Bioinformatics is on the rise, forecasted to grow by about $16 billion from 2024 to 2029 given its value to managing mass datasets critical to modern drug discovery and development. Two talent acquisition experts share how the field has evolved in the past few years and which skills are most in demand.
Thousands of employees across HHS were terminated Monday evening after the U.S. Supreme Court ruled last week that the Trump administration could move forward with its sweeping reorganization of the agency.
HIV pharma leaders are in Kigali, Rwanda for IAS 2025, touting their latest advancements in HIV and PrEP development on the heels of the landmark Yeztugo approval.
According to Makary, reducing user fees—which make up just under half of the FDA’s budget—could make it easier for smaller companies, individual investors and academics to participate in the process.
The molecule, developed in collaboration with Massachusetts-based Kailera Therapeutics, is headed for a new drug application in China and global clinical trials.
Despite the FDA commissioner’s promises of partnership and collaboration, personnel changes and continued federal cuts create uncertainty for an industry already struggling with nearly half a decade of investment scarcity.
The drug came to AstraZeneca through its acquisition of CinCor Pharma in 2023, with the hopes of beefing up its cardiovascular and kidney disease pipelines.
FEATURED STORIES
Lined up for the FDA in the coming weeks are a cell-based gene therapy for a rare skin disease and two product expansions for Regeneron, one with partner Sanofi.
As the biopharma industry grapples with the uncertain macro environment brought on by the new administration, CEOs, regulators and many others speak out.
Pharma stocks went on a wild ride Wednesday amid whiplashing tariff threats from the U.S. president.
Experts express concern that last week’s unprecedented FDA layoffs will trigger a little-known mechanism that could result in a “disaster” the Trump administration doesn’t see coming.
As the industry awaits official word from the administration on how the tariffs will hit, analysts go over the possibilities with one certainty: there will be increased costs for medicines.
Wegovy and Zepbound are just the latest drug dyads to face-off in the competitive pharma market, continuing a legacy of rivalry that includes blockbuster drugs Keytruda, Humira and Eliquis.
FROM BIOSPACE INSIGHTS
While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience that would make change possible.
LATEST PODCASTS
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis talks to Dr. Peter Marks, Director, CBER about his thoughts on the future of cell and gene therapies.
J&J, GSK, Eli Lilly and others struck high-value transactions in the early days of biopharma’s annual kickoff conference. Meanwhile, Biogen proposes to acquire struggling neuro partner Sage, and obesity dominates discussions as Pfizer goes “all in.”
In this short teaser, BioSpace’s Head of Insights Lori Ellis talks to CBER Director Peter Marks and Tom Whitehead, Co-Founder of the Emily Whitehead Foundation about anticipated discussions at the upcoming GenScript Biotech Forum.
Job Trends
Cellares Announces Agreement with Kite to Evaluate Its Cell Shuttle Automated Manufacturing Platform
Cellares today announced that Kite , a Gilead Company, will evaluate Cellares’ automated manufacturing platform, the Cell Shuttle.
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SPECIAL EDITIONS
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.
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.
DEALS
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Following a lawsuit filed last week, Sage has officially rejected Biogen’s unsolicited buyout offer, which valued the embattled biotech at just $469 million.
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Protein degradation–focused Neomorph nabs its third Big Pharma deal of around $1.5 billion in less than a year.
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The deal follows a $1.06 billion U.S. contract in July 2024 and a $1.24 billion agreement with an Asia-based pharma a few months later.
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On the company’s Q4 earnings call where an eyepopping $88.8 billion in full-year sales were revealed, leaders shifted focus away from enormous takeovers to single-digit billion buy outs.
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With an eye toward advancing a novel antibody-drug conjugate for gastrointestinal cancers, ArriVent is the latest biopharma player to ink a deal with a Chinese biotech.
WEIGHT LOSS
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Many of these unlawful and unauthorized shipments were explicitly tagged for compounding, according to a new analysis. Separately, a group of state attorneys general has raised concerns about the unsafe GLP-1 drugs finding their way to American consumers.
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Obesity drug developers Aardvark, Helicore and Metsera have all netted raises in the past two weeks.
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The data, published in JAMA Psychiatry, add to the growing body of evidence supporting the use of GLP-1 receptor agonists for addictive disorders.
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From revenue to R&D investment, Novo and Lilly and their mega-blockbuster weight loss drugs Zepbound and Wegovy have moved into a new pharma stratosphere, far eclipsing their rivals.
