The antibody anselamimab, which AstraZeneca picked up in its 2021 purchase of Caelum Biosciences, failed to improve survival and reduce hospitalizations, but the company sees promise in data from an unspecified patient subgroup.
Johnson & Johnson’s $23.7 billion in second-quarter earnings, driven by cancer and neuroscience drugs, exceeded analyst expectations, while CEO Joaquin Duato set a target of $50 billion in oncology sales by 2030.
In advance of this week’s adcomm, the FDA flags ocular toxicities associated with the antibody-drug conjugate, which received accelerated approval in August 2020 but was pulled from the market two years later after a confirmatory trial failed to improve progression-free survival.
Shanghai-based LaNova Medicines—which has captured the attention of some of the biggest Western pharmas—will be folded into fellow Chinese company Sino Biopharmaceutical in a deal worth up to $951 million.
In a July 9 memo, the director of the FDA’s Center for Biologics Evaluation and Research contended there was not enough evidence that the benefits of Moderna’s COVID-19 vaccine Spikevax outweighed its risks in healthy children.
Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees and tying review times to drug prices; the regulator opens its trove of complete response letters in the name of transparency; and two companies receive rejections for rare disease therapies.
FEATURED STORIES
Biogen’s effort to buy Sage against the board’s wishes and a long-time effort by investor Alcorn to scuttle Aurion’s IPO underscore the cutthroat nature of biopharma dealmaking.
Ahead of Robert F. Kennedy Jr.’s confirmation hearings, experts—and RFK’s own family—expressed concerns about his vaccine-related views, though the same experts are largely unfazed by the level of power he and Marty Makary could ultimately wield over the FDA.
After two years characterized by layoffs, pipeline reorganizations, FDA delays and clinical holds, Novavax CEO John Jacobs says the company is at a pivot point.
Riding recent momentum in the Duchenne muscular dystrophy space, Capricor Therapeutics, Wave Life Sciences, Regenxbio and more aim to deliver the next wave of progress with near-term data and regulatory milestones.
Achondroplasia, which affects around one in 20,000 babies, has just one approved treatment: BioMarin’s Voxzogo. However, new investigational treatments are vying to compete in the area.
The Japanese pharma had one asset rejected by the FDA and withdrew a regulatory application for another, but already this month the company has secured an approval for AstraZeneca-partnered Dato-DXd, to be marketed as Datroway.
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, we discuss the expanded approval of Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys, Alnylam’s high stakes ATTR-CM win and highlights from ADA.
BioSpace’s Lori Ellis and Chantal Dresner bring live updates from day three of #DIA2024 in San Diego.
This week on Denatured, Head of Insights Lori Ellis and guests discuss the persisting challenges of diversity, equity and inclusion when designing clinical trials.
Job Trends
AbbVie (NYSE: ABBV) today announced that new data from its innovative antibody-drug conjugate (ADC) platform will be showcased across three oral presentations at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting (May 31 - June 4, 2024).
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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
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A longtime biopharma exec and Moderna shareholder argues in an anonymous email to the companies’ CFOs that they have a fiduciary responsibility to close the deal. Analysts say the proposal is interesting but “too simplistic.” -
While supportive of Amylyx’s acquisition of a GLP-1 drug, analysts say the company’s future hinges on key upcoming readouts from multiple products in its pipeline. -
The acquisition of the contract development and manufacturing organization will allow Agilent Technologies to provide a one-stop source for gene-editing services for its customers. -
Oral doses of SIGA Technologies’ antiviral drug Tpoxx will help the U.S. maintain its reserves of the vaccine in preparation for future potential outbreaks, according to the company. -
After completing a buyout transaction with The Column Group to remove it from the stock exchange, NGM Bio has raised a $122M Series A to fund a registrational study for a rare liver disease drug and a Phase II trial in hyperemesis gravidarum.
WEIGHT LOSS
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Novo said supply of Wegovy and Ozempic is in good shape after the drugs were removed from the FDA’s shortage list last week. But Eli Lilly reported slower than expected sales in the third quarter due to wholesaler destocking. -
Novo Nordisk’s total revenue in the third quarter missed analysts’ expectations but sales of weight loss drug Wegovy exceeded the consensus forecast. Still, the Danish drugmaker narrowed its full-year guidance for revenue and operating profit. -
While expected and seen as largely incremental, Jefferies analyst Peter Welford in a Tuesday note to investors said the detailed data for three early-stage assets support moving them into Phase IIb studies and creates a “foothold” for AstraZeneca in the weight loss space. -
Jefferies analyst Roger Song in an investor note said that Viking Therapeutics’ readout for its investigational therapy VK2735 exceeded expectations, with “class-leading” weight loss. Patients on 100-miligram doses of the pill lost 8.2% of their body weight after 28 days. -
In part 1 of the pivotal ESSENCE trial, Novo Nordisk’s weight loss drug Wegovy demonstrated “statistically significant and superior improvement” in liver fibrosis in patients with metabolic dysfunction–associated steatohepatitis.
