Isaralgagene civaparvovec is a “potential best-in-class gene therapy for Fabry disease,” according to analysts at H.C. Wainwright. Sangamo plans to use pivotal Phase I/II data to build an accelerated approval case for the asset.
In May, Revolution Medicines projected its cash and equivalents of $2.1 billion would last into the second half of 2027. With new funding from Royalty Pharma, the biotech has withdrawn that runway end date.
The star of Monday’s deal is gusacitinib, a small-molecule drug that Formation is developing for chronic hand eczema. Sanofi will explore additional indications for gusacitinib in a Phase I study.
Eli Lilly’s bimagrumab led to weight loss that was due almost entirely to fat reduction when combined with semaglutide, marketed by rival Novo Nordisk as Wegovy. BMO Capital Markets called the data “impressive” while raising concerns about the antibody’s safety profile.
Speaking at BIO2025, rare disease leaders from Ultragenyx, Amylyx and Yale questioned the need for the new regulatory pathway proposed by FDA Commissioner Marty Makary. They acknowledged, however, that creative thinking is required to enable more treatments for patients with ultrarare diseases.
Jacqueline Corrigan-Curay, who stepped into the role as the agency’s top drug regulator in January, is departing in July, according to an email sent to agency staff.
FEATURED STORIES
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.
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.
While some biopharma companies beat expectations, others fell short for various reasons, with some deciding to return or axe assets.
Hundreds of companies are currently running clinical trials in the increasingly lucrative obesity space. BioSpace looks at five candidates with data expected before the end of the year.
Clinical trial concerns and a negative advisory committee vote ultimately sunk the treatment.
This week, Q2 earnings from Novo Nordisk and Eli Lilly revealed that the competition between the pharma giants’ weight-loss drugs Wegovy and Zepbound is getting closer.
FROM BIOSPACE INSIGHTS
Listen now for a high-level discussion on overcoming pharmaceutical supply chain challenges through end-to-end integration.
LATEST PODCASTS
In this episode of Denatured, BioSpace’s head of insights Lori Ellis and Colin Zick, partner at Foley Hoag LLP, spend time discussing some of the points brought up in the Bioprocessing Summit last month. They explore the connections between hammers, AI, The Planet of the Apes and monoliths.
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.
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.
Job Trends
Pfizer Inc. announced that a Phase 3 study of the antibody-drug conjugate ADCETRIS® in combination with lenalidomide and rituximab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma showed a statistically significant and clinically meaningful improvement in overall survival compared to lenalidomide and rituximab plus placebo.
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SPECIAL EDITIONS
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.
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
DEALS
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The first two weeks of October saw BMS’s $4.8 billion buyout of Mirati, Lilly’s $1.4 billion purchase of Point, Kyowa Kirin’s $387 million acquisition of Orchard and AbbVie’s $110 million Mitokinin deal. -
An increase in funding share and available lab space helps to keep the Bay State’s biotech and pharma sectors strong. -
The European Commission on Thursday ordered Illumina to divest Grail, opening the next chapter in the years-long regulatory saga. Illumina is reviewing the order, Reuters reported. -
From Statera Biopharma and Sorrento Therapeutics to Aceragen and Infinity Pharmaceuticals, 2023 has seen a record high 28 bankruptcies in the biotech space so far. Here’s why. -
Following rumors last week of a potential acquisition by Sanofi, Bristol Myers Squibb on Sunday announced that it paid $4.8 billion to gain access to Mirati Therapeutics’ oncology-focused portfolio.
WEIGHT LOSS
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The clinical-stage biotech emerged from stealth on Thursday with several oral and injectable candidates, including a GLP-1 receptor agonist in Phase I trials, in an effort to challenge Novo Nordisk and Eli Lilly. -
Nearly all doses of Eli Lilly’s highly popular weight-loss drug Zepbound and type 2 diabetes medication Mounjaro will have limited availability through the second quarter of 2024, according to the regulator. -
With Wednesday’s readout showing symptom improvements in obstructive sleep apnea patients, Eli Lilly is preparing to file for a label expansion for its blockbuster weight-loss drug Zepbound. -
The German biopharma company on Tuesday announced ambitious pipeline plans that include starting 10 new Phase II and III trials over the next 12 to 18 months. -
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.
