The FDA will select at most five companies that align with national priorities, including lower drug prices and increased domestic investment.
The voluntary pauses follow two patient deaths associated with the Duchenne muscular dystrophy gene therapy.
A retrospective cohort study found that semaglutide and tirzepatide are linked with significantly lower risks of dementia and stroke, hinting at potential neuroprotective effects of GLP-1 therapies.
Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug regulator in George Tidmarsh, a handful of new drugs get turned away from the market and pharma companies continue to commit billions to reshoring manufacturing.
BMO Capital Markets pointed to FDA leadership, and CBER Director Vinay Prasad in particular, as potential factors in the agency’s decision to issue a complete response letter for Replimune’s viral treatment RP1 for advanced melanomas. Shares of the company tumbled 75% on Tuesday.
The acquisition, which will give Sanofi a combination vaccine for respiratory syncytial virus and human metapneumovirus, follows the pharma’s potential $1.4 billion COVID vaccine licensing deal with Novavax last year, plus a number of other big-ticket commitments outside of the vaccine space.
FEATURED STORIES
Even before the FDA’s recent approval of Dato-DXd in breast cancer, analysts predicted sales of the antibody-drug conjugate could hit $5.9 billion in 2030. However, the asset faced a series of setbacks in 2024.
Traditionally carrying a dire prognosis, the treatment paradigm for multiple myeloma is changing, with CAR T therapies, bispecifics and more contributing to multifaceted regimens unique to each patient’s needs.
Biopharma executives make their predictions for the year ahead, from a bold forecast for the return of the megadeal to a plea for the slow, healthy recovery of the industry at large.
As I ran from interview to interview across San Francisco, I was consistently warmed by the stories I was told by biotech and pharma executives—and the general comradery in the air throughout the chaotic event.
With incoming president Donald Trump threatening a trade war with China, experts told BioSpace that the new administration will likely understand why medicines should be treated differently.
Annemarie Hanekamp has overseen some of the most transformative changes in oncology over her years in Big Pharma. Now, she will oversee BioNTech’s transition from a COVID-19 vaccine maker to an “end-to-end organizational oncology powerhouse.”
FROM BIOSPACE INSIGHTS
Establishing trust through thought leadership is no longer optional in today’s cautious biopharma market. This webinar will show leaders how strategic insights and targeted outreach can turn awareness into high-converting leads. Watch now.
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Bayer joined BMS in announcing major overhaul; Takeda drops up to $2 billion for an anti-amyloid drug from AC Immune; and BioSpace reflects on last week’s ASGCT meeting—the good, the bad and the ugly.
On this episode of Denatured, Lori Ellis and guests discuss President Biden’s Executive Order on Advancing Women’s Health Research and Innovation and the outlook of investment in women’s health.
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.
Job Trends
Eli Lilly and Company announced positive topline results from the QWINT-2 and QWINT-4 phase 3 clinical trials evaluating once-weekly insulin efsitora alfa in adults with type 2 diabetes using insulin for the first time and those who require multiple daily insulin injections.
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SPECIAL EDITIONS
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.
BioSpace did a deep dive into executive pay, examining the highest compensation packages, pay ratios and golden parachutes—what a CEO would get paid to leave.
DEALS
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AbbVie on Thursday announced it has acquired Celsius Therapeutics to expand its immunology portfolio with a first-in-class TREM1 inhibitor CEL383, following other big players looking to cash in on the hot immuno market. -
After being spun off of sequencing giant Illumina, Grail on Tuesday is set to start trading on the Nasdaq Global Select Market following a years-long antitrust battle with regulators. -
The combined company began trading Friday under the Nasdaq symbol TECX. A $130 million private placement was also completed, with a cash runway into mid-2027. -
Vanda Pharmaceuticals has rejected two unsolicited takeover offers, saying that they are “opportunistic attempts” to acquire the biotech at a heavily discounted price. -
The pace of mergers and acquisitions has accelerated. In this deep dive, BioSpace takes a closer look at the nature of recent deals and the players involved.
