In December 2024, the FDA affirmed that the shortage of tirzepatide, marketed as Zepbound for weight loss, had ended, formally barring compounders from producing their knockoff versions of the drug.
FDA Commissioner Marty Makary talks about his plans to revamp drug development and reduce ‘conflicts of interest’ between the agency and pharma industry; Roche and Regeneron jump on the U.S. manufacturing train as Trump’s tariffs loom; and Eli Lilly scores a big win for orforglipron while Novo Nordisk reveals it has applied for FDA approval of its oral semaglutide.
Paul Stoffels left his perch as J&J’s chief scientific officer in 2022 to replace Galapagos’ founding CEO Onno van de Stolpe, inheriting a company that had suffered a series of clinical failures since its 1999 creation.
Roche is committing $50 billion while Regeneron inked a $3 billion manufacturing deal with Fujifilm, allowing the pharma to “nearly double” its U.S. large-scale manufacturing capacity.
Combining Trodelvy with Keytruda and pushing it into the frontline setting could “potentially double” the ADC’s market in metastatic triple-negative breast cancer, according to analysts at Truist Securities.
Analysts at Leerink Partners said in a Monday note that DESTINY-Breast09’s findings “could support an approval” for Enhertu in first-line HER2+ metastatic breast cancer.
FEATURED STORIES
As the industry awaits official word from the administration on how the tariffs will hit, analysts go over the possibilities with one certainty: there will be increased costs for medicines.
Wegovy and Zepbound are just the latest drug dyads to face-off in the competitive pharma market, continuing a legacy of rivalry that includes blockbuster drugs Keytruda, Humira and Eliquis.
Billions in market cap are being shed as the markets reel over President Donald Trump’s escalating trade war. Eli Lilly’s value has dropped more than $95 billion in just one month.
FROM BIOSPACE INSIGHTS
A Discussion with IQVIA’s Michelle Gyzen Sr. Director, Regulatory Affairs and Drug Development Solutions
LATEST PODCASTS
Novartis, Eli Lilly and more put on their deal-making caps, Bristol Myers Squibb targets $2 billion in savings through 2027, sales continue to soar for Lilly and Novo Nordisk’s GLP-1s and Regeneron sues Sanofi over an alleged failure to provide adequate information about Dupixent sales.
Robert F. Kennedy Jr.’s HHS nomination moves to a full Senate vote; Donald Trump’s tariff war sparks China-related concerns for biopharma; Pfizer, Merck and more announce Q4 and 2024 earnings; and the non-opioid painkiller space heats up as FDA approves Vertex’s Jounavx.
In this episode, presented by the Genscript Biotech Global Forum 2025, BioSpace’s Head of Insights Lori Ellis talks to Tom Whitehead, co-founder of the Emily Whitehead Foundation, about how standard care, cell and gene therapies and their impact on patients.
Job Trends
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SPECIAL EDITIONS
In this deep dive, BioSpace explores the diverse therapeutic modalities now in development, as well as the opportunities and battles for market dominance in this emerging space.
Year-over-year BioSpace data show there were fewer job postings live on the website in the fourth quarter of 2024, and the decrease was higher than the third quarter’s drop.
The J.P. Morgan Healthcare Conference started off with a flurry of deals that reinvigorated excitement across the biopharma industry. Johnson & Johnson moved to acquire Intra-Cellular Therapies for $14.6 billion, breaking a dealmaking barrier that kept Big Pharma’s 2024 biotech buyouts to under $5 billion.
DEALS
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On the company’s Q4 earnings call where an eyepopping $88.8 billion in full-year sales were revealed, leaders shifted focus away from enormous takeovers to single-digit billion buy outs. -
With an eye toward advancing a novel antibody-drug conjugate for gastrointestinal cancers, ArriVent is the latest biopharma player to ink a deal with a Chinese biotech. -
Five years ago, Gilead signed a massive deal with Galapagos. After a restructuring, the pharma is still hunting for the potential it saw at the original signing. -
Biopharma executives shared their thoughts on the potential impacts of the new administration; Annalee Armstrong recaps JPM and her talks with Biogen, Gilead, Novavax and more; Wegovy’s higher dose induces more weight loss; AstraZeneca and Daiichi Sankyo’s Dato-DXd scores its first FDA approval. -
Biopharma executives make their predictions for the year ahead, from a bold forecast for the return of the megadeal to a plea for the slow, healthy recovery of the industry at large.
WEIGHT LOSS
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While Kallyope’s drugs are mechanistically unique, the biotech is competing in a crowded space, with other therapies that appear to elicit superior weight-loss. -
As high prices and supply issues drive consumers to alternative markets for GLP-1s, physicians aren’t too interested in using these therapies to treat conditions like heart disease risk that have existing cheap standards of care. -
The Outsourcing Facilities Association, a trade group representing compounders, filed a similar lawsuit in October last year after the FDA formally ended the tirzepaptide shortage. -
Many of these unlawful and unauthorized shipments were explicitly tagged for compounding, according to a new analysis. Separately, a group of state attorneys general has raised concerns about the unsafe GLP-1 drugs finding their way to American consumers. -
Obesity drug developers Aardvark, Helicore and Metsera have all netted raises in the past two weeks.