POLICY
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Healthcare players are pointing fingers amid regulatory crackdowns on pharmacy benefit managers, but proposed reforms wouldn’t address a dearth of competition in the larger market. -
A recent study estimated that Wegovy’s label expansion beyond obesity could push Medicare spending to $145 billion annually, but analysts remain dubious of the estimate. -
The U.S. House of Representatives on Monday overwhelmingly passed the bipartisan bill, which targets WuXi AppTec, WuXi Biologics and other Chinese biotech companies as potential national security risks. -
As Congress considers a bill that aims to distance U.S. biopharma from five Chinese companies, the industry must emphasize the importance of prioritizing patient care over power plays. -
Eli Lilly this week announced plans to sell single-dose vials of its weight loss drug Zepbound directly to consumers. Novo Nordisk could adopt a similar strategy for Wegovy as its CEO is set to testify Sept. 24 before the Senate health committee.
Many hiring managers agree on candidate interview behaviors that annoy them – sometimes to the extent of sinking the interviewee’s chances.
Job interviewing can be an unnerving experience, but if you know how to handle some of the stickiest situations encountered in interviewing, you can be that much more confident.
Many principles of an online interview are unknown to everyone and they lack confidence. Here are some virtual interview tips to help enhance your skills.
Consider limiting the use of “manage” on your resume, opting instead for more powerful keywords for your resume that can better indicate you’re a leader.
If you’re having trouble finding your confidence again, try these tips for regaining a (healthy) ego.
The interview process at many organizations is not limited to a single interview. Multiple interviews are common and can occur for numerous reasons.
HOTBEDS
IN CASE YOU MISSED IT
The Annals of Internal Medicine ran a large-scale study in July, pointing to the lack of an association between childhood aluminum exposure through vaccination and chronic conditions. The Health Secretary, in an opinion piece earlier this month, called the paper a “ballyhooed study.”
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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In pursuit of Merck’s blockbuster Keytruda, GSK’s Jemperli scored its own broad FDA label expansion, allowing its use in first-line endometrial cancer regardless of biomarker status. -
As part of a major reorganization, Vir Biotechnology has discontinued the bulk of its virology work and pivoted to cancer in an exclusive licensing deal with Sanofi. -
Incyte announced Tuesday it is realigning its research and development priorities to focus on dermatology and inflammatory assets obtained from the $750 million acquisition of Escient Pharmaceuticals. -
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.
NEUROSCIENCE
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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. -
A federal appeals court Monday backed Teva and Viatris’ challenge to a lower court ruling, finding that the companies can again make their case against Johnson & Johnson’s patent covering its schizophrenia drug Invega Sustenna. -
The filing of a Biologics License Application for a subcutaneous version of Biogen and Eisai’s Leqembi (lecanemab) has been delayed due to procedural reasons, the companies announced Monday. -
While disease-modifying therapies largely steal the spotlight in Alzheimer’s drug development, several companies are working to solve this less-discussed but disruptive facet of the illness. -
Imagine testing a really good drug for HER2+ breast cancer in someone with liver cancer. Would it be any surprise when that drug fails?
CELL AND GENE THERAPY
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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. -
A new analyst survey suggests that doctors are still prescribing Sarepta’s Elevidys, even after a series of deaths in certain populations marred the gene therapy’s record. -
The patient-specific nature of autologous cell therapies presents unique challenges that can best be addressed by a middle path between on-site and centralized manufacturing. -
Capsida has yet to disclose the exact cause of death. The patient had received the gene therapy CAP-002 for a type of epilepsy. -
Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three years off development timelines.
