Flagship Pioneering’s ProFound Therapeutics will use its proprietary technology to mine the expanded proteome for novel cardiovascular therapeutics. Novartis has promised to pay up to $750 million per target, though it has not specified how many targets it will go after.
Without providing further context, HHS Secretary Robert F. Kennedy Jr. says that Gavi needs to “start taking vaccine safety seriously” by considering “the best science available.”
Peter Marks, who headed the FDA’s Center for Biologics Evaluation and Research before being forced to resign in March, said the agency’s new risk-based COVID-19 vaccine framework contradicts the current administration’s push for transparency and gold-standard science.
Are long R&D cycles, overwhelming literature reviews, or patent bottlenecks slowing your path to innovation? In the fast-evolving life science landscape, AI is no longer a luxury, it’s a necessity.
The seven new members of the CDC’s influential Advisory Committee on Immunization Practices recommended Merck’s new anti-RSV monoclonal antibody, discussed mRNA vaccine technology while injecting misinformation into the debate, heard updates on the upcoming flu season and, finally, voted to remove thimerosal from all flu vaccines.
The newly appointed members of the CDC’s influential vaccine committee meet Wednesday and Thursday under an unusually rapid timeline, with unexpected topics on the agenda.
FEATURED STORIES
President-elect Donald Trump and his incoming administration are unlikely to attempt a wholesale restructuring of U.S. healthcare and could promote M&A activity, but controversial picks like Robert F. Kennedy could impact vaccine sales, experts say.
Not exactly known for its dealmaking, Sarepta Therapeutics has thrown down a massive wad of cash to work with Arrowhead Pharmaceuticals on RNAi-based medicines.
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.
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.
Projected to be worth over $38 billion in the global healthcare market by 2032, AI simulations have the potential to streamline clinical trials and help address inequities in underserved patient populations.
Emboldened by technological advances and a deeper knowledge of glioblastoma, Merck, Kazia Therapeutics, CorriXR Therapeutics and others are targeting the often-fatal brain tumor.
FROM BIOSPACE INSIGHTS
Establishing trust through thought leadership is no longer optional in today’s cautious biopharma market. Learn how strategic insights and targeted outreach can turn awareness into high-converting leads.
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Job Trends
Eli Lilly’s and AstraZeneca’s Former Head of Research Dr. Jan Lundberg Elected as a New Board Member
AlzeCure Pharma AB announced that Professor Jan Lundberg has been elected as a new board member at the company’s annual general meeting in 2024.
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SPECIAL EDITIONS
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
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.
DEALS
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After rejecting a previous takeover offer from Future Pak, Vanda Pharmaceuticals is now fielding another acquisition proposal from Cycle Pharmaceuticals, which values the biotech at $8 per share.
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Telix Pharmaceuticals is looking to cash in on radiopharmaceuticals, which have emerged as one of the hottest spaces in oncology, with an initial public offering to help support its pipeline of targeted radiation products.
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Illumina on Monday announced that its board of directors is spinning off Grail and has applied to list the cancer diagnostics company on the Nasdaq.
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Analysts predict a booming year for mergers and acquisitions, powered by obesity drug sales and pressure from upcoming patent expirations.
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As evidenced by this week’s buyouts by J&J and Merck, Big Pharma appears to have found a sweet spot favoring smaller deals over megabillion-dollar acquisitions.
WEIGHT LOSS
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Ahead of a Senate health committee hearing next week with Novo Nordisk CEO Lars Jørgensen, Sen. Bernie Sanders claims he has secured assurances from generics developers that they will charge a significantly lower monthly price than the $969 Americans currently pay for the Danish drugmaker’s diabetes blockbuster.
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Infusions of Vertex and CRISPR Therapeutics’ Casgevy and bluebird bio’s Lyfgenia have begun; Moderna targets 10 approvals through 2027; more oral obesity drug data; the latest from ESMO and more.
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The release of early-stage data on three oral weight loss drug candidates hints at which companies have the strongest hand, but the comparisons are rife with confounding variables, leaving analysts unsure about where to place their bets.
