Follow along as BioSpace tracks job cuts and restructuring initiatives.
Biogen and Denali’s Parkinson’s disease drug failed to significantly slow disease progression in a Phase 2b study, missing both primary and secondary endpoints.
After getting slapped with a surprise refuse-to-file letter signed by former CBER Director Vinay Prasad, Moderna’s flu vaccine application will now go before the FDA’s Vaccine advisory committee.
Biotech has been pulling off some remarkable science of late, while M&A and IPOs return to bolster the sector. But that doesn’t mean the industry is back from the brink. BioSpace gathered three early-stage biotech CEOs and members of the NextGen Class of 2026 to talk about surviving and thriving in this rollercoaster market, all while bringing forward the next generation of medicines.
Update: Reversal after 20 deaths allows new Japan patients to take Amgen’s rare disease drug Tavneos
Kissei Pharmaceutical is reversing a recommendation related to Amgen-shared Tavneos that it made just a few days ago, now saying the rare disease drug can be given to new patients.
By partnering with a UN-backed body, Roche has enabled companies to make the medicine for supply in 129 countries.
FEATURED STORIES
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.
BioSpace Senior Editor Annalee Armstrong headed to the J.P. Morgan Healthcare Conference with a months-long story idea brewing. Unfortunately, it was one she’s written before.
Of the 102 company launches or series A financings since October 2023, just nine had a woman at the helm, according to a BioSpace analysis. This is happening in an era of biotech where new company founders are searching for CEOs with a track record.
At the J.P. Morgan Healthcare Conference, the Biotech CEO Sisterhood assembled in Union Square to showcase the large group of women and allies in biopharma as their authentic selves.
Faced with the encroaching threats of patent expirations and generics, biopharma companies in 2024 invested 33% more in licensing deals, on average, than in 2023 with an eye toward enriching their pipelines with novel and potentially more effective therapies.
AbbVie launched a revamped version of its Allē loyalty program, which ultimately was not adopted by providers. The marketing misstep comes as the company’s aesthetics franchise faces broader pressures.
LATEST PODCASTS
In this episode of Denatured, as part of our series on the European life sciences investment ecosystem, you’ll be hearing from Regina Hodits, managing director at Angelini Ventures and Sofia Ioannidou, VC partner at Andera Life Sciences. They explore Germany’s biotech and life sciences ecosystem, including the science, infrastructure and policy changes needed to help European companies scale globally while staying rooted in Europe.
Fallout from the resignation of FDA Commissioner Marty Makary continues as several other senior regulators are removed from their posts; pharma’s top paid CEOs make up to 358 times more than their employees; Revolution Medicine’s pancreatic cancer results highlight movement in the deadly disease space; more.
In this episode of Denatured, you’ll be hearing from Miguel Forte, president of the International Society for Cell and Gene Therapy (ISCT), and Jon Ellis, co-founder & CEO of Trenchant Bios, speaking live from the ISCT annual meeting. We dive into mesenchymal stem cells and induced pluripotent stem cells, exploring the science behind them, the manufacturing challenges, and the potential for scalable, engineered next-generation therapies.
Subscribe to GenePool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
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
-
A trifecta of newly inked tech partnerships—from Eli Lilly, Bristol Myers Squibb and Incyte—exemplify the increasingly central role that AI is playing in drug development. -
Eli Lilly joins hands with Engage Bio, acquiring the DNA delivery platform developer in hopes of bolstering its genetic medicines portfolio. -
Right after reporting a major Phase 3 LAG-3 miss that has rattled analysts, Regeneron Pharmaceuticals revealed a back-loaded partnership with Parabilis Medicines aimed at adding a new drug class to its early-stage pipeline. -
Degron Therapeutics will have stiff competition in immunology, as Novartis inked a $5.7 billion agreement with Monte Rosa Therapeutics last year to develop molecular glues for undisclosed immune-mediated conditions. -
MacroGenics is selling the manufacturing plant to Bora, a Taiwan-based CDMO, to raise cash to support the progress of its drug development pipeline.
WEIGHT LOSS
-
Lilly met analysts’ sky-high expectations with 28.3% weight loss over 80 weeks for the triple hormone receptor agonist retatrutide in a highly anticipated readout on Thursday. -
Aardvark Therapeutics had previously voluntarily suspended studies of ARD-101—and a related asset called ARD-201—after detecting anomalous echocardiographic readings in healthy volunteers that could indicate reduced heart efficiency. -
Despite seeing some regain, patients in two trials maintained most of their weight loss after switching to either Foundayo or lower-dose Zepbound from other injectable incretin therapies. -
With Siran Biotechnology under its fold, GSK will have access to a long-acting siRNA therapy that could induce weight loss while preserving lean mass, in addition to addressing other weight-related comorbidities. -
Analysts and investors alike had been eagerly awaiting sales figures for Novo Nordisk’s Wegovy pill. The answer blew past expectations by 86%.
