The new additions would bring ACIP membership to 14 total. Several of the proposed members have taken part in anti-vaccine activity or made anti-vaccine statements.
As more and more groups call for the health secretary’s removal from office, senators will question Kennedy on his recent moves, including the controversial firing of CDC Director Susan Monarez.
In this episode presented by Taconic Biosciences, BioSpace’s head of insights Lori Ellis discusses how preclinical research companies are helping drug developers navigate the current challenging funding environment with Mike Garrett, CEO.
The reprioritization effort will help AC Immune extend its cash runway through the third quarter of 2027.
While the new framework signals continued flexibility at the FDA regarding rare disease approvals, some analysts and advocates question what tangible impacts the new guidelines will have.
YouTube has shut down a channel containing hundreds of videos of comments made by doctors and other influencers—including CBER Director Vinay Prasad, Health Secretary Robert F. Kennedy Jr. and NIH Director Jay Bhattacharya—during the pandemic. This comes as Prasad reveals further details about last week’s updated COVID-19 approvals.
FEATURED STORIES
Biopharma executives make their predictions for the year ahead, from a bold forecast for the return of the megadeal to a plea for the slow, healthy recovery of the industry at large.
As I ran from interview to interview across San Francisco, I was consistently warmed by the stories I was told by biotech and pharma executives—and the general comradery in the air throughout the chaotic event.
With incoming president Donald Trump threatening a trade war with China, experts told BioSpace that the new administration will likely understand why medicines should be treated differently.
Annemarie Hanekamp has overseen some of the most transformative changes in oncology over her years in Big Pharma. Now, she will oversee BioNTech’s transition from a COVID-19 vaccine maker to an “end-to-end organizational oncology powerhouse.”
While investors and analysts push for a deal, Biogen CEO Chris Viehbacher and Head of Development Priya Singhal refuse to make one out of desperation.
Amidst a “renaissance” of interest in neuropsychiatry, Seaport’s executive team is taking nothing for granted.
LATEST PODCASTS
These days you can hardly move without figuratively bumping into antibody-drug conjugates (ADCs). This week we discuss Pfizer’s strategic priorities for oncology - focused on ADCs and less on small molecules - and how the market is being influenced by the IRA.
This episode explores the drug pricing gap between consumer experience and industry norms. Join Lori and our KOLs as we explore the drivers of healthcare costs, the CBO, rebates, and overall spend in this new series.
This week Lori, Greg and Tyler discuss AbbVie: how longtime CEO Richard Gonzalez navigated Humira’s LOE, his victorious retirement announcement, and the future of biosimilars.
Job Trends
Pfizer Highlights Progress in Accelerating Breakthrough Cancer Medicines at ASCO 2024 Annual Meeting
Pfizer Inc. highlights its progress in advancing new potential standards of care in Oncology at the 2024 American Society of Clinical Oncology Annual Meeting, taking place May 31 to June 4 in Chicago.
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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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Days after backing out of two Ionis-partnered neuro programs, Biogen has inked a potential $1.8 billion buy of Human Immunology Biosciences and boosting its late-stage immunology pipeline. -
Neuroscience-focused Rapport Therapeutics and radiopharma developer Telix Pharma announced their respective plans Friday for initial public offerings on the Nasdaq for undisclosed dollar amounts. -
Johnson & Johnson announced Thursday it is paying $850 million in cash, plus a potential milestone payment, for privately held biotech Proteologix and its atopic dermatitis-focused bispecific antibody candidates. -
While the FTC continues to review its $16.5 billion buy of Catalent, Novo Holdings announced Wednesday it has acquired a majority stake in Single Use Support, an Austrian life sciences tools company. -
With its $525 million investment, Royalty Pharma will acquire the royalties and milestones for ImmuNext’s anti-CD40 therapy frexalimab, which is currently in Phase III trials for multiple sclerosis.
