The star of Ipsen’s acquisition is an MDM2 blocker being proposed as an add-on therapy to ruxolitinib for myelofibrosis. The drug could be available to patients “as early as 2028,” according to Ipsen CEO David Loew.
Viridian Therapeutics’ Lumvoa is the first FDA-approved treatment for thyroid eye disease that includes data for both active and chronic forms of the illness.
BridgeBio Pharma plans to file for approval in the third quarter. If granted, the oral drug could present a “highly differentiated” option over current achondroplasia therapies, according to Jefferies.
Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
Dealmaking across biopharma is shifting dramatically as the SEC rolls out new regulations to ease burdens on newly public companies and antitrust review is replaced by drug pricing as the policy concern du jour.
Jefferies expects Moderna to have around seven commercial products in the coming years which, along with a projected 10% revenue growth, could help the company break even in 2028.
Dual and even triple or quadruple track processes have come roaring back in 2026 thanks to a glut of M&A that has refilled investors’ wallets. Big Pharma is being put on notice that time is critical if they want to acquire.
Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agency’s new investigational new drug pilot program as a sign of normalcy.
In this episode of Denatured, as part of our series on the European life sciences investment ecosystem, you’ll hear from Hakan Goker, managing director at M Ventures and Maina Bhaman, partner at Sofinnova Partners. We explore the UK biotech ecosystem: from the Golden Triangle’s evolving role to the challenges of scaling companies, unlocking pension capital and staying globally competitive.
Encouraging data for combination regimens of Revolution Medicines’ zoldonrasib “reinforce the path to leadership in PDAC” for the biotech, according to Truist Securities.
The approval of Ionis Pharmaceuticals’ Tryngolza for severe hypertriglyceridemia could spur “substantial growth” for the product, according to William Blair.
Gilead’s Trodelvy can now be used as a monotherapy and in combination with Merck's Keytruda to treat certain patients with triple-negative breast cancer.
The FDA’s recently altered outlook on the evidence required for approval of rare disease drugs could have immediate benefits for companies including Skyhawk Therapeutics, Capricor Therapeutics and Biohaven.
Recent BioSpace industry conference conversations point to sponsors pushing earlier on safety, quality and performance data, leading to demand for nitrosamine analysis, IVRT/IVPT and microbiome database capabilities.
Jubilant HollisterStier received a warning letter over problems that the FDA said necessitate an immediate and comprehensive assessment of the contract manufacturing organization’s global operations.
A few short days after announcing an FDA pivot on a separate asset, REGENXBIO is planning to test the agency’s apparent newfound rare disease outlook on another late-stage gene therapy.
A new report from RBC Capital Markets lists Biotechnology Innovation Organization chief executive John Crowley and military physician Heidi Overton as potential candidates for the role of FDA commissioner—in addition to the agency’s current acting leader, top food regulator Kyle Diamantas.
The FDA has so far secured 600 new hires and is looking for 1,600 more as interim leadership at the agency aims to rebuild the workforce and morale after more than a year of intense attrition.
Lilly has already spent more than $25 billion in potential business development commitments this year, including the $6.3 billion buyout of Centessa Pharmaceuticals that closed today.
AbbVie scooped up immunology player Apogee Therapeutics for nearly $11 billion in one of the year’s top deals to-date, while Sanofi made a big play to survive its upcoming Dupixent patent cliff; FDA uncertainty continues as the agency changes direction on gene therapies by uniQure and REGENXBIO; and Jef Akst and Annalee Armstrong report back from San Diego.
The combined business entity with Boundless Bio, which will carry Serapha Bio’s name and fold in Boundless Bio, will focus on the development of a gene editor for alpha-1 antitrypsin deficiency.
For the 2026 fiscal year, Takeda anticipates declines in revenue and profit, highlighting what CEO-elect Julie Kim says is the need for the company to “invest in future growth.”
Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
With positive feedback on a Phase 3 trial design, Ollin Biosciences has collected a $330 million series B to advance its VEGF/Ang2 antibody, which bested Genentech’s therapy in a head-to-head study.
Controlling CEOs, manipulative middle managers and high-performing jerks can damage employees’ trust in employers and motivate them to hit the job market. Kaye/Bassman’s Michael Pietrack discusses the problematic behaviors executives must watch for in the workplace.
Even biopharma’s biggest players have been forced to take a hard look at their businesses and realign their cost structures to cope with the continued and compounding challenges plaguing the industry.
While merger and acquisition activity has been robust of late, frequent changes in guidance and leadership at the regulator add risk to any transaction.
As Sangamo runs out of cash, Eli Lilly and Astellas have emerged as stalking horse bidders for key assets, including a Fabry gene therapy currently being submitted for potential FDA approval.
Given its intravenous route of administration, Merck’s tulisokibart will likely “need to be meaningfully improved” over Roche’s afimkibart, which can be given subcutaneously, BMO Capital Markets analysts said. Both assets are being tested for ulcerative colitis.
Eli Lilly’s weight-loss franchise—including the tirzepatide products Mounjaro and Zepbound, and the weight-loss pill Foundayo—is projected to account for nearly half of the total sales of the top 10 drugs in 2032.
