The Commissioner’s National Priority Vouchers aim to offer accelerated pathways to drugs that meet certain criteria, perhaps including a low price-tag. But the policy is vaguely defined and was announced without public input, going against the FDA’s own published practices, experts say.
BioNTech also laid off 63 employees in June in conjunction with the discontinuation of its cell therapy manufacturing operations in Gaithersburg, Maryland.
The Department of Health and Human Services is terminating around $500 million in BARDA contracts associated with mRNA vaccine development, a move that will affect several pharma companies, including Moderna, Pfizer, Sanofi and AstraZeneca.
From tariffs to drug pricing to the FDA, biopharma CEOs find themselves pulled into policy discussions on this year’s second quarter earnings calls.
George Tidmarsh takes over temporarily at CBER following Vinay Prasad’s abrupt departure; Replimmune trial leaders protest rejection reportedly driven by FDA’s top cancer regulator Richard Pazdur; Merck’s $3 billion savings push claims 6,000 jobs; and Pfizer CEO Albert Bourla addresses President Donald Trump’s new threats around Most Favored Nation drug pricing.
The regulatory environment is placing extreme pricing pressure on pharmaceutical manufacturers. Their success in the market depends on mounting an agile response.
Albert Bourla confirmed that he called President Donald Trump after receiving a letter asking Pfizer and a clutch of other pharmaceutical companies to lower drug prices or face consequences.
FEATURED STORIES
Marty Makary, likely FDA commissioner under President Trump, appeared before Congress this week as the agency he’s set to lead continues to be rocked by sweeping changes and about-faces.
A BioSpace analysis of all 80 priority review vouchers that have been handed out across the three FDA programs that offer them found that 2024 was the busiest year yet. Companies have disclosed spending $513 million on vouchers that were earned in 2024 so far.
Konstantina Katcheves, Senior VP of Innovative Global Business Development at Teva Pharmaceuticals brings insights from the World Economic Forum to SCOPE 2025.
Merck’s Keytruda holds on to the top spot while AbbVie’s Humira—once the world’s top-selling drug—continues to cede its market share to biosimilar competitors.
Congress did not reauthorize the rare pediatric disease priority review program at the end of 2024. Advocates say the ripple effect is already being felt across biopharma.
In the current legal and political landscape, it is all about survival for DEI initiatives.
FROM BIOSPACE INSIGHTS
Building and scaling biopharma workforces can go beyond recruiting permanent employees to include fractional workers and consultants. A Slone Partners executive discusses how these blended workforces operate, highlighting the strategic benefits.
LATEST PODCASTS
In this episode, Lori and guests discuss the pursuit of adequate representation and how clinical trials are being shaped by the legal environment they operate within.
Second-quarter earnings season continues with Big Pharma beating Wall Street expectations, the author of an encrypted email sent to BioSpace has a proposal for Moderna and Merck, Roche and Viking seek quicker entry to the obesity market, and AAIC is in full swing.
Despite early 2024 optimism, BioSpace’s Job Market Trends report outlines a still sluggish situation in the biopharma industry, Novartis and J&J announce Q2 earnings, GLP-1 market leaders expand into China and the Cassava Sciences saga continues.
Job Trends
AbbVie announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval of risankizumab for the treatment of adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional or biologic therapy.
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SPECIAL EDITIONS
In this deep dive, BioSpace explores the next big thing in obesity.
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.
DEALS
  1. Venture capital in the sector hit $9.2 billion in the second quarter of 2024, up from $7.4 billion in Q1, while exits fell on a slower M&A cycle and picky IPO market.
  2. M&A activity surges and IPOs return as the biotech industry navigates a changing business landscape marked by strategic consolidation and renewed investor focus on innovation.
  3. The Connecticut-based biotech, which emerged from stealth last year, has secured $202 million to date as it looks to move two assets targeting prostate and breast cancer into the clinic.
  4. Armed with a combined $850 million in cash, the companies said Thursday the resulting biotech will have a pipeline that could deliver 10 clinical readouts over the next 18 months.
  5. The size of the global immunology market is projected to nearly double by 2032 to a quarter of a trillion dollars. Here are this year’s standout deals in the space.
WEIGHT LOSS
  1. In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis, Miguel Forte and Ali Pashazadeh speculate on the impending Trump administration, discuss current challenges faced by CEOs and weigh investment in GLP-1s.
  2. According to the World Health Organization, GLP-1 receptor agonists are currently being used in a highly medicalized manner. Healthcare systems need to enact more holistic solutions, focusing on health promotion, disease prevention and policy interventions.
