Viatris, which Pfizer created in 2020, voluntarily withdrew extended-release products made at a plant in Ireland after an analysis revealed an issue that could affect bioavailability.
An investigational cocktail was tied to a 0% overall response rate in patients with gastroesophageal cancer, but developers Agenus and MiNK Therapeutics aren’t giving up on the program just yet.
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.
Analysts are cautiously optimistic about an IPO rebound for biopharma. BioSpace is keeping track of companies that seek to trade on the public markets this year.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
While Merck’s PD-1/VEGF asset appears to match the performance of Summit Therapeutics’ ivonescimab, the pharma’s Phase 1/2 readout in non-small cell lung cancer still leaves analysts with some questions moving into later-stage development.
FEATURED STORIES
After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to exercise regulatory flexibility, while other experts bemoaned the agency’s lack of consistency. With new safety guidelines for gene editing therapies, the FDA has taken a first step toward fixing both problems.
The Merck update, which will shed light on a $588 million bet to succeed Keytruda, is part of a roster of presentations that could shape the future of ADCs, protein degraders and KRAS-targeted therapies.
In nuclear medicine, innovation alone isn’t enough. What matters is whether it can be delivered on time, every time, because timing is critical for our patients. And that delivery promise must hold up under real-world pressure – from routine variability to sudden disruptions that can reroute global logistics overnight.
Gilead, AstraZeneca and Vertex have acquired more than just a therapeutic asset in recent deals. BioSpace takes a look at five recent transactions where the staff was the real centerpiece.
BioSpace looks back at 2025 and where the FDA is going in 2026.
During the pharma earnings season, which begins on Tuesday, Novo Nordisk will report the first revenue numbers from an oral GLP-1 medicine, while other companies are expected to address the FDA, drug pricing and Trump’s new tariffs.
LATEST PODCASTS
Listen to this in-depth discussion on how AI can help identify end-to-end data weaknesses, as well as broader implications regarding the inevitability of human interaction, with guests from GSK, IQVIA, Exelixis and DataHow.
This week on The Weekly we talk struggles with GLP-1 drug shortages and what that might mean for Novo and Lilly competitors; Regeneron and Sanofi positive results for Dupixent in COPD. Plus, Merck buys Caraway, Beigene’s deal with Ensem, ups and downs for Flagship.
CRISPR gene-editing has had its first ever approval in the UK. Will the FDA follow suit? What can patients expect the price tag to be?
Subscribe to GenePool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
SPECIAL EDITIONS
The BioSpace team hit the ground running at the J.P. Morgan Healthcare Conference earlier this month to bring you the news from the streets of San Francisco.
BioSpace data show job postings live increased quarter over quarter, while layoffs fell year over year.
Recent breakthroughs and three decades of progress in treating Huntington’s disease
DEALS
-
The acquisition of Neurona will put UCB in both the epilepsy and cell therapy space, even as many of its fellow pharmas move away from the latter modality. -
J&J will hand over the rights to bota-vec for $25 million upfront, clearing MeiraGTx to seek regulatory approvals in the U.S. and EU in 2027. -
Commitments in obesity- and diabetes-focused deals reached $22 billion in the first quarter of 2026—already eclipsing last year’s total of $20.3 billion, according to a new J.P. Morgan report. -
Johnson and Johnson kicked off first-quarter earnings season with a “modest” beat and an ambitious goal; Replimune failed again to gain approval for its advanced melanoma therapy, as analysts tout increased accountability brought by the FDA’s new policy of publicizing complete response letters; and Revolution Medicines’ pancreatic cancer candidate doubled survival in one of cancer’s most intractable foes. -
Eli Lilly is putting its obesity windfall to work again, striking a new deal to acquire CrossBridge Bio, a small Texas biotech known for its cancer tech.
WEIGHT LOSS
-
While Novo Nordisk’s Wegovy pill reached more than 3,000 patients in its first week on the market, analysts at RBC Capital Markets said a direct comparison of the two figures could be misleading given the shorter data collection time for Foundayo. -
Obesity-focused Kailera Therapeutics debuted on the Nasdaq Friday after raising a record $625 million, beating Moderna’s $600 million from 2018. -
More patients on Eli Lilly’s tirzepatide lost over 5% of their lean mass versus those on Novo Nordisk’s semaglutide, according to a study that has yet to be peer reviewed. -
Right after the FDA flagged safety concerns for Eli Lilly’s newly approved obesity pill, the pharma posted diabetes data demonstrating a clean safety profile and revealed plans to seek approval in the indication. -
The FDA is asking Eli Lilly to submit cardiovascular and liver safety data from an ongoing Phase 3 trial of Foundayo by July.
