The CDC’s Advisory Committee on Immunization Practices was scheduled to convene Oct. 22 to 23, but this meeting has been postponed, with no new date specified. The delay comes as the VA published new research showing that COVID-19 shots prevented hospitalizations and death.
The layoffs are part of the company’s shift to a new structure enabling cost efficiency for its new model.
Looking for a job in oncology? Check out the BioSpace list of nine companies hiring life sciences professionals like you.
Sanofi’s Orano Med-partnered radioligand therapy AlphaMedix achieved all primary efficacy endpoints, which included a measure of overall response rate, in the mid-stage ALPHAMEDIX-02 study.
The centerpiece of the deal is orelabrutinib, a BTK inhibitor in late-stage development for multiple sclerosis that Biogen once paid $125 million for but abandoned after less than two years of testing.
In the Phase III FIBRONEER-IPF study, Jascayd demonstrated significant lung capacity improvements over placebo.
FEATURED STORIES
Morale is low at the FDA, which was hit with layoffs this week following RFK Jr.’s confirmation. Biopharma leaders and agency insiders fear further workforce cuts could delay new medicines.
2023 marked the most bankruptcies in biopharma in more than a decade, with 14 companies filing for Chapter 11 protection. The number remained high in 2024.
A cautionary tale illustrates how forging a deal with a Big Pharma can have unexpected and far-reaching tax consequences.
Elisa Cascade, CPO at Advarra explains why addressing the challenges faced by clinical research sites is vital for improving patient trust and the overall viability of clinical trials.
COUR Pharmaceuticals has been around a while, but not until last year did the company solidify behind its ultimate mission with a series A raise.
The hammer came down on an unspecified number of FDA employees this weekend, days after Robert F. Kennedy Jr. was confirmed as HHS Secretary.
LATEST PODCASTS
The FDA took center stage last week as it approved the first-ever MASH therapy and considered additional approvals for CAR-T therapies, whose safety the agency has been investigating since last year.
This episode focuses on a healthy discussion regarding the IRA, particularly the unintended consequences to small molecule development within the industry and for patients.
Heather, Greg and Tyler discuss a busy news week including Wegovy’s label expansion, biosimilars, surprise donanemab delays for Eli Lilly and speculate on election impact.
Job Trends
Moderna, Inc. (NASDAQ:MRNA) today announced that the Company will present data from its respiratory portfolio, including vaccines and vaccine candidates against COVID-19.
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SPECIAL EDITIONS
In this deep dive, BioSpace investigates China’s rise as a biotech powerhouse.
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.
DEALS
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Telix abruptly pulled the plug on its initial public offering plans to begin trading Friday on the Nasdaq, saying the company “did not feel that the proposed discounts were aligned with its duty to its existing shareholders.” -
Biogen recently bolstered its pipeline with a potential $1.8 billion acquisition of Human Immunology Biosciences, following other big players looking to cash in on a global immunology market estimated to grow to $257 billion by 2032. -
In an SEC filing on Friday, Alumis said it aims to start late-stage trials of a TYK2 inhibitor in plaque psoriasis this year and is seeking public funding for the studies. -
After rejecting a previous takeover offer from Future Pak, Vanda Pharmaceuticals is now fielding another acquisition proposal from Cycle Pharmaceuticals, which values the biotech at $8 per share. -
Telix Pharmaceuticals is looking to cash in on radiopharmaceuticals, which have emerged as one of the hottest spaces in oncology, with an initial public offering to help support its pipeline of targeted radiation products.
WEIGHT LOSS
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While the regulator conducts another review into the supply of Eli Lilly’s tirzepatide, compounders will be able to continue selling their own remixed versions of the blockbuster drug. -
Senator Elizabeth Warren told the Federal Trade Commission that the acquisition of contract manufacturer Catalent could increase Novo’s dominance over the hot GLP-1 market, reducing competition and increasing prices. -
Cell and gene therapy investment rebounds; WuXi Biologics and other companies named in BIOSECURE Act mull options; Bayer, J&J and Pfizer’s recent layoffs; updates from the weight loss space. -
Eli Lilly CEO David Ricks is confident his company and peer Novo Nordisk are years ahead in the weight loss space, as biotechs press on with compelling data. -
Alongside the settlement, Novo and Viatris have asked the U.S. Patent and Trademark Office to terminate its review of the validity of the Danish drugmaker’s semaglutide patents.
