Analysts agree that the failure of Novo Nordisk’s semaglutide to reduce Alzheimer’s disease progression removes a “modest” or “perceived” overhang on Biogen and the anti-amyloid antibody class in general, clearing the way for increased uptake of Leqembi and Eli Lilly’s Kisunla.
“We felt we had a responsibility to explore semaglutide’s potential, despite a low likelihood of success,” Martin Holst Lange, Novo’s R&D chief, said on Monday.
NervGen will meet with the FDA early next year to align on a regulatory path forward for NVG-291 in chronic spinal cord injury.
Asundexian’s Phase III win could also bode well for Bristol Myers Squibb, which is also developing a Factor XIa inhibitor called milvexian for stroke prevention, analysts said.
A source familiar with the matter said the White House initially requested the resignation of Sanjula Jain-Nagpal, a policy and research official at the FDA.
The regulator has received reports that a group of patients treated with Adzynma had neutralizing antibodies against the protein the therapy replaces.
FEATURED STORIES
Executives from Eli Lilly, Merck and other companies foresee the FDA’s new onshoring proposal being anything from a bureaucratic waste of time to a transformative program that will eliminate inspection-related complete response letters.
The BioSpace 40 Under 40 winner opens up about his very personal career transformation from wealth management to biotech—and what it’s like to develop a drug for amyotrophic lateral sclerosis and frontotemporal dementia as a potential patient himself.
Last month, “historic positive results” from uniQure’s gene therapy snapped the Huntington’s community out of years of failure. As the biotech prepares to submit for FDA approval, BioSpace looks at four more candidates on the near horizon.
Pivotal results from uniQure’s gene therapy for Huntington’s disease have brought new light to patients who have known only disappointment in recent years—but one expert worries that communication of the results is creating “false expectations.”
M&A is back, the S&P XBI is rising again, a biotech pulled off an IPO and positive data is pulling in investors again. This may just be the industry’s new normal.
AI is changing the nature of leadership in biopharma. Here’s how executives can not only adapt, but lead the way.
LATEST PODCASTS
This week’s release of the Make America Health Again report revealed continued emphasis on vaccine safety; Health Secretary Robert F. Kennedy Jr.’s faceoff with senators last week amounted to political theater; the FDA promises complete response letters in real time and shares details on a new rare disease framework; and Summit disappoints at the World Conference on Lung Cancer in Barcelona.
In this episode presented by Taconic Biosciences, BioSpace’s head of insights Lori Ellis discusses how preclinical research companies are helping drug developers navigate the current challenging funding environment with Mike Garrett, CEO.
Health Secretary Robert F. Kennedy Jr. will appear before the Senate Finance Committee Thursday, ahead of a vaccine advisory committee meeting later in September. Meanwhile, deal-making appetite appears healthy, and the weight loss space continues generating clinical data and other news.
Job Trends
A BioSpace survey found that 56% of employed and 81% of unemployed respondents are considering jobs outside biopharma. Some are also seriously thinking about leaving the U.S. to find employment in the field.
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SPECIAL EDITIONS
In this deep dive, BioSpace examines what’s next for Leqembi, the true cost of anti-amyloid antibodies, and what other Alzheimer’s treatments are coming down the pipeline.
If it feels like there has never been a tougher time to look for work, you’re not alone—and you’re likely not wrong.
In this deep dive, BioSpace examines how small, medium and large companies are using artificial intelligence and machine learning to enhance their drug discovery efforts.
DEALS
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Bristol Myers Squibb and insitro first partnered in 2020 to develop induced pluripotent stem cell models of amyotrophic lateral sclerosis and frontotemporal dementia. Last December, BMS exercised its option for an ALS target. -
The acquisition will give BioCryst an investigational injectable drug for hereditary angioedema, potentially complementing its FDA-approved oral drug Orladeyo. -
AviadoBio will have the option to exclusively license UGX-202, a vision-restoring gene therapy for the rare eye condition retinitis pigmentosa. -
Novo will add Akero’s efruxifermin to its MASH portfolio, which includes Wegovy after the GLP-1 gained an FDA nod in the indication earlier this year. -
The centerpiece of the deal is orelabrutinib, a BTK inhibitor in late-stage development for multiple sclerosis that Biogen once paid $125 million for but abandoned after less than two years of testing.
WEIGHT LOSS
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Rybelsus can now be used as a primary or secondary prevention pill to lower the risk of major adverse cardiovascular events in at-risk patients with type 2 diabetes. -
CMS Administrator Mehmet Oz clarified that a deal has not yet been sealed with the manufacturer of semaglutide, Novo Nordisk, or any other GLP-1 drugmaker. -
After beating Novo Nordisk’s semaglutide last month, Lilly’s much anticipated oral candidate orforglipron has taken down AstraZeneca’s Farxiga in a head-to-head trial. -
Kailera’s lead asset, KAI-9531, elicited an average weight loss of more than 17% in a Phase III study in China. The biotech expects to launch a global late-stage program for the drug this year. -
The U.S. government remains shut down, with the FDA closed for new drug applications until further notice; cell and gene therapy leaders gather for the annual meeting in Phoenix with the field in a state of flux; Pfizer and Amgen will make drugs available at a discount as President Donald Trump’s tariffs still loom; and new regulatory documents show how Pfizer beat out the competition for Metsera.
