Novartis and Antares Therapeutics are shooting for the stars, launching a joint mission to develop small molecule oncology therapies.
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.”
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.
FEATURED STORIES
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.
While merger and acquisition activity has been robust of late, frequent changes in guidance and leadership at the regulator add risk to any transaction.
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.
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.
While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Voucher program is still bereft of important details, with candidate selection and interference from the agency’s senior leaders topping the list.
LATEST PODCASTS
This week, in (our inaugural episode!) BioSpace’s Greg Slabodkin, Tyler Patchen and Lori Ellis discuss the good, the bad and the ugly of biopharma’s reported Q3 earnings. They also tackle what’s going on at Pfizer, ADCs, deals and more.
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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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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.
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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. -
China’s Haisco Pharmaceutical continues to wield deals, this time out-licensing rights to two late-stage programs to New Jersey biotech Nuvectis. -
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. -
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.
WEIGHT LOSS
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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. -
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.
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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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. -
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.
NEUROSCIENCE
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Results for Definium Therapeutics psychedelic candidate for major depressive disorder “exceeded expectations,” according to Stifel, while Jefferies called the efficacy data “profound.” -
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.” -
Insilico Medicine and SK Biopharmaceuticals will use generative AI to develop novel therapies for unspecified neuroimmune disorders. -
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.
CELL AND GENE THERAPY
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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. -
Analysts homed in on Duchenne muscular dystrophy and myotonic dystrophy type 1 assets during first quarter earnings as major players like REGENXBIO and Novartis as well as Dyne, Wave, Solid and Sarepta near the regulatory finish line.
