Late-breaking Phase III data show ianalumab, Novartis’ dual-targeted antibody, reduced disease activity and patient burden in Sjögren’s disease, the pharma reported at the American College of Rheumatology Convergence congress on Wednesday.
Genentech is letting go of 118 employees in South San Francisco. The news comes about two months after the biotech ended a partnership with Adaptive Biotechnologies.
Shingrix sales in the U.S. took a 15% dive in the third quarter. GSK is now the second Big Pharma to report declining vaccine sales, after Sanofi reported a similar decline last week.
Already sky high after the success of its limb-girdle muscular dystrophy therapy, reported on Monday, BridgeBio’s shares rose nearly 8% more as encaleret balanced calcium levels in patients with a genetic thyroid disorder.
Despite the rejection, analysts saw Regeneron’s use of an alternate filler for Eylea HD as a positive development, with BMO Capital Markets noting that this could signal the end of manufacturing troubles for the franchise.
The reprioritization initiative extends Aldeyra’s cash runway into the second half of 2027.
FEATURED STORIES
Jefferies has predicted more small tuck-in deals to come, as biotechs struggle to access capital despite key clinical milestones on the horizon.
A new report from Pitchbook suggests we’re in for a period of more sustainable investing, with VC firms continuing to create and invest in companies, just more carefully.
The overturning of the FDA’s lab-developed tests rule is just the tip of the iceberg. With the loss of Chevron deference, power has shifted from federal agencies to the courts, with potential implications for everything from the FDA shortage list to CMS drug price negotiations.
Arguably the most notable of the FDA’s upcoming decisions is that regarding Gilead’s twice-yearly HIV prophylaxis lenacapavir.
Here’s how companies can ensure they’re in compliance with new requirements that go into effect in August.
The medium-sized biopharma is showing off new results from dordaviprone and Zepzelca, both of which were acquired through Jazz Pharmaceuticals’ dealmaking over the last five years.
LATEST PODCASTS
J&J beat expectations this week to launch the Q3 earnings season; a study about children treated with bluebird bio’s Skysona comes at a bad time for the company; Sen. Warren calls for scrutiny of Novo’s purchase of Catalent; and other news.
In the third episode of our mini series on artificial intelligence, Lori and guests continue their exploratory discussion on AI and the opportunity in patient lives.
Cell and gene therapy investment rebounds; WuXi Biologics and other companies named in BIOSECURE Act mull options; Bayer, J&J and Pfizer’s recent layoffs; updates from the weight loss space.
Job Trends
Moderna, Inc. announced that the U.S. Food and Drug Administration has approved mRESVIA, an mRNA respiratory syncytial virus vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.
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SPECIAL EDITIONS
In this deep dive, BioSpace investigates China’s rise as a biotech powerhouse.
In this deep dive, BioSpace explores the next big thing in obesity.
BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
DEALS
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Roche has once again returned to China to bolster its antibody-drug conjugate pipeline, this time striking a licensing deal with Innovent for $1 billion in biobucks. -
High profile failures and long timeframes for revenue have shifted investment away from Phase I, as VCs seek to mitigate risk, Pitchbook said in its 2025 outlook. -
BioArctic received $100 million upfront with another $1.25 billion in potential milestone payments on the line for two pyroglutamate-amyloid-beta antibodies. -
Photys is eligible for up to $186 million from Novo Nordisk for its PHICS small molecules that pair a kinase to a disease-causing protein for phosphorylation. -
BioSpace Senior Editor Annalee Armstrong reflects on the year that was, and what’s to come in 2025.
WEIGHT LOSS
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Two recent documents—one from the FDA, the other from a commission organized by The Lancet Diabetes & Endocrinology—indicate an evolving mindset toward treating obesity as a chronic disease. -
While Kallyope’s drugs are mechanistically unique, the biotech is competing in a crowded space, with other therapies that appear to elicit superior weight-loss. -
As high prices and supply issues drive consumers to alternative markets for GLP-1s, physicians aren’t too interested in using these therapies to treat conditions like heart disease risk that have existing cheap standards of care. -
The Outsourcing Facilities Association, a trade group representing compounders, filed a similar lawsuit in October last year after the FDA formally ended the tirzepaptide shortage. -
Many of these unlawful and unauthorized shipments were explicitly tagged for compounding, according to a new analysis. Separately, a group of state attorneys general has raised concerns about the unsafe GLP-1 drugs finding their way to American consumers.
