The Seattle-based company came to ASCO25 with new data on its neuroendocrine tumor–treating lead therapy, with big vibes and speedy speech.
Given the evidence, the committee has recommended that the labels for Novo Nordisk’s Wegovy and Ozempic be updated to include the “very rare” risk of non-arteritic anterior ischemic optic neuropathy.
Otsuka’s investigational antibody sibeprenlimab approximately halved levels of this key biomarker in patients with immunoglobulin A nephropathy.
In a roundtable event on Thursday, HHS Secretary Robert F. Kennedy Jr. said his office will work to eliminate barriers that keep cell and gene therapies from the market.
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.
FEATURED STORIES
Pharmaceutical companies are combining antibodies with radioisotopes in a bid to more precisely deliver radiation to cancers and tumors.
This week marked the start of the third-quarter earnings season, with Johnson & Johnson exceeding Wall Street’s expectations. Pfizer is projected to have a strong quarter, while Eli Lilly could pull ahead of Novo Nordisk in the obesity space. Moderna, by contrast, has a decidedly negative outlook.
Artificial intelligence won’t replace people in biopharma, but it is infiltrating every step of drug development, including in some ways that aren’t so obvious.
Sanofi looks to follow a deep history of Big Pharma offloading their consumer healthcare businesses.
Analysts expect the partners’ first-mover advantage, clinical data and existing presence in lung disease to translate into significant sales, with GlobalData predicting Dupixent’s COPD revenues will top $6.5 billion within 10 years.
As companies roll out data showing the power and improved safety profile of antibodies that target two antigens, analysts say the class could overtake monoclonal antibody Keytruda as the “immunotherapy backbone” of solid tumor treatment.
FROM BIOSPACE INSIGHTS
While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience that would make change possible.
LATEST PODCASTS
The team comes together to discuss the dominant themes of what was an incredibly busy week of events in San Francisco during JPM 2024.
The BioSpace team is recording from San Francisco as they bring you the the latest highlights from Day 3 at JPM2024.
The BioSpace team is recording from San Francisco as they bring you the the latest highlights from Day 2 at JPM2024.
Job Trends
Moderna, Inc. reported financial results and provided business updates for the first quarter of 2024.
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SPECIAL EDITIONS
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.
A new generation of checkpoint inhibitors is emerging, with some showing more promise than others. From recent TIGIT failures to high-potential targets like VEGF, BioSpace explores what’s on the horizon in immuno-oncology.
Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the instability of the HHS.
DEALS
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Contineum Therapeutics priced its initial public offering Friday, scaling back its expectations for gross proceeds of $110 million for clinical trials of a challenger to Boehringer Ingelheim and Roche. -
Acorda Therapeutics becomes the latest biotechnology company in 2024 to go bankrupt and shutter its business, following years of financial difficulty. Merz Therapeutics will acquire two commercial medicines from Acorda for $185 million. -
Genmab announced Wednesday it is buying ProfoundBio and its pipeline of next-generation antibody-drug conjugates being developed for gynecologic cancers and other solid tumors. -
Following a series of rejections and clinical failures, Eiger BioPharmaceuticals has declared bankruptcy and will sell all its assets as the company winds down operations. -
Avalo Therapeutics rolled the dice on a big pivot Wednesday, acquiring AlmataBio and focusing on the biotech’s ex-Eli Lilly hidradenitis suppurativa candidate over its existing assets.
WEIGHT LOSS
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Encouraged by the potential of the weight-loss candidates acquired from Carmot Therapeutics, Roche will speed up the development of its obesity programs, seeking to differentiate itself in the market. -
With promising Phase II data in hand, Viking Therapeutics is pushing its subcutaneous GLP-1/GIP receptor dual agonist into late-stage development, the company announced on Wednesday. -
Despite early 2024 optimism, BioSpace’s Job Market Trends report outlines a still sluggish situation in the biopharma industry, Novartis and J&J announce Q2 earnings, GLP-1 market leaders expand into China and the Cassava Sciences saga continues. -
Eli Lilly’s tirzepatide, which has previously been approved in China for diabetes, can now also be used for chronic weight management in the world’s second most populated country. -
While type 2 diabetes and obesity are the primary conditions currently treated with blockbuster GLP-1 drugs, Novo Nordisk and Eli Lilly aim to enter additional markets.
