The FDA is asking Novavax for a non-mandatory postmarketing commitment to produce additional clinical data for its investigational COVID-19 vaccine.
The tradipitant saga stretches back to September 2024, when the FDA declined to approve Vanda’s drug in gastroparesis, a stomach condition characterized by delayed gastric emptying.
Proquad is rarely a newsmaker from Merck’s earnings, but this time around, the U.S. has had a series of measles outbreaks. Sales of the vaccine were $539 million for the quarter, a 5% decline from the same period in 2024.
Where thousands of former Health and Human Services employees will work next is unknown, but biopharma companies likely aren’t the main destination. Two biopharma executives discuss potential landing spots.
Roche’s exposure to the tariffs is mostly limited to four medicines, three of which it already produces in the U.S., according to CEO Thomas Schinecker, who declined to reveal what these assets are.
In this discussion, our guests explore how recent regulatory changes are shaping the future of AI in drug development in the US market. Watch now.
FEATURED STORIES
Congress, the Federal Trade Commission and the U.S. Patent and Trademark Office are all targeting Big Pharma’s practice of filing multiple, overlapping patents that stifle generic and biosimilar competition.
The vaccine maker is competing with well-established rivals in markets that have a mix of demand issues as well as commercial and structural headwinds, as the biotech looks to establish new growth drivers.
In this deep dive BioSpace dissects the global obesity and diabetes markets along with the growing pipelines that aim to serve them.
Experts say Novo Nordisk and Eli Lilly’s GLP-1 drugs are unlikely to reach more countries in the near term, but Sanofi’s diabetes treatment has gained ground globally.
As the pharma industry awaits congressional action on the bill, gaping holes in the domestic drug manufacturing ecosystem have never been clearer.
The recent invalidation of an AAV gene therapy patent overlooks the complexity of innovation in biotechnology and could put a broad swath of intellectual property at risk.
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 BioSpace’s Greg Slabodkin, Tyler Patchen and Lori Ellis discuss Zepbound, Wegovy, the weight loss race and the future of this drug class.
This week, in (our inaugural episode!) BioSpace’s Greg Slabodkin, Tyler Patchen and Lori Ellis discuss the good, the bad and the ugly of biopharma’s reported Q3 earnings. They also tackle what’s going on at Pfizer, ADCs, deals and more.
Job Trends
Moderna, Inc. (NASDAQ:MRNA) today announced that the Company will present data from its respiratory portfolio, including vaccines and vaccine candidates against COVID-19.
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SPECIAL EDITIONS
BioSpace did a deep dive into executive pay, examining the highest compensation packages, pay ratios and golden parachutes—what a CEO would get paid to leave.
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.
DEALS
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Despite not having a single candidate in the clinical stage, the Moderna-backed biotech is offering 6.25 million shares for $15 apiece in an initial public offering. Shares are expected to begin trading Friday. -
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.
WEIGHT LOSS
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Eli Lilly on Thursday said it is again suing spas and clinics over compounded and counterfeit forms of tirzepatide, the active ingredient in blockbusters Mounjaro and Zepbound, which the pharma says can cause harmful side effects. -
Novo Nordisk CEO Lars Jørgensen has agreed to appear before the Senate health committee in a hearing on the prices of its blockbuster drugs Ozempic and Wegovy. -
While GLP-1 drugs remain wildly popular and are a highly lucrative sector, data analytics firm GlobalData contends manufacturing and cost will remain overhangs on the obesity market. -
The plethora of genes involved in obesity presents an intriguing opportunity for both gene silencing and ex vivo gene therapy approaches. -
Building on last year’s potential $7 billion partnership with Flagship Pioneering, Pfizer and Flagship-founded ProFound Therapeutics will work on discovering new obesity candidates.
POLICY
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Amgen’s Enbrel, Bristol Myers Squibb’s Eliquis and Johnson & Johnson’s Stelara will account for 51.4% of the Inflation Reduction Act’s drug price negotiation savings in 2026, according to the Brookings Institution. -
In June, the regulator placed a partial clinical hold on a Phase I trial of the companies’ antibody-drug conjugate after three patient deaths were reported. -
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.
We’ll answer these questions and a few others here in order to help you determine which path best fits your needs for the future of your biotech career.
Have you ever thought seriously about entrepreneurship? While large organizations appear to dominate the life sciences industry, startups and small businesses have started to compete in the marketplace.
We interviewed Krissy Fuller, a human resources consultant, to learn more about the issue of mandated vaccines from an HR perspective and shared her predictions on what changes she thinks will last after the pandemic.
Learn some essential tips on how to build a resume or how to enhance your resume during COVID-19. These tips can increase the chances of getting you to the interview stage.
If you’re setting new career goals, try including these tips to shape a path forward.
After you’ve been in a role for a decent amount of time it can feel like you have learned all that there is to learn. But that’s not to say that you’ve learned all you can from the company and the people that work there.
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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In an effort to build its commercial capacity, Moderna on Thursday announced it is lowering research and development spending, while pushing back its target for breaking even by two years to 2028. -
BioMarin’s new business strategy leaves investors with questions; Lykos CEO steps down; Terns releases compelling data on oral weight loss candidate; and more. -
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.
NEUROSCIENCE
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Following a series of clinical failures, optimism builds for the first disease-modifying treatment. -
Disappointed with Phase I/II results for two Ionis-partnered programs, one for amyotrophic lateral sclerosis and another for Angelman syndrome, Biogen has opted to not proceed with their development. -
After missing their initial target in March 2024, Eisai and Biogen have initiated a rolling BLA for a subcutaneous maintenance formulation of Leqembi, which could offer a more convenient dosing schedule for Alzheimer’s disease patients. -
With Monday’s agreement, AbbVie joins the industry’s growing interest in next-generation psychiatric therapies and looks to leverage Gilgamesh Pharmaceuticals’ research platform to discover novel neuroplastogens. -
Takeda on Monday said it is paying AC Immune $100 million upfront for an option on a Phase Ib/II Alzheimer’s disease candidate that could activate the immune system to clear amyloid beta plaques.
CELL AND GENE THERAPY
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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. -
With several recent approvals in the space and more on the horizon, BioSpace looks at some of the key decisions and their larger significance both for patients and science. -
Brazil’s Ministry of Health and nonprofit Caring Cross announced a collaboration Tuesday aimed at local manufacturing of CAR-T cell and stem cell gene therapies at a much lower cost than Europe and the U.S. -
Capstan Therapeutics is looking to move its CAR-T cell candidate forward after securing financing from pharma venture arms and VC firms. -
Two days after winning FDA approval, Orchard Therapeutics on Wednesday provided its U.S. launch plans for metachromatic leukodystrophy gene therapy Lenmeldy, which has a wholesale acquisition cost of $4.25 million for the one-time treatment.
