Donald Trump’s proposed tariffs on the EU would increase manufacturing costs for pharma companies and would stall medical innovation, according to the results of a recent survey by the Biotechnology Innovation Organization.
Eisai’s new fiscal 2027 forecast for Leqembi is roughly 50% lower than its projections a year ago.
Blujepa, which treats UTIs in female patients aged 12 and up with common and uncomplicated infections, will hit the market in the second half of this year.
Marty Makary earlier this month distanced himself from the recent shake-ups at the FDA, including the cancellation of its vaccines advisory committee meeting and the steep layoffs at the agency.
President Donald Trump continues to warn of tariffs on the pharmaceutical industry; Susan Monarez replaces Dave Weldon as CDC director nominee; Novo Nordisk joins the triple-G race; Alnylam wins approval for Amvuttra in ATTR-CM; and Cassava Sciences ends development of simufilam in Alzheimer’s.
After years of controversy and allegations of doctored data, Cassava is moving on from Alzheimer’s.
FEATURED STORIES
Even as Biogen and Eisai’s Leqembi and Eli Lilly’s Kisunla slowly roll out onto the market, experts question the efficacy of these anti-amyloid antibodies and the amyloid hypothesis overall.
Novartis, Biogen, Takeda and Novo Nordisk are all betting on advances in the molecular glue degraders space, collectively investing billions in hopes of treating cancer, Alzheimer’s disease, cardiometabolic disease and more.
Some 90% of investigational drugs fail—and success rates are even more dire in the neuro space. Here, BioSpace looks at five clinical trial flops that stole headlines over the past 12 months.
FROM BIOSPACE INSIGHTS
In a year when eradicated diseases are on the uptick in America, how will American children survive RFK Jr.’s vaccine scrutiny and inconsistency? Two experts call on pharma and regulatory bodies to rebuild trust.
LATEST PODCASTS
HHS Secretary RFK Jr. removes the COVID-19 vaccine recommendation for healthy kids and pregnant women—the latest in a string of changes to vaccine policies; judge issues an order to halt HHS’ reorganization and mass layoff plans; Rocket Pharmaceuticals’ pivotal Danon disease trial is on hold after a patient death; and President Trump has named Mehmet Oz to spearhead his Most Favored Nation drug pricing policy.
In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the importance of target product profiles, particularly when navigating funding challenges, with Ian Fisher, head of development analytics.
China continues to be a source of innovation as Pfizer strikes biggest pact yet; HHS provides more info on Trump’s Most Favored Nation executive order; FDA Commissioner Marty Makary and CBER director Vinay Prasad reveal new COVID-19 vaccine strategy following Novavax approval; ODAC underway after chaotic planning; more.
Job Trends
Positive high-level results of the ADRIATIC Phase III trial showed AstraZeneca’s IMFINZI® demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoints of overall survival and progression-free survival in patients with limited-stage small cell lung cancer who had not progressed following concurrent chemoradiotherapy compared to placebo after cCRT.
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SPECIAL EDITIONS
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.
Year-over-year BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the first quarter of 2025.
DEALS
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The deal, announced late Wednesday, will provide AbbVie with access to Cerevel Therapeutics’ pipeline of clinical-stage and preclinical candidates for psychiatric and neurological diseases. -
This week we discuss ups and downs in the weight loss and ADC markets - including Altimmune, Pfizer setbacks, AbbVie’s ImmunoGen buy and more. -
The acquisition will give Roche access to Carmot’s clinical portfolio of three GLP-1 receptor agonists, placing it squarely in the middle of the competition to treat overweight and obesity. -
AbbVie’s $10.1 billion ImmunoGen buy and Altimmune’s Phase II win demonstrate that the antibody-drug conjugate market is red hot in cancer and GLP-1 drugs for weight loss are an absolute craze. -
Facing the loss of Humira revenues from biosimilar competition, AbbVie is looking to grow its pipeline by acquiring ImmunoGen and its antibody-drug conjugate Elahere, which was granted FDA accelerated approval last year.
WEIGHT LOSS
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A report from the Kaiser Family Foundation estimates that the FDA’s recent approval of Novo Nordisk’s Wegovy to reduce the risk of heart attack and stroke in people with cardiovascular disease will open Medicare coverage to one in four beneficiaries with obesity. -
While Sanofi restructures and parts with employees from U.S. and Belgian sites, a new company in the GLP-1 space emerges from stealth.
