Empaveli reduced proteinuria by 68% versus placebo in glomerulopathy and glomerulonephritis, an effect that was sustained through one year of follow-up.
While ALTO-203 missed its depression-related endpoints, improvements in EEG biomarkers, attention and wakefulness point to signals of drug activity, William Blair said, though the analysts pointed to other indications as potentially more promising for future development.
Susan Monarez, already acting director of the CDC, said during her confirmation hearing that she sees no causal link between vaccines and autism.
Jefferies analysts called the proxy filing, which is a standard disclosure after a merger agreement, “much more intriguing than normal” given the regulatory turmoil it revealed.
Minovia’s lead product is MNV-201, an autologous hematopoietic stem cell product that is enriched with allogeneic mitochondria.
Flagship Pioneering’s ProFound Therapeutics will use its proprietary technology to mine the expanded proteome for novel cardiovascular therapeutics. Novartis has promised to pay up to $750 million per target, though it has not specified how many targets it will go after.
Without providing further context, HHS Secretary Robert F. Kennedy Jr. says that Gavi needs to “start taking vaccine safety seriously” by considering “the best science available.”
FEATURED STORIES
A tale of two multi-billion schizophrenia deals, AstraZeneca touts strong sales while deflecting questions about an investigation into China exec, the Huntington’s pipeline builds momentum and layoffs continue with Sana Biotechnology and 23andMe.
Novo Holdings’ acquisition of Catalent has ignited concerns from industry stakeholders, who fear that the consolidation could limit competition, but there is also the possibility that the deal could represent an opportunity for smaller-scale CDMOs to find new partners.
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.
BioSpace takes a look at the headlines across a heavy earnings week for biotechs, checking in on Allogene, Rapport and more.
CEO Roberto Iacone admitted in an interview that the market remains tough, even for a biotech in the red-hot ADC world. But Alentis is targeting an IPO as early as 2025.
Digitization enables each drug to have a software-enhanced version optimized for individual patients.
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
This week Lori, Greg and Tyler discuss AbbVie: how longtime CEO Richard Gonzalez ⁠navigated Humira’s LOE⁠, his victorious retirement ⁠announcement⁠, and the future of biosimilars.
This week Lori, Greg and Tyler discuss the ⁠Accelerated Approval of Amtagvi⁠, the first one-time cell therapy for solid tumors and the first TIL therapy; the ⁠FTC and HHS probe⁠ into generic drug shortages and some recent ADC-focused raises from ⁠ProfoundBio⁠ and ⁠Firefly Bio⁠.
This week, Greg, Heather and Tyler discuss reaction to ⁠Novo Nordisk’s purchase of Catalent⁠ and speculate on what that means for existing manufacturing contracts, customers and consequences with ⁠regulators⁠.
Job Trends
Thermo Fisher Scientific One Lambda Laboratories, a CLIA facility in Fishers, Ind., has introduced a new CXCL10 testing service, which allows for non-invasive urine sample collection and testing, with results available in as little as 24 hours, providing valuable information faster than currently used tests.
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SPECIAL EDITIONS
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.
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.
DEALS
  1. The FTC and the U.S. Department of Justice’s antitrust division will have another 30 days to examine Novo Nordisk Foundation’s acquisition of contract manufacturer Catalent, according to an SEC filing.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
WEIGHT LOSS
  1. 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.
  2. In agreeing with Novo Nordisk and Eli Lilly, Pennsylvania judge Karen Spencer Marston said the court should first settle questions of gastroparesis diagnosis and sufficient warnings for side effects.
  3. Through its online pharmacy LillyDirect, Eli Lilly announced Tuesday it will allow patients to purchase single-dose vials of Zepbound—without the autoinjector—at a 50% discount or more versus other incretin obesity treatments.
  4. In this deep dive BioSpace dissects the global obesity and diabetes markets along with the growing pipelines that aim to serve them.