POLICY
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Under Friday’s final ruling anti-obesity medications for weight-loss will remain ineligible for Medicare coverage. -
Kennedy, a long-time opponent of vaccines, stated that the MMR vaccine is “the most effective way” to combat the measles outbreak, which has already claimed the lives of two children in the U.S. -
Pharma’s reprieve from Donald Trump’s tariffs is expected to be temporary, with Leerink analysts anticipating possible sector-specific duties “in the next month or so.” -
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. -
Trump has repeatedly called April 2 “Liberation Day,” alluding to a more sweeping and aggressive set of tariffs. Leerink Partners analysts said that the risks from Trump’s tariffs on the biopharma industry are “underappreciated.”
Requesting disability accommodations is vital for your success in the workplace. You can find out everything about how to ask for accommodations in our guide.
Before searching for a job in the life sciences industry, it is essential to understand the differences between working as a contractor and a full-time employee.
Mentioning these certifications in your resume will set you apart from other candidates, clearing your path to your desired role. Learn here how to add certification to resume.
Applying to your first pharma internship may feel overwhelming, but it doesn’t have to be. Discover how to find, prepare for and be successful in an internship in the pharma industry in our guide.
Learn how to successfully hire interns. Also, find some tips on how to manage and support both in-office and remote interns in our comprehensive guide.
Just because everyone around you seems to be switching to a work-from-home position does not mean it is the right decision for you. It’s important to weigh the options carefully before you decide.
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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The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a third-party provider while releasing Amylyx’s investigational ALS therapy from a previous pause. -
Datroway, formerly known as Dato-DXd, significantly improved median progression-free survival in a Phase III study but failed to do so for overall survival. -
Even before the FDA’s recent approval of Dato-DXd in breast cancer, analysts predicted sales of the antibody-drug conjugate could hit $5.9 billion in 2030. However, the asset faced a series of setbacks in 2024. -
Traditionally carrying a dire prognosis, the treatment paradigm for multiple myeloma is changing, with CAR T therapies, bispecifics and more contributing to multifaceted regimens unique to each patient’s needs. -
The conversion of Calquence’s accelerated approval in mantle cell lymphoma comes a day before the drug was listed among the 15 products to be subject to IRA-prescripted price negotiations for Medicare this year.
NEUROSCIENCE
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Alector is kicking off a resource realignment effort that will include a workforce reduction. The biotech expects its current cash position to last it through 2026. -
While taldefgrobep alfa failed to show improved motor function in spinal muscular atrophy, treated patients saw a marked reduction in body fat. Biohaven plans to launch a Phase II trial in obesity by the end of the year. -
Cassava Sciences has revealed the late-stage clinical failure of controversial Alzheimer’s drug simulfilam. The company had pledged to share the results whether “good, bad or ambiguous.” -
Sage Therapeutics discontinued development of its lead candidate dalzanemdor after a third clinical failure, leading analysts to question the biotech’s future profitability. -
After previously failing studies in Parkinson’s and Alzheimer’s, dalzanemdor’s latest stumble in Huntington’s disease has pushed Sage Therapeutics to pull the plug on the NMDA receptor modulator.
CELL AND GENE THERAPY
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Tim Hunt, CEO of the Alliance for Regenerative Medicine, said Monday at the 2024 Cell & Gene Meeting on the Mesa that investments reached $10.9 billion in the first half of this year—outpacing 2019’s $9.8 billion total—but far below the pandemic peak. -
The Financial Times reported Thursday that WuXi AppTec is looking to sell its cell and gene therapy manufacturing unit, with facilities in Philadelphia, while WuXi Biologics wants to offload some of its production sites in Europe. -
Stephen Majors from the Alliance for Regenerative Medicine, which hosts the conference, spoke with BioSpace about what the more than 2,000 attendees can expect to learn next week in Phoenix about the pressing issues confronting the industry. -
To say that 2seventy bio’s short two years of existence have been dramatic is an understatement. CEO Chip Baird told BioSpace transparency and a committed staff have kept the biotech going through thick and thin. -
District Judge Jesse Furman ruled that the plaintiff, UMB Bank, does not have standing to bring the case against Bristol Myers Squibb because it is not a properly appointed trustee for shareholders’ contingent value rights.
