Acelyrin and Alumis plan to close their merger in the second quarter of 2025, pending clearances and shareholder approval.
The last few years have been tough for the insulin market, with recent policies and high-level pressure forcing companies to lower drug prices.
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.
Less than two months after two FDA-related setbacks, Atara Biotherapeutics is again cutting its workforce in half. This time, it’s also hitting pause on two CAR T programs, including one affected by an FDA clinical hold in January.
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.
TNKase is the first stroke drug to win FDA approval in nearly three decades.
FEATURED STORIES
Sanofi looks to follow a deep history of Big Pharma offloading their consumer healthcare businesses.
Analysts expect the partners’ first-mover advantage, clinical data and existing presence in lung disease to translate into significant sales, with GlobalData predicting Dupixent’s COPD revenues will top $6.5 billion within 10 years.
As companies roll out data showing the power and improved safety profile of antibodies that target two antigens, analysts say the class could overtake monoclonal antibody Keytruda as the “immunotherapy backbone” of solid tumor treatment.
FROM BIOSPACE INSIGHTS
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.
LATEST PODCASTS
In this episode of Denatured, presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses how AI transformation can help organizations navigate a rapidly evolving regulatory environment with senior director of regulatory innovation and technology, Michelle Gyzen.
Sanofi and BMS paid big money for rare disease and cancer assets, while Regeneron got in the obesity game; AstraZeneca, Gilead and Amgen shone at ASCO; RFK Jr. and the CDC appeared to disagree over COVID-19 vaccine recommendations and several news outlets are questioning the validity of the White House’s Make America Healthy Again report.
HHS Secretary RFK Jr. removes the COVID-19 vaccine recommendation for healthy kids and pregnant women—the latest in a string of changes to vaccine policies; judge issues an order to halt HHS’ reorganization and mass layoff plans; Rocket Pharmaceuticals’ pivotal Danon disease trial is on hold after a patient death; and President Trump has named Mehmet Oz to spearhead his Most Favored Nation drug pricing policy.
Job Trends
Global biotechnology leader CSL announced top-line results from the Phase 3 AEGIS-II trial evaluating the efficacy and safety of CSL112 compared to placebo in reducing the risk of major adverse cardiovascular events in patients following an acute myocardial infarction.
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SPECIAL EDITIONS
A new generation of checkpoint inhibitors is emerging, with some showing more promise than others. From recent TIGIT failures to high-potential targets like VEGF, BioSpace explores what’s on the horizon in immuno-oncology.
Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the instability of the HHS.
Year-over-year BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the first quarter of 2025.
DEALS
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Italian biopharma Chiesi Farmaceutici SpA announced Sunday it was acquiring rare disease-focused Amryt Pharma in a deal that could reach up to $1.48 billion in value. -
The pharma titan adds an intriguing blood pressure medication to its line up with a buyout of CinCor. -
Ipsen bolsters rare disease portfolio with acquisition of liver disease specialist Albireo. -
Thursday, Fate Therapeutics announced it terminated the 2020 collaboration agreement with Johnson & Johnson’s biopharma subsidiary Janssen. -
Aurinia and Sun Pharma agree to file a joint motion to dismiss a key patent dispute.
WEIGHT LOSS
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In what Guggenheim Partners called one of Metsera’s “critical program milestones” this year, its ultra-long-acting amylin injection MET-233i showed promising weight-loss over about eight months. -
Given the evidence, the committee has recommended that the labels for Novo Nordisk’s Wegovy and Ozempic be updated to include the “very rare” risk of non-arteritic anterior ischemic optic neuropathy. -
Eli Lilly joins up with Camurus to make long-acting versions of the pharma’s obesity and diabetes drugs, joining the industry’s growing pipeline of programs that are differentiated by the frequency of dosing. -
Sanofi and BMS paid big money for rare disease and cancer assets, while Regeneron got in the obesity game; AstraZeneca, Gilead and Amgen shone at ASCO; RFK Jr. and the CDC appeared to disagree over COVID-19 vaccine recommendations and several news outlets are questioning the validity of the White House’s Make America Healthy Again report. -
Regeneron’s shares have declined nearly 17% following the failure of the company’s Dupixent follow-up itepekimab.