While existing antibody-drug conjugates have been incredible advancements in cancer care, patients are ready for a better experience. At the BIO International Convention in San Diego on Thursday, BioSpace will lead a discussion on the next generation of ADCs.
Despite an overall survival miss, Leerink Partners said Pfizer’s antibody-drug conjugate showed “promising” signals of efficacy in a subgroup of patients who had undergone only one prior line of treatment.
With drug pricing now embedded in U.S. policy, business development teams in biotech and pharma are changing the way they strike deals, including acknowledging policy uncertainties with renegotiation clauses.
Former FDA, CDC and NIH leaders convene at the BIO International Convention to discuss the dismantling of the Department of Health and Human Services under the Trump administration—and where we go from here.
Having stuck with local production in the years when offshoring to lower-cost locations was in fashion, Aquestive’s CEO is well placed to explain what the recent reshoring drive means for manufacturers.
Anticipated to be one of fastest-growing jobs in manufacturing, pharmaceutical jobs offer a salary 32% higher than the average U.S. manufacturing role.
Among the health department’s efforts is an expedited investigational new drug pilot program that would leverage collaborations with U.S. research institutions to reduce early trial timelines by as much as 12 months.
The resubmission for RGX-121, expected in the third quarter, comes as the FDA has deemed REGENXBIO’s existing data “sufficient” to support an accelerated filing. It immediately follows a similar reversal of position regarding uniQure’s embattled Huntington’s disease gene therapy.
Results for Definium Therapeutics psychedelic candidate for major depressive disorder “exceeded expectations,” according to Stifel, while Jefferies called the efficacy data “profound.”
Formed by Sofinnova Partners and former Sanofi executive Frédéric Marrache, Bionyra Pharma emerged from stealth Monday with an initial focus in inflammatory bowel disease and atopic dermatitis.
About two months into CEO Belén Garijo’s new tenure, Sanofi’s R&D chief has departed, with Xaira’s chief medical officer set to take charge of the pharma’s pipeline.
As uniQure prepares its closely watched Huntington’s disease gene therapy for FDA review, the biotech is also making waves in chronic epilepsy with another gene therapy that Stifel says is off to a "promising start."
Eli Lilly plans to use BioArctic’s technology to shuttle an undisclosed drug candidate into the brain. The pharma hasn’t specified which neurodegenerative disease it will target.
AbbVie will add Apogee’s IL-23 blocker to its current immunology stalwarts Skyrizi and Rinvoq, which have helped the pharma ride out the steep patent cliff left behind from mega-blockbuster drug Humira.
Nura Bio will use the series B financing to carry two neuroprotective drug candidates through early- to mid-stage clinical studies, one targeting ALS and the other for a broader neurological profile.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
The U.S. government has argued that it pays too much of biopharma R&D costs, demanding that other high-income countries contribute fairly to global innovation efforts.
The FDA in February briefly refused to review Moderna’s flu vaccine, citing trial inadequacies, but reversed course a few days later. A verdict is expected by Aug. 5.
Memento’s lead asset is a bispecific antibody that blocks VEGF and activates Tie2. The biotech plans to test the candidate in retinal conditions such as neovascular age-related macular degeneration and diabetic macular edema.
While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Review voucher program is still bereft of important details, with candidate selection and interference from the agency's senior leaders topping the list.
UniQure’s planned third-quarter submission for its Huntington’s disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantas—but how long will it last? And how can companies be sure these positive decisions won’t just be reversed?
Backed by institutional investors and seasoned industry leaders, cAMPfield Therapeutics is advancing a clinical program aimed at reshaping the landscape for inflammatory bowel disease.
In this episode of Denatured, you’ll hear from Mark Lowdell, CSO & co-founder at INmuneBio Inc. and Vishwas Seshadri, CEO & director at Abeona Therapeutics. We explore how recessive dystrophic epidermolysis bullosa has become a defining case study for gene and cell therapy and what this ultra‑rare disease reveals about the future scalability of advanced therapies.
The takeovers depend on Moderna reaching an agreement with the German government, which risks losing investment from drugmakers over planned healthcare reforms.
Following the mid-stage readout, Verastem Oncology has decided to move away from its investigational pancreatic cancer drug combo, instead putting resources behind its KRAS inhibitor pill for solid tumors.
RayThera will bring three preclinical assets into the Biogen fold, all with anti-inflammatory activity. The most mature of these assets is expected to enter Phase 1 development in Q3.
After being rejected in June 2022, GSK paid Spero Therapeutics $66 million for an exclusive worldwide license to develop and commercialize the drug. It’s the second oral antibiotic GSK has brought to market since the beginning of last year.
Looking for a job in Boston? Here’s a list of 7 companies on BioSpace currently hiring biopharma roles in Boston–plus a few more hiring in Waltham and Weston.
Biopharmas that announced Series B financing this year and are looking for employees as they grow include two companies that received $100 million or more. One has partnerships with three Big Pharmas.
Cost cutting is just one factor driving biopharmas to whittle away at their workforces. An analyst discusses more common reasons layoffs occur and which employees are most at risk.
