Dispatch seeks to address two main challenges of immunotherapies in solid tumors: the lack of a target and the immunosuppressive tumor environment.
The FDA will select at most five companies that align with national priorities, including lower drug prices and increased domestic investment.
The voluntary pauses follow two patient deaths associated with the Duchenne muscular dystrophy gene therapy.
A retrospective cohort study found that semaglutide and tirzepatide are linked with significantly lower risks of dementia and stroke, hinting at potential neuroprotective effects of GLP-1 therapies.
Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug regulator in George Tidmarsh, a handful of new drugs get turned away from the market and pharma companies continue to commit billions to reshoring manufacturing.
BMO Capital Markets pointed to FDA leadership, and CBER Director Vinay Prasad in particular, as potential factors in the agency’s decision to issue a complete response letter for Replimune’s viral treatment RP1 for advanced melanomas. Shares of the company tumbled 75% on Tuesday.
FEATURED STORIES
M&A didn’t return as hoped for in 2024. The biopharma industry is heading into the J.P. Morgan Healthcare Conference next week in a grim mood.
Madrigal Pharmaceuticals, X4 Pharmaceuticals and Day One Biopharmaceuticals secured their maiden approvals this year in metabolic dysfunction-associated steatohepatitis, WHIM syndrome and pediatric low-grade glioma. Geron Corporation and ImmunityBio also notched wins.
This year saw lofty highs and devastating lows for neuroscience drug developers like Bristol Myers Squibb, Eli Lilly and AbbVie, following the predictable pattern of successes and failures that characterizes this space.
Already established as cornerstone therapies in diabetes and obesity, GLP-1 receptor agonists also show potential in several other indications, including cancer, addiction and neurodegenerative diseases.
Novo Nordisk executives set a high bar for itself when it projected CagriSema could achieve 25% weight loss. When the GLP-1 combo didn’t hit that mark, investors reeled.
Suddenly the hottest thing in biopharma isn’t a new indication, disease target or modality—it’s manufacturing, and all of pharma is going to be vying for capacity and talent.
LATEST PODCASTS
This week, we’re talking money! Following the release of BioSpace’s 2024 Salary Report, we discuss salary trends and how they are impacting the biopharma workforce.
The FDA took center stage last week as it approved the first-ever MASH therapy and considered additional approvals for CAR-T therapies, whose safety the agency has been investigating since last year.
This episode focuses on a healthy discussion regarding the IRA, particularly the unintended consequences to small molecule development within the industry and for patients.
Job Trends
AbbVie (NYSE: ABBV) will participate in the Bank of America Securities Healthcare Conference on Wednesday, May 15, 2024.
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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 Federal Trade Commission has asked for an additional 30 days for its review of Novo Nordisk’s $16.5 billion acquisition of Catalent, with the companies expecting to complete the merger by the end of 2024. -
The Swiss drugmaker is paying $1 billion and committing up to $750 million in milestones for Mariana Oncology’s preclinical cancer pipeline and clinical supply capabilities, the companies announced Thursday. -
Ono Pharmaceutical will pay $25.60 per share in an all-cash deal to buy Deciphera Pharmaceuticals for its potential blockbuster oncology drugs and U.S. sales infrastructure, the companies said Monday. -
Citing anonymous sources involved in a Phase III trial, STAT News reported Sunday that MorphoSys’ pelabresib may worsen the risk of progression to acute myeloid leukemia, potentially putting Novartis’ proposed $2.9 billion acquisition at risk. -
Is there a connection between Bristol Myers Squibb’s announcement that it will reduce its headcount by 6% and the company’s recent acquisitions of Karuna, Mirati and RayzeBio?
WEIGHT LOSS
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In metabolic dysfunction-associated steatotic liver disease, a retrospective analysis shows that patients on GLP-1 receptor agonists are 14% less likely to progress to cirrhosis. -
When doses were increased rapidly in a Phase I study, patients on Roche’s investigational oral GLP-1 receptor agonist experienced nausea, vomiting, constipation, diarrhea, as well as abdominal distension. -
On the heels of Terns’ positive Phase I results that analysts compared with Lilly’s and Pfizer’s weight loss pills in development, Novo Nordisk showcased more details about its own oral candidate. -
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. -
A study published Tuesday in The New England Journal of Medicine showed that children between the ages of six and 12 who took liraglutide for just over a year experienced a significant reduction in body mass index compared to placebo.
