Granite will focus on two antibody therapies, both targeting crucial players in the inflammatory cascade to address autoimmune diseases.
In this episode presented by DIA, BioSpace’s head of insights Lori Ellis discusses how collaboration and investment shape the the future of women’s health with Martin Hodosi, partner at Kearney and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine.
With a new raise provided by Flagship Pioneering, the new company is aiming to find “the silent window” before disease symptoms set in.
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.
FEATURED STORIES
Having established success in cancer, biopharma is now looking to leverage CAR T therapies against a new target, autoimmune disorders, with several early- to mid-stage readouts expected this year.
Facing declining valuations and funding challenges, public biotechs like bluebird bio are going private to restructure, reduce regulatory burdens and refocus on long-term growth.
Johnson & Johnson has been fighting thousands of lawsuits over its now-discontinued talc products for 16 years. A pending judge’s ruling could finally put the issue to bed once and for all.
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, the third and final conversation of our mini-series on diversity in clinical trials, Lori and guests discuss framing strategies designed to protect DEI initiatives from legal challenges.
Well-financed startup Tome is winding down operations just as two new companies, Borealis Biosciences and GondolaBio, are launching. Meanwhile, in the midst of already tense relations with China, House lawmakers raise the alarm about U.S. companies working with the country’s military on trials.
Last week, the Biden administration revealed the first drug prices negotiated under the Inflation Reduction Act; Lykos, Grail and others make substantial staffing cuts, and Pfizer/BioNTech see mixed results for their COVID/flu vaccine.
Job Trends
Pfizer Inc. announced detailed overall survival results from the Phase 2 MagnetisMM-3 study of ELREXFIO™ in patients with heavily pretreated relapsed or refractory multiple myeloma.
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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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Pfizer’s sudden market withdrawal of sickle cell therapy Oxbryta, which some analysts predicted would reach $750 million in sales by the end of the decade, has left patients and healthcare providers with few options, while investors question the pharma giant’s dealmaking prowess. -
ARCH Venture Partners is the latest venture capital firm to raise a multi-billion-dollar fund. The cash will be used to support new startups working with AI. -
Novo Nordisk and Eli Lilly are expected to rule the obesity market for a few more years without much challenge. To ensure they stay there as competition enters, the companies are spending billions in licensing and M&A deals. -
Flagship Pioneering–backed Generate:Biomedicines has signed its second major Big Pharma partnership, bringing in $65 million upfront to use its AI platform to discover novel protein drug candidates. -
The drop in interest rate is slightly bigger than anticipated and good news for the biotech industry, but little will change in the near term.
WEIGHT LOSS
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The letters come amid the Outsourcing Facilities Association’s ongoing lawsuit against the FDA over the regulator’s decision to end the shortage for tirzepatide. -
Now that they’ve received the go-signal from both U.S. and EU anti-trust regulators, Novo Holdings and Catalent expect to wrap up their deal in the coming days. -
The EMA approved a kidney disease–related label expansion for the blockbuster GLP-1 drug after a study showed reduced risk of death by 20%. -
The discontinuation of STRIDES is a rare stumble for the next-generation obesity field and comes just weeks after Amgen announced underwhelming mid-stage data for MariTide. -
Eli Lilly is aggressively ramping up its manufacturing capacity for tirzepatide as compounding pharmacies continue to challenge an FDA decision to formally end the shortage of the obesity and diabetes drug.
POLICY
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Amid growing concern of the overuse and misuse of obesity drugs, the UK’s pharmacies regulator rolled out stricter guidelines for online pharmacies selling medicines including Novo Nordisk’s Wegovy and Eli Lilly’s Mounjaro. -
J&J, AstraZeneca, Novo Nordisk and Roche are among the companies that might take a hit from the soon-to-be-enacted fees, according to analysts. -
Robert F. Kennedy, Jr.—Trump’s pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA, particularly financial links between the two, which could indicate trouble for the user-fee model. -
While the former Biden administration showcased the Inflation Reduction Act as a key victory in the fight over high drug prices in the U.S., Trump has so far been mum on how the controversial law could evolve in the coming years. -
Senators on the Health, Education, Labor and Pensions committee were critical of Kennedy’s long history as an anti-vaccine campaigner.
