Meanwhile, Bayer CEO Bill Anderson said Donald Trump’s Most Favored Nations policy could present an opportunity for European countries to make sure they are also funding their “fair share” of biopharma innovation.
The commitment is part of Roche’s recently announced $50 billion investment in the U.S., but a company spokesperson said that could change if certain yet-unspecified policies are implemented that could “harm our industry’s ability to operate and innovate in America.”
The third cycle of the drug price negotiations will involve drugs under Medicare Part B. New prices are set to take effect in 2028.
The Most Favored Nation directive would allow drugmakers to directly sell their products to patients at a lower cost, cutting out what President Donald Trump called “the middlemen.”
Azafaros will use the Series B haul to push lead asset nizubaglustat into late-stage studies for Niemann-Pick disease Type C and GM1/GM2 gangliosidoses later this year.
While industry groups decried the Trump administration’s new drug pricing order, analysts say it lacked details and the teeth to make a major impact without an act of Congress.
FEATURED STORIES
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.
Since the 2022 launch of ChatGPT, biopharma has poured money into this new form of artificial intelligence, but companies remain cautious with unproven technology.
The race is on to develop therapeutic cancer vaccines that could give immunotherapies an edge, and late-stage trials could soon provide more-robust data about candidates’ efficacy and safety.
This week’s legal losses by J&J and BMS reinforce the notion that Medicare drug price negotiation is here to stay, and investors continue to favor biologics over small molecules.
On June 10, the FDA will convene its Peripheral and Central Nervous System Drugs Advisory Committee to discuss the New Drug Application for Lilly’s Alzheimer’s drug.
FROM BIOSPACE INSIGHTS
While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience that would make change possible.
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George Tidmarsh takes over temporarily at CBER following Vinay Prasad’s abrupt departure; Replimmune trial leaders protest rejection reportedly driven by FDA’s top cancer regulator Richard Pazdur; Merck’s $3 billion savings push claims 6,000 jobs; and Pfizer CEO Albert Bourla addresses President Donald Trump’s new threats around Most Favored Nation drug pricing.
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Job Trends
Pfizer Announces Positive Top-Line Data for Full Season Two Efficacy of ABRYSVO ® for RSV in Older Adults.
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SPECIAL EDITIONS
BioSpace did a deep dive into executive pay, examining the highest compensation packages, pay ratios and golden parachutes—what a CEO would get paid to leave.
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.
DEALS
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The British drugmaker’s rare disease subsidiary Alexion will take on a number of Pfizer’s preclinical gene therapy programs and technologies to advance its genomic medicines pipeline. -
The Federal Trade Commission’s increased scrutiny of mergers has now hit IQVIA, whose proposed acquisition of Propel Media has been challenged by the watchdog agency. -
The Federal Trade Commission released new draft guidelines for assessing mergers, while an Alzheimer’s conference yielded promising data and J&J kicked off Q2 earnings season with a sound beat. -
The proposed regulatory framework provides a tougher stance on mergers, impacting industries such as biopharma where the FTC’s recent lawsuit seeks to block Amgen’s Horizon Therapeutics buy. -
The Swiss pharma is expanding its neuroscience pipeline with an upfront $500 million payment to DTx Pharma and additional payments of up to $500 million upon completion of certain milestones.
WEIGHT LOSS
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Stringent regulation, manufacturing costs and absence of price control contribute to high GLP-1 agonist costs in the U.S. Patients could go to other countries for cheaper treatment. -
The persistent shortage of genuine glucagon-like peptide 1 receptor agonist products has led to an increase in fake versions, the World Health Organization warned on Monday. -
More than 3,000 people in the U.S. suffered from side effects of Ozempic in 2023, according to exclusive reporting on Wednesday from Reuters citing data from America’s Poison Centers. -
The Danish pharma has signed a collaboration and license agreement with Swiss biotech EraCal Therapeutics to access a novel candidate for controlling appetite and body weight. -
The team comes together to discuss the dominant themes of what was an incredibly busy week of events in San Francisco during JPM 2024.
