Despite hitting its efficacy targets in the Phase III COAST-1 study, Sanofi’s amlitelimab remains “meaningfully inferior” to Dupixent, according to analysts at Leerink Partners.
Hengrui Pharmaceuticals has been busy this year, signing a nearly $2 billion cardio contract with Merck in March and a 12-asset agreement with GSK in July worth up to $12 billion.
In coordination with the United States President’s Emergency Plan for AIDS Relief, Gilead will make its twice-yearly HIV prophylactic Yeztugo available to resource-limited countries “at no profit.”
Perhaps the most interesting of the pile of FDA rejection letters was for Lykos Therapeutics’ MDMA therapy. Letters sent to Stealth BioTherapeutics, Regeneron and more were also released as the agency also promised future CRLs “promptly after they are issued to sponsors.”
The new additions would bring ACIP membership to 14 total. Several of the proposed members have taken part in anti-vaccine activity or made anti-vaccine statements.
As more and more groups call for the health secretary’s removal from office, senators will question Kennedy on his recent moves, including the controversial firing of CDC Director Susan Monarez.
FEATURED STORIES
ADARx Pharmaceuticals CEO Zhen Li found her way to biopharma through Merck, where she was inspired by the application of powerful science to human medicine.
When talking to some of the most impressive women in biopharma, the conversation inevitably turned to what these women wanted other entrepreneurs to know. Here’s the best of the best of that advice.
Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the regulator considers more drastic action.
What will Boston Pharmaceuticals CEO Sophie Kornowski do now that the company is selling off its pipeline and winding down operations? Whatever it is, data will take her there.
Amid a season of regulatory and scientific advances, experts reveal a culture of data hoarding among cell and gene therapy developers that is reinforcing fragmentation, stalling innovation and delaying access to treatments.
Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based combination shot that targets both influenza and COVID-19. Now, the entire vaccine sector is sizing up a new regulatory world, companies’ next steps uncertain.
FROM BIOSPACE INSIGHTS
United States Pharmacopeia is recruiting expert volunteers from academia, industry, regulatory and healthcare to develop, revise and approve medicine, dietary supplement and food ingredient standards and solutions used in more than 150 countries to improve global public health. The volunteers will serve from 2025 to 2030.
LATEST PODCASTS
President Donald Trump unwrapped a massive drug pricing policy as CMS prepares for the next round of Medicare drug price negotiations; Vinay Prasad to take the helm at the FDA’s Center for Biologics Evaluation and Research; Bayer cuts 2,000 more employees; Eli Lilly’s Zepbound scores again; and the Galapagos story turns again.
In this episode of Denatured BioSpace’s head of insights Lori Ellis discusses the public health consequences of vaccine hesitancy and the critical distinction between skepticism and cynicism with Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
A new executive order aims to smooth the path for getting U.S. manufacturing facilities up and running; HHS says it will require placebo-controlled trials for all vaccine approvals; tariff threats hit BioNTech; Novo Nordisk’s FDA application for an oral version of Wegovy is accepted; and more.
Job Trends
Job postings in California took a dip in December during the holiday period, but activity is expected to pick up in January.
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SPECIAL EDITIONS
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.
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
DEALS
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Currently trailing Eli Lilly and Structure Therapeutics in the oral weight loss space, Novo Nordisk strikes a deal with Septerna to put new discovery-stage programs into play. -
The ADARx Pharmaceuticals partnership, which could be worth “several billion dollars” in the end, adds to AbbVie’s existing work in the space after the $1.4 billion acquisition of Aliada Therapeutics in October 2024. -
GSK secures rights to Boston Pharmaceuticals’ efimosfermin alfa, which the pharma plans to develop for fatty liver diseases such as metabolic dysfunction-associated steatohepatitis and alcohol-related liver disease. -
It’s another wild twist in the story of Galapagos, a company that has been around for more than 25 years but has yet to get a therapy approved. -
M&A and IPOs got off to a quick start in 2025 only to crash into a wall of policy challenges. Upfront payment for licensing transactions, however, grew as pharmas looked for less-risky deals.
WEIGHT LOSS
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In combination with Eli Lilly’s tirzepatide, marketed as Zepbound for obesity, Scholar Rock’s monolonal antibody helped patients lose the same amount of weight as patients on tirzepatide alone while preserving more muscle mass. -
Another patient has died from acute liver failure after receiving Sarepta’s gene therapy for DMD ; After a quiet start to the year, M&A is back with one deal for a gene editing biotech reinvigorating that sector; and RFK Jr. installs a suite of new vaccine board members who share his skeptical views on vaccines. -
At 12 weeks, weight loss ranged from 2.6% to 11.3%, compared to a gain of 0.2% in the placebo group. Guggenheim analysts were also impressed by the tolerability profile. -
For $812 million, Novo Nordisk will enlist Deep Apple to discover and develop a non-incretin therapy for obesity, months after the Danish pharma’s amylin efforts underwhelmed investors. -
The deal is Lilly’s second obesity tie-up in a week, after sinking up to $870 million into an agreement with Camurus to develop long-acting versions of molecules against GLP-1 and other incretins.
