Biopharma leaders react to the forced resignation of CBER Head Peter Marks as RFK Jr.’s promised job cuts begin at the FDA; Novo Nordisk presents mixed results from oral semaglutide in cardiovascular disease; the EU’s Committee for Medicinal Products for Human Use declines to recommend Eli Lilly’s Alzheimer’s drug; and pharma R&D returns grew in 2024.
Already reeling from years of market chaos, the announced departure of CBER chief Peter Marks sent a ripple across biopharma markets.
Organon’s workforce cuts come several months after the company’s loss of exclusivity to its second-largest product, Atozet.
The latest cuts, which are part of a larger reduction of 10,000 at the Department of Health and Human Services, were reportedly underway Tuesday, with CDER Office of New Drugs Director Peter Stein added to the list of casualties.
Cell therapy and oncology–focused Carisma Therapeutics started layoffs late last year. Now the company plans to wind down fully.
Merck continues to build the case for the pulmonary arterial hypertension drug that won FDA approval in 2024.
FEATURED STORIES
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.
As I ran from interview to interview across San Francisco, I was consistently warmed by the stories I was told by biotech and pharma executives—and the general comradery in the air throughout the chaotic event.
With incoming president Donald Trump threatening a trade war with China, experts told BioSpace that the new administration will likely understand why medicines should be treated differently.
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
This week we discuss ups and downs in the weight loss and ADC markets - including Altimmune, Pfizer setbacks, AbbVie’s ImmunoGen buy and more.
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Listen to this in-depth discussion on how AI can help identify end-to-end data weaknesses, as well as broader implications regarding the inevitability of human interaction, with guests from GSK, IQVIA, Exelixis and DataHow.
Job Trends
AstraZeneca will showcase new clinical and real-world data across its leading inhaled, biologic and early science respiratory portfolio at the American Thoracic Society International Conference, in San Diego, CA from May 17 - 22, 2024.
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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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Investors drove up the price of Kyverna Therapeutics’ stock by 59% in its initial public offering on Thursday afternoon, the first day of trading, reaching a peak per-share price of $35.01. -
On Thursday, Kyverna Therapeutics is debuting on the Nasdaq with an upsized initial public offering which the biotech will use to support its pipeline of anti-CD19 CAR T therapy candidates. -
While analysts are bullish on Novo Holdings’ $16.5 billion acquisition of Catalent, they say it raises questions for companies that have contracted the CDMO for manufacturing. -
The Swiss pharma’s dealmaking momentum continues in early 2024 with the acquisition of German biotech MorphoSys in an effort to strengthen its oncology portfolio. -
Metagenomi could potentially raise over $100 million if the underwriters exercise their option to purchase additional shares in full, assuming an initial public offering price of $16 per share.
WEIGHT LOSS
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Eli Lilly, Rivus Pharmaceuticals and more target different biological processes in hopes of generating higher-quality weight loss and avoiding metabolic issues. -
Zealand Pharma is looking to build on last week’s positive Phase Ib trial results by raising around $1 billion in a public offering, with the proceeds being used to advance its obesity candidates. -
Novo Nordisk on Monday announced it is boosting its manufacturing capabilities with a $4.1 billion commitment to construct a second fill and finishing facility in Clayton, North Carolina. -
Data showed that Eli Lilly’s Zepbound could resolve obstructive sleep apnea in at least 43% of patients, solidifying the pharma’s case for label expansion. -
Altimmune’s obesity candidate pemvidutide strongly preserved lean muscle mass, with fat accounting for more than 78% of weight lost by participants in a Phase II study.