  5. Patients taking Novo Nordisk’s blockbuster GLP-1 drug appear to be more likely to harbor thoughts of suicide or self-harm, especially if they are already suffering from anxiety or depressive disorders, according to a new study.
POLICY
  1. From March 2020 through September 2022, Biohaven wielded meals at high-end restaurants and paid speaking opportunities to induce healthcare providers to prescribe its migraine therapy Nurtec ODT, according to the Department of Justice.
  2. Less than a day into his second term, President Donald Trump ordered a freeze on communications at major public health agencies, among other moves that have sent waves through the biopharma industry.
  3. The settlement is the largest deal to date with the people primarily who played an “instrumental role” in driving the opioid crisis, according to the office of Massachusetts Attorney General Andrea Joy Campbell.
  4. Robert F. Kennedy, Jr.’s recent disclosures have revealed several potential conflicts of interest, including investments in two biopharma companies.
  5. The U.S. Court of Federal Claims ruled that Vanda cannot claim a breach of confidentiality for specifications that it did not develop itself.
CAREER HUB
The interview process at many organizations is not limited to a single interview. Multiple interviews are common and can occur for numerous reasons.
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.
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.
HOTBEDS
Where are the Best Places to Work in life sciences? BioSpace’s annual Best Places to Work list demonstrates a company’s desirability in the recruitment marketplace - find out who made the list this year.
IN CASE YOU MISSED IT
In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the concerns and opportunities of patient data driving AI tasks with Louise Molloy, associate director medical information and pharmacovigilance.
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
  1. Truqap’s positive clinical data comes after it failed a late-stage study in metastatic triple-negative breast cancer. It helps AstraZeneca position itself as a top player in the prostate cancer space, alongside its Big Pharma colleagues.
  2. ADC Therapeutics, Sutro Biopharma and Zai Lab are among those developing antibody-drug conjugates to address payload and toxicity challenges of current ADCs—and rapidly grow the multibillion-dollar market.
  3. The agreement will give Kura enough capital to support the development and launch of its menin inhibitor ziftomenib.
  4. Analysts are split on whether the positive trial results will help Merck stem future Keytruda losses as the mega-blockbuster goes off patent in 2028.
  5. The deal has secured Novartis the chance to work with Ratio Therapeutics on a novel drug candidate that could fortify the Big Pharma against competition from would-be radiopharmaceutical rivals such as BMS and Lilly.
NEUROSCIENCE
  1. The investigational injection fosgonimeton appeared to have better efficacy in patients with more severe disease, according to post-hoc subgroup analyses, though none resulted in statistically significant effects.
  2. Recursion’s oral drug candidate for cerebral cavernous malformation showed no improvements in patient- or physician-reported outcomes at 12 months. The biotech will engage with the FDA to determine the need for an additional study.
  3. The BTK inhibitor showed promise in non-relapsing secondary progressive multiple sclerosis but not relapsing MS. The company said it plans to apply for approval for the former “as soon as possible.”
  4. The FDA has three regulatory milestones in the next two weeks, including a decision on a subcutaneous formulation of an effective multiple sclerosis therapy.
  5. 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.
CELL AND GENE THERAPY
  1. One patient died of respiratory failure in a Phase I study of Lyell Immunopharma’s investigational CAR-T therapy. The company on Wednesday said it has not definitively linked the fatality to the treatment.
  2. FDA
    After winning expanded approval for its gene therapy for Duchenne muscular dystrophy, Sarepta’s leadership and analysts see a sizeable commercial opportunity on the horizon.
  3. Exsilio Therapeutics emerged from stealth on Tuesday with a platform that leverages mRNA technology to develop redosable genomic medicines for a range of complex diseases.
  4. FDA
    While Thursday’s label expansion and traditional approval for the gene therapy is an important milestone, many challenges still face the Duchenne muscular dystrophy community.
  5. FDA
    On the heels of a Phase III flop for Pfizer’s Duchenne muscular dystrophy gene therapy candidate, the FDA has green lighted the expanded use of Sarepta Therapeutics’ Elevidys.