Novartis has been investing heavily in its cardiovascular pipeline this year, forging partnerships with Flagship startup ProFound Therapeutics and China’s Argo Biopharmaceutical, among others.
Regeneron’s antibody duos significantly lowered eye itching and redness, as well as pin prick reactivity, in people with cat and birch allergies. Still, BMO Capital Markets expressed uncertainty about the assets’ “commercial potential in a highly generic market.”
The 2025 Bioprocessing Summit revealed knowledge gaps and changing mindsets. As some companies look towards the future, others struggle with the present and past.
Presenting at the World Sleep Congress 2025, the Dublin-based company’s Phase II study bested Takeda drug in both efficacy and safety.
While a win for consumers, the regulatory action did nothing to stem the manufacture of compounded versions of the popular obesity drugs that are made by Novo Nordisk and Eli Lilly. In fact, the FDA seems to be signaling that “some level of compounded product is acceptable,” according to BMO Capital Markets.
Shares of Rapport Therapeutics popped Monday morning after Phase IIa data for RAP-219 exceeded analyst and Wall Street expectations, reducing seizures by almost 78% in patients with drug-resistant focal onset seizures.
FEATURED STORIES
A BioSpace analysis of all 80 priority review vouchers that have been handed out across the three FDA programs that offer them found that 2024 was the busiest year yet. Companies have disclosed spending $513 million on vouchers that were earned in 2024 so far.
Konstantina Katcheves, Senior VP of Innovative Global Business Development at Teva Pharmaceuticals brings insights from the World Economic Forum to SCOPE 2025.
Merck’s Keytruda holds on to the top spot while AbbVie’s Humira—once the world’s top-selling drug—continues to cede its market share to biosimilar competitors.
Congress did not reauthorize the rare pediatric disease priority review program at the end of 2024. Advocates say the ripple effect is already being felt across biopharma.
In the current legal and political landscape, it is all about survival for DEI initiatives.
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.
LATEST PODCASTS
BioSpace’s Lori Ellis and Chantal Dresner bring live updates from day three of #DIA2024 in San Diego.
This week on Denatured, Head of Insights Lori Ellis and guests discuss the persisting challenges of diversity, equity and inclusion when designing clinical trials.
This week’s news ranged from BioSpace’s on-the-ground updates from DIA to safety concerns in clinical trials to BIOSECURE Act updates to new projections that the GLP-1 market could top $100 billion within 10 years.
Job Trends
Global biotechnology leader CSL and Arcturus Therapeutics announce Nature Communications has published results from an integrated phase 1/2/3a/3b study evaluating the safety, immunogenicity, and efficacy of ARCT, 154, a novel self-amplifying COVID-19 vaccine and the world’s first approved sa-mRNA COVID-19 vaccine.
Subscribe to Genepool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
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
-
A report from J.P. Morgan shows an increase in biopharma activity so far this year and where some improvement can be made. -
Sangamo and Pfizer’s hemophilia A gene therapy candidate scored a Phase III victory last week. However, with the genomic medicine company soon to run out of cash, Sangamo’s short-term prospects look bleak but not unsalvageable, analysts say.
-
Under the deal announced Monday with the California biotech, German pharma Boehringer Ingelheim is gaining access to novel immune checkpoint inhibitors designed to activate the immune system to fight cancer cells. -
A longtime biopharma exec and Moderna shareholder argues in an anonymous email to the companies’ CFOs that they have a fiduciary responsibility to close the deal. Analysts say the proposal is interesting but “too simplistic.” -
While supportive of Amylyx’s acquisition of a GLP-1 drug, analysts say the company’s future hinges on key upcoming readouts from multiple products in its pipeline.
WEIGHT LOSS
-
Cantor Fitzgerald analyst Olivia Brayer found supplementary bone mineral density data for Amgen’s obesity candidate MariTide that could point to a potentially greater fracture risk than previously revealed, but some other analysts view the findings as a nonissue. -
With Novo Holdings’ $16.5 billion buyout of Catalent being reviewed by regulators, what work the contract drug manufacturer may or may not be performing for Eli Lilly remains a point of contention. -
Novo said supply of Wegovy and Ozempic is in good shape after the drugs were removed from the FDA’s shortage list last week. But Eli Lilly reported slower than expected sales in the third quarter due to wholesaler destocking. -
Novo Nordisk’s total revenue in the third quarter missed analysts’ expectations but sales of weight loss drug Wegovy exceeded the consensus forecast. Still, the Danish drugmaker narrowed its full-year guidance for revenue and operating profit. -
While expected and seen as largely incremental, Jefferies analyst Peter Welford in a Tuesday note to investors said the detailed data for three early-stage assets support moving them into Phase IIb studies and creates a “foothold” for AstraZeneca in the weight loss space.