WEIGHT LOSS
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Novo Nordisk and Eli Lilly are expected to rule the obesity market for a few more years without much challenge. To ensure they stay there as competition enters, the companies are spending billions in licensing and M&A deals. -
Amid a flurry of weight loss readouts, a fresh-on-the-scene startup has come out with Phase I results showing weight loss at day 36 on par with or better than competitors, with few gastrointestinal side effects. -
In a high-profile showdown Tuesday with Sen. Bernie Sanders’ Senate health committee, Novo Nordisk CEO Lars Fruergaard Jørgensen will be asked to defend the drugs’ U.S. monthly list prices of $969 and $1,349, respectively. -
Novo Nodrisk’s cannabinoid receptor–targeting obesity pill was picked up in the $1.1 billion acquisition of Inversago Pharmaceuticals last year. -
With Thursday’s positive opinion from the Committee for Medicinal Products for Human Use, the matter now heads to the European Commission which will have the final say on whether Wegovy’s label will be updated.
POLICY
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The Senate hearing for FDA Commissioner nominee Marty Makary comes after President Trump’s NIH pick, Jay Bhattacharya, was grilled by the legislative body on Wednesday. -
The last few years have been tough for the insulin market, with recent policies and high-level pressure forcing companies to lower drug prices. -
Konstantina Katcheves, Senior VP of Innovative Global Business Development at Teva Pharmaceuticals brings insights from the World Economic Forum to SCOPE 2025. -
Pfizer reacts to Donald Trump’s tariff threats on big pharma, another regulatory meeting is canceled under RFK Jr., AbbVie and Eli Lilly strike mid-sized deals in obesity and molecular glues, priority review vouchers set to take a hit and immuno-oncology matures. -
Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that will apply to all EU member states as well as Norway, Liechtenstein and Iceland.
A career in regulatory affairs combines knowledge of law, science, economics and more. Those who follow this biotech career path aren’t necessarily scientists, but they do need to understand the science behind the products that they need to regulate.
Are you currently working full time and in school earning a master’s degree? If so, do learn these time management skills to balance your personal and professional life.
Establishing boundaries between your personal and professional lives is the key to maintaining fulfilling versions of each.
Is your job is slowly starting to make you feel unmotivated or unproductive? Are you unable to work properly? Use these motivation tips to rejuvenate yourself.
As we leave the winter of 2020-21 behind, let’s learn more about the strategies to help college graduates secure employment during COVID-19.
Let’s review the six tips for finding work during the coronavirus pandemic.
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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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. -
Alongside the layoffs, Alligator will also suspend work on all of its earlier-stage assets and devote its resources to lead candidate mitazalimab, being developed for the frontline treatment of metastatic pancreatic cancer. -
The cancers were diagnosed 19 to 92 months after Skysona treatment. -
At the conference, AstraZeneca and Daiichi Sankyo will present their case for Dato-DXd in NSCLC, while BioNTech and Merus will reveal promising mid-stage data for their respective cancer candidates.
NEUROSCIENCE
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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. -
New research has found that MS patients treated with anti-CD20 antibodies, such as Roche’s Ocrevus, do not experience significantly slower progression of disability. -
New revelations from the showdown between Novo Nordisk’s CEO and Bernie Sanders’ Senate health committee Tuesday; PhRMA’s legal victory in IRA case; the federal interest rate cut and anticipated approval for schizophrenia.
CELL AND GENE THERAPY
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Fatalities are an unfortunate reality of clinical trials. How can companies best protect themselves? -
After more than a decade devoid of therapeutic advancements, a first-in-class T cell receptor therapy could be on the immediate horizon for synovial sarcoma patients. -
The company’s candidate, giroctocogene fitelparvovec, met its primary and key secondary objectives of superiority compared to the standard treatment of regular Factor VIII infusions. -
The Department of Health and Human Services’ Office of the Inspector General found that bluebird bio’s fertility support program for its gene therapies could potentially violate federal anti-kickback statutes. -
After a long and challenging journey for its stem cell therapy NurOwn, BrainStorm Cell Therapeutics has aligned with the FDA on the parameters of a Phase IIIb ALS trial that is expected to begin by the end of 2024.
