The Annals of Internal Medicine ran a large-scale study in July, pointing to the lack of an association between childhood aluminum exposure through vaccination and chronic conditions. The Health Secretary, in an opinion piece earlier this month, called the paper a “ballyhooed study.”
Phase Ib data show Hernexeos can elicit a confirmed objective response rate of 44% in patients with HER2-mutated NSCLC who had previously been treated with a directed antibody-drug conjugate.
Gray Delany’s ouster comes days after Health Secretary Robert F. Kennedy Jr. controversially axed 22 mRNA vaccine contracts under the Biomedical Advanced Research and Development Authority.
Skysona can now only be used in patients with cerebral adrenoleukodystrophy who have no available treatment alternatives or stem cell donors.
After exiting the FDA less than two weeks ago for unclear reasons, Vinay Prasad is once again director of the Center for Biologics Evaluation and Research, HHS confirmed to several outlets Saturday.
Under PreCheck, the FDA will communicate more frequently with pharmaceutical companies, helping them as they establish or expand manufacturing sites in the U.S.
FEATURED STORIES
At a Thursday ASGCT 2024 session, CBER Director Peter Marks made the case for a better, “more convergent” global framework on cell and gene therapies, especially for rare diseases.
Launched in 2021, the public-private consortium on Wednesday updated ASGCT attendees on its efforts to bring adeno-associated virus gene therapies to more rare disease patients.
A new BioSpace report finds that life science professionals are prioritizing diversity less when job hunting. Still, DEIB programs don’t appear to be going anywhere.
Amylyx’s recent decision to withdraw its ALS drug Relyvrio from the market highlights an important business decision for companies: when to continue marketing or investigating a drug that has failed a pivotal or confirmatory study.
As Sarepta Therapeutics moves closer to full approval and an expanded label for its gene therapy, some experts push back on clinical efficacy and cost while others note the hope it provides patients with Duchenne muscular dystrophy.
It wasn’t calls from lawmakers but market competition with Eli Lilly’s Zepbound that prompted Novo Nordisk to lower the prices of its blockbuster weight-loss drug.
LATEST PODCASTS
In this episode of Denatured, Jennifer Smith-Parker speaks to Kenneth Galbraith, CEO of Zymeworks and Josh Smiley, president and COO of Zai Lab, about how renewed confidence is driving biotech entering 2026.
Eli Lilly’s retatrutide exceeds expectations in Phase III, capping off a sparkling 2025 for the obesity titan; an internal FDA safety review finds no confirmed pediatric deaths caused by COVID-19 vaccines, and Commissioner Marty Makary says no black box warning will be attached to the shots; and BioSpace looks at six biotechs that could be pharma’s next buy.
In this episode of Denatured presented by AnaptysBio, Jennifer Smith-Parker speaks to Dr. Joe Murray, Mayo Clinic; Marilyn Geller, the Celiac Disease Foundation; and Dr. Paul Lizzul, AnaptysBio, about the challenges and opportunities facing celiac disease treatment.
Job Trends
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its fourth quarter and full year 2023 financial and operating results on Friday, February 2, 2024, before the U.S. financial markets open.
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SPECIAL EDITIONS
In this deep dive, BioSpace investigates China’s rise as a biotech powerhouse.
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.
DEALS
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If the letter of intent to acquire your company has been signed, you might be asking what happens next. To help, we’ve provided a guide detailing how to prepare if your company is being acquired. -
Stay on top of what’s happening at JPM. BioSpace is covering all the key announcements all week. -
In a presentation led by Robert J. Bradway, Amgen chairman and chief executive officer, the company covered recent acquisitions, Repatha and Lumakras updates, biosimilars and its broader financial outlook. -
Stay on top of what’s happening at JPM. BioSpace is covering all the key announcements all week. -
Tuesday, AbbVie partnered with Anima Biotech to discover and develop mRNA modulators in a collaboration of up to $582 million. The partnership will focus on three oncology and immunology targets.
WEIGHT LOSS
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The filing comes as Novo fights tooth-and-nail with rival Lilly to regain its footing at the top of the weight loss market. -
Participants in a Phase III trial who switched to Eli Lilly’s orforglipron after 72 weeks of treatment with Wegovy or Zepbound largely maintained their weight loss for up to a year. -
Eli Lilly’s retatrutide exceeds expectations in Phase III, capping off a sparkling 2025 for the obesity titan; an internal FDA safety review finds no confirmed pediatric deaths caused by COVID-19 vaccines, and Commissioner Marty Makary says no black box warning will be attached to the shots; and BioSpace looks at six biotechs that could be pharma’s next buy. -
These deals radically reshaped the biopharma world, either by one vaccine rival absorbing another, a Big Pharma doubling down after another failed acquisition or, in the case of Pfizer and Novo, two heavyweights duking it out over a hot obesity biotech. -
In the midst of regulatory and political upheaval, biopharma’s R&D engine kept running, churning out highs and lows in equal parts. Here are some of this year’s most glorious clinical trial victories.
