This manufacturing site in Richmond, Virginia, is the first of four projects that Eli Lilly plans to reveal this year as part of a $27 billion U.S. investment announced earlier this year.
The over-representation of males and Hispanic patients in Eli Lilly’s Phase III ATTAIN-1 study could explain why orforglipron “underperformed” expectations in a previous readout, according to analysts at BMO Capital Markets.
OLN324 targets both VEGF and Ang2, the same mechanism of action as Roche’s Vabysmo, the Swiss giant’s multi-blockbuster treatment for wet macular degeneration and diabetic macular edema.
The world of healthcare is evolving to more predictive care and patients are taking greater control—a trend already emerging around GLP-1 weight loss treatments. As PwC warns, pharma will need to be ready.
A new analyst survey suggests that doctors are still prescribing Sarepta’s Elevidys, even after a series of deaths in certain populations marred the gene therapy’s record.
The sub-analysis, presented at the European Association for the Study of Diabetes congress, showed improved safety data to counteract past tolerability issues.
FEATURED STORIES
A BioSpace analysis of all 80 priority review vouchers that have been handed out across the three FDA programs that offer them found that 2024 was the busiest year yet. Companies have disclosed spending $513 million on vouchers that were earned in 2024 so far.
Konstantina Katcheves, Senior VP of Innovative Global Business Development at Teva Pharmaceuticals brings insights from the World Economic Forum to SCOPE 2025.
Merck’s Keytruda holds on to the top spot while AbbVie’s Humira—once the world’s top-selling drug—continues to cede its market share to biosimilar competitors.
Congress did not reauthorize the rare pediatric disease priority review program at the end of 2024. Advocates say the ripple effect is already being felt across biopharma.
In the current legal and political landscape, it is all about survival for DEI initiatives.
Two recent documents—one from the FDA, the other from a commission organized by The Lancet Diabetes & Endocrinology—indicate an evolving mindset toward treating obesity as a chronic disease.
LATEST PODCASTS
This week on Denatured, Head of Insights Lori Ellis and guests discuss the persisting challenges of diversity, equity and inclusion when designing clinical trials.
This week’s news ranged from BioSpace’s on-the-ground updates from DIA to safety concerns in clinical trials to BIOSECURE Act updates to new projections that the GLP-1 market could top $100 billion within 10 years.
BioSpace’s Lori Ellis and Chantal Dresner bring live updates from the first day of #DIA2024 in San Diego.
Job Trends
Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.
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SPECIAL EDITIONS
In this deep dive, BioSpace investigates China’s rise as a biotech powerhouse.
In this deep dive, BioSpace explores the next big thing in obesity.
BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
DEALS
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After dropping $4 billion on a deal with the Japanese company last year, Merck is getting back some of its investment as Daiichi Sankyo buys into a Phase I/II T-cell engager therapy acquired from Harpoon Therapeutics. -
Sangamo Therapeutics announced Tuesday it secured an exclusive licensing agreement with Roche’s Genentech, which is paying $50 million in near-term upfront fees and milestone payments to develop novel genomic medicines for neurodegenerative diseases. -
Biotech entrepreneur Arie Belldegrun and former Roche CEO Franz Humer are part of the credit firm’s push to provide companies with another source of funding, Symbiotic Capital announced Tuesday. -
As part of a pipeline realignment, Bristol Myers Squibb is returning the rights to Agenus for its proprietary TIGIT bispecific antibody program and terminating their 2021 license, development and commercialization agreement. -
With an upfront $800 million payment and $325 million in potential milestones, Otsuka Pharmaceutical is acquiring Jnana Therapeutics’ drug discovery platform and rare disease candidate, the companies announced Thursday.