POLICY
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The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues. -
Bouncing back from a previous rejection, ImmunityBio on Monday secured the FDA’s green light for its IL-15 superagonist Anktiva for non-muscle invasive bladder cancer. -
Policy changes by health insurance companies will likely determine which Humira biosimilars rise to the top. -
Following an investigation regarding antitrust practices against Pharmacosmos’ Monofer, CSL Vifor has proposed a sweeping multi-channel communication campaign designed to reverse allegedly misleading messages about its rival. -
Following a months-long safety review, the regulator on Thursday said it is now requiring updated black box warnings for all commercially available CAR-T therapies to reflect the risk of secondary malignancies.
The following tips from a seasoned recruiter can reduce serious ATS-related errors and help increase the value of the time investment.
For new graduates with limited experience, as well as career-changers whose experience is outside the area they now wish to pursue, fighting the underqualified label is tough
To find out more about career transitions within the life sciences, we interviewed Modu Feyisitan, MPH. Modu provided insight regarding her move from a role as an Epidemiologist within county government into private healthcare. She shares what motivated her to make a job change.
Not only can we humanize with storytelling; we can use stories to connect.
Your amazing résumé in which you creatively maximized available space or ensured perfectly aligned lists by using advanced formatting can confuse an applicant tracking system.
The first biopharma interview after college will increase your stress and anxiety. However, we offer a few time-tested tips to help you nail your first interview.
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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AstraZeneca’s Imfinzi (durvalumab) and tremelimumab were granted Orphan Drug designation by the U.S. Food and Drug Administration as a possible treatment for hepatocellular carcinoma. -
Tecentriq is the company’s PD-L1 checkpoint inhibitor. Avastin is an antibody that binds to VEGF and interferes with tumor blood supply. -
The trial met its co-primary endpoints, showing statistically significant and clinically meaningful improvements in overall survival and progression-free survival compared to standard-of-care, Bayer’s Nexavar. -
The drug failed to meet statistical significance for overall survival. However, the company is putting a positive spin on it, saying it showed a clear improvement trend in OS for patients treated with Opdivo compared to sorafenib. -
Researchers with the Hubrecht Institute in Utrecht, Netherlands and Radboud University in Nijmegen, Netherlands, recently developed a human model using organoids to evaluate the function of specific genes commonly mutated in liver cancer.
NEUROSCIENCE
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Alzheon Inc. unveiled promising data from a Phase II biomarker trial of its investigational drug ALZ-801 to treat early Alzheimer’s disease. -
Research on Alzheimer’s, specifically in neuroscience, continues with the Alzheimer’s Drug Discovery Foundation, Critical Path Institute, Abbvie, AlzeCure Pharma and more. -
BioVie announced topline results from a Phase II biomarker study in Alzheimer’s disease showing patient improvements in cognition and reductions in neural inflammation.
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NIH researchers found that symptomatic herpes viruses were associated with neurological symptoms, but there was no evidence that herpes viruses are linked to Alzheimer’s disease.
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New study supports link between Alzheimer’s and other diseases and points out potential risk factors for developing Alzheimer’s later in life.
CELL AND GENE THERAPY
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Avidity has been given the go-ahead by the FDA to request accelerated approval of delpacibart braxlosiran—potentially the first disease-modifying treatment for facioscapulohumeral muscular dystrophy—with an application in the second half of 2026. -
In a roundtable event on Thursday, HHS Secretary Robert F. Kennedy Jr. said his office will work to eliminate barriers that keep cell and gene therapies from the market. -
Interim results from a small group of children in a Phase I/II trial are essentially in line with that of Elevidys, according to BMO Capital Markets analysts. -
The Platform Technology Designation, which predates the current FDA leadership, is designed to streamline the drug development and review process, particularly for rare diseases. -
J&J has a multi-year head start, but Gilead believes it can win market share by delivering a drug with better safety and at least as good efficacy.