POLICY
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The U.K.’s National Institute for Health and Care Excellence has endorsed the use of Eli Lilly’s Zepboundfor weight management in patients with BMI of 35 kg/m2 and above and at least one weight-related comorbidity. -
An FDA advisory committee on Tuesday overwhelmingly rejected Lykos Therapeutics’ investigational MDMA-assisted therapy for post-traumatic stress disorder due to safety concerns and how the company conducted its trials. -
Illumina on Monday announced that its board of directors is spinning off Grail and has applied to list the cancer diagnostics company on the Nasdaq. -
A Delaware state court ruled that expert witnesses can present scientific evidence in 69,000 cases involving the discontinued heartburn drug Zantac. News of the court ruling Monday wiped roughly $8.9 billion from GSK’s market value. -
Regeneron and Sanofi will have to wait until September 2024 for the FDA to decide whether to expand Dupixent’s label to include uncontrolled chronic obstructive pulmonary disease.
“Quitting with class” means separating yourself from your current employer in such a way that you leave your professional reputation intact, keep those bridges unburnt, and even set yourself up for glowing recommendations (or even another future job offer?) from your employer.
Whether you’re a recent graduate about to embark on your career or a seasoned professional navigating the difficult waters of professional development and career pathing, a mentor can be an invaluable resource for career advice, support, connections, and encouragement.
Making the step up into a management position is an important professional milestone. To help with that difficult decision, here are 10 signs you’re ready for a management position in biopharma.
Not every organization conducts exit interviews, but for many, they are very important procedures when an employee leaves. Learn how to successfully conduct yourself in an exit interview in our guide.
Treating an interview as anything but serious is a huge mistake. I have interviewed thousands of people and some high school graduates performed better in an interview than some college degreed individuals.You don’t need a PhD to perform well in an interview. Proper preparation is the key.
You Never Have a Second Chance to make a Good First Impression! When you are applying for a job online your resume is the first impression an organization will have of you.
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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At Thursday’s Oncology Innovation Day, Pfizer laid out its business strategy which includes building up its biologics business, specifically antibody-drug conjugates and bispecific antibodies. -
Janux Therapeutics on Monday announced positive updated clinical data for both of its clinical programs in prostate cancer advanced or metastatic solid tumors. -
The cancer space has been aflutter with notable approvals so far this year, but there are several more candidates with significant data expected over the next four months. BioSpace takes a closer look. -
A year after Roche returned Gavreto’s global rights to Blueprint Medicines, Rigel Pharmaceuticals has acquired the U.S. rights to the FDA-approved treatment for non-small cell lung cancer. -
The biotech will use the oversubscribed Series C financing to advance its next-generation KRAS blocker FMC-376, which saw its first patient dosed in a Phase I/II clinical trial on Thursday.
NEUROSCIENCE
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TauRx Pharmaceuticals and Anavex Life Sciences presented positive results from their candidates at the Clinical Trials in Alzheimer’s Disease (CTAD) conference in San Francisco, CA. -
Athira Pharma’s experimental Alzheimer’s therapy, fosgonimeton, continues to show signs of being able to improve cognition and function in patients. -
Eli Lilly’s investigational antibody donanemab met all of its primary and secondary endpoints in the Phase III TRAILBLAZER-ALZ 4 study, the company announced Wednesday. -
BioSpace sat down with Roche Global Head of Neurodegeneration Rachelle Doody, Ph.D. and Alzheimer’s Drug Discovery Foundation Co-founder Howard Fillit, M.D. to discuss the highlights. -
Full data from the Phase III Clarity AD trial show Eisai and Biogen’s lecanemab has a favorable safety profile in patients with Alzheimer’s disease.
CELL AND GENE THERAPY
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A report from analysts at Jefferies suggested that new screenings for metachromatic leukodystrophy and Duchenne muscular dystrophy could bump sales of the gene therapy Libmeldy by more than $100 million. -
Addition joins a growing list of launches this year, following in the footsteps of startups like Crystalys Therapeutics and Ollin Biosciences. -
Backed by Italy-based Fondazione Telethon ETS, Waskyra, for Wiskott-Aldrich syndrome, is the first gene therapy from a non-profit sponsor to win FDA approval. -
For traditional approval, CAR T therapies will need to establish superiority over current standard treatments, including already-approved CAR T products. -
As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.