POLICY
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In one of the first demonstrations of the impact of last year’s Loper Supreme Court decision on challenges to agency authority, a judge ruled that the FDA does not have authority to regulate tests developed by clinical laboratories. -
Companies that have broken ground on or are actively constructing manufacturing facilities in the U.S. are exempted from the tariffs, according to President Donald Trump’s social media post on Thursday. -
Though details remain scant, the pending order is expected to be the latest effort in President Donald Trump’s campaign to bring drug prices down to the same level as economically similar countries. -
While last week’s recommended changes by CDC advisors to the MMRV vaccine schedule are unlikely to have a tangible effect on Merck’s business, the company said the removal of choice for healthcare providers is “concerning.” -
The FDA’s proposed Rare Disease Evidence Principles review process is a starting point for getting rare disease therapies across the finish line, but industry leaders say there are more concrete steps the regulator could take to help patients.
Candidates looking to enter biotech should focus on cultivating key skills, thoughtfully crafting their resumes and putting their best, most authentic foot forward in interviews. An internship, co-op or fellowship won’t hurt, either.
This webinar will help you discover effective strategies for launching your career in biotechnology. You will gain valuable insights from industry experts and leave with the essential tools you need to thrive in this dynamic field.
A clinical research associate is a professional who oversees clinical trials. Here are our top tips on how to become one.
For biopharma executives who are between roles, navigating the transitionary time can be challenging. However, they can remain visible and valuable so they’re ready to seize their next big opportunity.
In a tough labor market where layoffs continue, some are considering—or even moving—from industry to academia, according to a BioSpace poll. A career coach, scientist and general practitioner turned research coordinator share their thoughts.
Learn how to craft a resume that stands out by exploring 10 common resume mistakes and how to avoid them.
HOTBEDS
REPORTS
If people are your greatest asset, it is imperative that your organization maintains a positive employer brand presence and talent pipeline. This report covers how you can build a strong employer brand with prospective employees, current employees - and former employees.
In challenging conditions, how can employers optimize the employee experience to retain their top talent and make the most of their current teams?
In the 2020 US Life Sciences Diversity & Inclusion report, BioSpace dives into how different segments of employees experience and perceive policies, attitudes and actions. Our data suggests that there are significant disparities between segments.
CANCER
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Truist analysts called the results “encouraging” while pointing out certain unknowns in the data. Immuneering plans to kick off a registrational trial for atebimetinib later this year. -
For the last two years, Keytruda has reigned as the world’s top-selling drug—a distinction under threat with key patent protections expiring in 2028. -
Moving forward, Innate will focus on the clinical development of its antibody-drug conjugate IPH4502, the lymphoma candidate lacutamab and the AstraZeneca-partnered monalizumab. -
The White House is clamping down on pharma’s ability to buy new molecules from Chinese biotechs; Sanofi, Merck and others abandon the U.K. after the introduction of a sizeable levy; Novo CEO Maziar Mike Doustdar lays off 9,000 while the company presents new data at EASD; Capsida loses a patient in a gene therapy trial; and CDER Director George Tidmarsh walks back comments on FDA adcomms.
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On the FDA’s docket for the back half of September is Merck’s proposed subcutaneous formulation of its blockbuster cancer drug Keytruda.
NEUROSCIENCE
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With AbbVie’s $1.2 billion acquisition of Gilgamesh Pharmaceuticals’ lead depression drug, the psychedelic therapeutics space has soundly rebounded from Lykos’ rejection last year. There are now seven programs in Phase III trials across the sector, with multiple companies vying for that first approval. -
VectorY Therapeutics will evaluate the use of SHP-DB1, a capsid developed by Shape Therapeutics, to deliver therapies to the brain, including VectorY’s developmental Huntington’s and Alzheimer’s disease treatments. -
LB Pharma landed on the Nasdaq Thursday, with 3 million additional shares sold than expected. -
Capsida has yet to disclose the exact cause of death. The patient had received the gene therapy CAP-002 for a type of epilepsy. -
Presenting at the World Sleep Congress 2025, the Dublin-based company’s Phase II study bested Takeda drug in both efficacy and safety.
CELL AND GENE THERAPY
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The centerpiece of the collaboration is the gene editor ABO-101, being developed for primary hyperoxaluria type 1, a rare disease that leads to severe kidney stones. -
As industry leaders gather at the annual event in Phoenix, the cell and gene therapy space remains in a state of flux, with M&A activity and regulatory support signaling momentum while commercialization challenges continue to hinder broader investor interest. -
Smarter design through targeted delivery and human-relevant testing can save the industry from costly safety failures. -
Following up on previous, dimly received issuances, a new set of ideas published by the FDA to streamline regulatory pathways for cell and gene therapies ‘for small populations’ is receiving a warmer welcome—but experts warn it will take more to turn the tide for the fraught therapeutic space. -
Takeda is looking to offload its cell therapy platform and preclinical assets to a yet-unidentified external partner. 137 employees will be let go as part of the move.