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Compounding pharmacies aren’t the only makers of off-brand versions of Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. The situation is causing the FDA regulatory headaches and, more seriously, posing potential risks to the public.
POLICY
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The FDA and CDC have also recommended pausing the use of Ixchiq in seniors 60 years and older while safety investigations are ongoing.
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As the Trump administration slashes funding for HIV-related research and infrastructure, Gilead, Immunocore and more are targeting the next goalpost: a cure.
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With President Donald Trump expected to deliver a drug pricing order on Monday that Big Pharma and patient groups alike have railed against, the industry’s tumultuous ride is far from over.
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Yes, according to leading vaccine physician Paul Offit, who denounced the new placebo-controlled trial requirements for vaccines and sought greater clarity: “I don’t know what they’re talking about.”
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A new executive order from President Donald Trump aims to cut down the 5-to-10-year timeline to build new facilities while stepping up the rigor of inspections on foreign plants.
BioSpace spoke to HR leaders about how they have been supporting companies navigating a challenging economy while meeting the needs of the workforces they support.
Politics can be a touchy subject, especially during a presidential election year. How should you engage in political discussions at work?
A string of rejections prompt some to look beyond research roles in the biopharma industry as they seek to launch a career.
The past year saw the slowest year-over-year growth in biopharma salaries in the past five years, according to the BioSpace 2024 Life Sciences Salary Report.
Staffing agencies say contract work is a great way to break into an industry and avoid a resume gap.
Plus, tips on applying to multiple jobs at the same company, making new work friends, and how to ask for more time at the offer stage.
HOTBEDS
IN CASE YOU MISSED IT
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an anonymous senior FDA official. Given Elevidys’ full approval, however, experts told BioSpace this path would set up a length legal battle between the regulator and Sarepta Therapeutics.
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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According to Tempest, its options include a partnership or licensing deal, as well as a merger or an acquisition.
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The FDA approved the use of Opdivo with Yervoy in front-line colorectal cancer, while a Manhattan court junked a class action complaint over the blood cancer drug Pomalyst.
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Stifel analysts were bullish on the data, which showed a 16.5% drop in body-mass index among patients with damage to the hypothalamus taking Rhythm Pharmaceuticals’ Imcivree.
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An independent data monitoring board found that BeiGene’s ociperlimab was unlikely to significantly boost overall survival in patients with untreated NSCLC.
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Cell therapy and oncology–focused Carisma Therapeutics started layoffs late last year. Now the company plans to wind down fully.
NEUROSCIENCE
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Biohaven in recent months has reported a clinical stumble in spinal muscular atrophy, alongside a Phase I readout for its protein degrader candidate that investors found underwhelming.
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After failing to hit the primary endpoint in a Phase III trial, Neumora is remixing study parameters in two replicate trials, with data expected in the first half of 2026.
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Despite not differentiating itself from placebo, the Texas-based company said it plans to push pilavapadin into Phase III trials before long.
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Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that will apply to all EU member states as well as Norway, Liechtenstein and Iceland.
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Mission Therapeutics is down to its clinical assets MTX652 and MTX325, which work by disabling a key enzyme that interferes with the cell’s normal process of removing faulty or dysfunctional mitochondria.
CELL AND GENE THERAPY
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As FDA seeks to rehire some fired employees, Donald Trump threatens to enact tariffs on pharma companies unless they reshore manufacturing; another lawsuit hits the complex GLP-1 compounding space as Eli Lilly offers expanded Zepbound options; and struggling gene therapy biotech bluebird bio goes private in an attempt to stay solvent.
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At the 2025 National Biotechnology Conference, gene therapies, bispecific antibodies and other novel modalities—relative newcomers to medicine—will be much discussed. In this curtain raiser, BioSpace speaks with conference chair Prathap Nagaraja Shastri of J&J about these highly anticipated topics.
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The treatment, called DB-OTO, is one of several early-stage gene therapies being developed to treat relatively straight-forward causes of genetic deafness.
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The proposed acquisition by global investment firms Carlyle and SK Capital Partners could net shareholders $3 per share plus potential CVR dollars and provide bluebird bio with primary capital to expand the commercial reach of its gene therapies.
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The move comes weeks after Pfizer terminated its partnership with Sangamo Therapeutics for another hemophilia gene therapy.