A year to the day after the Trump administration slashed $500 million in funding from mRNA-based programs, the FDA approved Moderna’s flu vaccine based on the technology. Weeks later, Moderna and Merck revealed positive Phase 3 results for their personalized mRNA-based cancer vaccine. In the words of one mRNA specialist, “science won.”
After years of price pressures, the trade group argues “the economics of generics have deteriorated to the point where sustainability of the industry is in peril.”
BioNTech, Summit Therapeutics, GSK and Roche have made a splash at the ongoing World Conference on Lung Cancer taking place in South Korea. These companies and their partners have all shared new findings for their closely watched programs, highlighting overall survival benefits in various types of lung cancer.
SERENA-4 was assessing AstraZeneca’s Etcamah as a first-line option for certain patients with advanced breast cancer—a setting that could have meant a $2.9 billion opportunity for the drug.
Scholar Rock’s spinal muscular atrophy drug, now to be called Isembyld, was originally rejected in September 2025, when the FDA cited compliance problems at a third-party manufacturer.
Heading into an FDA hearing on Monday regarding the future of psychedelic treatments, public comments show wide support for further exploring the therapeutic potential of these compounds—to match rising support within the agency.
Join BioSpace’s Managing Editor, Director of Insights and Vice President of Marketing for an inside look at how PR, communications and marketing teams can successfully leverage webinars, podcasts and integrated content campaigns to elevate executive voices, share industry expertise and engage key biotech and pharma audiences.
FEATURED STORIES
Following their blowout win in melanoma last month, Merck and Moderna are leading the way among a new crop of personalized cancer vaccines. Here are five companies with similar therapies hoping to break through where others have previously failed.
With oral cyclic peptides offering small molecule convenience and antibody‑like selectivity, the modality is gaining momentum. But bioavailability below 1%, minimal PK data and fragile synthesis still slow progress. Viva Biotech’s experts outlined how hybrid synthesis, ADME/PK modeling and AI‑guided design are expanding what peptide therapeutics can reach.
Applications in flow cytometry, cell sorting, target validation, and therapeutic discovery
Novartis’ shares fell 13% this week after the report of three separate late-stage asset setbacks. The impact went beyond the Swiss drugmaker, dragging peers down across the market.
Newly solidified in their roles as the heads of CBER and CDER, Karim Mikhail and Michael Davis have been working for months to right the ship that had begun to capsize under former Commissioner Marty Makary. Meanwhile, Jared Seehafer will become the first-ever deputy commissioner focused on artificial intelligence.
Back-to-back failures of multiple late-phase trials have raised questions about how Novartis has deployed capital in pursuit of drugs to drive growth through the 2030s.
FROM BIOSPACE INSIGHTS
This guide explores the evolving role of podcasts, webinars, and thought leadership programs in biopharma and provides practical recommendations for public relations agencies, corporate communications teams, and commercial marketers looking to elevate their visibility and influence.
LATEST PODCASTS
In this episode of Denatured, sponsored by SK pharmteco, Jennifer Smith-Parker speaks to Arvind Singh, vice president and global head of supply chain. In this episode, we explore how CDMOs are reshaping supply‑chain strategy for a new generation of complex modalities.
September has been a rough month already for Novo Nordisk, which canned two more late-stage trials of its embattled IL-6 inhibitor, and Novartis, which took Phase 3 hits in both cardiovascular and muscular dystrophy indications; Ultragenyx’s big bet in Angelman syndrome failed to yield benefit in Phase 3 but Ionis’ Pharmaceuticals nabbed the first targeted approval for Alexander disease; and on the business side, biopharma investment is back in a big way.
In this episode of Denatured, you’ll hear from Christina Takke, managing partner at V-Bio Ventures and Mariette van der Velden-Roesink, founding partner at Curie Capital. We explore why the Benelux region remains scientifically strong, but investment fragmented, and what it will take to turn it into a more unified biotech investment corridor.
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SPECIAL EDITIONS
Job postings increase and competition dips, according to BioSpace data.
