The move comes weeks after Pfizer terminated its partnership with Sangamo Therapeutics for another hemophilia gene therapy.
Many of these unlawful and unauthorized shipments were explicitly tagged for compounding, according to a new analysis. Separately, a group of state attorneys general has raised concerns about the unsafe GLP-1 drugs finding their way to American consumers.
The postponed ACIP meeting comes barely a week after Robert F. Kennedy, Jr. was confirmed as Secretary of Health and Human Services, despite controversy regarding his anti-vaccine history.
The meeting, which will include Pfizer CEO Albert Bourla as the newly named board of directors’ chair, will reportedly cover key topics for the lobbying group, including the Inflation Reduction Act.
BridgeBio beat investor expectations with 1,028 unique prescriptions for ATTR-CM therapy Attruby, setting the company up to beat a 2025 sales consensus of $86 million.
A year ago, AstraZeneca walked away from the bulk of its roxadustat partnership with FibroGen—though the pharma at the time decided to retain its relationship with the biotech’s China operations.
FEATURED STORIES
As companies roll out data showing the power and improved safety profile of antibodies that target two antigens, analysts say the class could overtake monoclonal antibody Keytruda as the “immunotherapy backbone” of solid tumor treatment.
Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market. However, recent years have seen a number of high-profile market withdrawals and failed confirmatory trials.
Large pharmaceutical companies were out in force at this week’s 2024 Cell & Gene Meeting on the Mesa, as they look to expand their presence in the industry.
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
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.
President Donald Trump unwrapped a massive drug pricing policy as CMS prepares for the next round of Medicare drug price negotiations; Vinay Prasad to take the helm at the FDA’s Center for Biologics Evaluation and Research; Bayer cuts 2,000 more employees; Eli Lilly’s Zepbound scores again; and the Galapagos story turns again.
In this episode of Denatured BioSpace’s head of insights Lori Ellis discusses the public health consequences of vaccine hesitancy and the critical distinction between skepticism and cynicism with Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
Job Trends
Today, Thermo Fisher Scientific announced the latest recipients of the Oncomine Clinical Research Grant, recognizing research from the Melanoma Institute Australia, the University of Turin in Italy and Atrium Health Wake Forest Baptist Medical Center.
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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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Amid mounting pressure from investors and shareholders, Bayer’s supervisory board unanimously appointed outsider Bill Anderson as its new CEO.
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Karuna Therapeutics acquired exclusive rights to Goldfinch Bio’s investigational TRPC4/5 channel candidates in a deal potentially worth $520 million.
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Sen. Elizabeth Warren (D-MA) voiced concerns to the FTC regarding the prospective acquisitions of Horizon Pharmaceuticals and Opiant Pharmaceuticals by Amgen and Indivior.
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bluebird bio, Inc. is expecting gross proceeds of $120 million with its newly announced public offering of 20,000,000 shares.
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Editas announced the sale of its iPSC-derived iNK programs to Shoreline Biosciences. Shoreline also licensed Editas’ SLEEK technology.
WEIGHT LOSS
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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.
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Currently trailing Eli Lilly and Structure Therapeutics in the oral weight loss space, Novo Nordisk strikes a deal with Septerna to put new discovery-stage programs into play.
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President Donald Trump unwrapped a massive drug pricing policy as CMS prepares for the next round of Medicare drug price negotiations; Vinay Prasad to take the helm at the FDA’s Center for Biologics Evaluation and Research; Bayer cuts 2,000 more employees; Eli Lilly’s Zepbound scores again; and the Galapagos story turns again.
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In addition to eliciting greater weight loss than Novo Nordisk’s Wegovy, Eli Lilly’s Zepbound does not come at the expense of safety, according to newly released comprehensive tolerability data—findings that Leerink analysts say confirm the GLP-1 drug’s edge in the closely watched market race.
