Eisai’s new fiscal 2027 forecast for Leqembi is roughly 50% lower than its projections a year ago.
Leerink analysts warned that Kennedy’s remarks to FDA staff would likely be a negative for the biotech industry.
Health and Human Services employees aren’t the only ones out of work. Thousands of private-sector biopharma professionals lost their jobs in the first quarter.
According to analysts at Jefferies, legislation such as the newly proposed bills that aim to streamline regulatory processes would be a positive for the biotech industry.
Novartis plans to build seven new facilities in the U.S., touting the creation of up to 1,000 new jobs at the company. The new facilities will include a biomedical research hub in California, two radioligand plants, and four manufacturing sites.
FDA
Analysts at William Blair expect drug developers will continue to perform “at least some animal testing” on their investigational products. Though the process to phase out animal testing will begin “immediately,” no specific timetable was given.
Biotech companies are already seeing regulatory delays and plenty of uncertainty after around 3,500 FDA employees were cut by the Trump administration.
FEATURED STORIES
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.
After the rejection of Lykos Therapeutics’ MDMA-based PTSD treatment tempered excitement for psychedelic therapeutics, a recent approval and positive data are generating new momentum, which experts expect to continue throughout 2025 and 2026.
Biopharma doubles down on immunology and inflammation as companies target new pathways and seek to improve on current options in inflammatory bowel disease, atopic dermatitis, myasthenia gravis and more.
LATEST PODCASTS
Plus, how the geopolitical tensions with China will affect U.S. biopharma
FDA
Plus, another big buy points to strength of CDMO market and a new treatment for pulmonary arterial hypertension
The pharmaceutical industry is facing critical attention, particularly around drug pricing and development costs. Drug development cost is about 10% of the total healthcare spend in the United States. Broader issues such as local monopolies, utilization, unit, and costs and local monopolies, politics and a fragmented payer system contribute to the increasingly high costs to patients.
Subscribe to Genepool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
SPECIAL EDITIONS
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.
Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the instability of the HHS.
Year-over-year BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the first quarter of 2025.
DEALS
  1. The potential purchase by the Japanese conglomerate could secure access to Calliditas’ IgA nephropathy therapy Tarpeyo, which won the FDA’s full approval in December 2023.
  2. Recent M&A activity indicates a potential resurgence in the appetites of larger companies for psychiatric drug development, but experts say the space may not offer a sufficient risk-reward proposition for R&D.
  3. As we near the end of second quarter of 2024, the initial public offerings among biotechs have slowed, but the market is still going strong.
  4. 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.
  5. 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.
WEIGHT LOSS
  1. BioMarin’s new business strategy leaves investors with questions; Lykos CEO steps down; Terns releases compelling data on oral weight loss candidate; and more.
  2. Phase I data for TERN-601 suggests Terns’ oral GLP-1 candidate for obesity could be a contender in the market next to big names like Lilly, Pfizer and Roche.
  3. Terns Pharmaceuticals will advance TERN-601 into Phase II after early-stage data showed the oral therapy led to weight loss of 4.9%, comparable with weight loss pills Lilly and Pfizer are developing, according to analysts.
  4. A broad indication for MariTide could help Amgen secure Medicare coverage for the treatment following FDA approval, CEO Robert Bradway said at Wednesday’s Morgan Stanley Global Healthcare Conference.
  5. Like its U.S. and European counterparts, Britain’s Medicines and Healthcare Products Regulatory Agency found no conclusive link between the use of GLP-1s and a heightened risk of suicidal and self-injury thoughts.
POLICY
  1. Faced with potential monetary fines, Johnson & Johnson said Monday it is abandoning a proposed 340B rebate plan for hospitals involving two of its blockbuster drugs, Stelara and Xarelto.
  2. Women are already underrepresented in clinical trials; the new abortion and IVF laws could make it worse.
  3. Sen. Bernie Sanders’ aggressive targeting of Danish drugmaker Novo Nordisk’s Ozempic and Wegovy pricing, and not Eli Lilly’s rival drugs, is not fair.
  4. Despite the settlement, the Securities and Exchange Commission on Thursday sued Cassava Sciences in the Western District Court of Texas, claiming that the company misled investors regarding the Phase IIb performance of its Alzheimer’s disease drug candidate.