POLICY
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The selection of controversial TV personality Mehmet Oz to run the agency overseeing Medicare and Medicaid follows Trump’s pick of RFK Jr. to run its parent department, HHS. -
While the full impact of the Supreme Court decision remains unknown, the new regulatory landscape could be a net positive for drug developers. -
Trump’s HHS pick, Robert F. Kennedy Jr., is an anti-vaccine campaigner who has previously said that he plans to gut the FDA on allegations of corruption and reduce the NIH’s headcount. -
Suggestions that the U.S. should emulate other countries on drug price controls or patents obscure how our present policies have allowed drug development to flourish.
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Analyst reactions to Donald Trump’s election victory were mixed Wednesday, with potential positives including an FTC that is likely to be more friendly to M&A, and negatives including concerns about what role Robert F. Kennedy, Jr. might play in healthcare.
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.
Just like first impressions, the first 30 days at your new job can set the tone for a new position.
Providing interview feedback to the candidate after an interview is very crucial if you want to pick out only the best. This article will help you do that efficiently.
Are you feeling that your productivity is decreasing at work? Here are some beneficial time management strategies to be mindful of to get work done efficiently.
Here are some of the best remote companies to work for this year. These companies can provide you with the right kind of exposure that will help you professionally.
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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Opdivo showed a 52% progression-free survival advantage over Adcetris in newly diagnosed Hodgkin’s lymphoma, according to a Phase III study that combined either therapy with doxorubicin, vinblastine and dacarbazine. -
Thursday’s agreement with Orano Med is the second in as many months. Sanofi in September made its first foray into the radioligand space with a $110 million licensing deal with Orano Med and Texas biotech RadioMedix. -
Jazz Pharmaceuticals contends that its alkylating agent Zepzelca significantly improved both overall survival and progression-free survival in patients with extensive-stage small cell lung cancer, when used as a front-line maintenance therapy with Roche’s Tecentriq. -
Sales of Johnson & Johnson’s oncology drugs jumped nearly 19% in the third quarter, driven by cancer treatment Darzalex which brought in more than $3 billion. -
The FDA is looking at four events for the remainder of October, one of which is an advisory committee meeting for a dual SGLT inhibitor for use alongside insulin in type 1 diabetes and chronic kidney disease.
NEUROSCIENCE
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Neurocrine Biosciences’ potential competitor to Bristol Myers Squibb’s KarXT improved symptoms of schizophrenia in a Phase II trial, but only at the low dose tested. -
While approved by the Medicines and Healthcare products Regulatory Agency, the Alzheimer’s drug failed to win the backing of the U.K.’s National Institute for Health and Care Excellence, which said that its benefits were “too small to justify the cost.” -
Psychedelic drug developers are undeterred by the FDA’s Complete Response Letter for the company’s MDMA therapy for PTSD, and experts expect Lykos will ultimately obtain approval. -
On the heels of last week’s FDA rejection of Lykos’ MDMA-assisted PTSD therapy, Atai announced Tuesday positive preliminary results for its DMT-based treatment for depression from a Phase Ib study. -
Crexont was previously rejected by the regulator in June 2023, citing insufficient safety data. However, Amneal Pharmaceuticals’ resubmission included findings from a healthy volunteer study.
CELL AND GENE THERAPY
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BioSpace’s Lori Ellis discusses the risks and challenges of cell and gene therapy combination products with DIA speakers James Wabby, AbbVie and Rob Schulz, Suttons Creek, Inc. -
Belgian biotech Galapagos is teaming with Blood Centers of America to help deploy its decentralized CAR-T therapy manufacturing platform closer to treatment centers across the U.S. -
Following back-to-back approvals in lymphocytic leukemia, Bristol Myers Squibb’s CAR-T therapy Breyanzi on Wednesday won the FDA’s green light for relapsed or refractory follicular lymphoma. -
While these technologies are now a therapeutic reality, the ASGCT 2024 annual meeting this week was a reminder of just how far we are from widespread use. -
With 15 patients started across its three gene therapies, bluebird bio claims a 138% year-over-year revenue growth and aims to initiate up to around 100 new patients in the current year.