WEIGHT LOSS
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The Danish startup, whose lead candidate has parallels to Amgen’s MariTide, launches on the heels of Amgen’s Phase II data release for the drug last week. -
SURMOUNT-5’s results reflect those of multiple real-world studies, which have found that tirzepatide treatment results in stronger weight loss than semaglutide. -
Amylin analogs present a strong alternative or complement to GLP-1 receptor agonists, potentially eliciting higher-quality weight loss with a cleaner tolerability profile. -
With Amgen’s MariTide results at the lower end of investors’ expectation of 20% to 25% weight loss, the much-anticipated readout sent the company’s shares tumbling. -
While taldefgrobep alfa failed to show improved motor function in spinal muscular atrophy, treated patients saw a marked reduction in body fat. Biohaven plans to launch a Phase II trial in obesity by the end of the year.
POLICY
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The Health and Human Services Secretary said that he will find and eliminate the cause of autism by September, an idea that suggests how little he knows about the condition. -
GeoVax was using its HHS contract to develop its next-generation multi-antigen COVID-19 vaccine, which is in Phase IIb development. -
Despite these cuts, the FDA should be able to stay above a “trigger” level that would prevent it from collecting fees from the pharma industry and deprive it of approximately half of its annual funding, according to The Washington Post. -
In the wake of unprecedented workforce cuts at the FDA, former Commissioner Scott Gottlieb and an unnamed former CBER director spoke to analysts about potential implications for drug review timelines and agency morale. -
Playing both sides of trade war, pharma companies are asking for certain compensations for scientific innovation and a smoother regulatory framework.
You can follow these job hunting tips to optimize your job search and prefer finding the jobs that you want and not any irrelevant ones. Here’s how to do it.
Since almost every job market has become more competitive, you need to start improving your skills. Here are a few tips that can help you in skill development.
Before we look at the tips and tricks that can help you bag a job in pharma, we should look at the complications that you might face when getting the job.
Workplace issues can arise anytime so it is always better to be prepared to seek out the problems directly in a mannered way to avoid any kind of personal rivalry.
Let’s talk about some common mistakes job candidates make during interviews, so you can steer clear of them for your next interview! Here’s how to nail a job interview.
Here are some effective career development tips that can help you stay ahead and accomplish milestones. Don;t miss any of it if you want a successful career.
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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With an eye toward advancing a novel antibody-drug conjugate for gastrointestinal cancers, ArriVent is the latest biopharma player to ink a deal with a Chinese biotech. -
Ascentage is looking to use the IPO proceeds to advance its Phase III candidates for chronic or small lymphocytic leukemia and for certain types of chronic myeloid leukemia. -
The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a third-party provider while releasing Amylyx’s investigational ALS therapy from a previous pause. -
Datroway, formerly known as Dato-DXd, significantly improved median progression-free survival in a Phase III study but failed to do so for overall survival. -
Traditionally carrying a dire prognosis, the treatment paradigm for multiple myeloma is changing, with CAR T therapies, bispecifics and more contributing to multifaceted regimens unique to each patient’s needs.
NEUROSCIENCE
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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. -
Monday’s agreement comes days after PTC discontinued the development of another asset, utreloxastat, due to disappointing Phase II data in amyotrophic lateral sclerosis. -
Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track record of propelling R&D for some of medicine’s most challenging illnesses. -
Emboldened by technological advances and a deeper knowledge of glioblastoma, Merck, Kazia Therapeutics, CorriXR Therapeutics and others are targeting the often-fatal brain tumor.
CELL AND GENE THERAPY
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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. -
Multiple players are exploring whether modalities designed to combat B cell malignancies can be repurposed against lupus, myasthenia gravis and other conditions traced to misdirected immune response. -
While some of the initial excitement around immunotherapies has waned, companies—particularly smaller biotechs—are developing newer iterations that will take cancer care to the next level. -
The biotech beat Wall Street’s third-quarter revenue forecast by 6%, driven by increased uptake of its achondroplasia drug Voxzogo. However, William Blair downgraded BioMarin’s shares to market perform due to a “lack of near-term catalysts” and uncertainty around Voxzogo’s potential revenue growth. -
With Sarepta’s gene therapy Elevidys now available to a majority of Duchenne muscular dystrophy patients, experts express cautious optimism while emphasizing the need for further data.