  3. Following an appeal by the Danish Medicines Agency, the European Union’s drug regulator will review two new studies that have strengthened the link between Novo Nordisk’s blockbuster GLP-1 and a rare eye disease.
  4. 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.
  5. The Hansoh deal will let Merck compete in the crowded oral GLP-1 space alongside fellow pharma giants Eli Lilly, Novo Nordisk and Roche.
POLICY
  1. FDA
    In a recent interview, FDA Commissioner Marty Makary said there “should be nothing political about the FDA.” Recent actions taken by HHS Secretary Robert F. Kennedy, Jr. and others within the department appear to be at odds with this sentiment.
  2. FDA
    As Marty Makary nears the end of his first month on the job, the FDA Commissioner sat down for two interviews, offering statements that alternatively contradict and jibe with reported events.
  3. Merck, Bristol Myers Squibb, Sanofi and Roche had little clarity on the potential impact of President Donald Trump’s pharmaceutical tariffs but many companies are already preparing for what’s to come.
  4. The so-called ‘Most Favored Nations’ rule would set drug pricing for Medicare in line with the prices paid by other nations, where drugs can be much cheaper.
  5. 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.
CAREER HUB
If you’re considering preparing for your next interview, know that you need to learn the art of drafting a perfect cover letter to show that you’re a great match for the position.
We sat down with Associate Director of Talent Acquisition Jennifer Metivier and Chief People Officer Jennifer Peterson of Obsidian Therapeutics to discuss what type of candidates they prefer.
If you’re considering a career change from pharma to biotech, you’ll be happy to hear that according to industry experts, the transition is more common than you might think.
Keep reading to take a look at some of the best pharma jobs for travelers. These jobs will allow you to see different parts of the world while working in an exciting and fast-paced industry.
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.
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
In a series of memos last week, Center for Biologics Evaluation and Research Director Vinay Prasad outlined the FDA’s thinking on the recent limited approvals for updated COVID-19 vaccines.
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. Eli Lilly inked two collaborations on Monday, one focused on cardiometabolic diseases with South Korea’s OliX Pharmaceuticals and another for cancer therapies with Australia’s AdvanCell.
  2. Adding a new indication for the CAR T cell therapy could help BMS offset the loss-of-exclusivity headwinds it faces in the coming years.
  3. Kuro Oncology and partner Kyowa Kirin are on track for an NDA submission for ziftomenib in the second quarter of this year.
  4. Despite significant dips in its vaccines sales, the British pharma narrowly beat consensus estimates for Q4 2024 and raised 2031 sales projections to just over $50 billion.
  5. Faced with the encroaching threats of patent expirations and generics, biopharma companies in 2024 invested 33% more in licensing deals, on average, than in 2023 with an eye toward enriching their pipelines with novel and potentially more effective therapies.
NEUROSCIENCE
  1. ALS
    Misses from amyotrophic lateral sclerosis hopefuls Denali Therapeutics and partners AbbVie and Calico Life Sciences mark the latest setbacks for the controversial platform trial, the results from which have largely mirrored the dismal success rate in ALS overall.
  2. Backed by ARCH Venture Partners, F-Prime Capital and Mubadala Capital, the new company will develop a pipeline of brain-penetrant small molecules to address inflammation, metabolic dysfunction and restoring lysosomal function.
  3. ALS
    Denali’s failure on Monday continues biopharma’s losing streak against amyotrophic lateral sclerosis. PTC Therapeutics and Amylyx have seen similarly disappointing results.
  4. Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy for hemophilia A and B.
  5. Effectively treating and preventing this common form of dementia will require a cocktail of drugs and a combination of approaches, as well as a drive toward early detection.
CELL AND GENE THERAPY
  1. Analysts did not seem very concerned by the treatment-related serious adverse event, noting that NGN-401 was well-tolerated at a lower dose and showed promising efficacy outcomes.
  2. The investigational therapy, vesleteplirsen, had been positioned as an updated version of Sarepta’s original exon 51-skipping Duchenne muscular dystrophy drug Exondys 51.
  3. Truist Securities analyst Asthika Goonewardene in an investor note said data for anito-cel—particularly its safety profile—will help differentiate the CAR T therapy from Legend Biotech and J&J’s entrenched Carvykti in relapsed and refractory multiple myeloma.
  4. In our anniversary episode, we discuss a rare earnings miss for Eli Lilly, a pivotal metabolic dysfunction–associated steatohepatitis victory for Novo Nordisk’s Wegovy, growing excitement about CAR Ts for autoimmune disease and the ongoing controversy over HeLa cells.
  5. 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.