Follow along as BioSpace tracks job cuts and restructuring initiatives.
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.
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.
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.
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.
Roche has tapped Simcere Zaiming for a new T cell engager that could have broad application in B cell–mediated diseases including lymphoma and autoimmune conditions.
FEATURED STORIES
Almost as many biotechs have opted for a reverse merger to reach the public markets as those executing more traditional initial public offerings this year.
BMS is barreling toward a clinical trial readout that an H.C. Wainwright analyst believes could contribute to the return of mergers between mega-cap drugmakers.
Efficacy plateaus, muscle loss and weight rebound are testing the limits of GLP-1 success, pushing companies toward new mechanisms and multitarget designs to close the gap. But progress depends on understanding disease biology and selecting the right drug candidates to derisk clinical trials.
Well-known for its oncology efforts and making recent headlines for a rumored mega merger with AstraZeneca, Bristol Myers Squibb is also dedicating considerable resources to neurological and psychiatric diseases, with a “continuum of care” mindset.
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.
Thanks in part to the revolution cell therapy brought to treating blood cancers, the modality is now showing promise in some autoimmune applications. This expansion is poised to yield even wider benefits.
LATEST PODCASTS
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.
In this episode of Denatured, you’ll hear from Hilary Rosselot, executive director at the National Fragile X Foundation and Jordi Fàbrega, co-founder & CEO at CONNECTA Therapeutics. From trial endpoints and placebo effects to neuroplasticity modulation, we explore what it will take to build a sustainable path to the first approved therapy.
FDA extends its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy as an unhappy shareholder advocates for change; Merck and Moderna tout positive data for their mRNA-based cancer vaccine; Trump nominates White House aide Heidi Overton as FDA commissioner; and the oral obesity market heats up with rivals Eli Lilly and Novo Nordisk going head-to-head.
Subscribe to GenePool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
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
-
With the acquisition of Merida Biosciences, Eli Lilly is gaining a precision degradation platform for therapies that selectively target and destroy pathologic antibodies for allergic and autoimmune diseases. -
Through its DualityBio deal, Roche’s Genentech hopes to create antibody-drug conjugates with payloads that can circumvent growing cancer drug resistance. -
At the center of Biohaven’s agreement with SK Biopharmaceutical is the ion channel platform and the lead epilepsy candidate opakalim, for which Phase 2/3 data are expected later this year. -
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026. -
Twenty-five biotechs have used the IPO route to go public this year—with five of those debuts occurring this month alone. It’s the most IPOs since 2021, when the industry recorded 78 during the height of the COVID-19 pandemic.
WEIGHT LOSS
-
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. -
The Phase 3 study is evaluating two doses of Novo’s Wegovy pill in people with obesity or overweight in combination with a reduced-calorie diet and increased physical activity. -
Touting an “exceptional” gastrointestinal safety profile for its oral obesity drug candidate in a study of healthy volunteers, Enveda plans to test the asset in people stopping GLP-1 treatment.
POLICY
-
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 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. -
Three fatalities occurring recently in Chinese clinical trials have spurred two members of U.S. Congress to urge the FDA to enact new policies designed to protect American patients. -
If confirmed by the Senate, Heidi Overton—officially revealed Wednesday as President Donald Trump’s choice for FDA commissioner—is expected to be a boon for developers of psychedelic therapeutics and non-opioid pain drugs, but could tow the party line on vaccines. -
While there are several FDA-approved psychiatric medicines on the market, many patients still struggle to achieve lasting symptom relief. Psychedelics could help fill this gap.
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.
Looking for a biopharma job? Check out the BioSpace list of 12 top companies hiring life sciences professionals like you.
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.
The choices that change a career often look like extra work at the time. Executive coach Angela Justice examines why the projects, questions, relationships and conversations people almost dismiss can become the ones they later recognize as turning points.
AI tools can help job seekers write resumes and mass apply to open positions, but those aren’t the only, or best, ways to use them. A career coach shares how she advises clients to make the most of AI during the application and interview process.
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
-
The approval of rusfertide—now to be branded Mimrylo—for polycythemia vera marks a key win for Takeda, which now has crossed the FDA finish line for two of three critical product launches slated for the coming year. -
A future expansion of Rasonque into first-line pancreatic ductal adenocarcinoma could set Revolution Medicines up to hit $2.3 billion in sales by 2028, according to Truist Securities. -
The FDA granted the approval of Revolution Medicines’ daraxonrasib, now to be known as Rasonque, in pancreatic adenocarcinoma 6.5 months ahead of deadline. -
The Phase 3 readout is the first for ivonescimab beyond non-small cell lung cancer to show a significant overall survival benefit, according to Summit Therapeutics and China-based partner Akeso. -
Gastroesophageal adenocarcinoma presents the biggest market opportunity for Jazz Pharmaceuticals’ Ziihera, according to Truist Securities, which forecasts peak sales of the drug to reach $2.5 billion.
NEUROSCIENCE
-
The FDA’s August approval of Takeda’s Orzeyful for treating the full set of narcolepsy symptoms initiated a new era in the sleep market. -
It’s smooth sailing for Definium Therapeutics as the psychedelic biotech charts another win for its LSD candidate, this time in anxiety. The psychedelic previously notched a late-stage victory in depression. -
Epicrispr Biotechnologies is working on an epigenetic medicine for facioscapulohumeral muscular dystrophy, while Infinimmune will advance a pair of antibodies for atopic dermatitis. -
Jazz Pharmaceuticals is reaching into its wallet once again, this time buying Actio Biosciences and an experimental therapy for KCNT1+ epilepsy, a form of the disease with no FDA-approved treatments. -
Definium Therapeutics’ closely watched anxiety readout could further validate its single-dose LSD candidate, while Compass Pathways advances a psilocybin program through a rolling FDA filing.
CELL AND GENE THERAPY
-
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. -
Biopharmas developing CAR T therapies for autoimmune indications face major barriers to maximizing the market. Advances in the provider ecosystem and clinical infrastructure, as well as access and education, will be key to launching at scale. -
Setbacks to efforts to use Cellares’ automated platform to make an approved CAR-T cell therapy led BMS to terminate its partnership with the manufacturing specialist. -
FDA extends its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy as an unhappy shareholder advocates for change; Merck and Moderna tout positive data for their mRNA-based cancer vaccine; Trump nominates White House aide Heidi Overton as FDA commissioner; and the oral obesity market heats up with rivals Eli Lilly and Novo Nordisk going head-to-head.