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Following a similar decision in case the trade group Outsourcing Facilities Association brought against FDA over its decision to declare the end of the shortage of Novo Nordisk’s semaglutide, Judge Mark Pittman agreed that Eli Lilly’s tirzepatide is in sufficient supply, meaning compounding pharmacies can no longer sell the lucrative weight loss drugs.
POLICY
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The FDA on Tuesday approved Day One Biopharmaceuticals’ type II RAF inhibitor Ojemda, which is designed to penetrate the blood-brain barrier, for the treatment of relapsed or refractory pediatric low-grade glioma.
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While Bristol Myers Squibb did not explicitly mention China as the company expands and diversifies its manufacturing capacity, Cellares said the BIOSECURE Act would be a boon to its own growth.
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The U.S. Supreme Court on Monday indicated that it will not hear Vanda Pharmaceuticals’ petition in its patent case against Teva Pharmaceuticals regarding the former’s sleep-wake disorder drug Hetlioz.
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The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues.
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Bouncing back from a previous rejection, ImmunityBio on Monday secured the FDA’s green light for its IL-15 superagonist Anktiva for non-muscle invasive bladder cancer.
No matter where in the process you are, here are the questions you should be asking your interviewer.
Here’s a breakdown of how to talk to a future employer about an employment gap in your resume depending on the situation that caused it. So keep reading.
Transferable skills are skills you’ve used in any sector of your life and career that are transferable and applicable to what you what you want to do next.
In the meantime, here are a few things you can do to fill your resume while you’re in between jobs.
Our recent article describing six prominent careers in the biopharma industry was well-received by both college students and current biopharma professionals. As the first installment in a six-part series, we present an in depth review of a rewarding career as a genetic counselor.
A well-written thank you letter after interview can help you make an impact on the interviewers. It can increase your chance of getting hired so learn how to write one.
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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Tecentriq is an anti-PD-L1 checkpoint inhibitor. Avastin binds to the VEGF protein, which plays a significant role in the development and maintenance of blood vessels by cancer cells.
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Incidence rates for liver cancer began rising in the mid-1970s, and they are expected to go up through at least 2030. This report aims to give an overview of liver cancer, as well as explore current therapies, drugs in the pipeline and the future treatment landscape for patients and their caregivers living with liver cancer.
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AstraZeneca’s Imfinzi (durvalumab) and tremelimumab were granted Orphan Drug designation by the U.S. Food and Drug Administration as a possible treatment for hepatocellular carcinoma.
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Tecentriq is the company’s PD-L1 checkpoint inhibitor. Avastin is an antibody that binds to VEGF and interferes with tumor blood supply.
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The trial met its co-primary endpoints, showing statistically significant and clinically meaningful improvements in overall survival and progression-free survival compared to standard-of-care, Bayer’s Nexavar.
NEUROSCIENCE
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The internet and “common wisdom” aren’t always right. Here are some of the top myths about three common conditions, and the truth from leading experts in their fields.
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TauRx announced preliminary results from the Phase III study, showing HMTM, its potent inhibitor of tau aggregates, could slow Alzheimer’s disease progression or cognitive decline.
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While Biogen and Eisai’s recent lecanemab data breathed new life into the anti-amyloid approach, experts say combination therapies will likely play a significant role in treating Alzheimer’s disease.
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Biogen and Eisai’s lecanemab win this week provides an opportunity to stop and consider whether science is closer to a cure or symptom management for Alzheimer’s disease.
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This week, researchers published results from studies on treatments in lung disease, Alzheimer’s and various cancers. Here’s a look at that and more.
CELL AND GENE THERAPY
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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.
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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.
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Lilly will use Rznomics’ proprietary ribozyme technology to develop RNA editing therapies for congenital hearing loss.
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After warnings that the dragged-out process was putting the cell therapy company at risk of bankruptcy, bluebird bio now has a new deal to offer shareholders.
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It’s another wild twist in the story of Galapagos, a company that has been around for more than 25 years but has yet to get a therapy approved.