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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.
POLICY
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Rocket Pharmaceuticals’ gene therapy Kresladi has been hit with an FDA Complete Response Letter requesting additional chemistry, manufacturing and controls information to complete its review. -
The FDA on Thursday rejected Merck and Daiichi Sankyo’s HER3-targeted antibody-drug conjugate patritumab deruxtecan in a Complete Response Letter, citing problems with a third-party manufacturer. -
New recommendations from the Centers for Disease Control and Prevention call for the use of respiratory syncytial virus vaccines in adults aged 75 and older, but limited its use in 60- to 74-year-olds. -
AbbVie and Genmab on Wednesday announced the FDA has expanded the label of their bispecific antibody Epkinly, allowing it to be used in patients with relapsed or refractory follicular lymphoma. -
Verona Pharma on Wednesday secured the FDA’s approval for Ohtuvayre, which the company contends is the first inhaled chronic obstructive pulmonary disease medicine with a new mechanism of action in over 20 years.
While there are all kinds of advice out there, here are a few things NOT to do in your next interview. Make sure to avoid these interview mistakes at all costs.
Being able to tell the difference between various life science roles can be difficult. To help, here is a guide to three commonly confused roles: Scientist I, Scientist II and Senior Scientist.
Let’s take a closer look at a few things that you should definitely do, as well as a couple that you shouldn’t, in order to make a good first impression.
When a recruiter or hiring manager is scanning it, you want them to be able to immediately understand your strengths, experiences and why you’re the right fit for the open position.
Whose contact information do you provide? What if they ask for multiple people? Below we answer common questions when it comes to selecting references for a job.
BioSpace interviewed Marianne Stanford, Ph.D., who shared her thoughts on the immunology field and the career path of an immunologist.
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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While its investigational regimen fell short of the primary efficacy endpoint, AVEO dug into data from its control group and touted a “clinically meaningful” improvement in progression-free survival in patients receiving Fotivda monotherapy. -
Agenus is now looking for alternative pathways to initiate a Phase III trial for BOT/BAL, including potential partnerships. -
Fresh off its $13-billion acquisition of medical devices developer Shockwave Medical, Johnson & Johnson is expecting greater business growth in the future. -
The last few months have been difficult for Gilead, with several late-stage failures and development discontinuations. Amid these problems, Merdad Parsey will be stepping down from his CMO role early next year. -
Immutep shares jumped nearly 20% on Friday after data showed its LAG-3 therapy—plus Keytruda—elicited strong response rates in head and neck squamous cell carcinoma patients in the front-line setting.
NEUROSCIENCE
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The regulator’s new draft guidance, released on Monday, provides additional details regarding the use of surrogate and biomarker endpoints to support accelerated approvals. -
In Monday’s neurology update for investors, Roche touted data from a small Ib/IIa trial for trontinemab, an investigational therapy for Alzheimer’s disease which demonstrated “rapid and robust” amyloid plaque reduction.
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Acadia Pharmaceuticals is terminating development of its antipsychotic drug pimavanserin, which did not demonstrate a statistically significant improvement over placebo in the late-stage study’s primary endpoint. -
Boehringer Ingelheim has paid $27.3 million upfront to Sosei Heptares to develop a small molecule agonist of GPR52 to treat the positive, negative and cognitive symptoms of schizophrenia. -
With Monday’s FDA rejection of their long-acting glatiramer acetate formulation, Viatris and Mapi Pharma continue the biopharma industry’s recent losing streak in multiple sclerosis.
CELL AND GENE THERAPY
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While an adverse event reported in Intellia’s gene therapy trial was a “non-concern” for analysts, it follows a handful of patient deaths in other trials for the modality and sent the company’s stock tumbling in pre-market trading. -
Acute systemic infection caused the patient to develop fatal capillary leak syndrome, highlighting the unpredictability of gene therapies and potentially challenging investment in the space, analysts say. -
Taking center stage at the American Society of Gene and Cell Therapy meeting was the first-ever reported case of a personalized in vivo CRISPR editing therapy, which substantially eased the symptom burden in an infant. -
Since Elevidys’ accelerated approval in 2023, experts have been clamoring for more data, particularly in older and non-ambulatory children. New results, presented Friday, show mobility improvements in 8- to 9-year-old patients after one year of follow-up. -
Lilly will use Rznomics’ proprietary ribozyme technology to develop RNA editing therapies for congenital hearing loss.