POLICY
-
A new executive order could usher in psychedelics as the “key next wave” of mental health therapies, according to analysts at RBC Capital Markets. -
The pharma industry “own Congress, they own the media,” Health Secretary Robert F. Kennedy, Jr. told lawmakers by way of explaining the bad press against FDA Commissioner Marty Makary following the second rejection of Replimune’s advanced melanoma drug. -
Erica Schwartz, a former deputy surgeon general and member of the U.S. military, will take over from what has amounted to a rapid succession of CDC leaders over the past year. -
Greater transparency in FDA decision-making was possibly the most common theme for stakeholders interviewed by the Institute for Clinical and Economic Review in a new report focused on strengthening the agency’s accelerated approval program. -
Industry leader Steve Ubl has served as PhRMA’s CEO for more than a decade, the longest tenure of any head of the trade group.
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.
Recruiters can play a significant role in biopharma professionals getting hired, especially in an employer-driven job market. However, when working with them, candidates need to avoid making six key mistakes, from waiting too long to ask for help to prematurely contacting hiring companies.
While you should never rely solely on AI tools when applying for jobs, they can greatly benefit the application process. Recruiting expert Bryan Blair discusses how using large language models can set you apart from the competition and includes a prompt framework to get you started.
In a competitive job market, how applicants present themselves in interviews is critical. Asking about promotions and expressing dislike for the work they’d be doing are just a few reasons hiring managers don’t extend job offers.
With leaner teams and tighter budgets, senior leaders can face tremendous strain as they juggle increased workloads and leadership responsibilities. In this column, Kaye/Bassman’s Michael Pietrack discusses how pressure builds and what can ease it.
Biopharma professionals need to understand today’s job market and how they can stand out to position themselves for success. Three talent acquisition and recruiting experts discussed these topics in a BioSpace webinar, from the importance of contract work to the value of an advocate.
HOTBEDS
IN CASE YOU MISSED IT
In this episode of Denatured, you’ll be hearing from Edoardo Negroni, co-founder & managing partner at AurorA-TT and Naveed Siddiqi, senior partner, Venture Investments at Novo Holdings. We debate whether Europe’s world-class science can be matched by a truly integrated venture ecosystem—and what it would take, in practice, to get there.
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
-
Trastuzumab pamirtecan, being developed under a 2023 partnership between BioNTech and DualityBio, elicited a 44.1% overall response rate in a Phase 2 trial. -
Pivotal findings for the off-the-shelf cell therapy surpassed William Blair’s expectations and sent Allogene Therapeutics’ stock up more than 50% in pre-market trading Monday morning. -
In a difficult disease, Revolution Medicines achieved what the pancreatic cancer community has long desired: a significant improvement in survival. The Phase 3 results will support global regulatory filings. -
Darovasertib, in combination with crizotinib, more than doubled progression-free survival in a registrational trial, leading Truist analysts to declare a “best-in-class efficacy profile” for the PKC inhibitor. -
Telix is Regeneron’s entry ticket into the radiopharma game, helping to better round out the company’s cancer portfolio, according to Truist Securities.
NEUROSCIENCE
-
GSK discontinued Wellcovorin in 1999, but the FDA in September last year asked the pharma to refile an application, pointing to its potential to treat cerebral folate deficiency with “autistic features.” -
Takeda and Denali Therapeutics first partnered in early 2018 to advance drugs for neurodegenerative diseases. One asset, for Alzheimer’s disease, was previously discontinued after an FDA hold and disappointing early data. -
In the buyout, Eli Lilly picks up Centessa Pharmaceuticals’ lead asset cleminorexton, which could go toe-to-toe with Takeda’s oveporexton, currently under FDA review with a decision expected in the third quarter. -
The FDA has some big verdicts lined up in the second quarter, including one for a closely watched obesity drug that many anticipate will further intensify competition in weight loss. -
At the AD/PD annual meeting, Eisai presented real-world data suggesting Leqembi’s long-term safety and efficacy in people homozygous for APOE4, who were identified in trials as being at higher risk of brain bleeds while on the treatment. Alzheon, meanwhile, added further detail to trial results of its candidate in patients with the same genetic profile.
CELL AND GENE THERAPY
-
The draft guidance supports the agency’s new pathway designed to speed up the development of custom gene therapies. -
In this episode of Denatured, you’ll hear from Jason Jones, head of global business development at Cellular Origins and Alexander Seyf, founder & CEO of Autolomous. They discuss how the push to scale cell and gene therapy manufacturing is accelerating interest in automation, digitization, robotics and deeper collaboration across the ecosystem. -
Gilead Sciences has inked three deals this year so far totaling $14.77 billion, a marked escalation of the company’s usual M&A pace. Executives detailed the rationale for buying Arcellx, Ouro Medicine and Tubulis GmbH and whether they are interested in further deals. -
As cell and gene therapy developers face rising pressure to produce therapies faster and at lower cost, the industry is leaning on robotics, digital systems and partnerships to bridge the gap between innovation and delivery. -
While the accelerated approval unlocks only a small market opportunity for Rocket Pharmaceuticals, it will give the biotech a chance to prepare for future product launches, according to Jefferies.