WEIGHT LOSS
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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. -
After psychological side effects doomed the first generation of cannabinoid receptor 1–targeting drugs for weight loss, Novo Nordisk, Corbus Pharmaceuticals and Skye Bioscience are betting that a new mechanism of action will improve the safety profile. -
Scaling GLP-1 manufacturing capacity remains a key priority for the pharma industry, to help supply catch up with the insatiable demand for weight loss drugs.
POLICY
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The latest cuts, which are part of a larger reduction of 10,000 at the Department of Health and Human Services, were reportedly underway Tuesday, with CDER Office of New Drugs Director Peter Stein added to the list of casualties. -
Analysts at financial firm Cantor Fitzgerald are urging President Donald Trump to rethink his appointment of Robert F. Kennedy Jr. as Secretary of Health and Human Services. -
The European Union’s CHMP said that the benefits of the drug, already approved in the U.S., do not outweigh the risk of potentially fatal brain swelling and bleeding. -
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. -
Donald Trump’s proposed tariffs on the EU would increase manufacturing costs for pharma companies and would stall medical innovation, according to the results of a recent survey by the Biotechnology Innovation Organization.
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Conducting some research before your job interview can help ease your mind. You will feel less stressed once you know what to look forward to during the meeting and which skills will allow you to shine.
Setting yourself apart from other job candidates can be a challenging thing to do - but it doesn’t have to be with these eight important tips!
Your CV can be the ticket that lands you your dream job - as long as you focus on making sure that it’s well-written with the help of these CV writing tips.
Differing skillsets mean that extroverts and introverts will usually approach the same job differently. Here is how each of them do it.
If you’ve been getting the itch to job search but you aren’t sure if you should, here are some reasons to possibly leave a job that might help you decide if you should stay or if you should go.
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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In a deal expected to close in Q1 2025, Roche will gain access to Poseida’s off-the-shelf CAR T candidates. -
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.
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As market values increase for computational biology and data science, biopharma companies are looking to hire R&D professionals in those areas. A biotech talent acquisition expert shares his insights on these in-demand roles. -
Regulators squeezed in two final approvals before the calendar change with the UK approval of Merck’s Winrevair and the FDA’s greenlight for an injectable formulation of BMS’s cancer blockbuster. -
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.
NEUROSCIENCE
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The past four years have brought disappointment for the Huntington’s community, but optimism is growing as companies including Prilenia and Wave Life Sciences eye paths to approval of therapies that could address the underlying cause of the disease. -
A fatal, highly hereditary illness with no disease-modifying treatments, Huntington’s is long overdue for a therapeutic win. Here, BioSpace looks at five candidates that could change the trajectory for patients. -
With Eisai and Biogen’s Leqembi and Eli Lilly’s Kisunla launching onto the market, the 2024 Clinical Trials of Alzheimer’s Disease conference focused on the role these drugs might play, as well as combination therapies and innovative new treatment options. -
Leqembi’s sales continue to be underwhelming, according to analysts, who contend the companies’ Alzheimer’s disease therapy is being held back by barriers such as coverage, infusion centers and time to diagnosis. -
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.
CELL AND GENE THERAPY
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With the help of third-party investors, the new venture will focus on three genetic and rare diseases: tuberous sclerosis complex, erythropoietic protoporphyria and alpha-A1 antitrypsin deficiency. -
The recent invalidation of an AAV gene therapy patent overlooks the complexity of innovation in biotechnology and could put a broad swath of intellectual property at risk. -
Regeneron, Akouos and Mass Eye and Ear are testing therapies that can reverse genetic protein deficiency to restore hearing, with promising early results. -
Likely to miss its initiation target, bluebird bio has renegotiated the loan deals of its agreement with Hercules Capital, giving it until June 30 next year—at the latest. -
Eli Lilly’s new research and development facility in Boston’s Seaport district will focus on DNA- and RNA-based therapies, as well as other priority areas such as diabetes and obesity.