POLICY
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As Marty Makary and Jay Bhattacharya sail through the Senate health committee vote, Weldon’s confirmation hearing is canceled. Guggenheim Partners heralded the last-minute move to revoke Dave Weldon’s nomination as “a positive sign for reigning in vaccine criticism.” -
BioSpace remembers COVID-19 five years after the pandemic was declared, Novo Nordisk’s CagriSema again misses expectations as the company joins a lawsuit filed by drug compounders against the FDA, Viking secures ample supply of its investigational obesity medication, J&J strikes out in depression, and Makary and Bhattacharya near confirmation. -
Marty Makary, likely FDA commissioner under President Trump, appeared before Congress this week as the agency he’s set to lead continues to be rocked by sweeping changes and about-faces. -
Days after suffering a rejection in Australia, the Alzheimer’s drug hit another roadblock in the U.K., which found the drug not cost-effective. -
Analysts at Jefferies see Makary as a positive for the rare disease space, given his support for accelerated approvals and openness to “customizing regulatory pathways for rare diseases.”
A resume is your introduction to a potential employer, and as the saying goes, “You only get one chance to make a good first impression.” Follow these resume writing tips today.
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.
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’s year-end rush includes nine target action dates, mostly for rare disease and cancer therapies. -
Protara is advancing a cell therapy that triggers both adaptive and innate antitumor immune responses, while CG Oncology’s approach makes use of an oncolytic immunotherapy that preferentially targets cancer cells and proliferates inside them, destroying them from the inside. -
One year after a potential $1.7 billion deal with Hansoh Pharma, GSK goes back to China to forge another alliance with DualityBio for another deal that could be worth up to $1 billion as it continues to build up its ADC portfolio. -
Keros’ elritercept has shown promising efficacy signals in myelofibrosis and myelodysplastic syndromes and could pose a formidable challenge to Bristol Myers Squibb’s Reblozyl. -
The deal with Tubulis will help Gilead regain its footing in the ADC space following the withdrawal of Trodelvy in bladder cancer and its late-stage fail in NSCLC.
NEUROSCIENCE
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From Eli Lilly to Karuna Therapeutics to current owner Bristol Myers Squibb, the newly approved schizophrenia drug had quite the journey to market. Former Karuna and Lilly executives discuss the “accidental” and “serendipitous” discovery. -
After the FDA declined to approve Lykos Therapeutics’ MDMA-assisted therapy for post-traumatic stress disorder, companies are pivoting away from or delaying similar therapeutics targeting the psychiatric disease. -
BMS’ KarXT targets muscarinic receptors and “is at least 2-3 years ahead of the competition” including AbbVie and Neurocrine Biosciences, Truist Securities wrote in a note to investors. -
Results from TEMPO-1, which showed that tavapadon significantly improved motor symptoms in patients with Parkinson’s disease, will help AbbVie as it builds a regulatory case for the D1/D5 dopamine receptor agonist. -
Despite the settlement, the Securities and Exchange Commission on Thursday sued Cassava Sciences in the Western District Court of Texas, claiming that the company misled investors regarding the Phase IIb performance of its Alzheimer’s disease drug candidate.
CELL AND GENE THERAPY
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Vertex has filed a complaint against the Department of Health and Human Services, seeking to make its fertility preservation program available to federally insured patients needing Casgevy treatment. -
Lexeo Therapeutics’ investigational gene therapy reduces left ventricular volume and wall thickness in patients with Friedreich’s ataxia, according to a small study. -
Interius BioTherapeutics has received approval from Australia’s Human Research Ethics Committee to begin the first-in-human trial of an investigational in vivo CAR-T therapy designed to treat B-cell malignancies. -
Following a disappointing readout last year, uniQure on Tuesday posted promising Phase I/II data for its investigational gene therapy AMT-130 and nabbed the first-ever Regenerative Medicine Advanced Therapy designation from the FDA in Huntington’s disease. -
The groundwork being done in 2024 is building the foundation for global collaboration in the future.
