Digitization enables each drug to have a software-enhanced version optimized for individual patients.
Novo Nordisk shares tumbled last year when obesity candidate CagriSema failed to clear a weight loss bar of 25%. Now, executives are taking another look at the data but steering clear of making hard bets.
Alumis held its initial public offering in June last year, while Acelyrin debuted on the Nasdaq in mid-2023.
In a mid-stage study, the candidate itolizumab achieved 23.3% clinical remission rate at 12 weeks, numerically better than Humira’s 20% at the same time point.
According to the lawsuit, Sanofi has failed to provide partner Regeneron adequate information regarding the sales of Dupixent—including agreements with payers and pharmacy benefit managers that determine pricing and rebates for the drug.
As Eli Lilly ends the year with Zepbound in good supply, TD Cowen analyst Steve Scala asked CEO David Ricks if the company has taken the GLP-1 supply chain too far.
Bristol Myers Squibb clocked $10 million in sales for new schizophrenia drug Cobenfy in the fourth quarter of 2024, with the launch proceeding ahead of expectations.
FEATURED STORIES
As Novo Nordisk cuts 9,000 people from its organization in a restructuring effort, BioSpace looks back on the Danish pharma company’s rise.
Suddenly one obesity asset has come to define Amgen but executives see a fuller portfolio that will bring the big biotech into the future.
The vaginal microbiome plays a critical role in women’s health, from infection resistance to fertility, yet it continues to remain underexplored. With DNA Genotek™’s OMNIgene™•VAGINAL collection kit, researchers and innovators are empowered to collect stablized samples with precision to support women’s healthcare research and development of healthcare for women.
Contingent value rights are rising in a down market, helping to close the gap between buyer and seller expectations in biotech transactions.
Executives at Novartis have not been shy about a desire to buy more companies, with cardiovascular a big focus. In total, the Swiss pharma has put $17.23 billion on the line in M&A and licensing deals this year.
Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three years off development timelines.
FROM BIOSPACE INSIGHTS
Establishing trust through thought leadership is no longer optional in today’s cautious biopharma market. This webinar will show leaders how strategic insights and targeted outreach can turn awareness into high-converting leads. Watch now.
LATEST PODCASTS
This week’s release of the Make America Health Again report revealed continued emphasis on vaccine safety; Health Secretary Robert F. Kennedy Jr.’s faceoff with senators last week amounted to political theater; the FDA promises complete response letters in real time and shares details on a new rare disease framework; and Summit disappoints at the World Conference on Lung Cancer in Barcelona.
In this episode presented by Taconic Biosciences, BioSpace’s head of insights Lori Ellis discusses how preclinical research companies are helping drug developers navigate the current challenging funding environment with Mike Garrett, CEO.
Health Secretary Robert F. Kennedy Jr. will appear before the Senate Finance Committee Thursday, ahead of a vaccine advisory committee meeting later in September. Meanwhile, deal-making appetite appears healthy, and the weight loss space continues generating clinical data and other news.
Subscribe to Genepool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
SPECIAL EDITIONS
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.
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.
DEALS
  1. Find out which biopharma companies are raking in the cash this week, as companies from around the globe provide updates on their financing rounds and IPOs.
  2. Horizon Discovery Group brings new gene editing and gene modulation tools to PerkinElmer’s expanding life sciences portfolio.
  3. Kiadis has three compounds in the clinic: K-NK002 in Phase II for HSCT in blood cancer; K-NK003 for relapsed or refractory acute myeloid leukemia (AML); K-NK-ID101 for COVID-19.
  4. Syneos Health announced on Wednesday that it has agreed to acquire Synteract, a full-service Contract Research Organization (CRO) focused on the biopharmaceutical industry.
  5. Novartis acquired Vedere Bio in a deal totaling up to $280 million. The takeout broadens Novartis’ footprint in gene and cell therapy, with Vedere Bio’s gene therapy platforms for ophthalmic disorders.
WEIGHT LOSS
  1. This week’s release of the Make America Health Again report revealed continued emphasis on vaccine safety; Health Secretary Robert F. Kennedy Jr.’s faceoff with senators last week amounted to political theater; the FDA promises complete response letters in real time and shares details on a new rare disease framework; and Summit disappoints at the World Conference on Lung Cancer in Barcelona.
  2. FDA
    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.
  3. The World Health Organization’s Essential Medicines list guides high-level procurement and coverage decisions for over 150 countries.
  4. Health Secretary Robert F. Kennedy Jr. will appear before the Senate Finance Committee Thursday, ahead of a vaccine advisory committee meeting later in September. Meanwhile, deal-making appetite appears healthy, and the weight loss space continues generating clinical data and other news.
