The 2025 Bioprocessing Summit revealed knowledge gaps and changing mindsets. As some companies look towards the future, others struggle with the present and past.
Presenting at the World Sleep Congress 2025, the Dublin-based company’s Phase II study bested Takeda drug in both efficacy and safety.
While a win for consumers, the regulatory action did nothing to stem the manufacture of compounded versions of the popular obesity drugs that are made by Novo Nordisk and Eli Lilly. In fact, the FDA seems to be signaling that “some level of compounded product is acceptable,” according to BMO Capital Markets.
Shares of Rapport Therapeutics popped Monday morning after Phase IIa data for RAP-219 exceeded analyst and Wall Street expectations, reducing seizures by almost 78% in patients with drug-resistant focal onset seizures.
Ivonescimab elicited better overall survival in Asian patients with non-small cell lung cancer than in those from North America and European countries, in Western countries narrowly missing the statistical significance threshold the FDA is seeking.
KER-0193 is a modulator of ion channels connected to autism spectrum disorder. The FDA bestowed orphan drug and rare pediatric drug designations on the candidate earlier this year.
FEATURED STORIES
The primary focus in scaling up production should first be the adoption of lean manufacturing principles used in virtually every other industry.
After decades of limited progress—owing to the difficulty of treating the disease and resultant market risk—glioblastoma research is entering a new phase spurred by smarter trials, targeted funding and renewed interest from companies like Merck and Jazz Pharmaceuticals.
Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy families have turned to the news for answers. Meanwhile, the FDA insists it remains committed to notifying companies of any regulatory action before sharing information with the media or public.
Against steep odds and well-established paradigms, these four companies have successfully been commercializing their products on their own.
Though nerves abound for funders and founders in the industry, money continues to flow into startups, sometimes in eye-popping numbers. BioSpace rounds up the biggest raises so far this year.
Acknowledging the limits of disease-modifying drugs like Leqembi and Kisunla, companies like Bristol Myers Squibb, Acadia, Otsuka and Lundbeck are renewing a decades-old search for symptomatic treatments, including in high-profile drugs like Cobenfy.
LATEST PODCASTS
HHS Secretary RFK Jr. removes the COVID-19 vaccine recommendation for healthy kids and pregnant women—the latest in a string of changes to vaccine policies; judge issues an order to halt HHS’ reorganization and mass layoff plans; Rocket Pharmaceuticals’ pivotal Danon disease trial is on hold after a patient death; and President Trump has named Mehmet Oz to spearhead his Most Favored Nation drug pricing policy.
In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the importance of target product profiles, particularly when navigating funding challenges, with Ian Fisher, head of development analytics.
China continues to be a source of innovation as Pfizer strikes biggest pact yet; HHS provides more info on Trump’s Most Favored Nation executive order; FDA Commissioner Marty Makary and CBER director Vinay Prasad reveal new COVID-19 vaccine strategy following Novavax approval; ODAC underway after chaotic planning; more.
Job Trends
While the Chicago metropolitan area is not a major life sciences hub, a recent Cushman & Wakefield report predicts the Chicago market should be a growth spot in the coming years. Chicago Biomedical Consortium and COUR Pharmaceuticals executives share what makes the area a hot spot.
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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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The acquisition of SiteOne provides a bit of diversification for Lilly, which has burrowed into the obesity and diabetes space with mega-blockbuster tirzepatide and several follow-on molecules. -
In addition to a $140 million series D, GRIN Therapeutics has signed a global licensing deal for the epilepsy disorder drug radiprodil worth $50 million upfront. -
The deal helps revitalize the TREM2 target after the high-profile failure of AbbVie and Alector’s candidate last year. -
BioSpace’s NextGen companies are rising in one of the most confounding biotech markets ever experienced. Executives sounded off on how to keep your head above water during our webinar, Are We There Yet? -
The largest Chinese licensing deal behind Pfizer’s is Novartis’ partnership with Shanghai Argo Biopharma, worth potentially more than $4 billion.
WEIGHT LOSS
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Robert F. Kennedy Jr. testified in front of largely combative congresspeople on vaccine policy, his MAHA report and more; the mass leadership exodus at the FDA continues as CDER and CBER shed key staff; Kennedy’s revamped CDC vaccine advisors convene for their first meeting; Novo and Lilly present new data at the American Diabetes Association’s annual meeting; and BioSpace recaps BIO2025. -
Eli Lilly’s bimagrumab led to weight loss that was due almost entirely to fat reduction when combined with semaglutide, marketed by rival Novo Nordisk as Wegovy. BMO Capital Markets called the data “impressive” while raising concerns about the antibody’s safety profile. -
While Eli Lilly brushed off concerns about gastrointestinal side effects for oral weight loss candidate orforglipron, analysts from William Blair worried that adverse events are not tapering off as expected. -
After consistently failing to meet investor expectations, Novo Nordisk touted a safety profile for CagriSema in line with the GLP1-RA class, while reporting mid-stage data for its GLP1- and amylin-targeting drug amycretin that raised dosing questions. -
Analysts at William Blair say dapiglutide’s 11.6% weight reduction at 28 weeks could still be better, given that Zealand’s study predominantly included men and enrolled patients with lower BMI at baseline.