POLICY
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Vocal skeptics of COVID-19 vaccinations gave mRNA a bad name and government funding for mRNA research is now being cut. On the flip side, at least one CEO said the pandemic also provided “elevated acceleration” for the field, which also holds promise in therapeutics for cancer and rare diseases. -
The report takes from HHS Secretary Robert F. Kennedy Jr’s playbook, calling out rising autism rates, the vaccine schedule and over medication of children as reasons for chronic diseases. -
In an opinion issued late Thursday night, U.S. District Judge Susan Illston wrote that the president and department agency heads do not have the authority to reorganize the government without Congress’ input. -
The “One Big Beautiful Bill Act” includes negotiation exemptions for orphan drugs approved to treat more than one rare disease and has implications for PBMs. Also on Thursday, the White House released its MAHA report with a mission to “make our children healthy again.” -
Canada’s health agency says it has been “taking all necessary action safeguard the drug supply and ensure Canadians have access to the prescription drugs they need.”
Even if you aren’t looking for a new role in biopharma, nurturing relationships will only benefit you in the long run. To help, here is a complete guide to networking in the life science industry.
To help alleviate some of the stress related to finding a new job, we’ve created a comprehensive guide detailing how to prepare for your biopharma job search.
Requesting disability accommodations is vital for your success in the workplace. You can find out everything about how to ask for accommodations in our guide.
Before searching for a job in the life sciences industry, it is essential to understand the differences between working as a contractor and a full-time employee.
Mentioning these certifications in your resume will set you apart from other candidates, clearing your path to your desired role. Learn here how to add certification to resume.
Applying to your first pharma internship may feel overwhelming, but it doesn’t have to be. Discover how to find, prepare for and be successful in an internship in the pharma industry in our guide.
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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Adaptimmune is rolling out its T cell therapy Tecelra for synovial sarcoma, recording $1.2 million in sales since its approval in August 2024. Nevertheless, it is pausing development of two oncology assets to save money. -
With Keytruda, the best-selling drug in the world, facing the end of exclusivity in 2028, BioSpace looks at five drugs that have taken the leap off the patent cliff. -
The French pharma is getting Black Diamond’s de-prioritized molecule for non-small cell lung cancers with specific mutations whose development had been paused to save money. -
Roche’s up to $1 billion investment will provide access to Oxford BioTherapeutics’ antibody-drug conjugate platform for undisclosed cancer targets. -
Monday was a busy day for AstraZeneca, which also paid up to $1 billion to acquire Belgian biotech EsoBiotec and its cell therapy pipeline and technology.
NEUROSCIENCE
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The treatment, called DB-OTO, is one of several early-stage gene therapies being developed to treat relatively straight-forward causes of genetic deafness. -
After SPN-820’s failure, Supernus is relying on its non-stimulant ADHD drug Qelbree and the recently approved Parkinson’s therapy Onapgo to sustain the company. -
The partnership splits the rights to Stoke’s epilepsy antisense oligonucleotide, with up to $385 million in potential payments due to Stoke. -
Helmed by Roche alums, Newleos Therapeutics is taking over four drugs dropped from the Swiss pharma’s pipeline in early 2024. -
Biogen and Eisai have spent much of Leqembi’s launch convincing physicians and patients that it’s safe to treat Alzheimer’s disease. With patients now hitting the 18-month mark of treatment, the conversation is finally shifting to efficacy.
CELL AND GENE THERAPY
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Traditionally carrying a dire prognosis, the treatment paradigm for multiple myeloma is changing, with CAR T therapies, bispecifics and more contributing to multifaceted regimens unique to each patient’s needs. -
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis talks to Dr. Peter Marks, Director, CBER about his thoughts on the future of cell and gene therapies. -
Along with its gene editing therapy Casgevy, Vertex is offering fertility preservation support for its patients—a program that the HHS claims violates anti-kickback statutes. -
Biopharma executives were busy Monday, striking high-value deals and providing updates on cancer, obesity and vaccine pipelines. -
In exchange for its investigational gene therapies, Regenxbio will receive $110 million upfront and up to $700 million in milestones. After hitting an all-time low of $6.95 at close of business yesterday, the stock surged on the news by nearly 20% before markets opened Tuesday.
