Blujepa is also approved for uncomplicated urinary tract infection in females 12 years and older.
The 2024–2025 formulations of COVID-19 vaccines had an effectiveness rate of 76% at preventing emergency or urgent care visits in children aged 9 months through four years, according to a new report.
In a first for the Parkinson’s field, AC Immune’s immunotherapy has stabilized key biomarkers that suggest an effect on the disease’s course.
Analysts were hoping for a safety profile similar to what was achieved in Phase II but an abnormal sense of touch, called dysesthesia, has emerged in the late-stage TRIUMPH-4 trial.
While new late-stage data point to some liver toxicity signals, analysts at BMO Capital Markets said Tukysa’s efficacy outcomes “appear to more than make up for any safety concerns.”
Also on Thursday, Zealand held its Capital Markets Day in London, outlining the strategy for its weight management franchise in the near-term, including launching five products by 2030.
FEATURED STORIES
A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
The introduction of AbbVie’s hepatitis C drugs in 2014 forced Gilead’s hand in the fight for market dominance in hepatitis C. A similar dynamic is now playing out between Eli Lilly and Novo Nordisk in the obesity space, with some key differences.
The industry’s ability to generate a return on billions of dollars of investment rests on a heavily regulated supply chain defined by time-pressured logistics.
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
LATEST PODCASTS
In this bonus episode, BioSpace’s Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel take a look at Q3 job market performance, layoffs and wider employment trends and policies impacting the biopharma workforce.
The U.S. government remains shut down, with the FDA closed for new drug applications until further notice; cell and gene therapy leaders gather for the annual meeting in Phoenix with the field in a state of flux; Pfizer and Amgen will make drugs available at a discount as President Donald Trump’s tariffs still loom; and new regulatory documents show how Pfizer beat out the competition for Metsera.
In this episode presented by PII, BioSpace’s head of insights discusses with guests Oliver Eden and Travis Webb how autoinjectors offer opportunities to improve delivery systems, patient compliance and clinical trial processes.
Job Trends
Tapping into the hidden job market can be challenging but is important in today’s employer-driven market. Three talent acquisition experts share tips for accessing hard-to-find roles.
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SPECIAL EDITIONS
In this deep dive BioSpace analyzes the neuropsychedelic therapeutics pipeline, which grabbed headlines in February when the FDA accepted the New Drug Application for Lykos Therapeutics’ MDMA capsules for PTSD.
In this deep dive, BioSpace takes a closer look at the drug price crisis in the U.S. As President Joe Biden and former President Donald Trump gear up for a rematch in the 2024 election, we explore how federal reforms to lower costs could be leveraged on the campaign trail.
The job response rate has risen year over year, according to BioSpace data, indicating competition for roles posted on our website has increased.
DEALS
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Due to the litigation Pfizer filed Friday and Monday against Metsera, Novo Nordisk and the biotech’s lead shareholder, CEO Albert Bourla was limited in what he could say. But he said Pfizer was the best fit for Metsera. -
Both companies have submitted revised bids, with Novo’s coming in $1.9 billion higher than Pfizer’s. -
At the center of the licensing deal is an NLRP3 inhibitor that has shown “encouraging efficacy in acute inflammation models,” according to TransThera, indicating its potential in various metabolic and inflammatory diseases. -
Manifold will use its tissue-targeting shuttle technology to help Roche develop new therapeutics for diseases of the central nervous system. -
Pfizer has filed two separate lawsuits in an effort to stop Novo Nordisk’s unsolicited bid to acquire obesity biotech Metsera.
WEIGHT LOSS
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In an investor call Thursday, AstraZeneca CEO Pascal Soriot outlined his company’s approach to obesity drug development based on “the medical aspect” of weight loss, including driving down visceral fat. -
The court’s decision allows Metsera to walk away from its previous acquisition agreement with Pfizer in favor of Novo Nordisk’s higher bid. -
Pressure from the FTC and Pfizer is building around Novo Nordisk’s bid to snatch obesity biotech Metsera. The antitrust watchdog has spotted issues with the structure of Novo’s bid, while its New York-based rival has put more money on the table. -
Pfizer and Novo Nordisk seem to want Metsera bad. Analysts are wondering, though: Is the obesity biotech really worth this much effort? -
Investors got to hear Novo Nordisk’s side of the Metsera bidding war drama for the first time on Wednesday, as the company reported third-quarter earnings. A rough quarter underscored the stakes for the Danish pharma.