Research associates are always in demand. Check out these top companies currently hiring RAs.
Newer hiring models based on skills applicants have learned and their general potential for growth could avoid the drawbacks of relying on degrees and experience.
The biopharma industry is moving toward using AI to try to determine how well a given person would perform in a role, with applications that go beyond recruiting.
In a cooling job market, companies often can’t match job seekers’ expectations on factors such as salary and remote work.
My colleagues and I have often been asked, “When is it time to start looking for another role?” This three-level rubric can help.
In this job market report we’re reviewing life sciences job market movement in Q3 and what to expect for Q4 and beyond.
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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The conversion of Calquence’s accelerated approval in mantle cell lymphoma comes a day before the drug was listed among the 15 products to be subject to IRA-prescripted price negotiations for Medicare this year. -
The Phase III CodeBreaK 300 study returned disappointing overall survival data for Lumakras plus Vectibix in metastatic colorectal cancer, but in its approval announcement, the FDA pointed to significant improvements in progression-free survival, calling it the “major efficacy outcome” of the trial. -
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis talks to Dr. Peter Marks, Director, CBER about his thoughts on the future of cell and gene therapies. -
Annemarie Hanekamp has overseen some of the most transformative changes in oncology over her years in Big Pharma. Now, she will oversee BioNTech’s transition from a COVID-19 vaccine maker to an “end-to-end organizational oncology powerhouse.” -
JPM25 is in full swing as several pharma powerhouses—including Merck, Lilly and Amgen—detail their strategies for growth in the coming year.
NEUROSCIENCE
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The darlings of the weight loss and diabetes spaces, GLP-1 receptor agonists have shown promise against Alzheimer’s in recent studies—with Phase III results expected next year from Novo Nordisk. -
By speeding lifesaving drugs’ way to market and focusing on the underlying causes of disease, the pathway has helped save many lives. -
The Muna partnership will give GSK access to Muna’s MiND-MAP platform, which it will apply to postmortem brain samples to identify potential therapeutic targets for Alzheimer’s disease. -
Novartis, Gilead, Roche and Takeda commit to new partners in a spate of mid-sized collaborations this week. Meanwhile, Applied Therapeutics’ stock tanks 80% after govorestat is denied approval, Intra-Cellular Therapies seeks to expand Caplyta into major depressive disorder and the FDA investigates the safety of bluebird bio’s Skysona. -
Intra-Cellular submitted its application to the FDA for Caplyta’s approval in major depressive disorder, potentially opening up an additional $1 billion in sales. Still, the stock remains “cheap,” according to Jefferies analysts.
CELL AND GENE THERAPY
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The investigational therapy, vesleteplirsen, had been positioned as an updated version of Sarepta’s original exon 51-skipping Duchenne muscular dystrophy drug Exondys 51. -
Truist Securities analyst Asthika Goonewardene in an investor note said data for anito-cel—particularly its safety profile—will help differentiate the CAR T therapy from Legend Biotech and J&J’s entrenched Carvykti in relapsed and refractory multiple myeloma. -
In our anniversary episode, we discuss a rare earnings miss for Eli Lilly, a pivotal metabolic dysfunction–associated steatohepatitis victory for Novo Nordisk’s Wegovy, growing excitement about CAR Ts for autoimmune disease and the ongoing controversy over HeLa cells.
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In a tough fundraising space, cell therapy biotechs pursuing autoimmune indications review staffing to ensure the right expertise is in place to tackle the new disease area. -
BEAM-101 seems to be competitive with approved sickle cell treatments, William Blair analysts said in a note to investors, but a patient death underscores the need for less-toxic preconditioning treatments.