POLICY
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President Donald Trump plans to start with a “small tariff” on pharmaceutical imports before ramping duties up to 250% within a year and a half. -
The Department of Health and Human Services is terminating around $500 million in BARDA contracts associated with mRNA vaccine development, a move that will affect several pharma companies, including Moderna, Pfizer, Sanofi and AstraZeneca. -
The regulatory environment is placing extreme pricing pressure on pharmaceutical manufacturers. Their success in the market depends on mounting an agile response. -
Albert Bourla confirmed that he called President Donald Trump after receiving a letter asking Pfizer and a clutch of other pharmaceutical companies to lower drug prices or face consequences. -
Earlier this year, the Centers for Medicare and Medicaid Services scrapped a previous proposal, from the Biden administration, to include anti-obesity medications in Medicare Part D coverage.
Looking for a quality control job? Check out these nine companies hiring life sciences professionals like you.
Companies will look at job candidates’ LinkedIn profiles, so make sure yours is strong, from the summary of your expertise and qualifications to testimonials from colleagues.
After more than 20 years at Eli Lilly, Leslie Sam moved into independent consulting. To prepare for the transition, she focused on becoming technically deep and earning industry recognition.
Employed and unemployed biotech and pharma professionals are thinking about job hunting in other fields amidst a challenging labor market.
When you don’t get the promotion you wanted, it’s important to assess your company and yourself so you can improve your odds in the future.
Looking for an automation engineer job? Check out these seven companies hiring life sciences professionals like you.
HOTBEDS
REPORTS
Following a tumultuous start to 2023, layoffs have cooled off though recruiting activities have been significantly impacted by the economic environment.
The 2021 Salary Report is significant in more ways than one. This year, BioSpace analyzed salary data through two key lenses: the impact of the pandemic, and for the first time, race and ethnicity.
BioSpace’s 2022 Salary Report explores the average salaries and salary trends of life sciences professionals. Though movement in the labor market slowed during the pandemic, recovery has been swift and employers are once again having to cope with a highly competitive talent market.
CANCER
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Venclexta, when combined with azacitidine, elicited an overall survival benefit below 10% in patients with myelodysplastic syndromes. -
The deal gets NextCure the rights to Simcere’s novel ADC for solid tumors outside of China. -
Analysts at Truist Securities called J&J’s CAR T readout “compelling,” noting that the efficacy figures could position the cell therapy as a formidable competitor to the current standard of care, Gilead’s Yescarta. -
The FDA’s Oncologic Drugs Advisory Committee narrowly voted against the approval of Zusduri, citing the lack of a completely randomized study to back up the application. -
BioNTech will get CureVac’s early-stage cancer assets, including its mRNA-based glioblastoma therapy currently in Phase I development. CureVac had previously sued BioNTech for copyright infringement related to mRNA vaccine technology.
NEUROSCIENCE
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BPL-003 showed “robust” efficacy data in treatment-resistant depression, according to analysts from Jefferies, who noted that the asset could hit peak market sales of $1 billion. The results clear the way for the asset’s late-stage development and for the completion of a proposed merger with atai Life Sciences. -
The rise of monoclonal antibodies brought back hope for stalling or reversing the devastating neurodegenerative disease. Big Pharma has taken notice with a handful of high-value deals, GlobalData reports. -
Digging into a prespecified analysis for the mid-stage study, INmune Bio identified some clinical and biological benefits of its TNF inhibitor in patients with early Alzheimer’s disease who have at least two biomarkers of inflammation. -
The FDA found that data from a single Phase II study were “insufficient” to justify an accelerated approval review for sevasemten in Becker muscular dystrophy. -
While ALTO-203 missed its depression-related endpoints, improvements in EEG biomarkers, attention and wakefulness point to signals of drug activity, William Blair said, though the analysts pointed to other indications as potentially more promising for future development.
CELL AND GENE THERAPY
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Interim results from a small group of children in a Phase I/II trial are essentially in line with that of Elevidys, according to BMO Capital Markets analysts. -
The Platform Technology Designation, which predates the current FDA leadership, is designed to streamline the drug development and review process, particularly for rare diseases. -
J&J has a multi-year head start, but Gilead believes it can win market share by delivering a drug with better safety and at least as good efficacy. -
While an adverse event reported in Intellia’s gene therapy trial was a “non-concern” for analysts, it follows a handful of patient deaths in other trials for the modality and sent the company’s stock tumbling in pre-market trading. -
Acute systemic infection caused the patient to develop fatal capillary leak syndrome, highlighting the unpredictability of gene therapies and potentially challenging investment in the space, analysts say.
