last year, with the same topics anticipated to make an appearance at JPM. In this episode, our guests the industry’s need to catch up with women’s health issues and the innovative lead the APAC region has taken in clinical trials. Host Lori Ellis, Head of Insights, BioSpace Guests Miguel Forte, President, International Society for Cell & Gene Therapy; Board Member, ARM; CEO and Board Member, Kiji Therapeutics Ali Pashazadeh, Founder, Treehill Partners