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.
In its Q2 earnings call Thursday, Novartis said it is moving quickly to reshore its drug manufacturing operations, but CEO Vas Narasimhan told reporters that for most medicines, it typically takes three to four years to completely relocate production.
In the first six months of 2025, 385 employees resigned from the Center for Drug Evaluation and Research, compared with under 130 staff during the same period last year.
FDA reviewers flag “discordant results” in a briefing document published ahead of Friday’s advisory committee meeting for the partners’ application for the antipsychotic in post-traumatic stress disorder.
Looking for a biopharma job in Illinois? Check out the BioSpace list of six companies hiring life sciences professionals like you.
Following the death of two teenage patients with Duchenne muscular dystrophy following Elevidys treatment, Sarepta Therapeutics adds a black box warning to the gene therapy for acute liver injury and failure and parts with more than a third of employees.
With venture funding tightening in the post-COVID landscape, efficiency has become more critical than ever. In this interactive webinar industry experts explored actionable strategies for maintaining quality under financial pressure. Watch now.
FEATURED STORIES
Suddenly the hottest thing in biopharma isn’t a new indication, disease target or modality—it’s manufacturing, and all of pharma is going to be vying for capacity and talent.
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.
Novartis, Biogen, Takeda and Novo Nordisk are all betting on advances in the molecular glue degraders space, collectively investing billions in hopes of treating cancer, Alzheimer’s disease, cardiometabolic disease and more.
Even as Biogen and Eisai’s Leqembi and Eli Lilly’s Kisunla slowly roll out onto the market, experts question the efficacy of these anti-amyloid antibodies and the amyloid hypothesis overall.
The EPIC Act has been proposed with bipartisan and industry support to give small molecule drugs the same protection against price negotiation as biologics, but concerns over how to balance the federal budget could prevent a short-term fix to the IRA.
IPO
Around 25 companies have gone public this year, most of them in the early months. Most have tumbled from their original offer price.
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
Bayer cut its C-suite nearly in half amid a massive restructuring. Meanwhile, the U.S. government says it will pay for Wegovy for patients with heart disease.
This week, we’re talking money! Following the release of BioSpace’s ⁠2024 Salary Report⁠, we discuss salary trends and how they are impacting the biopharma workforce.
The FDA took center stage last week as it approved the first-ever MASH therapy and considered additional approvals for CAR-T therapies, whose safety the agency has been investigating since last year.
Job Trends
Regeneron Pharmaceuticals, Inc. announced that the investigational gene therapy DB-OTO improved hearing to normal levels in one child within 24 weeks, and initial hearing improvements were observed in a second child at a 6-week assessment.
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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. Orna Therapeutics announced Thursday it is acquiring ReNAgade Therapeutics, which launched in May 2023 with $300 million in Series A financing and is on BioSpace’s NextGen Class of 2024 startups to watch this year.
  2. Days after backing out of two Ionis-partnered neuro programs, Biogen has inked a potential $1.8 billion buy of Human Immunology Biosciences and boosting its late-stage immunology pipeline.
  3. Neuroscience-focused Rapport Therapeutics and radiopharma developer Telix Pharma announced their respective plans Friday for initial public offerings on the Nasdaq for undisclosed dollar amounts.
  4. Johnson & Johnson announced Thursday it is paying $850 million in cash, plus a potential milestone payment, for privately held biotech Proteologix and its atopic dermatitis-focused bispecific antibody candidates.
  5. While the FTC continues to review its $16.5 billion buy of Catalent, Novo Holdings announced Wednesday it has acquired a majority stake in Single Use Support, an Austrian life sciences tools company.
WEIGHT LOSS
  1. 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.
  2. 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.
  3. On the heels of Terns’ positive Phase I results that analysts compared with Lilly’s and Pfizer’s weight loss pills in development, Novo Nordisk showcased more details about its own oral candidate.
  4. A recent study estimated that Wegovy’s label expansion beyond obesity could push Medicare spending to $145 billion annually, but analysts remain dubious of the estimate.