POLICY
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The stop order came on Aug. 5, the same day Health Secretary Robert F. Kennedy Jr. terminated 22 mRNA vaccine projects under the Biomedical Advanced Research and Development Authority, though Vaxart’s candidate is protein-based. -
The Annals of Internal Medicine ran a large-scale study in July, pointing to the lack of an association between childhood aluminum exposure through vaccination and chronic conditions. The Health Secretary, in an opinion piece earlier this month, called the paper a “ballyhooed study.” -
Gray Delany’s ouster comes days after Health Secretary Robert F. Kennedy Jr. controversially axed 22 mRNA vaccine contracts under the Biomedical Advanced Research and Development Authority. -
Skysona can now only be used in patients with cerebral adrenoleukodystrophy who have no available treatment alternatives or stem cell donors. -
The recent announcement of RFK Jr.’s termination of mRNA vaccine contracts is the latest effort to undermine this promising technology at the federal level. Pharmaceutical companies and private investors must fill the gap and ensure that research into this critical resource continues.
Employers have adjusted to higher salaries. That also means they’ve become adamant they get specific skill sets, according to Greg Clouse, BioSpace recruitment manager.
Looking for a job in Texas? Check out these nine companies hiring life sciences professionals like you.
Whether they’re newly minted managers or C-suite executives, effective managers often lead with empathy, intellectual curiosity and vulnerability.
Generative AI could enhance and accelerate the way people work on clinical trials. In this Q&A, a management consultant shares his insights on benefits, risks and more.
While many describe California as having a tough life sciences market, there’s some optimism that employment opportunities will improve soon, according to California Life Sciences President and CEO Mike Guerra.
Employed and unemployed biotech and pharma professionals are thinking about job hunting in other fields amidst a challenging labor market.
HOTBEDS
REPORTS
Economic turbulence has persisted into 2023 and the life science industry is certainly not immune. How are organizations juggling business needs, budgets, recruitment and retention?
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.
CANCER
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In a detail-thin announcement, Amgen said that adding bemarituzumab to chemotherapy improved overall survival, though analysts pledged to wait for more data on safety and tolerability before assessing the drug. -
The FDA delivered two notable approvals for RSV immunization, UroGen overcame a negative advisory committee vote to secure an approval in bladder cancer, and more key regulatory nods from the past month. -
Gilead is betting up to $750 million on Kymera’s anti-CDK2 molecular glue for solid tumors, while Sanofi elected to move forward with another protein degrader from the biotech, designed to target immune-mediated diseases. -
In May, Revolution Medicines projected its cash and equivalents of $2.1 billion would last into the second half of 2027. With new funding from Royalty Pharma, the biotech has withdrawn that runway end date. -
In combination with Roche’s PD-L1 blocker Tecentriq, zanzalintinib bested Bayer’s Stivarga. Exelixis is positioning the drug candidate as a successor to cabozantinib, which is set to lose patent exclusivity in 2030.
NEUROSCIENCE
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BrainStorm Cell Therapeutics issued a statement Tuesday supporting a Citizens’ Petition submitted to the FDA requesting the approval of its cell therapy NurOwn, whose BLA was withdrawn in 2023. A Phase IIIb trial was scheduled to begin last month. -
After a season of regulatory upheaval, obesity and rare genetic diseases will likely remain major themes for biopharma in 2025, according to Jefferies. -
The high court sides with HHS on HIV PrEP drugs; Health Secretary RFK Jr.’s newly appointed CDC vaccine advisors discuss thimerosal in flu vaccines, skip vote on Moderna’s mRNA-based RSV vaccine; FDA removes CAR T guardrails; AbbVie snaps up Capstan for $1.2B to end first half; and psychedelics take off again with data from Compass and Beckley.
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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.
CELL AND GENE THERAPY
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The company’s intein-based technology is initially aimed at Stargardt disease, a type of macular degeneration. -
The layoffs will heavily affect Vertex’s operations in Rhode Island, where the biotech will consolidate three facilities into one. -
HHS Secretary Robert F. Kennedy Jr. made waves this week, firing the remaining members of the CDC’s Advisory Committee on Immunization Practices; Metsera’s amylin drug produced weight loss of 8.4% at 36 days; and FDA leaders gathered last week to discuss the future of cell and gene therapy, a sector that has been in turmoil since the ousting of CBER Chief Peter Marks.
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Gene therapies have ridden investor mania to huge valuations but commercialization challenges have pushed market caps to the floor. At a roundtable last week, FDA leaders promised faster approvals and broad support to the industry. -
In a roundtable event on Thursday, HHS Secretary Robert F. Kennedy Jr. said his office will work to eliminate barriers that keep cell and gene therapies from the market.
