The stock market—and biotech insiders—reacted negatively to the allegedly forced resignation of CBER Director Peter Marks, who said RFK Jr. does not seek “truth and transparency” but rather “subservient confirmation of his misinformation and lies.”
Unlike other hemophilia therapies, Qfitlia is indicated for both hemophilia A and B, and can be given in patients regardless of the presence of neutralizing antibodies against clotting factor VIII or IX.
BMO Capital Markets analysts said the results potentially position lepodisiran as “one of the most durable assets in development to date” in the competitive Lp(a) space, where drugs are designed to lower the risk of cardiovascular events such as heart attack and stroke.
Ayrmid’s offer is 50% higher than bluebird’s previously announced deal with Carlyle and SK Capital Partners.
According to BMO Capital Markets, Rybelsus’ outcomes in SOUL were “inconsistent,” failing to significantly lower cardiovascular death and nonfatal stroke.
Werner held roles at Bristol Myers Squibb, AstraZeneca and Novartis before landing at Alltrna, where she works to develop tRNA-based treatments for a range of diseases.
FEATURED STORIES
Even before the FDA’s recent approval of Dato-DXd in breast cancer, analysts predicted sales of the antibody-drug conjugate could hit $5.9 billion in 2030. However, the asset faced a series of setbacks in 2024.
There are currently no treatments available for celiac disease beyond a gluten-free diet. Several late-phase companies aim to change the paradigm and deliver hope and progress soon.
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.
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.
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Job Trends
Pfizer Inc. announced that Andrew Baum, M.D., will join the company as Chief Strategy and Innovation Officer, Executive Vice President.
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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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After a slow start to 2023 in an uncertain economic climate, biopharma mergers and acquisitions are on the rise. -
Mergers and acquisitions are trending upward as Novo Nordisk, Gilead, and Johnson & Johnson kick off the year with big deals. AI and other scientific advances will likely be the focus of M&As yet to come. -
Novo Nordisk seems to believe it can do a better job managing troubled Catalent than the contract manufacturer. However, the Danish drugmaker has its work cut out for it. -
Claiming that Karuna Therapeutics’ board of directors withheld crucial information, a shareholder has filed a lawsuit seeking to block the $14 billion merger with Bristol Myers Squibb. -
The neuroscience space saw a late push in merger and acquisition activity, while oncology start-ups reeled in the most venture capital funds. Industry leaders expect these trends to continue.
WEIGHT LOSS
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Pfizer said Thursday it is pushing ahead with a once-daily, modified-release formulation of its oral GLP-1 obesity therapy danuglipron, with dose optimization studies in the second half of 2024. -
Eli Lilly becomes the latest to make a major investment in immunology and inflammation, while antibody-drug conjugate biopharma Myricx Bio nets a large Series A round and new research highlights the potential and possible risks of GLP-1s. -
As Novo Nordisk’s weight loss drug enters the Chinese market, its patent is expiring in two years and biosimilar competition is rising. -
Eli Lilly’s Mounjaro outperformed Novo Nordisk’s Ozempic at inducing weight loss in obese or overweight adults, according to an observational study published Monday in JAMA Internal Medicine. -
GLP-1 receptor agonists could reduce the risk of 10 obesity-associated cancers, such as meningioma, multiple myeloma and colorectal cancer, according to an analysis of electronic health records.
POLICY
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For the Biden-Harris administration to compare the newly announced negotiated Medicare prices to the list prices for these drugs is, at best, not very meaningful. At worst, it’s disingenuous. -
Just months after a jury ordered payment to Pfizer in the patent infringement case, a Delaware judge has nullified the award and invalidated the patents behind the lawsuit involving AstraZeneca’s blockbuster lung cancer drug. -
The Biden administration on Thursday touted discounts of up to 79%, but many of these first 10 drugs are already sold well below list price.
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The Biden administration on Thursday announced that the Inflation Reduction Act’s Medicare Drug Price Negotiation Program will save the U.S. government around $6 billion in its first year of implementation. -
The new Medicare prices for the first 10 drugs negotiated under the Inflation Reduction Act are expected soon. Analysts and researchers are divided on the long-term effects of the law.
Here are tips for introverts who are trying to land their dream job.
According to Bloomberg, the Work Trend Index showed that 41% of the survey’s 30,000 respondents planned on leaving their current job.
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Non-negotiables are the factors that you decide must exist or must not exist in order for you to say yes to a position.
The pandemic and its subsequent effect on the workplace has been the source of stress for many professionals. Here are 3 ways to boost mental health at work.
Leadership can be a very challenging skill, and you cannot learn it overnight. People take years learning how to perform leadership at work that can be profitable for them.
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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Despite the disappointing late-stage results in non-small cell lung cancer, Jefferies analyst Stephen Barker contends the likelihood of FDA approval “remains high” for the experimental antibody-drug conjugate, though the regulator is now more likely to convene an advisory committee. -
Set to start in 2025, Relay Therapeutics is moving toward a pivotal study of experimental treatment RLY-2608 in heavily pretreated locally advanced or metastatic breast cancer. -
In advanced non-small cell lung cancer, Summit Therapeutics’ ivonescimab appears to be 49% more effective at reducing the risk of disease progression or death versus Merck’s Keytruda in a late-stage study. However, analysts contend the caveat is that the trial was conducted in an entirely Chinese patient population. -
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.
NEUROSCIENCE
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Psychedelic drug developers are homing in on the potential $16 billion depression treatment market, with a particular focus on treatment-resistant depression. -
Vaxxinity published data from an early-stage clinical trial showing that its investigative immunotherapy, UB-312, could improve movement in Parkinson’s disease and protect against pathological alpha-synuclein. -
A new observational study from the University of Iowa points to the potential of alpha-blocker drugs, commonly used to treat enlarged prostates, as a preventive therapeutic option for dementia with Lewy bodies. -
The next six months for the FDA are primed to be as groundbreaking as the first six, with Eli Lilly’s donanemab and Lykos Therapeutics’ MDMA-assisted PTSD therapy on the docket, among others. -
Accurately diagnosing Alzheimer’s disease pathologies is becoming increasingly important, but the U.S. is facing imaging resource constraints.
CELL AND GENE THERAPY
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Q&A: Development Scientist at AGC Biologics Sara Morlacchi analyzes the growth of the cell therapy industry and barriers for cost and accessibility. -
Pfizer will go toe-to-toe with CSL Behring following the FDA’s Friday approval of its hemophilia B gene therapy Beqvez and will launch a warranty program based on the durability of response. -
The Celularity CEO and founder tells BioSpace he believes that placenta-derived cells are the future of stem cell therapies to fight autoimmune disease, cancer, even aging. -
While Sanofi restructures and parts with employees from U.S. and Belgian sites, a new company in the GLP-1 space emerges from stealth. -
While Bristol Myers Squibb did not explicitly mention China as the company expands and diversifies its manufacturing capacity, Cellares said the BIOSECURE Act would be a boon to its own growth.
