Last month, investors’ hopes were dashed as Replimune suggested alignment had not yet been reached with the FDA on RP1’s future. Now, the regulator has accepted a refiled application after all.
Ivonescimab’s progression-free survival data in non-small cell lung cancer bode well for an upcoming overall survival readout, according to Truist analysts, who noted that “OS is likely to be statistically significant” in favor of the PD-1/VEGF bispecific.
Several sources are speculating that the potential buyer could be Eli Lilly, despite the breakdown of the pharma’s partnership with Nektar over atopic dermatitis therapy rezpeg.
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.
Glaukos’ Epioxa allows cross-linking therapy for keratoconus without requiring an incision. The biotech expects to launch the drug early next year.
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.
FEATURED STORIES
While it’s not unusual for certain positions to turn over with a new administration, the number of senior-level FDA staffers who have recently left the agency is unprecedented. The lack of communication, transparency and human decency is as well.
Bo Wang is a renowned AI scientist at the University of Toronto. He’s bringing his open-source culture and computational biology to Xaira Therapeutics in June.
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.
While Novartis and Bayer got there first, AstraZeneca, Bristol Myers Squibb and Eli Lilly are all vying to bring their radiopharmaceutical assets to a market projected to be worth over $13 billion by 2033.
Several companies will head to the FDA seeking approval of new Duchenne muscular dystrophy treatments next year but the death of a patient taking Sarepta’s Elevidys raises important safety questions.
Eli Lilly and Novo Nordisk are in a global battle for dominance in the weight loss space. BioSpace takes a look at the territory covered and what’s to come.
LATEST PODCASTS
This week, an FDA adcomm unanimously voted for the approval of Eli Lilly’s anti-amyloid antibody as thousands of layoffs continue to rattle the industry.
How do we ensure strategic vision and thoughtful implementation when pursuing new opportunities in science and technology? Our guests discuss challenges around reimbursement, intellectual property, change management and the critical nature of early engagement.
The biggest conferences of the year dominated news this week: the American Society of Clinical Oncology annual meeting and the BIO International Convention.
Job Trends
Takeda announced financial results for fiscal year 2023, delivering its Management Guidance for Core Operating Profit and exceeding its Management Guidance for Revenue and Core EPS performance at CER, in a year of significant loss-of-exclusivity impact.
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
-
Venture capital in the sector hit $9.2 billion in the second quarter of 2024, up from $7.4 billion in Q1, while exits fell on a slower M&A cycle and picky IPO market. -
M&A activity surges and IPOs return as the biotech industry navigates a changing business landscape marked by strategic consolidation and renewed investor focus on innovation. -
The Connecticut-based biotech, which emerged from stealth last year, has secured $202 million to date as it looks to move two assets targeting prostate and breast cancer into the clinic. -
Armed with a combined $850 million in cash, the companies said Thursday the resulting biotech will have a pipeline that could deliver 10 clinical readouts over the next 18 months. -
The size of the global immunology market is projected to nearly double by 2032 to a quarter of a trillion dollars. Here are this year’s standout deals in the space.
WEIGHT LOSS
-
The Hansoh deal will let Merck compete in the crowded oral GLP-1 space alongside fellow pharma giants Eli Lilly, Novo Nordisk and Roche. -
The letters come amid the Outsourcing Facilities Association’s ongoing lawsuit against the FDA over the regulator’s decision to end the shortage for tirzepatide. -
Now that they’ve received the go-signal from both U.S. and EU anti-trust regulators, Novo Holdings and Catalent expect to wrap up their deal in the coming days. -
The EMA approved a kidney disease–related label expansion for the blockbuster GLP-1 drug after a study showed reduced risk of death by 20%. -
The discontinuation of STRIDES is a rare stumble for the next-generation obesity field and comes just weeks after Amgen announced underwhelming mid-stage data for MariTide.
POLICY
-
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. -
Trump could use the findings of the probe to impose certain trade restrictions on pharma products, including tariffs. -
After the gutting of the Department of Health and Human Services, fears mount about the future direction of the FDA—with regulatory experts predicting delays in drug approvals and greater influence of political appointees. -
As the biopharma industry grapples with the uncertain macro environment brought on by the new administration, CEOs, regulators and many others speak out. -
According to analysts at Jefferies, legislation such as the newly proposed bills that aim to streamline regulatory processes would be a positive for the biotech industry.
“The Great Resignation” is a term that’s been coined to describe the wave of people leaving their jobs for other opportunities or exiting the workforce altogether.
A resume is your introduction to a potential employer, and as the saying goes, “You only get one chance to make a good first impression.” Follow these resume writing tips today.
Being confident about your skills and learning new things are some of the best career advice and tips a professional should know to become better at your workplace.
When dealing with a large group of people, the possibility of handling a disgruntled employee is very likely. Here’s how you can handle them efficiently.
Most people don’t know that asking questions can help with an application. Here are some unique questions for interviewer that you should remember to ask next time.
If you’re questioning which types of leaders you get along with the best, or you’re just wondering what types of leaders exist, you’re in the right place. Here’s a quick breakdown.
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
-
Novartis was among the most prolific pharma dealmakers in 2024, a trend that it expects to continue with more bolt-on deals this year to set up for sustainable long-term growth. -
In this episode, presented by the Genscript Biotech Global Forum 2025, BioSpace’s Head of Insights Lori Ellis talks to Tom Whitehead, co-founder of the Emily Whitehead Foundation, about how standard care, cell and gene therapies and their impact on patients. -
The layoffs follow an announcement in early January that I-Mab will re-prioritize resources to focus on advancing a CLDN18.2 and 4-1BB bispecific antibody for gastric cancers. -
The move is part of a strategic restructuring aimed at getting azenosertib to the market for patients with gynecological malignancies. -
Enhertu’s label expansion comes on the heels of the FDA’s approval of the partners’ Datroway for a related type of breast cancer.
NEUROSCIENCE
-
In a highly anticipated readout for the kappa opioid receptor class in major depressive disorder, Neumora’s navacaprant failed to meet the primary and key secondary endpoint in the first of three identical Phase III studies. -
This year saw lofty highs and devastating lows for neuroscience drug developers like Bristol Myers Squibb, Eli Lilly and AbbVie, following the predictable pattern of successes and failures that characterizes this space. -
Already established as cornerstone therapies in diabetes and obesity, GLP-1 receptor agonists also show potential in several other indications, including cancer, addiction and neurodegenerative diseases. -
BioArctic received $100 million upfront with another $1.25 billion in potential milestone payments on the line for two pyroglutamate-amyloid-beta antibodies. -
The report comes just two days after Novartis announced its own Parkinson’s drug failure.
CELL AND GENE THERAPY
-
While some of the initial excitement around immunotherapies has waned, companies—particularly smaller biotechs—are developing newer iterations that will take cancer care to the next level. -
The biotech beat Wall Street’s third-quarter revenue forecast by 6%, driven by increased uptake of its achondroplasia drug Voxzogo. However, William Blair downgraded BioMarin’s shares to market perform due to a “lack of near-term catalysts” and uncertainty around Voxzogo’s potential revenue growth. -
With Sarepta’s gene therapy Elevidys now available to a majority of Duchenne muscular dystrophy patients, experts express cautious optimism while emphasizing the need for further data. -
With an upfront payment of $50 million from Roche, the partnership will leverage Dyno Therapeutics’ in vivo gene therapy delivery technology, which synthesizes virus capsids with better functionality and manufacturability. -
While ex vivo genome editing results in highly effective cell therapies, it can lead to off-target effects. Caribou Biosciences has come up with a novel approach for potentially more precise gene editing compared to all-RNA guides.