POLICY
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The recommendations were made in a closed session with representatives from CBER, the CDC and Department of Defense. -
As Marty Makary and Jay Bhattacharya sail through the Senate health committee vote, Weldon’s confirmation hearing is canceled. Guggenheim Partners heralded the last-minute move to revoke Dave Weldon’s nomination as “a positive sign for reigning in vaccine criticism.” -
BioSpace remembers COVID-19 five years after the pandemic was declared, Novo Nordisk’s CagriSema again misses expectations as the company joins a lawsuit filed by drug compounders against the FDA, Viking secures ample supply of its investigational obesity medication, J&J strikes out in depression, and Makary and Bhattacharya near confirmation.
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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. -
Days after suffering a rejection in Australia, the Alzheimer’s drug hit another roadblock in the U.K., which found the drug not cost-effective.
Think about why you are the best candidate for the position and sell yourself. Here are a few ways to do that.
How do you find success (and not feeling like you’re drowning) when you have to onboard to a new job virtually? We have a few ideas.
Depending on your master’s program of interest and your personal qualifications, you might need to take months (or years) to develop into the type of candidate that is admitted.
If you are certain that attending graduate school is the right move for you, it’s time to look into the specifics of various programs.
While continued learning opportunities are easy to access and many are quite affordable, the real question is, can you list these courses on your resume? And if you do so, what will recruiters in the biotech field think of them?
Some semblance of a work-life balance is already a challenge to maintain, but doing so when you’re working and living in the same space takes effort and one (or more!) of these strategies.
HOTBEDS
IN CASE YOU MISSED IT
A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
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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Madrigal Pharmaceuticals, X4 Pharmaceuticals and Day One Biopharmaceuticals secured their maiden approvals this year in metabolic dysfunction-associated steatohepatitis, WHIM syndrome and pediatric low-grade glioma. Geron Corporation and ImmunityBio also notched wins. -
First approved in 2021, Jemperli has now become a cornerstone of GSK’s cancer business, earning more than $160 million in the third quarter. -
Both vibostolimab and favezelimab have had disappointing runs leading up to their termination, sustaining several late-stage failures. -
The FDA cited issues with a manufacturing facility as the reason for the rejection. J&J is currently “working closely” with the regulator to resolve these problems. -
Bristol Myers Squibb aims to generate around $1.5 billion in savings through 2025—a goal that it hopes to reach by lowering third-party expenditures, focusing only on key growth brands and cutting some 2,200 jobs by year-end.
NEUROSCIENCE
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This year has seen several biopharma companies drop Alzheimer’s and Parkinson’s disease programs, but experts say plenty are still chasing these multi-billion-dollar markets. -
Bristol Myers Squibb’s third-quarter results benefited from sales of its legacy brands Eliquis and Revlimid, as well as growth portfolio products such as Abecma, Breyanzi and Reblozyl. -
In another delay for the psychedelic treatment space, Compass Pathways announced adjusted timelines for two Phase III trials of its psilocybin to address treatment-resistant depression. -
Biogen touted strong Q3 sales of its Alzheimer’s drug Leqembi a day after announcing a deal worth up to $1.45 billion with Neomorph to discover and develop molecular glue degraders.
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On its third-quarter earnings call Tuesday, Sage highlighted the launch of its Biogen-partnered postpartum depression drug Zurzuvae but said it will stop pursuing approval for major depressive disorder, which the FDA previously denied.
CELL AND GENE THERAPY
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BioMarin Pharmaceuticals on Monday said it is restricting sales of its hemophilia A gene therapy to three countries in an effort to reduce costs and help the treatment become profitable by 2025. -
Longeveron and Lexeo Therapeutics are working on CGT therapies to treat Alzheimer’s disease, but it’s not clear whether they have a better chance of success than traditional approaches. -
Ultracompact CRISPR systems, which are in some cases one-third the size of Cas9, are being designed to be more specific and enable in vivo gene editing in difficult to reach tissues. -
Approved under the regulator’s accelerated pathway, Tecelra is also the first new synovial sarcoma therapy in more than a decade, according to Adaptimmune Therapeutics. -
Sarepta has been hit with another patent infringement lawsuit, this time from Sanofi and its subsidiary Genzyme alleging that the biotech used protected technology related to AAV vectors.
