In this bonus episode, BioSpace’s vice president of marketing ⁠Chantal Dresner⁠ and careers editor ⁠Angela Gabriel⁠ take a look at Q1 job market performance, layoffs and administration decisions impacting the workforce.
Dupixent, which was rejected by the FDA for chronic spontaneous urticaria in October 2023, is now approved as the first new targeted therapy for the indication in more than 10 years.
President Donald Trump in February threatened top pharma leaders, including Eli Lilly CEO David Ricks, with tariffs unless they reshore their manufacturing operations.
FDA
In an interview with former Fox News journalist Megyn Kelly, FDA Commissioner Marty Makary introduced a new mechanism-driven pathway that could be leveraged by rare disease therapies while saying that autism could potentially be driven by certain environmental factors.
BML Capital Management, an activist investor that owns 9.9% of Elevation’s shares, is urging the company to wind down operations given “the current state of the public equity market.”
Alis Biosciences’ plan is a familiar tactic in the private equity world, but the firm will instead be listed on the public markets “in due course.”
FDA
Losing the FDA’s senior negotiators would slow the renewal of the user fee programs “considerably,” according to policy and regulatory expert Steven Grossman.
FEATURED STORIES
Akero Therapeutics, 89bio, Boston Pharmaceuticals and more are working to bring novel treatment options for metabolic dysfunction-associated steatohepatitis to a market that could reach $16 billion by 2033.
While it’s not unusual for certain positions to turn over with a new administration, the number of senior-level FDA staffers who have recently left the agency is unprecedented. The lack of communication, transparency and human decency is as well.
Bo Wang is a renowned AI scientist at the University of Toronto. He’s bringing his open-source culture and computational biology to Xaira Therapeutics in June.
FROM BIOSPACE INSIGHTS
How does age affect employees’ experiences in the workplace? This report examines the intersection of age along with gender and other demographics.
LATEST PODCASTS
In this bonus episode, BioSpace’s vice president of marketing ⁠Chantal Dresner⁠ and careers editor ⁠Angela Gabriel⁠ take a look at Q4 job market performance and what we expect to see ahead.
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis talks to Dr. Peter Marks, Director, CBER about his thoughts on the future of cell and gene therapies.
J&J, GSK, Eli Lilly and others struck high-value transactions in the early days of biopharma’s annual kickoff conference. Meanwhile, Biogen proposes to acquire struggling neuro partner Sage, and obesity dominates discussions as Pfizer goes “all in.”
Job Trends
Last week, BioMarin revealed changes to its C-suite; now, the company has announced its second round of layoffs this year, following the termination of 170 employees in May.
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SPECIAL EDITIONS
In this deep dive, BioSpace explores the diverse therapeutic modalities now in development, as well as the opportunities and battles for market dominance in this emerging space.
Year-over-year BioSpace data show there were fewer job postings live on the website in the fourth quarter of 2024, and the decrease was higher than the third quarter’s drop.
The J.P. Morgan Healthcare Conference started off with a flurry of deals that reinvigorated excitement across the biopharma industry. Johnson & Johnson moved to acquire Intra-Cellular Therapies for $14.6 billion, breaking a dealmaking barrier that kept Big Pharma’s 2024 biotech buyouts to under $5 billion.
DEALS
  1. Initial rounds of VC financing totaled $7.7 billion over 137 deals for biopharma in 2024, compared to $3.8 billion over 156 deals in 2023.
  2. J.P. Morgan releases its quarterly look-ahead days before the entire biopharma industry descends on San Francisco for the annual J.P. Morgan Healthcare Conference.
  3. BioSpace presents 25 noteworthy biopharma startups in ’25; analysts forecast stronger M&A as the J.P. Morgan Healthcare Conference kicks off next week; GLP-1s continue to expand their reach as Novo, Lilly fight against compounders; and a look ahead to five key FDA decisions in Q1.
  4. Licensing deals have risen in prominence in a restrained market environment. Is it desperation, or an important part of the biotech ecosystem? Experts weigh in.
  5. Look for renewed investment driven by lower interest rates in the new year, and a continued focus on late-stage assets, oncology and reaping the benefits of AI.
WEIGHT LOSS
  1. Compounding pharmacies aren’t the only makers of off-brand versions of Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. The situation is causing the FDA regulatory headaches and, more seriously, posing potential risks to the public.
  2. 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.
  3. 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.
  4. Wegovy sales increased by more than 100% over 2024. But that wasn’t enough to satiate analysts who want to know why Novo Nordisk can’t access more patients, particularly in the U.S.
