The announcement by the Department of Health and Human Services highlighted a flurry of moves, which include the shifting of departments. Also this week, HHS Secretary Robert F. Kennedy Jr. tapped fellow vaccine critic David Geier to investigate vaccine safety within the CDC.
In this episode presented by DIA, BioSpace’s head of insights Lori Ellis discusses the evolution of women’s inclusion in clinical trials with Martin Hodosi, partner at Kearney and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine.
Looking for a biopharma job in Indiana? Check out the BioSpace list of seven companies hiring life sciences professionals like you.
Biopharma employees reporting a positive business outlook for their companies dropped month over month but increased year over year in February, according to the Glassdoor Employee Confidence Index. Glassdoor’s findings align with recent BioSpace data.
Last month, Deerfield Management accused Alcon of obstructing Aurion’s IPO plans so it could acquire the startup “at a discount.”
Soleno’s Vykat XR is the first drug approved for the rare disease that directly targets its hallmark symptom.
FEATURED STORIES
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.
The Japanese pharma had one asset rejected by the FDA and withdrew a regulatory application for another, but already this month the company has secured an approval for AstraZeneca-partnered Dato-DXd, to be marketed as Datroway.
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.
FROM BIOSPACE INSIGHTS
While Quantum computing has been reported to be five years away for many years now, companies are preparing for it by setting foundations with AI in development.
LATEST PODCASTS
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.
This week, Lori, Greg and Tyler discuss the first surge of IPO activity this year plus gene therapy pricing,
Job Trends
Merck, known as MSD outside of the United States and Canada, announced the discontinuation of the vibostolimab and pembrolizumab coformulation arm of the Phase 3 KeyVibe-010 trial.
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SPECIAL EDITIONS
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.
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.
DEALS
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Big Pharma’s appetite for safe and effective oral IBD drugs with novel mechanisms of action continues to grow, with my former company just the latest in a string of acquisitions in the space. -
Monday’s announced buyout of Virginia-based Landos Biopharma adds a mid-stage, oral NLRX1 agonist for ulcerative colitis and Crohn’s disease to AbbVie’s growing portfolio. -
Just weeks after Wegovy won FDA approval for cardiovascular disease, Novo Nordisk has bought mid-stage biotech Cardior Pharmaceuticals and its miRNA-targeting candidate for heart failure. -
The contract manufacturer plans to expand its U.S. footprint with a former Roche facility in Vacaville, California, which Lonza contends is one of the largest biologics manufacturing facilities in the world by volume. -
Following in the footsteps of Bristol Myers Squibb and Eli Lilly, AstraZeneca on Tuesday jumped into the radiopharmaceuticals space by acquiring Fusion Pharmaceuticals in a deal worth $2.4 billion.
WEIGHT LOSS
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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. -
All doses of Eli Lilly’s type 2 diabetes medication Mounjaro and weight-loss drug Zepbound are now available, according to an update on Friday to the FDA’s drug shortage database.
FDA
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Unlike Pfizer/BioNTech and Moderna, Novavax does not use mRNA technology for its COVID-19 vaccine, instead opting for a recombinant version of the virus’ spike protein to elicit protection. -
The FDA has three regulatory milestones in the next two weeks, including a decision on a subcutaneous formulation of an effective multiple sclerosis therapy. -
The agency’s inertia and bureaucratic roadblocks are throttling hope for millions of patients. A new center of excellence would provide a solution. -
J&J gained rights to the FcRn blocker nipocalimab when it acquired Momenta Pharmaceuticals in August 2020 for $6.5 billion. -
Emergent BioSolutions joins Bavarian Nordic on pharma’s frontline in the fight against the ongoing mpox emergency.
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
This report investigates anticipated job search activity and hiring outlook for the remainder of 2024.
BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
BioSpace’s 2024 Salary Report explores the average salaries and salary trends of life sciences professionals.
CANCER
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If approved, the potential restrictions would impact Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, which are marketed for the first-line treatment of several types of stomach cancer regardless of PD-L1 expression. -
Monday’s failure to improve overall survival in breast cancer “further dents belief” in the companies’ Dato-DXd and “likely complicates regulatory discussions for approval of this indication,” Jefferies analyst Peter Welford wrote in a note to investors. -
With Friday’s approval, Sanofi’s anti-CD38 antibody Sarclisa will go head-to-head with the first such therapy for multiple myeloma, Johnson & Johnson’s Darzalex, which raked in nearly $10 billion last year. -
The European Society for Medical Oncology’s annual meeting this week featured the hottest emergent areas of cancer treatment—antibody-drug conjugates, bispecifics and radiopharmaceuticals—while anti-TIGIT therapies made a bit of a comeback. -
Summit Therapeutics’ ivonescimab has the potential to challenge Merck’s blockbuster checkpoint inhibitor in non-small cell lung cancer, but experts stress the need for diverse and overall survival data.
NEUROSCIENCE
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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.
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After a long and challenging journey for its stem cell therapy NurOwn, BrainStorm Cell Therapeutics has aligned with the FDA on the parameters of a Phase IIIb ALS trial that is expected to begin by the end of 2024. -
As the DOJ and SEC look into two of its senior employees, Cassava Sciences’ CEO and one senior vice president have departed the company. -
Asceneuron, which develops small molecules targeting tau protein aggregation, plans to use the funds to advance its Alzheimer’s disease asset into Phase II.
CELL AND GENE THERAPY
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As Sarepta Therapeutics moves closer to full approval and an expanded label for its gene therapy, some experts push back on clinical efficacy and cost while others note the hope it provides patients with Duchenne muscular dystrophy. -
Tuesday afternoon’s session was standing room only as representatives from various biopharma companies presented on their work to improve the efficiency and quality of AAV production. -
AAVs and accelerated approval are just two of the topics being discussed at ASGCT. Meanwhile, the race between Vertex and bluebird bio’s gene therapies Casgevy and Lyfgenia is heating up. -
The FDA is looking at four decision deadlines in the coming three weeks, including two for a CAR-T therapy and another for a hepatitis B vaccine. -
In a joint conference event on Monday, cell therapy pioneer Carl June revealed unpublished results showing that in around 1,500 patients treated with CAR-T therapies, no cases of secondary malignancy could be definitively linked to the treatment.
