China’s Haisco Pharmaceutical continues to wield deals, this time out-licensing rights to two late-stage programs to New Jersey biotech Nuvectis.
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.
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.
FEATURED STORIES
Some observers see risks to becoming over-reliant on local facilities, noting the potential need for trade partners if domestic production is disrupted.
While Eli Lilly’s orforglipron is top of mind heading into the European Association for the Study of Diabetes meeting this week, experts told BioSpace the conference will also provide important insights into the therapeutic benefits of incretin therapies beyond weight loss.
After decades without much movement, a handful of new treatments for this rare autoimmune disease are now approved, and several companies, including argenx and Regeneron, have recently released promising late-stage trial results.
On the FDA’s docket for the back half of September is Merck’s proposed subcutaneous formulation of its blockbuster cancer drug Keytruda.
As Novo Nordisk cuts 9,000 people from its organization in a restructuring effort, BioSpace looks back on the Danish pharma company’s rise.
Suddenly one obesity asset has come to define Amgen but executives see a fuller portfolio that will bring the big biotech into the future.
LATEST PODCASTS
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.
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.
In this episode of Denatured, you’ll be hearing from Hannah Franklin, associate at Biovance Capital and Pablo Gabriel Cironi Lopez, director of life science investment at Caixa Capital Risc as they discuss the rise of Southern Europe’s biotech ecosystem.
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SPECIAL EDITIONS
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
Opportunities increased by the end of the first quarter, according to BioSpace data.
BioSpace looks back at 2025 and where the FDA is going in 2026.
DEALS
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Insilico Medicine and SK Biopharmaceuticals will use generative AI to develop novel therapies for unspecified neuroimmune disorders. -
Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was renewed earlier this year. -
Backed by institutional investors and seasoned industry leaders, cAMPfield Therapeutics is advancing a clinical program aimed at reshaping the landscape for inflammatory bowel disease. -
The takeovers depend on Moderna reaching an agreement with the German government, which risks losing investment from drugmakers over planned healthcare reforms. -
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.
WEIGHT LOSS
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Rhythm Pharmaceuticals’ Imcivree reduced fat—while boosting muscle—in patients with Prader-Willi syndrome. -
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. -
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. -
Eli Lilly and obesity rival Novo Nordisk stole the show at the American Diabetes Association conference, though plenty of other companies also had data to show for their own weight loss assets; GSK strikes the biggest traditional pharma buyout of 2026; and FDA initiatives still lack clarity. -
AstraZeneca is pushing its small molecule GLP-1 drug to Phase 3 development for weight control, diabetes and other cardiometabolic conditions despite the asset failing to best one from Structure Therapeutics.
POLICY
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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. -
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. -
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. -
The FDA must provide consistent and predictable regulatory frameworks if the U.S. is to maintain its leadership in gene therapy, one of the most consequential therapeutic fields of our generation. -
A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns surface about the politicization of the agency.
Three experts discuss whether biotech and pharma professionals should try to convince employers to adjust employment offers, mistakes people make during the process and tips for getting it right.
The people most trusted to deliver are not always the ones invited to shape direction. Executive coach Angela Justice examines why the habits that build a career can eventually limit advancement.
Scientists who focus only on generating data risk missing their role in shaping strategy and driving innovation.
Panel interviews can play a major role in getting jobs. Two career coaches discuss what to do before and during the interview, including identifying how to differentiate yourself, engaging in true conversations and not overlooking a key panel member.
Over one-third of BioSpace LinkedIn poll respondents have done free work while interviewing for jobs. A recruiting expert and career coach discuss why employers make work requests and how biopharma professionals should evaluate and respond to them.
Finding the right people for critical open roles can be difficult even for biopharma leaders. In this column, Kaye/Bassman’s Michael Pietrack discusses four pitfalls executives face during the hiring process, starting with confusing scientific brilliance with leadership ability.
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 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. -
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. -
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. -
While Merck and Gilead Sciences reported back-to-back late-stage victories for their weekly HIV pill, the partners also discontinued a Phase 3 program for their cancer combo after disappointing lung cancer survival data. -
Nuvalent Bio is GSK’s third big-ticket purchase this year, after the pharma dropped $2.2 billion in January for RAPT Therapeutics and $950 million in February for 35Pharma.
NEUROSCIENCE
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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. -
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. -
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. -
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. -
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.
CELL AND GENE THERAPY
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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. -
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. -
Instead of using viral vectors, SonoThera’s genetic medicines are delivered through an ultrasound-mediated technology that could help sidestep key safety issues with conventional delivery methods. -
All six non-Hodgkin lymphoma patients on Legend Biotech’s CAR T therapy responded to treatment—findings that could make the biotech an attractive takeover target, according to analysts at Oppenheimer. -
For Peter Pitts, a former associate commissioner at the FDA, the appointment to the board of BrainStorm Cell Therapeutics is an opportunity to fulfill a promise he made long ago to a patient with ALS.