While agents like AbbVie's Humira have transformed the treatment landscape, not all patients benefit equally from the drug. Better biomarker analysis and more investment in mechanistic trials can inform the development of more effective therapies with broader clinical value.
Jazz Pharmaceuticals is diversifying its oncology strategy, orchestrating a new antibody deal with AbCellera that offers $56 million upfront, plus $792 million in biobucks for each of the three initial programs.
After a regulatory odyssey that delayed a filing for what would be the first genetic medicine for Huntington’s disease, the FDA has agreed that three-year data from uniQure’s Phase 1/2 trial are sufficient to support an accelerated biologics license application.
Be Biopharma's terminated trial is the latest setback in the hemophilia space, where companies like Pfizer and BioMarin have opted to pull their respective products from the market after weak traction.
Although Edgewise Therapeutics’ hypertrophic cardiomyopathy asset missed expectations, Truist Securities called the data “excellent,” leaning on a safety profile that could eliminate the need for risk evaluation and mitigation strategies.
Moderna appears to have aligned with the FDA ahead of an advisory committee meeting for its mRNA-based flu vaccine, which the regulator initially turned away in February; biotech IPOs are going gangbusters, including two new records raises in as many weeks; layoffs continue across biopharma; plus much more.
Precision science is ruling the M&A scene as pharmas prepare for loss of exclusivity on key products, PwC says in a new report. Biotechs should be prepared with a dual-track process with the IPO window now open.
Even something as simple as “Tell me about yourself” can trip up biopharma professionals during job interviews. Two recruiting experts discuss what candidates should and shouldn’t say when answering five specific questions.
The Vaccines and Related Biological Products Advisory Committee will meet June 18 to discuss Moderna’s seasonal flu vaccine mRNA-1010 after the FDA initially refused to accept the application in February.
While falling short of statistical significance, Incyte and Mirum Pharmaceuticals’ ALK2 inhibitor showed a “clear benefit” in reducing abnormal bone formation in a Phase 2 study of fibrodysplasia ossificans progressiva.
Alto Neuroscience is advancing a depression drug based on the dopamine agonist pramipexole, which an independent study has found to help boost feelings of pleasure in patients with mood disorders.
With a one-time dosing profile, Intellia Therapeutics’ gene editing asset could be “paradigm-shifting” for hereditary angioedema, according to Jefferies. The biotech anticipates market approval next year.
While biopharma’s overarching mission is to develop innovative medicines to improve patient outcomes, for these six people, the motivation came from much closer to home.
Neumora Therapeutics is laying off 35% of workers after its most advanced asset failed a pair of Phase 3 studies, sending the biotech’s stock spiraling early Monday.
Weeks after Boehringer Ingelheim and Eli Lilly retracted billions of dollar in German commitments, the nation’s government is reportedly changing a contentious element of its planned healthcare reforms.
Elicio Therapeutics’ investigational cancer immunotherapy failed to meet the primary endpoint of disease-free survival in a Phase 2 trial—a result the company attributed mostly to a disproportionate number of patients with higher residual disease.
Sanofi makes no mention of the Commissioner’s National Priority Voucher. Tzield was awarded the ticket in October 2025, but Sanofi requested withdrawal from the program after former CDER head Tracy Beth Høeg reportedly expressed skepticism of the drug.
Eli Lilly’s new JAK2 inhibitor—which it obtained from the recent acquisition of Ajax Therapeutics—reduced spleen volume by more than a third in 70% of patients with myelofibrosis.
Intellia Therapeutics's Senior Vice President Maria Natale discusses why the most successful launches are shaped long before approval, with strategy, structure and patient insight at the core.
DemeRx is launching the first U.S. clinical trial of an ibogaine-derived drug candidate, marking a pivotal moment for a controversial psychedelic long sidelined by safety concerns.
After suffering the market withdrawal of its only product, Amylyx is gearing up for a pivotal Phase 3 readout in post-bariatric hypoglycemia. But the company's driving ethos is still to treat “debilitating, devastating” neurodegenerative diseases, co-CEO Justin Klee told BioSpace.
Ibogaine’s unconventional “matrix pharmacology” may underlie both its therapeutic promise and unpredictable cardiac risks. Unraveling this mechanism could help drug developers hoping to bring ibogaine analogs to market.
After the FDA flagged patient deaths linked to Amgen's rare disease drug Tavneos and called for its voluntary removal, the pharma recruited an independent data analysis from Duke researchers to help build the case for the drug's continued market approval.
The RNA-based medicine is one of a handful of antibody-oligonucleotide conjugates that Novartis acquired last October when it took over neuromuscular-focused Avidity Biosciences.
Novo Nordisk said that the information affected by the breach shouldn’t allow third parties to “identify participants in our clinical trials” despite “unauthorized access” to patients’ personal data.
Strong science, lower costs and growing capital networks are putting Spain and Portugal on the biotech investment map, even as structural bottlenecks persist, according to two investors.
The staffing changes will focus resources on work that creates the highest impact for patients, according to Genentech. The number of employees affected is unknown, but longtime veteran Vishva Dixit is out.