Who is the highest paid CEO in all of pharma? In this special edition, BioSpace examines top paid CEOs and their pay packages.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
DEALS
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The agreement, which runs through 2033, comes as Samsung Biologics continues to expand its large manufacturing footprint in South Korea. -
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026. -
Biotech crossover rounds could top $4.22 billion across about 28 rounds this year, PitchBook forecasts. -
With M&A rising, venture capital returning and policy risks easing, biotech is on a positive trajectory following a prolonged post-pandemic slump, Truist Securities declared after a survey of sector leaders. -
The co-development deal comes after Pfizer reported a late-stage failure for a Seagen asset and the discontinuation of another investigational therapy developed by the company as a subsidiary of the pharma.
WEIGHT LOSS
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Structure Therapeutics’ oral GLP-1 candidate aleniglipron showed 72-week efficacy “in line” with Novo Nordisk’s oral Wegovy, BMO Capital Markets wrote in a note to investors. Meanwhile, Structure’s amylin and calcitonin receptor agonist ACCG-2671 showed “impressive” target engagement in a Phase 1 trial of healthy volunteers, according to Leerink Partners. -
Moonwalk Biosciences plans to shepherd its lead obesity asset into first-in-human trials in late 2027. In preclinical studies, MW101 has demonstrated weight loss and fat reduction while maintaining muscle mass. -
Current leaders Eli Lilly and Novo Nordisk have cornered the early market for weight loss therapeutics, but several other players, large and small, are bidding for a piece of the potential $200 billion pie. -
Eli Lilly’s best play for Foundayo is to bring it overseas, a more price-sensitive market where the pharma can more readily outcompete Novo Nordisk “given the high margins of a small-molecule therapy,” Truist analyst Srikripa Devarakonda told BioSpace. -
Roche, through its subsidiary Genentech, will gain access to the investigational asset HM17321, which is designed to not only elicit weight loss but also improve lean mass.
POLICY
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Inspection access is not “an administrative footnote,” leaders of key FDA divisions wrote in an editorial on Wednesday vowing to expand oversight of foreign clinical trial sites. -
CSL Vifor holds the marketing authorization for Tavneos in the U.K., where the drug is marketed as Avacopan Vifor. It continues to be sold on the U.S. market by Amgen despite concerns raised by the FDA. -
Astellas Pharma, BridgeBio, BeOne Medicines and six other large biotechs join the 17 Big Pharmas that previously signed on to President Donald Trump’s Most Favored Nation (MFN) drug pricing program, representing some 89% of the branded drug market. -
The U.S. is scrambling to compete with a strategically positioned China on the biotech stage as the Asian country surpasses America in biomedical research and clinical trials. So far, China is winning. -
The current classifications of vaccine recommendations could imply that not all shots require the consent of patients or their parents, according to Health Secretary Robert F. Kennedy Jr.
With U.S. data science jobs projected to grow 35% over the next decade, a recruiter and talent strategy director discuss the qualifications, technical skills and mindset needed to land these coveted positions.
Funding announcements can signal future hiring activity, giving biotech professionals a chance to build relationships before positions are posted. Industry experts share how to identify the funding events, milestones and company indicators most likely to lead to new jobs.
An executive who is rarely short on ideas needs someone to pull their big ideas through to implementation. Kaye/Bassman’s Michael Pietrack explains why this person, who he calls the implementer, may be the most important hire in the building.
A missed promotion can feel like a verdict on your potential. But people and organizations do not always develop at the same pace. Executive coach Angela Justice breaks down what a missed promotion is actually telling you—and what it isn’t.
Business stage is just one factor in whether biopharmas want job candidates to have oncology experience for oncology roles. Two recruiters explain when oncology expertise matters most, the mistakes job seekers make and how to make a good impression.
Working at a Big Pharma has its benefits, but there are limitations too. SERB Pharmaceuticals’ Thomas Kolaras discusses how moving to a midsize company creates new opportunities for sharpened thinking and leadership.
