Analysts at Truist Securities called the mid-stage data a “mixed bag,” also flagging gastrointestinal adverse events. However, the readout is unlikely to be “incremental” to Corcept’s overall stock narrative.
Interim results from a small group of children in a Phase I/II trial are essentially in line with that of Elevidys, according to BMO Capital Markets analysts.
In this episode of Denatured, presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses how AI transformation can help organizations navigate a rapidly evolving regulatory environment with senior director of regulatory innovation and technology, Michelle Gyzen.
The Platform Technology Designation, which predates the current FDA leadership, is designed to streamline the drug development and review process, particularly for rare diseases.
The lawsuit alleges that HHS leadership knew the records they used to guide their layoff decisions were inaccurate and contained errors.
Genrix’s velinotamig complements Cullinan’s own pipeline, according to William Blair, which added that the deal will put Cullinan in a better position to target autoimmune diseases.
FEATURED STORIES
Some analysts say so, and a recent study suggested Lilly’s tirzepatide beat Novo’s semaglutide at inducing weight loss, but there are other factors in the market race.
After a busy first half of 2024, several companies are expecting key data readouts in the neuropsychiatric and neurodegenerative disease spaces during the next six months.
Halia Therapeutics, NodThera and Gain Therapeutics target neuroinflammatory processes in hopes of modifying the course of Parkinson’s progression.
Why I advocated on Capitol Hill this month for the renewal of the FDA’s Priority Review Voucher program
The Federal Trade Commission criticized the business practices of pharmacy benefit managers this week, but drugmakers are also at fault for the high costs of medicines.
Artificial intelligence is making it faster to get drug candidates to the clinic, but to gain a competitive advantage, companies must have a strong foundation of data.
FROM BIOSPACE INSIGHTS
Establishing trust through thought leadership is no longer optional in today’s cautious biopharma market. Learn how strategic insights and targeted outreach can turn awareness into high-converting leads.
LATEST PODCASTS
Eli Lilly drops a second Phase III readout for orforglipron; AbbVie committed to the psychedelic therapeutics space with the $1.2 billion acquisition of Gilgamesh’s depression asset; the CDC taps vaccine skeptic Retsef Levi to lead its COVID-19 immunization working group; and the FDA prioritizes overall survival in cancer drug development.
Closely watched data from Eli Lilly and Viking Therapeutics this month have reignited the discussion around oral weight-loss drugs—and their ultimate place within the anti-obesity medication market.
In this episode presented by Cresset, BioSpace’s head of insights Lori Ellis discusses clinical trial fail rates and AI’s potential to reduce preclinical costs with Mutlu Dogruel, VP of AI and Mark Mackey, CSO of Cresset.
Job Trends
Looking for regulatory jobs in the biopharma industry? Check out the BioSpace list of seven top companies hiring for these critical roles.
Subscribe to Genepool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
SPECIAL EDITIONS
BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
BioSpace did a deep dive into executive pay, examining the highest compensation packages, pay ratios and golden parachutes—what a CEO would get paid to leave.
DEALS
-
The Swiss drugmaker gains rights to RVT-3101 in the U.S. and Japan. Telavant was formed in late 2022 by Roivant and Pfizer, which had a 25% stake in the venture and retains rights to the antibody in other countries. -
While Merck lost out to Pfizer earlier this year in snapping up Seagen, this week the company closed a deal worth a potential $22 billion with Daiichi Sankyo—further evidence of the industry’s insatiable appetite for ADC technology. -
Despite increasing antitrust scrutiny across the biopharma industry, the European Commission on Thursday said it found no competitive issues with Pfizer’s buyout of the antibody-drug conjugate company. -
Sail Biomedicines combines Laronde’s circular eRNA platform with Senda’s nanoparticle delivery technology in the pursuit of a new class of programmable medicines across therapeutic areas. -
The Danish pharma announced Monday that it is buying a Phase III hypertension candidate from Singapore-based KBP Biosciences. It is Novo Nordisk’s third high-value purchase in as many months.
WEIGHT LOSS
-
The European Medicines Agency on Friday said it found no evidence linking GLP-1 receptor agonists with suicidal thoughts and actions, following a review of patients taking Novo Nordisk’s semaglutide and liraglutide, and Eli Lilly’s dulaglutide and AstraZeneca’s exenatide. -
Florida District Judge Roy Altman earlier this week ruled against Eli Lilly, finding that the drugmaker cannot use state law to block reformulated versions of its blockbuster weight-loss and diabetes medication tirzepatide. -
The American Society of Health-System Pharmacists has released statistics showing the number of active and ongoing U.S. drug shortages has reached 323, the highest number since it began tracking the data. -
GLP-1 treatments are all the rage in this space, but they aren’t the only approach in development. The pipeline assets highlighted here offer a differentiated approach, potentially increasing efficacy or reducing side effects. -
A new Scandinavian study published Wednesday found no conclusive evidence to support the link between GLP-1 receptor agonists and an increased risk of thyroid cancer.