  5. In a Tuesday Senate hearing on Novo Nordisk’s drug pricing, CEO Lars Fruergaard Jørgensen said he would be willing to sit down with the three largest pharmacy benefit managers who committed that they would expand coverage of Ozempic and Wegovy if Novo lowers its list prices for the blockbuster drugs.
CAREER HUB
No matter in which industry you are, clear communication is very important. Follow these tips for clear communications to be prepared to fit in the work environment.
Thinking about starting a career in biotech? We’ve put together a guide to help you decide where to go within the biotech field and what steps you should take to get there.
The search for a biopharma job can be daunting, but it doesn’t have to be. Here is a complete guide to the biopharma job hunt, from researching job openings to writing resumes and cover letters.
Even if you aren’t looking for a new role in biopharma, nurturing relationships will only benefit you in the long run. To help, here is a complete guide to networking in the life science industry.
To help alleviate some of the stress related to finding a new job, we’ve created a comprehensive guide detailing how to prepare for your biopharma job search.
Requesting disability accommodations is vital for your success in the workplace. You can find out everything about how to ask for accommodations in our guide.
Before searching for a job in the life sciences industry, it is essential to understand the differences between working as a contractor and a full-time employee.
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
Many companies have foreshadowed deals to come during earnings calls in recent days. The return of M&A would be a welcome sign for the biopharma ecosystem, which has been battered by macro headwinds such as tariffs and the possibility of new drug pricing pressures.
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. In a tough fundraising space, cell therapy biotechs pursuing autoimmune indications review staffing to ensure the right expertise is in place to tackle the new disease area.
  2. Despite the PDUFA date being extended by three months for Merus’ zenocutuzumab, Truist Securities analyst Asthika Goonewardene in a Tuesday note to investors said the delay is not a cause for concern with an approval expected.
  3. Driven by the early approval of its updated COVID-19 vaccine, BioNTech far exceeded analysts’ expectations in the third quarter and reported its first quarterly profit in 2024. However, the German biotech also cut its outlook for the year.
  4. While some of the initial excitement around immunotherapies has waned, companies—particularly smaller biotechs—are developing newer iterations that will take cancer care to the next level.
  5. Offsetting Merck’s growth in the third quarter were disappointing revenues from its HPV vaccine Gardasil and type 2 diabetes pill Januvia, with the company on Thursday narrowing its 2024 sales and adjusted profit outlooks.
NEUROSCIENCE
  1. FDA
    The FDA has six target action dates ahead to round out September as drugs for gastroparesis, Niemann-Pick disease type C and more await decisions.
  2. BMO Capital Markets analyst Evan Seigerman said luvadaxistat’s inconsistencies between mid-stage trials raise questions about Neurocrine Biosciences’ developmental efforts moving forward.
  3. The next generation of Alzheimer’s therapeutics is moving away from amyloid plaques and tau tangles, offering multiple approaches to slow cognitive decline.
  4. Roche’s fenebrutinib this week scored a mid-stage win in relapsing multiple sclerosis, while Sanofi’s tolebrutinib met the primary endpoint in a Phase III trial for progressive MS but flopped in two late-stage relapsing MS studies.
  5. Days after Sanofi reported back-to-back failures for its BTK inhibitor, Roche’s fenebrutinib on Wednesday scored a mid-stage win in relapsing multiple sclerosis, demonstrating near-total elimination of disease activity.
CELL AND GENE THERAPY
  1. FDA
    The groundwork being done in 2024 is building the foundation for global collaboration in the future.
  2. Johnson & Johnson and Legend Biotech’s Carvykti cell therapy significantly improved survival in patients with multiple myeloma when used in the second-line setting, the companies announced on Tuesday.
  3. Rocket Pharmaceuticals’ gene therapy Kresladi has been hit with an FDA Complete Response Letter requesting additional chemistry, manufacturing and controls information to complete its review.
  4. One patient died of respiratory failure in a Phase I study of Lyell Immunopharma’s investigational CAR-T therapy. The company on Wednesday said it has not definitively linked the fatality to the treatment.
  5. FDA
    After winning expanded approval for its gene therapy for Duchenne muscular dystrophy, Sarepta’s leadership and analysts see a sizeable commercial opportunity on the horizon.