The U.S. government remains shut down, with the FDA closed for new drug applications until further notice; cell and gene therapy leaders gather for the annual meeting in Phoenix with the field in a state of flux; Pfizer and Amgen will make drugs available at a discount as President Donald Trump’s tariffs still loom; and new regulatory documents show how Pfizer beat out the competition for Metsera.
In this episode presented by Element Materials Technology, guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney discuss how small biotechs face mounting pressure amid manufacturing uncertainties.
Despite showing no meaningful benefit on lung function, Arcturus’ mRNA therapy ARCT-032 reduced mucus volume in patients with cystic fibrosis—an outcome William Blair found “potentially promising.”
With Avadel under its fold, Alkermes expects to accelerate its expansion into the sleep market, laying the foundation for its late-stage narcolepsy asset alixorexton.
A key question for investors going forward will be whether Moderna’s other latent virus vaccines for Epstein-Barr and shingles can succeed after the failure of the CMV program.
Looking for a job in regulatory? Check out the BioSpace list of eight companies hiring life sciences professionals like you.
FEATURED STORIES
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.
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.
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.
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.
The number of employees laid off increased year over year during the first quarter. BioSpace recaps the five largest rounds of layoffs, which included BMS and Novartis cuts.
LATEST PODCASTS
In this episode, Lori and guests continue their exploratory discussion on AI and focus on the challenges of globalization and return on investment.
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.
Job Trends
Looking for a biopharma job in Illinois? Check out these top five companies hiring life sciences professionals like you.
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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
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BridgeBio’s Attruby wins approval for transthyretin amyloid cardiomyopathy while the FDA accepts Alnylam’s application for Amvuttra in the indication; Cassava’s controversial Alzheimer’s drug flunks Phase III; Amgen’s MariTide fails to impress investors, Donald Trump’s controversial nominations continue. -
With Elevidys expansion in hand, Sarepta commits up to $10 billion to develop short interfering RNA–based drugs to build out its pipeline. -
Novartis has disclosed roughly $19.4 billion in deals in the past five years. CEO Vas Narasimhan says there’s more to come. -
The deal has secured Novartis the chance to work with Ratio Therapeutics on a novel drug candidate that could fortify the Big Pharma against competition from would-be radiopharmaceutical rivals such as BMS and Lilly. -
The acquisition will give BioNTech full ownership of an investigational bispecific antibody targeting the PD-L1/VEGF-A pathways, a hot area in oncology that could potentially replace standard checkpoint inhibitors for cancer treatment.
WEIGHT LOSS
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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. -
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. -
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. -
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. -
Amgen outperformed expectations in the fourth quarter of 2024, but revealed an FDA hold on early-stage obesity asset AMG 513 and the discontinuation of other programs.
POLICY
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The CMS last month declined to include anti-obesity medications in its Medicare coverage for Part D, a move that Lilly says could interfere with patients getting the appropriate medical care. -
After a tense exchange, Senator Patty Murray (D-WA) told Kennedy that by implementing sweeping cuts to the HHS, he is “enacting his budget,” which “Congress has not passed.” -
Drugmakers will be expected to commit to aligning U.S. prices with the lowest price set in a group of peer nations for all brand products across all markets that do not currently have generic or biosimilar competition. -
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. -
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.
Learn how to successfully hire interns. Also, find some tips on how to manage and support both in-office and remote interns in our comprehensive guide.
Just because everyone around you seems to be switching to a work-from-home position does not mean it is the right decision for you. It’s important to weigh the options carefully before you decide.
Finding the most cost-effective school for your undergraduate pharmaceutical degree can allow you to start working in the field without incurring astronomical student debt.
Peer review is integral to the scientific process, and one group plays a bigger role than you might think: Scientific Review Officers.
Take a look at which states pay the highest and lowest salaries for pharmacists and how that pay compares to the cost of living.
From research to sales and marketing, the pharma industry has a wide range of employment opportunities to accommodate those looking for a chance to work in the field.
HOTBEDS
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
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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. -
Abecma made $406 million in 2024, of which BMS paid $43 million to 2seventy bio as part of their profit-sharing agreement. -
The FDA’s Oncologic Drugs Advisory Committee recently voted to narrow the label for checkpoint inhibitors Keytruda and Opdivo in stomach and esophageal cancers based on PD-L1 expression levels—but the high unmet need in these patient populations should also be considered. -
On the agenda for the FDA this month are two RNA-based treatments for rare diseases. -
Imfinzi is one of AstraZeneca’s key growth drivers for 2025, with potential approvals in stomach and bladder cancers. The PD-L1 blocker brought in over $4.7 billion in sales last year.
NEUROSCIENCE
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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. -
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. -
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. -
Inhibikase’s setback continues biopharma’s losing streak against Parkinson’s, marked by several clinical failures and abandoned assets in recent months. -
The company, co-founded by Nobel Laureate Craig Mello, aims to push molecules for Huntington’s and a form of epilepsy into Phase I trials, with additional preclinical assets targeting Parkinson’s and Alzheimer’s.
CELL AND GENE THERAPY
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In a deal expected to close in Q1 2025, Roche will gain access to Poseida’s off-the-shelf CAR T candidates. -
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. -
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.
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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. -
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.