POLICY
-
GeoVax was using its HHS contract to develop its next-generation multi-antigen COVID-19 vaccine, which is in Phase IIb development. -
Despite these cuts, the FDA should be able to stay above a “trigger” level that would prevent it from collecting fees from the pharma industry and deprive it of approximately half of its annual funding, according to The Washington Post. -
In the wake of unprecedented workforce cuts at the FDA, former Commissioner Scott Gottlieb and an unnamed former CBER director spoke to analysts about potential implications for drug review timelines and agency morale. -
Playing both sides of trade war, pharma companies are asking for certain compensations for scientific innovation and a smoother regulatory framework. -
Analysts are “cautiously optimistic” about Trump’s executive order, noting that changes to the IRA drug price negotiation program will still require Congressional action before being implemented.
Conducting some research before your job interview can help ease your mind. You will feel less stressed once you know what to look forward to during the meeting and which skills will allow you to shine.
Setting yourself apart from other job candidates can be a challenging thing to do - but it doesn’t have to be with these eight important tips!
Your CV can be the ticket that lands you your dream job - as long as you focus on making sure that it’s well-written with the help of these CV writing tips.
Differing skillsets mean that extroverts and introverts will usually approach the same job differently. Here is how each of them do it.
If you’ve been getting the itch to job search but you aren’t sure if you should, here are some reasons to possibly leave a job that might help you decide if you should stay or if you should go.
Everyone wants a positive work environment but how do you find one? This article will provide you with deep insights into how you can find a company that you dream of.
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
-
Enhertu’s label expansion comes on the heels of the FDA’s approval of the partners’ Datroway for a related type of breast cancer. -
Bristol Myers Squibb’s Opdivo plus Yervoy, as well as Pfizer’s Braftovi, have each shown strong Phase III performances that could position them as new standards of care in certain subtypes of metastatic colorectal cancer. -
The Japanese pharma had one asset rejected by the FDA and withdrew a regulatory application for another, but already this month the company has secured an approval for AstraZeneca-partnered Dato-DXd, to be marketed as Datroway. -
The unsuccessful Phase III results are the latest to suggest that the blockbuster cancer drug is finally bumping up against its limits after racking up around 50 approvals since getting its first FDA nod in September 2014. -
Protein degradation–focused Neomorph nabs its third Big Pharma deal of around $1.5 billion in less than a year.
NEUROSCIENCE
-
By speeding lifesaving drugs’ way to market and focusing on the underlying causes of disease, the pathway has helped save many lives. -
The Muna partnership will give GSK access to Muna’s MiND-MAP platform, which it will apply to postmortem brain samples to identify potential therapeutic targets for Alzheimer’s disease. -
Novartis, Gilead, Roche and Takeda commit to new partners in a spate of mid-sized collaborations this week. Meanwhile, Applied Therapeutics’ stock tanks 80% after govorestat is denied approval, Intra-Cellular Therapies seeks to expand Caplyta into major depressive disorder and the FDA investigates the safety of bluebird bio’s Skysona. -
Intra-Cellular submitted its application to the FDA for Caplyta’s approval in major depressive disorder, potentially opening up an additional $1 billion in sales. Still, the stock remains “cheap,” according to Jefferies analysts. -
Monday’s agreement comes days after PTC discontinued the development of another asset, utreloxastat, due to disappointing Phase II data in amyotrophic lateral sclerosis.
CELL AND GENE THERAPY
-
Analysts did not seem very concerned by the treatment-related serious adverse event, noting that NGN-401 was well-tolerated at a lower dose and showed promising efficacy outcomes. -
The investigational therapy, vesleteplirsen, had been positioned as an updated version of Sarepta’s original exon 51-skipping Duchenne muscular dystrophy drug Exondys 51. -
Truist Securities analyst Asthika Goonewardene in an investor note said data for anito-cel—particularly its safety profile—will help differentiate the CAR T therapy from Legend Biotech and J&J’s entrenched Carvykti in relapsed and refractory multiple myeloma. -
In our anniversary episode, we discuss a rare earnings miss for Eli Lilly, a pivotal metabolic dysfunction–associated steatohepatitis victory for Novo Nordisk’s Wegovy, growing excitement about CAR Ts for autoimmune disease and the ongoing controversy over HeLa cells.
-
In a tough fundraising space, cell therapy biotechs pursuing autoimmune indications review staffing to ensure the right expertise is in place to tackle the new disease area.