HOTBEDS
REPORTS
Gain the latest insights into the biopharma hiring landscape with BioSpace’s Biopharma Job Market Report Q2 2026. Explore the trends shaping talent acquisition, from rising job postings and sustained R&D hiring to the market activity signaling stronger hiring demand ahead.
Opportunities increased by the end of the first quarter, according to BioSpace data.
In this whitepaper, BioSpace reviews the major trends impacting the CDMO sector and the evolving relationship between sponsors and providers. We examine the key qualities pharma and biotech should consider in CDMO selection, and how the macroeconomic and macrodevelopment factors affecting the space play a role in this selection.
CANCER
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Despite falling short of analyst expectations, Tyra Biosciences is taking its cancer drug to registrational development for non-muscle invasive bladder cancer. -
September has been a rough month already for Novo Nordisk, which canned two more late-stage trials of its embattled IL-6 inhibitor, and Novartis, which took Phase 3 hits in both cardiovascular and muscular dystrophy indications; Ultragenyx’s big bet in Angelman syndrome failed to yield benefit in Phase 3 but Ionis’ Pharmaceuticals nabbed the first targeted approval for Alexander disease; and on the business side, biopharma investment is back in a big way. -
Bristol Myers Squibb is positioning arlo-cel for quadruple-class exposed patients, which could help reduce competition with an upcoming multiple myeloma CAR T therapy from Gilead Sciences, according to BMO Capital Markets. -
Inhibrx CEO Mark Lappe was particularly keen on INBRX-106’s performance in patients with HPV-positive disease and sees a nearly $4 billion near-term opportunity thanks to the Phase 2 results. -
The approval opens up a “modest” market for AstraZeneca’s Etcamah, according to Leerink analysts, who nevertheless looked forward to an upcoming late-stage readout that could lead to a “significantly larger opportunity” for the drug.
NEUROSCIENCE
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While Novartis’ antibody-oligonucleotide conjugate failed to significantly improve hand function in patients with myotonic dystrophy type 1, the asset nevertheless showed signs of clinical activity in secondary and exploratory measures. -
While some drugmakers continue to walk the alpha-synuclein antibody path, others like AC Immune opt for new approaches that could bring the first-ever disease-modifying therapy for Parkinson’s disease. -
Zanvastro, an antisense oligonucleotide therapy, represents the first independent neurology launch for Ionis Pharmaceuticals, which intends to leverage the foothold for more approvals in rare neurodegenerative diseases, including Angelman syndrome. -
The biologics license application follows months of public speculation—and regulatory reversals—for uniQure’s AMT-130. If accepted by the FDA for priority review, approval could come in the second quarter of 2027. -
Novartis is planning to file for remibrutinib’s expanded approval in relapsing multiple sclerosis by next year, putting it just behind Roche’s own BTK inhibitor fenebrutinib.
CELL AND GENE THERAPY
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Encoded Therapeutics’ lead asset ETX101 is a gene therapy being tested for Dravet syndrome. Phase 1/2 data showed substantial reductions in seizures. -
In this episode of Denatured, sponsored by SK pharmteco, Jennifer Smith-Parker speaks to Arvind Singh, vice president and global head of supply chain. In this episode, we explore how CDMOs are reshaping supply‑chain strategy for a new generation of complex modalities. -
Novartis hits pause on several CAR T trials after three patient deaths, followed by Bristol Myers Squibb after separate safety signals; Revolution Medicines scores early FDA approval for groundbreaking pancreatic cancer drug; BioNTech suspends a mid-stage trial of its mRNA cancer immunotherapy after a futility analysis; and nine mid-sized biopharma companies join their big pharma peers in President Donald Trump’s Most Favored Nation drug pricing scheme.
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After downsizing by 50% last year, Arsenal Biosciences is again laying off employees. This time, 99 people are getting cut as part of a strategic shift to focus the company’s R&D efforts on in vivo CAR T therapies. -
Novartis suspended multiple studies of a CAR T candidate after three patients who received the therapy suffered fatal cases of immune effector cell-associated hemophagocytic syndrome. BMS, meanwhile, paused some CAR T trials after separately observing “transient and reversible inflammatory events” with its therapy.