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In metabolic dysfunction-associated steatotic liver disease, a retrospective analysis shows that patients on GLP-1 receptor agonists are 14% less likely to progress to cirrhosis.
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When doses were increased rapidly in a Phase I study, patients on Roche’s investigational oral GLP-1 receptor agonist experienced nausea, vomiting, constipation, diarrhea, as well as abdominal distension.
POLICY
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Recently appointed HHS Secretary Robert F. Kennedy Jr. in 2018 helped bring several cases against vaccine maker Merck, alleging injury linked to its HPV shot Gardasil.
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The hammer came down on an unspecified number of FDA employees this weekend, days after Robert F. Kennedy Jr. was confirmed as HHS Secretary.
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Continuing our SCOPE 2025 coverage, Rohit Nambisan, CEO at Lokavant addresses not only current challenges, but the life sciences industry’s responsibility to maintain scientific integrity.
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Robert F. Kennedy Jr.—whose history of anti-vaccine rhetoric has had the healthcare and biopharma industries on edge—was confirmed as Health and Human Services Secretary in a Senate vote along party lines.
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Senator Bill Cassidy voted with fellow Republicans on the Senate Finance Committee Tuesday morning to move forward the nomination of Robert F. Kennedy, Jr. for HHS secretary.
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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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Bristol Myers Squibb aims to generate around $1.5 billion in savings through 2025—a goal that it hopes to reach by lowering third-party expenditures, focusing only on key growth brands and cutting some 2,200 jobs by year-end.
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Some 90% of investigational drugs fail—and success rates are even more dire in the neuro space. Here, BioSpace looks at five clinical trial flops that stole headlines over the past 12 months.
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Incyte is abandoning its ALK2 blocker zilurgisertib, which it was trialing for myelofibrosis-associated anemia, while iTeos will deprioritize the development of inupadenant after it failed to meet the biotech’s clinical bar in a Phase II study of metastatic non-small cell lung cancer.
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Pfizer, facing increasing pressure from Novartis, is touting a Phase III win for Ibrance as the first clinical evidence supporting the CDK4/6 inhibitor class’ use in patients with a specific type of breast cancer.
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Candel’s trial was conducted under the FDA’s Special Protocol Assessment program, meaning that its data could be used as a basis for a regulatory application.
NEUROSCIENCE
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With Monday’s data from SAPPHIRE, Scholar Rock is building toward regulatory submissions for apitegromab in spinal muscular atrophy in the first quarter of 2025.
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Bristol Myers Squibb wins approval for the first novel schizophrenia drug in decades; Pfizer pulls Oxbryta from the market; new IVF and abortion laws could derail women’s health research; Roche touts CDK inhibitor deal and obesity pipeline and BioSpace heads to Meeting on the Mesa.
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From Eli Lilly to Karuna Therapeutics to current owner Bristol Myers Squibb, the newly approved schizophrenia drug had quite the journey to market. Former Karuna and Lilly executives discuss the “accidental” and “serendipitous” discovery.
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After the FDA declined to approve Lykos Therapeutics’ MDMA-assisted therapy for post-traumatic stress disorder, companies are pivoting away from or delaying similar therapeutics targeting the psychiatric disease.
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BMS’ KarXT targets muscarinic receptors and “is at least 2-3 years ahead of the competition” including AbbVie and Neurocrine Biosciences, Truist Securities wrote in a note to investors.
CELL AND GENE THERAPY
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Ultracompact CRISPR systems, which are in some cases one-third the size of Cas9, are being designed to be more specific and enable in vivo gene editing in difficult to reach tissues.
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Approved under the regulator’s accelerated pathway, Tecelra is also the first new synovial sarcoma therapy in more than a decade, according to Adaptimmune Therapeutics.
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Sarepta has been hit with another patent infringement lawsuit, this time from Sanofi and its subsidiary Genzyme alleging that the biotech used protected technology related to AAV vectors.
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The advantages of using circular RNAs—including increased durability, enhanced protein expression and substantially lower manufacturing costs compared to linear mRNAs—have driven a spate of investment in this technology.
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Fatalities are an unfortunate reality of clinical trials. How can companies best protect themselves?