POLICY
-
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question. -
Of the 17 companies that were implored by the White House last July to apply Most Favored Nation pricing to their drugs, Regeneron is the last to agree—the same day the FDA greenlit its gene therapy for hearing loss in kids. -
The FDA in July 2025 made publicly available over 200 complete response letters—an initiative that the investment community sees as “unanimously positive,” analysts told BioSpace. -
Two of the biggest insurance providers have expressed reluctance to participate in the government’s BALANCE program that would have made GLP-1 drugs more affordable to patients. -
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.
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.
Looking for a biopharma job? Check out the BioSpace list of 12 top companies hiring life sciences professionals like you.
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.
Some bosses stretch you. Others make work more bearable. Both can earn your loyalty. Only one is building your future. Leadership coach Angela Justice explains how to tell the difference.
As AI reshapes deeply specialized scientific work, R&D professionals must learn to navigate the shift to a skills-centered market. The key is knowing which skills to develop and how to leverage AI as scientific modalities evolve, technologies advance and regulatory complexity increases.
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
-
Merck and Kelun-Biotech’s antibody-drug conjugate significantly improved progression-free and overall survival in a pivotal endometrial cancer study, though the companies have yet to specify when they plan to file for approval. -
A month after reporting that its RAS inhibitor daraxonrasib doubled survival in advanced pancreatic cancer, Truist said Revolution Medicines “is evolving into a major revenue-generating oncology company,” and projects an approval in second-line disease by the end of the third quarter. -
The late-stage miss shakes analyst confidence in Regeneron’s clinical execution, according to BMO Capital Markets, also noting last year’s Phase 3 failure in chronic obstructive pulmonary disease. -
Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. On the biotech’s heels are Immuneering, Actuate Therapeutics, Erasca and more, looking to improve on that result with increased tolerability—and more time for patients. -
CREATE Medicines is working on a clinical-stage pipeline for cancer, while its autoimmune programs are still in preclinical testing.
NEUROSCIENCE
-
The recent approval of Regeneron’s Otarmeni underscores the maturation of gene therapies across a range of diseases. Here, BioSpace reviews genetic medicines in development for the central nervous system, retinal, cardiac and neuromuscular diseases. -
If Biogen has shown that tau can impact cognition, Denali’s technology—validated with an FDA approval in Hunter syndrome—could ensure the medicine gets where it needs to be for the greatest therapeutic impact, analysts said. -
While Biogen’s tau-targeting therapy didn’t demonstrate improvement on a dementia severity scale, the company touted biomarker and cognitive improvements from the Phase 2 study, leaving analysts eager for more data. -
The FDA’s extension will give reviewers more time to review a major amendment to Biogen and Eisai’s application for a subcutaneous induction formulation of Alzheimer’s therapy Leqembi. The new target action date is on Aug. 24. -
Catalyst Pharmaceuticals comes with a trio of approved drugs as Angelini Pharma expands its neuroscience offerings.
CELL AND GENE THERAPY
-
Shares of REGENXBIO declined 37% on a mixed data readout and other updates from the company’s first quarter earnings call Thursday. -
In this episode of Denatured, you’ll be hearing from Miguel Forte, president of the International Society for Cell and Gene Therapy (ISCT), and Jon Ellis, co-founder & CEO of Trenchant Bios, speaking live from the ISCT annual meeting. We dive into mesenchymal stem cells and induced pluripotent stem cells, exploring the science behind them, the manufacturing challenges, and the potential for scalable, engineered next-generation therapies. -
The FDA turned away Ebvallo in January, taking issue with the design of the registrational trial. In a recent meeting, however, the agency agreed that the study could in fact support the cell therapy’s approval. The news comes a week after the departure of controversial biologics Director Vinay Prasad. -
Sarepta Therapeutics has put in place several initiatives to help its gene therapy Elevidys return to growth, but recovery will take a long time, according to company executives. -
Comprehending the spate of recent rejections in the cell and gene therapy space may require looking no further than early-stage clinical trials of candidates from REGENXBIO, Excision BioTherapeutics and Intellia Therapeutics.