POLICY
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The $48 million award, granted through the Advanced Research Projects Agency for Health, will help Kernal take its in vivo mRNA-encoded CAR T therapy forward. -
Cell and gene therapy experts question where the FDA designation fits in an environment that features a range of intersecting regulatory perks. -
A new group of CDC advisors voted last month to separate the chickenpox vaccine from the measles, mumps, rubella components of the MMRV shot due to concerns over febrile seizures, while recommending a more risk-based approach to COVID-19 immunizations that mirrors recent FDA approvals. -
Jeanne Marrazzo, former director of the National Institutes of Allergy and Infectious Disease, was formally terminated Thursday after months on administrative leave, after filing a whistleblower report. -
Expanded exemptions for orphan drugs could mean prolonged protections for top-selling drugs like Merck’s Keytruda, which was initially approved under this designation in 2014.
Massachusetts’ increased investment in the life sciences industry includes boosting its life sciences tax incentive program by $10 million annually, aiding job creation in the state.
Many biopharma professionals view smaller companies as having the best flexibility and remote work options, but that doesn’t mean their larger counterparts are failing in that area. Several professionals, including Apogee Therapeutics and Insmed executives, share their insights.
Check out five New York companies hiring biopharma professionals like you, including 2025 Best Places to Work winners.
Plus, communication errors that cost job offers and how to craft a LinkedIn “About” section
Year-over-year BioSpace data shows there are fewer job postings live on the website and far more competition for them.
At Johns Hopkins University, the biomedical engineering program’s Design Team offering lets undergraduates dive deep into clinical projects that can help them land industry jobs, get provisional patents or even start companies.
HOTBEDS
REPORTS
This labor market report examines Q3 life science job market trends and the recruitment outlook for Q4 and beyond.
BioSpace surveyed life sciences employers to understand attitudes and current trends on AI usage in recruiting. This report explores the benefits of using AI tools in recruitment and provides practical recommendations for HR and talent acquisition professionals to leverage AI effectively. Concurrently, this report highlights the challenges and risks of using these tools without critical thought and intention.
As competition for life sciences talent peaks, BioSpace has undertaken research to determine what employers can do to ensure they don’t lose out on talent they actually want to hire and retain.
CANCER
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Pfizer, Merck, AstraZeneca and Bristol Myers Squibb were among the many biopharmas showing off novel cancer modalities at ESMO, with antibody-drug conjugates, bispecific antibodies and kinase inhibitors demonstrating encouraging efficacy and safety for various cancers. -
For $1.2 billion upfront and up to $10.2 billion in milestones, Takeda will gain access to a bispecific antibody fusion protein targeting both the PD-1 and IL-2 pathways, among other assets. -
Novo Nordisk’s leadership gets another shake-up as President Trump promises to significantly slash prices for its GLP-1 drugs; Summit/Akeso, Exelixis and more present new data at ESMO 2025; Replimune pops as FDA accepts resubmitted BLA; FDA names first winners of Commissioner’s National Priority Voucher program; and more. -
With data from the Phase III STELLAR-303 study in the books, Exelixis is plotting a 2025 regulatory application for zanzalintinib. -
In May, Summit released early data from the Phase III HARMONi study showing that while the PD-1/VEGF inhibitor resulted in significant progression-free survival improvements, it fell short of the overall survival bar.
NEUROSCIENCE
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Biohaven is proposing troriluzole for the treatment of spinocerebellar ataxia, a group of rare, genetic diseases that lead to the progressive loss of control over movement. -
A month after sparking optimism for patients with Huntington’s disease with highly positive data for AMT-130, uniQure revealed Monday that the FDA may be changing its tune on the evidence required for an approval application, a change of direction Stifel called “very challenging” for uniQure. -
Bristol Myers Squibb beat analyst and consensus estimates for the third quarter with $12.2 billion in sales, but executives on the company’s investor call faced questions about a sluggish uptake for schizophrenia drug Cobenfy as well as a highly anticipated Alzheimer’s psychosis readout for the product. -
To expand the population for the anti-amyloid Alzheimer’s drugs, Lilly and Biogen are testing presymptomatic patients. Will doctors be open to this paradigm-shifting change? -
New interim data from a Phase III trial puts the company on track to file for FDA approval next year in an indication that not only lacks a disease-modifying treatment but suffered significant setbacks after a patient died in a clinical trial for Sarepta’s investigational gene therapy.
CELL AND GENE THERAPY
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The startup, launched out of CEO Kevin Parker’s grad school idyll during the COVID lockdowns, is primed to find new targets where Big Pharmas won’t dare. -
Regeneron is aiming to file a regulatory application for DB-OTO by the end of the year. -
Novo had around 250 employees working on cell therapies, all of whom will be laid off, though a spokesperson declined to reveal which offices and locations will be affected. -
While the benefits of AI are clear, the amount data sets needed for effective AI integration is proving to be a challenge. This is particularly true for cell therapy companies as they are eagerly seeking ways to reduce development costs. Two experts at Charles River Laboratories provide insights by giving their takeaways from their own AI integrations. -
Investor reaction to the deal was muted, with BMO Capital Markets analysts saying they “continue to look for more” from Bristol Myers Squibb before they can “get excited about the near term turnaround story.”