  5. Novo Nordisk’s Wegovy has been on a winning streak as of late, with a metabolic dysfunction-associated steatohepatitis approval last month and prime position in the oral obesity race.
POLICY
  1. A second trial shows Novo Nordisk’s Wegovy improves heart health. Meanwhile, many other drugs are beginning to face generic competition, including from newly approved biosimilars.
  2. FDA
    In the next two weeks, the FDA will hand out regulatory verdicts to BMS, Outlook Therapeutics and BioLineRx.
  3. Under the $1.4 billion Project NextGen initiative, Regeneron was awarded a $326 million grant for its preventive monoclonal antibody, while Johnson & Johnson got $10 million to bankroll startups.
  4. The biotech’s experimental vaccine has shown a neutralizing response to XBB sublineages of COVID-19, which currently dominate new cases in the U.S. and Europe.
  5. Three years after the initial case, Teva Pharmaceuticals is finally settling its drug price-fixing charges with the Department of Justice for $225 million, payable over a five-year period.
CAREER HUB
Generous severance packages, getting out of toxic workplaces and finding a better job with better pay are a few reasons respondents to a recent BioSpace survey felt that being laid off was for the best.
Media coverage can help biopharma executives connect with, inform and inspire the public. In this column, Kaye/Bassman’s Michael Pietrack and three communications experts share how to make the most of these opportunities.
What if loyalty is holding you back? While it’s a sign of character, consistency and belief in a mission bigger than yourself, it can also keep you stuck in a job when you should be moving on.
It’s easy to get caught up in defending yourself against critique that feels unfair. Leadership coach Angela Justice recommends a different approach that can help you better align how you want to be seen with how you’re showing up.
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.
In the latest installment of his column, Kaye/Bassman’s Michael Pietrack shares five ways leaders can help their teams after a layoff, from acknowledging emotions to reestablishing culture.
Looking for a new opportunity in New Jersey? These nine companies have open roles that could be a great fit for you.
HOTBEDS
Where are the Best Places to Work in life sciences? BioSpace’s annual Best Places to Work list demonstrates a company’s desirability in the recruitment marketplace - find out who made the list this year.
IN CASE YOU MISSED IT
The eight new committee members replace the 17 Kennedy removed earlier this week. In “repopulating” the committee, the HHS Secretary fulfilled the fears of some analysts, naming scientists who appear to reflect his anti-vaccine views.
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
  1. Cullinan Therapeutics and Taiho Oncology’s zipalertinib elicited promising response rates in two mid-stage studies of non-small cell lung cancer patients with typical and uncommon EGFR mutations.
  2. Truist Securities called pumitamig’s data on Monday “very reassuring,” given the consistency between its performance in Chinese and global patient populations.
  3. 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.
  4. According to analysts, the new data could present a path to accelerated approval for ifinatamab deruxtecan, a product of Merck and Daiichi Sankyo’s troubled ADC partnership.
  5. IPO
    Some of the biggest SPACs from the industry’s pandemic-fueled heyday are no longer on the market.
NEUROSCIENCE
  1. IPO
    LB Pharma landed on the Nasdaq Thursday, with 3 million additional shares sold than expected.
  2. Capsida has yet to disclose the exact cause of death. The patient had received the gene therapy CAP-002 for a type of epilepsy.
  3. Presenting at the World Sleep Congress 2025, the Dublin-based company’s Phase II study bested Takeda drug in both efficacy and safety.
  4. 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.
  5. 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.
CELL AND GENE THERAPY
  1. As AAV9 and CRISPR programs navigate safety, delivery and scalability hurdles, small molecules offer a deployable, scalable bridge, complementing genetic approaches and accelerating meaningful impact for patients with Duchenne muscular dystrophy.
  2. It can cure deadly diseases, save long-term healthcare costs and transform lives. But the U.S. insurance system still isn’t ready to pay for it.
  3. Vertex Pharmaceuticals commits $45 million upfront to leverage Enlaza Therapeutics’ War-Lock platform to create drug conjugates and T cell engagers for autoimmune diseases and gentler conditioning for sickle cell/beta thalassemia gene-editing therapy Casgevy.
  4. Appia Bio’s shutdown continues an unfortunate trend this year that has seen biotech closures nearly every month.
  5. In late May, a patient died after receiving Rocket Pharmaceuticals’ investigational gene therapy for Danon disease, spurring the hold. After lowering the dose and changing the regimen of immune modulators patients receive, the company has received FDA clearance for the trial to continue.