  5. A study published Tuesday in The New England Journal of Medicine showed that children between the ages of six and 12 who took liraglutide for just over a year experienced a significant reduction in body mass index compared to placebo.
POLICY
  1. Konstantina Katcheves, Senior VP of Innovative Global Business Development at Teva Pharmaceuticals brings insights from the World Economic Forum to SCOPE 2025.
  2. Pfizer reacts to Donald Trump’s tariff threats on big pharma, another regulatory meeting is canceled under RFK Jr., AbbVie and Eli Lilly strike mid-sized deals in obesity and molecular glues, priority review vouchers set to take a hit and immuno-oncology matures.
  3. Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that will apply to all EU member states as well as Norway, Liechtenstein and Iceland.
  4. In the current legal and political landscape, it is all about survival for DEI initiatives.
  5. In the five weeks since Donald Trump returned as U.S. president, the FDA, NIH and CDC have been thrown into disarray, with meetings regarding vaccines and rare diseases canceled or indefinitely postponed—all without a clear reason why.
CAREER HUB
Here are three tips to help you land a management position when you’ve never been a manager.
Getting job-hunting and career advice is hard, especially when you get it from those who have worked for decades. Some advice is still helpful today, like making a good impression, but others are considered counter-productive.
The salary expectation question is one of the most difficult questions asked during a job interview. Here’s how you can answer the question perfectly.
The coronavirus disease (COVID-19) pandemic that has ravaged across the globe has demanded more experts in microbiology, particularly jobs in virology.
BioSpace’s Pharm Country Hotbed ranges from Connecticut, New York, New Jersey, Pennsylvania and Rhode Island.
“The Great Resignation” is a term that’s been coined to describe the wave of people leaving their jobs for other opportunities or exiting the workforce altogether.
A resume is your introduction to a potential employer, and as the saying goes, “You only get one chance to make a good first impression.” Follow these resume writing tips today.
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
Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the regulator that it got it wrong. Capricor plans to resubmit the application based on deramiocel’s existing dataset.
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. According to Jake Van Naarden, president of Lilly Oncology, the excess deaths could be due to the high rate of crossover in BRUIN CLL-321.
  2. Analysts called the data “very competitive” but raised questions about safety. Merck gained ownership of the ADC when it acquired VelosBio in November 2020 for $2.75 billion.
  3. The FDA’s year-end rush includes nine target action dates, mostly for rare disease and cancer therapies.
  4. Protara is advancing a cell therapy that triggers both adaptive and innate antitumor immune responses, while CG Oncology’s approach makes use of an oncolytic immunotherapy that preferentially targets cancer cells and proliferates inside them, destroying them from the inside.
  5. One year after a potential $1.7 billion deal with Hansoh Pharma, GSK goes back to China to forge another alliance with DualityBio for another deal that could be worth up to $1 billion as it continues to build up its ADC portfolio.
NEUROSCIENCE
  1. Oditrasertib, which blocks the inflammatory RIPK1 protein, earlier this year also failed a Phase II trial in amyotrophic lateral sclerosis, forcing the company to discontinue its development a few months later.
  2. Sage has decided to discontinue the development of dalzanemdor in Alzheimer’s disease. A study of the candidate in Huntington’s is ongoing, with early data expected later this year.
  3. 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.
  4. 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.
  5. 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.
CELL AND GENE THERAPY
  1. Cell therapy biotech Artiva Biotherapeutics plans to use the funds raised to support the development of its AlloNK therapy for systemic lupus erythematosus.
  2. Mid-stage data for 4D Molecular Therapeutics’ wet AMD drug 4D-150 show improvements in visual acuity, reduced injection rate and encouraging safety data.

  3. As the yearslong litigation over ownership of CRISPR gene editing continues, investors have forged ahead with funding the technology’s development by biopharma.
  4. To improve its reviewers’ understanding of cell and gene therapy manufacturing, the agency has launched a program that will involve a tour of manufacturing facilities and daily workshops for its staffers.
  5. Vertex has filed a complaint against the Department of Health and Human Services, seeking to make its fertility preservation program available to federally insured patients needing Casgevy treatment.