FDA Commissioner Marty Makary and CBER Director Vinay Prasad published an article in JAMA on Tuesday outlining the FDA’s priorities, including accelerating cures and the rapid deployment of artificial intelligence.
Instead of homing in on PSMA—currently the most validated target in prostate cancer—BMS and Philochem will instead collaborate on an early-stage molecule that binds to a novel marker called ACP3.
The company’s intein-based technology is initially aimed at Stargardt disease, a type of macular degeneration.
The American Medical Association is also urging an “immediate reversal” of the HHS Secretary’s decision to oust all 17 members of the CDC’s vaccine advisory board.
The layoffs will heavily affect Vertex’s operations in Rhode Island, where the biotech will consolidate three facilities into one.
Guggenheim Partners called Insmed’s Phase IIb readout “impressive across the board,” with an efficacy profile that positions TPIP to be best-in-class in pulmonary arterial hypertension.
FEATURED STORIES
As we near the end of second quarter of 2024, the initial public offerings among biotechs have slowed, but the market is still going strong.
CEO Pascal Soriot on Tuesday heralded a “new era of growth” for AstraZeneca with plans to launch 20 new medicines in six years. He’s delivered before but can he do it again?
Patent cliffs and other factors may lead other large drugmakers to embrace similar cost-cutting measures, experts tell BioSpace.
Approaches and targets for depression and other mental health illnesses have remained stagnant for decades. With several readouts for novel therapies on the horizon, that could be changing.
Despite weathering a difficult year, biopharma continues to see massive pay gaps between CEOs and their median employees, with top executives often earning hundreds of times more.
Until compelling surface targets for lung cancer are developed, antibody-drug conjugates will fail to treat most patients with lung cancer, experts told BioSpace.
LATEST PODCASTS
In this episode of Denatured, BioSpace’s head of insights Lori Ellis and Colin Zick, partner at Foley Hoag LLP, spend time discussing some of the points brought up in the Bioprocessing Summit last month. They explore the connections between hammers, AI, The Planet of the Apes and monoliths.
The White House is clamping down on pharma’s ability to buy new molecules from Chinese biotechs; Sanofi, Merck and others abandon the U.K. after the introduction of a sizeable levy; Novo CEO Maziar Mike Doustdar lays off 9,000 while the company presents new data at EASD; Capsida loses a patient in a gene therapy trial; and CDER Director George Tidmarsh walks back comments on FDA adcomms.
This week’s release of the Make America Health Again report revealed continued emphasis on vaccine safety; Health Secretary Robert F. Kennedy Jr.’s faceoff with senators last week amounted to political theater; the FDA promises complete response letters in real time and shares details on a new rare disease framework; and Summit disappoints at the World Conference on Lung Cancer in Barcelona.
Job Trends
Daiichi Sankyo and AstraZeneca’s Biologics License Application for datopotamab deruxtecan has been accepted in the U.S. for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer who have received prior systemic therapy.
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SPECIAL EDITIONS
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.
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
DEALS
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Eli Lilly stands to gain access to DICE Therapeutics’ DELSCAPE platform, which enables the design of orally available molecules for autoimmune and inflammatory diseases. -
The stock deal aims to strengthen Coherus Biosciences’ position in the field of cancer therapeutics and expand its product portfolio. -
The initial public offering on the Nasdaq is a last-ditch effort by the biotech as there is “substantial doubt” as to the company’s “ability to continue as a going concern” without the IPO, according to its SEC filing. -
The company is paying $3.2 billion upfront in cash for Chinook’s two immunoglobulin A nephropathy candidates, atrasentan and zigakibart, which will complement its own IgAN hopeful iptacopan. -
The Federal Trade Commission’s lawsuit takes an unusual strategy, according to legal experts, raising concerns and uncertainties in the biopharma industry.
WEIGHT LOSS
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The investment arm of the Novo Nordisk Foundation is acquiring contract development and manufacturing organization Catalent to help meet high demand for Ozempic and Wegovy. -
The biotech is taking a synergistic approach to obesity with two muscle-preserving antibodies set to enter a Phase II study in mid-2024 in combination with existing incretin-based treatments. -
Driven by soaring demand for its diabetes and weight loss drugs, Novo Nordisk on Wednesday reported better-than-expected full-year 2023 earnings with a 31% sales increase. -
Stringent regulation, manufacturing costs and absence of price control contribute to high GLP-1 agonist costs in the U.S. Patients could go to other countries for cheaper treatment. -
The persistent shortage of genuine glucagon-like peptide 1 receptor agonist products has led to an increase in fake versions, the World Health Organization warned on Monday.