POLICY
-
For the Biden-Harris administration to compare the newly announced negotiated Medicare prices to the list prices for these drugs is, at best, not very meaningful. At worst, it’s disingenuous. -
Just months after a jury ordered payment to Pfizer in the patent infringement case, a Delaware judge has nullified the award and invalidated the patents behind the lawsuit involving AstraZeneca’s blockbuster lung cancer drug. -
The Biden administration on Thursday touted discounts of up to 79%, but many of these first 10 drugs are already sold well below list price.
-
The Biden administration on Thursday announced that the Inflation Reduction Act’s Medicare Drug Price Negotiation Program will save the U.S. government around $6 billion in its first year of implementation. -
The new Medicare prices for the first 10 drugs negotiated under the Inflation Reduction Act are expected soon. Analysts and researchers are divided on the long-term effects of the law.
CAREER HUB
Most life science and biotech professionals are aware of the highly competitive process involved with trying to secure full-time positions in academia. Approximately 42% of life science professionals with doctorate degrees work in academia.* Unfortunately, only a fraction of them have full-time faculty positions.*
Ask yourself these questions to get an idea of whether a new job should be in your near future.
Establishing rapport with someone you’ve just met who also may hold your future in their hands is not easy. Continue reading to discover how to establish rapport with your interviewer.
The first few minutes of your job interview are critical, as studies show hiring managers form strong impressions to make their hiring decisions based on these early minutes of the interview.
Here are three tips to help you land a management position when you’ve never been a manager.
It has been said that qualifications are more of a “wish list” for employers, who do not expect to find someone who meets all the requirements.
Simply staying organized will help you make sure you never miss a beat. Here are a few small steps that’ll make a big difference.
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
-
BioNTech and Regeneron will face off against Merck and Moderna, which are advancing their investigational cancer vaccine mRNA-4157/V940 in combination with Keytruda, in advanced melanoma. -
AstraZeneca is seeking a fixed-duration approval for Calquence, which will allow patients with chronic lymphocytic leukemia to take breaks from the therapy and prevent excessive toxicities and drug resistance. -
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. -
The combination therapy is one step closer to becoming a potential new first-line standard of care for patients with unresectable or metastatic urothelial carcinoma in Europe.
-
The FDA has four big events in the coming two weeks, including an advisory panel meeting for an ultra-rare disease.
NEUROSCIENCE
-
Heather, Greg and Tyler discuss a busy news week including Wegovy’s label expansion, biosimilars, surprise donanemab delays for Eli Lilly and speculate on election impact. -
The FDA plans to convene an advisory committee meeting to discuss the safety profile and efficacy of Eli Lilly’s Alzheimer’s candidate, the company announced Friday. -
The regulator’s new draft guidance, released on Monday, provides additional details regarding the use of surrogate and biomarker endpoints to support accelerated approvals. -
In Monday’s neurology update for investors, Roche touted data from a small Ib/IIa trial for trontinemab, an investigational therapy for Alzheimer’s disease which demonstrated “rapid and robust” amyloid plaque reduction.
-
Acadia Pharmaceuticals is terminating development of its antipsychotic drug pimavanserin, which did not demonstrate a statistically significant improvement over placebo in the late-stage study’s primary endpoint.
CELL AND GENE THERAPY
-
Appia Bio’s shutdown continues an unfortunate trend this year that has seen biotech closures nearly every month. -
In late May, a patient died after receiving Rocket Pharmaceuticals’ investigational gene therapy for Danon disease, spurring the hold. After lowering the dose and changing the regimen of immune modulators patients receive, the company has received FDA clearance for the trial to continue. -
The FDA has postponed its decision date for Regenxbio’s Hunter syndrome gene therapy to review additional longer-term clinical data for the asset. -
Kriya is advancing a host of gene therapies for a wide variety of chronic diseases, including geographic atrophy, trigeminal neuralgia and type 1 diabetes. -
Prasad Returns, Delany Departs, Lilly’s Weight Loss Pill Disappoints and Sarepta’s Fallout ContinuesCBER Chief Vinay Prasad reclaimed his job less than two weeks after his mysterious exit; MAHA implementor Gray Delany is out after reportedly sparring with other agency officials over communications strategy; Eli Lilly’s first Phase III readout for oral obesity drug orforglipron missed analyst expectations; and Arrowhead Pharmaceuticals addresses the recent woes of its of partner Sarepta.