POLICY
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The European Union has approved the first-ever combination therapy consisting of an immunotherapy and a PARP inhibitor for the treatment of endometrial cancer, AstraZeneca announced Wednesday. -
As the U.S. moves away from reliance on Chinese CDMOs, Southern cities provide a model for how we can bolster domestic production capacity. -
On the heels of the FDA’s denial of its petition, a Delaware district court on Monday handed Novartis another loss in its efforts to keep the market free of Entresto copycats. -
At a private event held amid the fallout from the CrowdStrike incident, cybersecurity issues took a front seat, with the consequences of the evolving EU AI Act and the Loper Bright and Corner Post decisions also raising concerns for quality assurance and regulatory affairs professionals. -
With Medicare expenditures on Stelara increasing nearly tenfold, a new report from the HHS Office of Inspector General has found major differences in drug payment amounts under Part B versus Part D.
The coronavirus disease (COVID-19) pandemic that has ravaged across the globe has demanded more experts in microbiology, particularly jobs in virology.
BioSpace’s Pharm Country Hotbed ranges from Connecticut, New York, New Jersey, Pennsylvania and Rhode Island.
“The Great Resignation” is a term that’s been coined to describe the wave of people leaving their jobs for other opportunities or exiting the workforce altogether.
A resume is your introduction to a potential employer, and as the saying goes, “You only get one chance to make a good first impression.” Follow these resume writing tips today.
Being confident about your skills and learning new things are some of the best career advice and tips a professional should know to become better at your workplace.
When dealing with a large group of people, the possibility of handling a disgruntled employee is very likely. Here’s how you can handle them efficiently.
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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Follow-up data from the MARIPOSA study show a favorable overall survival trend versus Tagrisso in EGFR-mutated advanced non-small cell lung cancer. The findings come just weeks after the Rybrevant-Lazcluze combination was approved for the first-line treatment. -
Using a computational biomarker, the companies say they can identify which patients would derive significant clinical benefit from their experimental antibody-drug conjugate. AstraZeneca and Roche are co-developing and commercializing a companion diagnostic for the biomarker.
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Bispecific antibodies and anti-TIGIT therapies both appear to be writing comeback stories as cancer experts head to Barcelona for the 2024 European Society for Medical Oncology Congress. Radioligand therapies and synthetic lethality assets are also attracting attention. -
The company is building a new facility in California, its third U.S.-based radioligand therapy production site, and expanding an Indianapolis site for producing isotopes for cancer treatment. -
Proceeds from the oversubscribed financing will be used to advance ArsenalBio’s lead programs, which include a handful of solid tumor cell therapy candidates.
NEUROSCIENCE
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In this deep dive BioSpace analyzes the neuropsychedelic therapeutics pipeline, which grabbed headlines in February when the FDA accepted the New Drug Application for Lykos Therapeutics’ MDMA capsules for PTSD. -
While more programs now involve candidates with different targets, experts say anti-amyloid therapies will remain a primary player in treating the memory-robbing disease. -
In the next two weeks, the FDA is scheduled to decide on four drug applications and hold two highly anticipated advisory committee meetings. -
Johnson & Johnson on Wednesday reported late-stage trial data showing its first-in-class orexin receptor antagonist reduced major depressive disorder symptoms as an adjunctive treatment in patients with insomnia. -
Recent M&A activity indicates a potential resurgence in the appetites of larger companies for psychiatric drug development, but experts say the space may not offer a sufficient risk-reward proposition for R&D.
CELL AND GENE THERAPY
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Roche’s Genentech subsidiary is terminating for undisclosed reasons its 2021 contract with Adaptimmune for the development of allogeneic T-cell therapeutics. -
Investors were disappointed in data from a mid-stage study of Enlivex Therapeutics’ Allocetra cell therapy for the treatment of sepsis. The Israeli company is considering a follow-on trial in sepsis caused by urinary tract infection. -
The approvals, third line for BMS and 2seventy Bio’s Abecma and second line for J&J and Legend Biotech’s Carvykti, represent a new class of therapy for these blood cancer patients. -
Gamida Cell, whose cell therapy for blood cancer was approved last year by the FDA, is being taken private and restructuring due to liquidity constraints. -
Nanoscope Therapeutics nabbed a victory on the changed primary endpoint of its Phase IIb vision loss gene therapy trial Tuesday, teeing the biotech up to file for FDA approval of the candidate this year.