POLICY
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The Federal Trade Commission on Tuesday issued an interim report on the top pharmacy benefit managers, showing that they are generating massive profit at the expense of patients by inflating prescription drug costs.
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House Speaker Mike Johnson (R-La.) on Monday said he intends to have a “significant package of China-related legislation” signed into law by the end of this year, including the BIOSECURE Act which intends to stop federal contracts with Chinese “companies of concern.”
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The Biden administration is appealing a 2023 jury decision that declared invalid its patent protections over Gilead Sciences’ HIV prevention regimen of Truvada and Descovy. -
The groundwork being done in 2024 is building the foundation for global collaboration in the future. -
A federal judge ruled last week that the U.S. government can use its economic standing as a bulk purchaser to negotiate for better deals, handing Boehringer Ingelheim a loss in its legal challenge to the Inflation Reduction Act.
Do you wake up every morning dreading going to work? If this happens to you even once a week, it may be time to start looking for a new gig.
Here are three reasons why you need to boast a little, and ways to do just that.
The following tips from a seasoned recruiter can reduce serious ATS-related errors and help increase the value of the time investment.
For new graduates with limited experience, as well as career-changers whose experience is outside the area they now wish to pursue, fighting the underqualified label is tough
To find out more about career transitions within the life sciences, we interviewed Modu Feyisitan, MPH. Modu provided insight regarding her move from a role as an Epidemiologist within county government into private healthcare. She shares what motivated her to make a job change.
Not only can we humanize with storytelling; we can use stories to connect.
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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Following the regulatory victory of Balversa in urothelial carcinoma, Johnson & Johnson on Friday continued its bladder cancer winning streak with an 82.8% complete response rate forTAR-200 in high-risk non-muscle invasive bladder cancer. -
Following an upsized IPO earlier this year, CG Oncology on Friday posted promising Phase III data for cretostimogene, which elicited a 75% complete response rate in high-risk non-muscle invasive bladder cancer patients. -
AstraZeneca’s blockbuster BTK inhibitor Calquence significantly improved progression-free survival when used as a frontline treatment in patients with mantle cell lymphoma, according to Thursday’s late-stage results. -
The race is on to develop therapeutic cancer vaccines that could give immunotherapies an edge, and late-stage trials could soon provide more-robust data about candidates’ efficacy and safety. -
The new company, BridgeBio Oncology Therapeutics, is looking to advance two KRAS inhibitors and a blocker of the interaction between the RAS and PI3K pathways.
NEUROSCIENCE
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With a potential combined market value of $30 billion, BioSpace takes a deep dive into the Phase III data supporting Eisai and Biogen’s Leqembi and Eli Lilly’s investigational donanemab. -
With a recent study yielding positive results, experts say GLP-1 drugs are making headway in treating Alzheimer’s and other neurodegenerative diseases. -
With new Alzheimer’s drugs receiving—and expected to receive—FDA approval, the market for diagnostic biomarker tests is set to expand. -
The companies partnered to develop the antibody transport vehicle in late 2021, but will continue their 2018 agreement to pursue other drugs in preclinical development. -
Amid a re-energized Alzheimer’s disease space, Quest Diagnostics offers what the company contends is the first direct-to-consumer blood-based biomarker test to assess disease risk.
CELL AND GENE THERAPY
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Bluebird bio has re-emerged after a private equity buyout as Genetix Biotherapeutics, marking a return to its roots and a new path forward for manufacturing. -
The White House is clamping down on pharma’s ability to buy new molecules from Chinese biotechs; Sanofi, Merck and others abandon the U.K. after the introduction of a sizeable levy; Novo CEO Maziar Mike Doustdar lays off 9,000 while the company presents new data at EASD; Capsida loses a patient in a gene therapy trial; and CDER Director George Tidmarsh walks back comments on FDA adcomms. -
A new analyst survey suggests that doctors are still prescribing Sarepta’s Elevidys, even after a series of deaths in certain populations marred the gene therapy’s record. -
The patient-specific nature of autologous cell therapies presents unique challenges that can best be addressed by a middle path between on-site and centralized manufacturing. -
Capsida has yet to disclose the exact cause of death. The patient had received the gene therapy CAP-002 for a type of epilepsy.