POLICY
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PTC Therapeutics said Thursday the FDA has lifted a partial clinical hold on its Huntington’s disease candidate PTC518 after displaying favorable clinical trends in a mid-stage study. -
Eli Lilly on Thursday said it is again suing spas and clinics over compounded and counterfeit forms of tirzepatide, the active ingredient in blockbusters Mounjaro and Zepbound, which the pharma says can cause harmful side effects. -
The Federal Trade Commission is supporting the U.S. Patent and Trademark Office’s proposed new rules requiring parties to a patent dispute to disclose all settlement agreements, including pharmaceutical drug settlements. -
National Institutes of Health researchers in a Phase Ib/II study found a five-drug combination elicits strong remission rates in diffuse large B-cell lymphoma patients without using chemotherapeutic agents. -
The next six months for the FDA are primed to be as groundbreaking as the first six, with Eli Lilly’s donanemab and Lykos Therapeutics’ MDMA-assisted PTSD therapy on the docket, among others.
Besides making sure you don’t accidentally reply all to that company-wide notice, here are some words to reserve for your texts with friends.
The words and phrases you choose in your resume and cover letter can have a surprisingly powerful impact.
How do you leave your nerves behind and show your interviewer the real you? Here are a few tips for mastering interview small talk.
For the third part of a six-part series examining the six most in-demand biotech careers, we take a detailed look at the rising career of an operations research analyst.
A cover letter cannot be a canned or generic form letter; it needs to be specific in every way.
A phlebotomist is responsible for completing several types of bloodwork activities, including the drawing of patient blood to conduct tests and to store blood donations.
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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AstraZeneca and Daiichi Sankyo’s investigational antibody-drug conjugate Dato-DXd failed to significantly improve overall survival in non-small cell lung cancer patients versus docetaxel. -
Johnson & Johnson’s radiopharma candidate JNJ-6420 returned mixed results in an early-stage study, demonstrating strong biochemical and radiographic response but also resulting in four patient deaths. -
Until compelling surface targets for lung cancer are developed, antibody-drug conjugates will fail to treat most patients with lung cancer, experts told BioSpace. -
Pfizer’s Wyeth unit notched a legal victory over AstraZeneca on Friday as a federal jury found the British-Swedish company violated two key patents in developing and marketing its lung cancer drug Tagrisso. -
Bolstered by promising response data from its Phase II study, Amgen announced Thursday it got the FDA’s green light for its first-in-class bi-specific T-cell engager Imdelltra for extensive-stage small lung cancer.
NEUROSCIENCE
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The companies, which have been partners for a decade on various research programs, are pooling their efforts in two early-stage programs for Alzheimer’s and Huntington’s diseases using RNA-targeting medicines. -
Pivotal clinical trials in Alzheimer’s disease, Huntington’s disease, amyotrophic lateral sclerosis and multiple sclerosis are expected to read out this fall. Here’s a closer look. -
Following a controversial Rett Syndrome trial last year, Anavex Life Sciences’ blarcamesine has claimed another clinical victory—this time in an Alzheimer’s disease Phase IIb/III study. -
With a potential combined market value of $30 billion, BioSpace takes a deep dive into the Phase III data supporting Eisai and Biogen’s Leqembi and Eli Lilly’s investigational donanemab. -
With a recent study yielding positive results, experts say GLP-1 drugs are making headway in treating Alzheimer’s and other neurodegenerative diseases.
CELL AND GENE THERAPY
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Sarepta did not hold an investor call for its second-quarter earnings report or provide an updated full-year revenue outlook. -
From innovation in manufacturing to more-flexible regulation and better communication with payers, much needs to happen to make CGTs commercially viable. But it is possible, experts agreed at a recent panel. -
The primary focus in scaling up production should first be the adoption of lean manufacturing principles used in virtually every other industry. -
The pivotal Phase II trial is testing Allogene’s CAR T candidate cemacabtagene ansegedleucel for large B-cell lymphoma. ALLO-647 was being used as a preparative lymphodepletion therapy. -
The FDA greenlit multiple new drugs this month and issued some notable label expansions, including for Eli Lilly’s Kisunla. Meanwhile, the regulator turned away a cell therapy for Duchenne muscular dystrophy and a gene therapy for the rare disease Sanfilippo syndrome.
