AviadoBio will have the option to exclusively license UGX-202, a vision-restoring gene therapy for the rare eye condition retinitis pigmentosa.
GoodRx, an online platform that offers drug discount coupons to patients, is in talks with the government to participate in the forthcoming TrumpRx program.
The British proposal to increase support for pharma is “clearly positive,” according to analysts at Leerink, who noted that the NHS’ move will improve patient access to treatments.
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 CDC’s Advisory Committee on Immunization Practices was scheduled to convene Oct. 22 to 23, but this meeting has been postponed, with no new date specified. The delay comes as the VA published new research showing that COVID-19 shots prevented hospitalizations and death.
The layoffs are part of the company’s shift to a new structure enabling cost efficiency for its new model.
FEATURED STORIES
As obesity drug developers compete for the highest weight-loss efficacy, experts contend that overall health outcomes—evidenced by successful studies in therapeutic areas like cardiovascular and sleep apnea—may prove a greater market advantage.
Facing declining valuations and funding challenges, public biotechs like bluebird bio are going private to restructure, reduce regulatory burdens and refocus on long-term growth.
Johnson & Johnson has been fighting thousands of lawsuits over its now-discontinued talc products for 16 years. A pending judge’s ruling could finally put the issue to bed once and for all.
As we reflect on five years of COVID-19, it’s clear that the impacts are still unfolding. The life sciences—and we as individuals—will never be the same again.
While drug developers work to mitigate the side effects associated with GLP-1–based obesity drugs, recent studies reveal that myriad variables are causing patients to stop treatment.
As sales of its COVID vaccine plummet, Novavax is looking ahead toward other novel vaccines, brought to market with the help of the company’s pharma partners—something it opted not to do as the pandemic swept the globe in 2020.
LATEST PODCASTS
On this episode of Denatured, Lori Ellis and guests discuss President Biden’s Executive Order on Advancing Women’s Health Research and Innovation and the outlook of investment in women’s health.
AAVs and accelerated approval are just two of the topics being discussed at ASGCT. Meanwhile, the race between Vertex and bluebird bio’s gene therapies Casgevy and Lyfgenia is heating up.
Follow News Editor Greg Slabodkin and Managing Editor Jef Akst as they travel with some 8,000 others for discussions of cell and gene therapy advances, challenges, regulations and more.
Job Trends
Omega Therapeutics, Inc. announced financial results for the first quarter ended March 31, 2024, and highlighted recent Company progress.
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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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After pulling its ALS drug Relyvrio from the market, Amylyx Pharmaceuticals is looking to target the GLP-1 space with the purchase of Eiger BioPharmaceuticals’ avexitide, which has been studied for the treatment of hyperinsulinemic hypoglycemia. -
The blood plasma pharma is considering a buyout offer from the founding family and asset manager Brookfield, which would delist the company from the Spanish and Nasdaq markets. -
Eli Lilly on Monday announced a $3.2 billion all-cash deal to purchase Morphic and its pipeline of oral integrin therapies in a move to expand the pharma’s presence in the autoimmune diseases space. -
GSK on Wednesday restructured its contract with CureVac to gain access to the biotech’s influenza and COVID-19 programs for $430 million upfront and up to $1.13 billion in future payments. -
Eli Lilly is expanding its radiopharmaceutical portfolio with a $140 million upfront payment to Radionetics Oncology and the exclusive future right to acquire the biotech for $1 billion.
WEIGHT LOSS
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Wegovy is being made available to Chinese patients five months after its approval in the country. Novo will sell the medicine for about $193.27 for a one-month supply. -
Despite crowding in the next-gen weight loss space, Metsera has raised over $500 million since its April launch, indicating a continued appetite for these drugs. -
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.
POLICY
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Senators Bill Cassidy and Bernie Sanders asked HHS Secretary Robert F. Kennedy, Jr. to make good on a pledge to appear before the committee regularly. It is not clear if or when the hearing, which was scheduled for Thursday, will take place. -
Under Friday’s final ruling anti-obesity medications for weight-loss will remain ineligible for Medicare coverage. -
Kennedy, a long-time opponent of vaccines, stated that the MMR vaccine is “the most effective way” to combat the measles outbreak, which has already claimed the lives of two children in the U.S. -
Pharma’s reprieve from Donald Trump’s tariffs is expected to be temporary, with Leerink analysts anticipating possible sector-specific duties “in the next month or so.” -
With the recently announced layoffs of 3,500 FDA staffers and exits of branch directors Patrizia Cavazzoni and Peter Marks, there could be a wealth of talent available to biopharma companies. Does this pose an ethical quandary? It depends on who you ask.
BioSpace recently interviewed Elizabeth Elting, founder and CEO of the Elizabeth Elting Foundation, to discuss her thoughts on how the pandemic has affected women in the workforce.
A well-designed career development program provides the right guidance and training for workers to improve their professional careers.
Do you know that growing emotional intelligence at workplace can be beneficial for career growth? If not, have a look at the article and learn some tips.
Controlling interruptions when working from home can be challenging, but a little planning and some established rules can help.
Are you an introvert who is worried about your performance? Well, do you know that these unique skills can make you an excellent leader? Let’s find out those skills.
If you’re struggling to find your dream job or unsure of what your next career move should be, career assessments might be the next right step. Here’s how to do it.
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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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. -
Even before the FDA’s recent approval of Dato-DXd in breast cancer, analysts predicted sales of the antibody-drug conjugate could hit $5.9 billion in 2030. However, the asset faced a series of setbacks in 2024. -
The conversion of Calquence’s accelerated approval in mantle cell lymphoma comes a day before the drug was listed among the 15 products to be subject to IRA-prescripted price negotiations for Medicare this year. -
The Phase III CodeBreaK 300 study returned disappointing overall survival data for Lumakras plus Vectibix in metastatic colorectal cancer, but in its approval announcement, the FDA pointed to significant improvements in progression-free survival, calling it the “major efficacy outcome” of the trial. -
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.
NEUROSCIENCE
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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. -
Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track record of propelling R&D for some of medicine’s most challenging illnesses. -
Emboldened by technological advances and a deeper knowledge of glioblastoma, Merck, Kazia Therapeutics, CorriXR Therapeutics and others are targeting the often-fatal brain tumor. -
Despite the “unfortunate” failure, William Blair analysts do not believe that the utreloxastat readout will heavily affect PTC, instead postulating that the upcoming FDA decision on its phenylketonuria candidate sepiapterin will be a stronger driver of the biotech’s stock.
CELL AND GENE THERAPY
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As it nears a crucial FDA action date for its transthyretin amyloid cardiomyopathy candidate, BridgeBio focuses on its late-stage pipeline. -
No patients have received Casgevy, CRISPR Therapeutics and Vertex Pharmeceuticals’ recently approved sickle cell gene therapy. Experts weigh in on the path to profit for the treatment and the therapeutic class in general. -
BioMarin executives sought to calm an anxious investor base Wednesday with a public address and pledge to achieve a nearly 50% bump in annual revenue by 2027. But analysts were left wanting. -
Proceeds from the oversubscribed financing will be used to advance ArsenalBio’s lead programs, which include a handful of solid tumor cell therapy candidates. -
Eli Lilly offers weight loss drug Zepbound directly to consumers while Novo Nordisk continues to struggle with supply challenges for its own GLP-1s. Meanwhile, gene therapies for retinal diseases target competitive market, and layoffs persist.
