The FDA was scheduled to release its decision on Novavax’s updated, protein-based COVID-19 vaccine on April 1, but the agency’s principal deputy commissioner intervened.
Pharma’s reprieve from Donald Trump’s tariffs is expected to be temporary, with Leerink analysts anticipating possible sector-specific duties “in the next month or so.”
Following the dramatic late-night resignation of Peter Marks last Friday, Steele, a senior advisor to the division, takes the reins in a department inside an agency beset by cuts, layoffs, and confusion.
After some high-profile crashes, the one-time biotech darling is inching toward success with its Hunter syndrome treatment, which today began a rolling BLA for accelerated approval.
Trump has repeatedly called April 2 “Liberation Day,” alluding to a more sweeping and aggressive set of tariffs. Leerink Partners analysts said that the risks from Trump’s tariffs on the biopharma industry are “underappreciated.”
Johnson & Johnson will not appeal the dismissal of its bankruptcy proposal.
FEATURED STORIES
Biogen’s effort to buy Sage against the board’s wishes and a long-time effort by investor Alcorn to scuttle Aurion’s IPO underscore the cutthroat nature of biopharma dealmaking.
Ahead of Robert F. Kennedy Jr.’s confirmation hearings, experts—and RFK’s own family—expressed concerns about his vaccine-related views, though the same experts are largely unfazed by the level of power he and Marty Makary could ultimately wield over the FDA.
After two years characterized by layoffs, pipeline reorganizations, FDA delays and clinical holds, Novavax CEO John Jacobs says the company is at a pivot point.
FROM BIOSPACE INSIGHTS
In a year when eradicated diseases are on the uptick in America, how will American children survive RFK Jr.’s vaccine scrutiny and inconsistency? Two experts call on pharma and regulatory bodies to rebuild trust.
LATEST PODCASTS
This week Lori, Greg and Tyler discuss drug pricing reforms. CMS sent offers to manufacturers of the 10 drugs that have been selected for Medicare price negotiations. What’s the best way forward that benefits patients while still supporting the innovation that makes these drugs possible? How will the election impact negotia
Lori, Greg and Tyler discuss last week’s call for a class-wide box warning on all commercial CAR T therapies, while investigations are ongoing into cases of secondary malignancies. How do we approach this balancing act of treatment and side effects?
BioSpace’s Lori Ellis and Chantal Dresner discuss anticipated job market trends for 2024 including unemployment, anticipated job search activity and hiring trends.
Job Trends
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc, with Pfizer Inc. and Shionogi as shareholders, announced that Health Canada has granted approval for APRETUDE for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in at risk individuals who are HIV-1 negative.
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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
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Genmab announced Wednesday it is buying ProfoundBio and its pipeline of next-generation antibody-drug conjugates being developed for gynecologic cancers and other solid tumors. -
Following a series of rejections and clinical failures, Eiger BioPharmaceuticals has declared bankruptcy and will sell all its assets as the company winds down operations. -
Avalo Therapeutics rolled the dice on a big pivot Wednesday, acquiring AlmataBio and focusing on the biotech’s ex-Eli Lilly hidradenitis suppurativa candidate over its existing assets. -
Gamida Cell, whose cell therapy for blood cancer was approved last year by the FDA, is being taken private and restructuring due to liquidity constraints. -
The Swiss contract manufacturer’s cash deal for Roche’s facility in Vacaville, California, is one of the world’s largest manufacturing sites for biologics—a major growth driver for Lonza and other CDMOs.
WEIGHT LOSS
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This week, Q2 earnings from Novo Nordisk and Eli Lilly revealed that the competition between the pharma giants’ weight-loss drugs Wegovy and Zepbound is getting closer. -
Eli Lilly comfortably cleared analyst estimates in the second quarter after improving supply of its blockbuster tirzepatide brands Mounjaro and Zepbound, which together generated more than $4 billion in sales. -
Novo Nordisk’s semaglutide brands Ozempic and Wegovy fell short of analyst expectations in the second quarter, mainly held back by supply headwinds. The company’s shares dropped more than 7% in Wednesday morning trading. -
A day after Eli Lilly’s obesity and weight-loss therapies were removed from the regulator’s database, Novo Nordisk also made strides in boosting the supply of all but one of semaglutide’s shortages. -
The company is projecting that future growth will be driven by geographic and label expansions for its rare disease assets, as well as potential approvals in obesity.