FDA
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Milestone Pharmaceuticals hit another bump in the road in its quest to get Cardamyst approved for paroxysmal supraventricular tachycardia when the FDA issued a Complete Response Letter on Friday. -
Soleno’s Vykat XR is the first drug approved for the rare disease that directly targets its hallmark symptom. -
Biosimilars are essential healthcare equalizers, but their regulation is overly complicated due to lobbying by makers of branded biologics looking to maintain blockbuster revenue. -
This is the third indication for Fabhalta after Novartis won FDA approval of the small molecule in paroxysmal nocturnal hemoglobinuria and primary immunoglobulin A nephropathy. -
The FDA approval of Alnylam’s Amvuttra sets up a three-way race with Pfizer and BridgeBio, which both market transthyretin stabilizers for transthyretin amyloid cardiomyopathy.
Getting caught between younger team members and older bosses can be stressful for millennial managers. A leadership expert and millennial manager share tips for bridging the gap between these groups.
For reasons including downsizing, avoiding retirement and a tight labor market, senior-level biopharma professionals are increasingly turning to fractional roles, according to two recruitment experts.
Massachusetts’ biopharma jobs increased 2.6% in 2023, according to the MassBio Industry Snapshot. Whether the state’s jobs grow in 2024 remains to be seen based on this year’s layoffs and seemingly slowed hiring based on BioSpace data.
The federal judge’s decision Tuesday said the Federal Trade Commission exceeded its statutory authority in implementing a final rule aimed at restricting noncompete clauses.
Massachusetts’ new salary range transparency law can be a tool for companies looking to attract biopharma professionals while also helping candidates and current employees improve their job searches and salaries, according to two experts.
By building and nurturing a strong personal brand, you can benefit in multiple ways, including enhancing your credibility, attracting opportunities and inspiring investor confidence.
HOTBEDS
REPORTS
How does being Black affect the workplace experience as a life sciences professional? BioSpace surveyed our community to gain a greater understanding of Black employees’ feelings of inclusion and their perspectives on employer DEI initiatives.
Over the last two decades, women have achieved near equal levels of representation in life sciences - though there are distinct gaps in leadership and pay equity. The experience of women also differs vastly depending on age, race, and other factors.
How does age affect employees’ experiences in the workplace? This report examines the intersection of age along with gender and other demographics.
CANCER
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The new formulation of Keytruda, currently under FDA review, is sparking conflict with Halozyme, which makes enzymes that convert intravenous drugs into injectable versions. -
At the heart of the deal is the drug candidate dordaviprone, which is months away from a regulatory verdict for its use in H3 K27M-mutated diffuse glioma. -
Pfizer reacts to Donald Trump’s tariff threats on big pharma, another regulatory meeting is canceled under RFK Jr., AbbVie and Eli Lilly strike mid-sized deals in obesity and molecular glues, priority review vouchers set to take a hit and immuno-oncology matures.
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Merck’s Keytruda holds on to the top spot while AbbVie’s Humira—once the world’s top-selling drug—continues to cede its market share to biosimilar competitors. -
The approval for the first-line treatment of esophageal squamous cell carcinoma comes shortly after a label expansion for the drug in gastric and gastroesophageal cancers as BeiGene also pushes forward a pipeline of novel cancer therapies.
NEUROSCIENCE
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The partnership splits the rights to Stoke’s epilepsy antisense oligonucleotide, with up to $385 million in potential payments due to Stoke. -
Helmed by Roche alums, Newleos Therapeutics is taking over four drugs dropped from the Swiss pharma’s pipeline in early 2024. -
Biogen and Eisai have spent much of Leqembi’s launch convincing physicians and patients that it’s safe to treat Alzheimer’s disease. With patients now hitting the 18-month mark of treatment, the conversation is finally shifting to efficacy. -
The approval comes days after Germany’s Merck KGaA confirmed it was in advanced talks to acquire SpringWorks. -
Leqembi’s sales in the U.S. continue to underwhelm, overshadowed by its growth in international markets.
CELL AND GENE THERAPY
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The Philadelphia market has gained recognition not only for its cell and gene therapy sector but also its real estate scene and talent pool. Vittoria Biotherapeutics, Interius BioTherapeutics and Chamber of Commerce for Greater Philadelphia executives share why the area is a life sciences hot spot. -
Biopharma doubles down on immunology and inflammation as companies target new pathways and seek to improve on current options in inflammatory bowel disease, atopic dermatitis, myasthenia gravis and more. -
In this episode, presented by the Genscript Biotech Global Forum 2025, BioSpace’s Head of Insights Lori Ellis and Tom Whitehead continue to discuss the patient and caregiver experience, where Tom gives his insights to the future of CGTs. -
Gilead beat consensus estimates in Q4 with $7.6 billion in revenue, driven largely by its HIV drug Biktarvy and CAR T therapies Trodelvy and Yescarta. -
Vertex expects to make the newly approved non-opioid pain medicine Journavx available by the end of February.