  5. Amgen outperformed expectations in the fourth quarter of 2024, but revealed an FDA hold on early-stage obesity asset AMG 513 and the discontinuation of other programs.
FDA
  1. TNKase is the first stroke drug to win FDA approval in nearly three decades.
  2. Two recent documents—one from the FDA, the other from a commission organized by The Lancet Diabetes & Endocrinology—indicate an evolving mindset toward treating obesity as a chronic disease.
  3. 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.
  4. ITF, IntraBio and Orchard are among the companies that have won FDA nods in the past year for Duchenne muscular dystrophy, Niemann-Pick disease type C, metachromatic leukodystrophy and more.
  5. Pemgarda has a standing emergency use authorization as a prophylaxis for immunocompromised patients, but FDA’s stringent requirements for antibody activity boxed out its potential use as a post-exposure treatment.
CAREER HUB
Looking for a biopharma job in Illinois? Check out these top five companies hiring life sciences professionals like you.
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.
Looking for a quality control job? Check out these nine companies hiring life sciences professionals like you.
Companies will look at job candidates’ LinkedIn profiles, so make sure yours is strong, from the summary of your expertise and qualifications to testimonials from colleagues.
After more than 20 years at Eli Lilly, Leslie Sam moved into independent consulting. To prepare for the transition, she focused on becoming technically deep and earning industry recognition.
Employed and unemployed biotech and pharma professionals are thinking about job hunting in other fields amidst a challenging labor market.
When you don’t get the promotion you wanted, it’s important to assess your company and yourself so you can improve your odds in the future.
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
Such a change would put the U.S. more in line with guidance in other countries and with the World Health Organization, which recommends one dose for children and adolescents only if they have comorbidities.
REPORTS
After a tumultuous 2022, life science employers are settling into their hiring goals for 2023. Though they may be hiring at lower volume, the majority of organizations are still actively recruiting.
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.
CANCER
  1. The approval for the first-line treatment of esophageal squamous cell carcinoma comes shortly after a label expansion for the drug in gastric and gastroesophageal cancers as BeiGene also pushes forward a pipeline of novel cancer therapies.
  2. The partners are pushing to expand Enhertu’s list of indications beyond its standing uses in breast, lung and gastric cancers.
  3. Protagonist Therapeutics notches a milestone in its pact with Takeda for rusfertide. New data show that many patients with a chronic blood cancer taking the drug didn’t need to have their blood removed to bring down dangerously high hemocrit levels.
  4. More than a decade after Merck’s Keytruda and BMS’ Yervoy ushered in the immuno-oncology revolution, the space is at a crossroads, with experts highlighting novel targets, combinations and pre-emptive immunization as the next wave for IO.
  5. The company will push through with an accelerated approval application for odronextamab in follicular lymphoma, leaving diffuse large B cell lymphoma behind.
NEUROSCIENCE
  1. The Phase IIa results continue a surge of momentum in a treatment space that last week saw the approval of Vertex’s Journavx as the first novel mechanism for acute pain in decades.
  2. In a Phase IIb trial, GH001 elicited significant drops in treatment-resistant depression. The news comes less than two weeks after J&J secured FDA monotherapy approval for its esketamine nasal spray Spravato in the same indication.
  3. After the Phase II failure of its lead asset from Cerevel, AbbVie is resetting expectations and narrowing the clinical program to an adjunct approach—for now.
  4. Analysts were unfazed by the news that Takeda will cease development of soticlestat after Phase III failures, while responding positively to the announcement that Julie Kim will take the helm of the Japanese giant in 2026.
  5. Inhibikase’s setback continues biopharma’s losing streak against Parkinson’s, marked by several clinical failures and abandoned assets in recent months.
CELL AND GENE THERAPY
  1. In this episode, presented by the Genscript Biotech Global Forum 2025, BioSpace’s Head of Insights Lori Ellis talks to Tom Whitehead, co-founder of the Emily Whitehead Foundation, about how standard care, cell and gene therapies and their impact on patients.
  2. Riding recent momentum in the Duchenne muscular dystrophy space, Capricor Therapeutics, Wave Life Sciences, Regenxbio and more aim to deliver the next wave of progress with near-term data and regulatory milestones.
  3. While the last decade has brought considerable progress for patients with DMD, substantial unmet need remains. Several companies including Wave, Dyne and Avidity are looking to answer the call with investigational therapies targeting greater efficacy and broader reach.
  4. At J.P. Morgan, most biopharma executives expressed a neutral stance on the incoming administration, but just days later, President Trump issued multiple executive orders that concern the industry.
  5. Five years ago, Gilead signed a massive deal with Galapagos. After a restructuring, the pharma is still hunting for the potential it saw at the original signing.