POLICY
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Siding With Novo and Lilly, Court Agrees to First Tackle ‘Cross Cutting Issues’ in GLP-1 LitigationsIn agreeing with Novo Nordisk and Eli Lilly, Pennsylvania judge Karen Spencer Marston said the court should first settle questions of gastroparesis diagnosis and sufficient warnings for side effects. -
The chair of the House Committee on Oversight and Accountability wants the CEOs of CVS Caremark, Express Scripts and Optum Rx to fix statements they made in a hearing last month that contradicted the committee’s and Federal Trade Commission’s findings. -
Congress, the Federal Trade Commission and the U.S. Patent and Trademark Office are all targeting Big Pharma’s practice of filing multiple, overlapping patents that stifle generic and biosimilar competition. -
Well-financed startup Tome is winding down operations just as two new companies, Borealis Biosciences and GondolaBio, are launching. Meanwhile, in the midst of already tense relations with China, House lawmakers raise the alarm about U.S. companies working with the country’s military on trials. -
The number of patients who will be eligible for Novo Nordisk’s blockbuster GLP-1 under new Medicare Part D plan guidelines will vary depending on how cardiovascular disease is defined, according to researchers.
Working from home can cause burnout and stress. The stress caused leads to low performance sometimes. Here are nine ways to prevent work from home burnout.
It’s no secret that employers ask tricky interview questions. But what do you do if you find yourself fumbling for words to answer these tricky questions?
Following up after an interview can be essential to help you gain peace of mind and reinforce your interest. Here’s how to improve follow up after interview.
Instead of letting LinkedIn slide to the bottom of your to-do list day after day, dedicate some time to it. Here’s what you need to add to your LinkedIn post.
Deciding on when to switch your job can be a difficult decision to make.
The pharmaceutical industry is full of job opportunities for people in various fields. Read on to find out more information about high-paying pharma industry jobs.
HOTBEDS
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
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The acquisition was featured Monday in Roche’s Pharma Day presentation, which also included projections of more than $3 billion in annual sales from three early-stage obesity and diabetes drugs. -
Six months after treatment with the radiopharmaceutical therapy, 77.8% of patients with meningioma were alive and had not experienced further disease progression, beating the 26% benchmark established in earlier studies. -
Johnson & Johnson linked Carvykti to a 45% reduction in risk of death and Darzalex to a 61% improvement in minimal residual disease-negativity, boosting the prospects of two key growth drivers for the company. -
One upcoming decision—on a perioperative PD-1 regimen for lung cancer—comes as the FDA considers an overhaul of trial designs in this treatment setting. -
The FDA’s Oncology Drugs Advisory Committee voted near-unanimously that the benefits of PD-1 inhibitors like Keytruda and Opdivo in PD-L1 low patients do not outweigh the risks.
NEUROSCIENCE
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Cognitive function in the liraglutide cohort declined 18% slower than in the placebo arm over one year of treatment, researchers announced Tuesday at the Alzheimer’s Association International Conference. -
The European Medicines Agency’s Committee for Medicinal Products for Human Use found that Leqembi’s benefits do not outweigh the risks of severe side effects associated with the treatment. -
Biogen and Sage Therapeutics’ investigational neuroactive steroid did not significantly improve upper limb tremors in patients with essential tremor, the companies announced Wednesday. -
While supportive of Amylyx’s acquisition of a GLP-1 drug, analysts say the company’s future hinges on key upcoming readouts from multiple products in its pipeline. -
While type 2 diabetes and obesity are the primary conditions currently treated with blockbuster GLP-1 drugs, Novo Nordisk and Eli Lilly aim to enter additional markets.
CELL AND GENE THERAPY
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Following back-to-back approvals in lymphocytic leukemia, Bristol Myers Squibb’s CAR-T therapy Breyanzi on Wednesday won the FDA’s green light for relapsed or refractory follicular lymphoma. -
While these technologies are now a therapeutic reality, the ASGCT 2024 annual meeting this week was a reminder of just how far we are from widespread use. -
With 15 patients started across its three gene therapies, bluebird bio claims a 138% year-over-year revenue growth and aims to initiate up to around 100 new patients in the current year. -
At a Thursday ASGCT 2024 session, CBER Director Peter Marks made the case for a better, “more convergent” global framework on cell and gene therapies, especially for rare diseases. -
An autologous and personalized regulatory T cell therapy is safe in patients with type 1 diabetes, but does not help preserve β-cell function.
