Novartis’s Cosentyx failed to beat a placebo in a Phase 3 clinical trial in giant cell arteritis. The antibody drug was being developed as an alternative to Roche and AbbVie drugs whose approved uses include treating this autoimmune disorder affecting blood vessels.

The post Blockbuster Novartis Drug Fails Key Test Hoped to Expand Its Use to Rare Blood Vessel Disorder appeared first on MedCity News.

To make the time fly, we are firing up the trusted coffee kettle and brewing another cup of stimulation. Our choice today is strawberry creme, which occupies a prominent spot in our pantry. But now, the time has come to get cracking. Here are a few items of interest to help you get started. We hope you have a lovely day, and do keep in touch. Feedback, tips, and suggestions are always welcome. …

Spain is investigating Novo Nordisk over concerns it may be illegally advertising its weight loss drugs Ozempic and Wegovy, EuroNews tells us. It is the latest in a string of inquiries into the company, with authorities in at least two other European countries accusing Novo Nordisk of unlawfully promoting its medications in recent years. Health officials worry drugmakers are seeking to boost already sky-high demand, possibly in violation of a European Union ban on consumer advertising for drugs that can only be obtained via prescription. The latest kerfuffle involves a campaign Novo Nordisk launched in Spain this month to raise public awareness about the health risks of obesity. The company also launched a website — which has since been taken down — on obesity’s health risks that cited endorsements from key scientific societies, recommended questions for people to ask their doctors, and offered weight loss tips. The tips included a healthy diet, exercise and sleep, and did not explicitly mention any medicines, but the Spanish health ministry said the campaign could serve as “covert advertising” for Novo Nordisk drugs.

AstraZeneca chief executive officer Pascal Soriot would like to move the drugmaker’s stock market listing to the U.S., The Times of London reports. Soriot has spoken privately of his preference to move the listing on a number of occasions and has even discussed moving AstraZeneca’s domicile. But he is likely to face resistance from parts of the board should he push for such a move, as well as the U.K. government, which is not believed to have been informed. Soriot, who has led AstraZeneca since 2012, has spoken publicly of his concerns about how Europe has fallen behind the U.S. and China, the company’s two largest markets, in innovating new medicines. He is known to be deeply frustrated with the U.K.’s operating environment, particularly restrictions on the approval of new medicines by the National Institute for Health and Care Excellence and the pricing of medicines under a National Health Service sales rebate scheme. Any attempt to move the listing would be highly controversial and a significant blow to the London stock market and the U.K. life sciences sector, which the Labor government set as a priority in its industrial strategy.

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After all, the world keeps spinning no matter what the thermometer says. Hope you have a successful day and conquer the world. And of course, do keep in touch. …

Novo Nordisk’s top executives ignored internal warnings that the company was not sufficiently prepared for the launch of its weight loss drug Wegovy, leaving the drugmaker in a more vulnerable position when rival Eli Lilly entered the market, Reuters reports. Novo has enjoyed $46 billion in net profits since 2021, when Wegovy became the first highly effective obesity treatment approved in the U.S. But Lilly’s Zepbound therapy outstripped Wegovy in weekly new prescriptions this year as Novo struggles to convince investors it can remain competitive amid the weight loss drug boom. Novo is reorganizing its leadership team following the surprise ouster of chief executive office Lars Fruergaard Jorgensen. Other key executives already stepped down, including U.S. chief Doug Langa, who had insisted on a commercial launch soon after Wegovy’s U.S. approval. In heated internal discussions, sales and marketing executives urged Langa to first secure more supply and health insurance coverage, without which many patients could not afford Wegovy’s monthly cost of up to $1,300. Lilly was not expected to enter the market for at least two years and Novo could have been better prepared, according to former employees.

The House Judiciary Committee has subpoenaed a former Pfizer executive who is considered central to its investigation into an allegation that clinical testing related to the development of the company’s Covid-19 vaccine was purposefully delayed until after the 2020 presidential election, CNN reports. The demand for documents and a deposition from Philip Dormitzer comes after the committee says he failed to comply with requests to appear voluntarily and turn over records. Dormitzer is a key figure in the legislative probe. The committee has alleged it had information that the former Pfizer executive, after he left for a job with GSK, told his colleagues that Pfizer had delayed announcing its Covid vaccine was effective until after the election. The Wall Street Journal had reported that GSK brought those claims to federal prosecutors in Manhattan. But Dormitzer disputed that there had been any delay in seeking approval for the vaccine.

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AbbVie is acquiring Capstan Therapeutics, a startup with technology that enables in vivo engineering of immune cells. The University of Pennsylvania spinout’s lead program recently began a Phase 1 test as a potential treatment for B cell-mediated autoimmune disorders.

The post AbbVie’s $2.1B Acquisition Adds In Vivo Cell Therapy to Its Immunology & Inflammation Pipeline appeared first on MedCity News.

Novo Nordisk, AbbVie, and Roche each have weekly injectable drug candidates designed to bind to and activate the amylin receptor to trigger weight loss. Metsera’s contender, MET-233i, is designed with technology that enables longer dosing intervals and the company is proceeding with development of this engineered peptide as a monotherapy and as part of a drug combination.

The post Metsera’s Amylin Drug Looks Good in Phase 1, Shows Potential to be a Once-Monthly Obesity Med appeared first on MedCity News.

Emrelis, an antibody drug conjugate developed by AbbVie, is now FDA approved for patients whose non-small cell lung cancer overexpresses the protein c-Met. The pharma company said this ADC is its first internally developed solid tumor medicine as well as its first solid tumor FDA approval in lung cancer.

The post AbbVie’s Solid Tumor Strategy Gets a Win With Accelerated FDA Approval in Lung Cancer appeared first on MedCity News.

The hulking factories are tucked away off the roads around the village of Ringaskiddy — operated by the likes of Pfizer, Johnson & Johnson, and BioMarin, whose plant featured signs last week touting a new facility “coming Q1 2027.”

The nearby town of Carrigtwohill crows that it’s grown “+400% over the past 20 years,” a surge driven by sites run by AbbVie and Gilead. 

And down in Kinsale, an Eli Lilly campus rises up out of the Irish countryside, a hub that recently underwent an $800 million expansion to meet the surging demand for the company’s obesity and diabetes drugs. Placards along the edge of the property celebrate Lilly’s sponsorship of the upcoming Kinsale 10-mile road race. 

“It’s absolutely everything to this area,” Jack White, a member of the County Cork council, told STAT, referring to the presence of pharma manufacturing here. 

President Trump is less fond of the industry’s operations in Ireland. As he seeks to impose tariffs on goods worldwide, part of a bid to bring companies back to the U.S. and generate jobs, he has specifically called out pharma manufacturing in this country and pledged to announce new levies on drugmakers. In his view, the U.S. trade imbalance with Ireland — one largely driven by pharmaceutical exports — is a particular injustice. As a result, the industry is now caught in his crosshairs, anxiously awaiting details from the administration.

“All of a sudden Ireland has our pharmaceutical companies, this beautiful island of five million people has got the entire U.S. pharmaceutical industry in its grasp,” Trump said in a March meeting with Irish Prime Minister Micheál Martin marking St. Patrick’s Day. “I’d like to see the United States not have been so stupid for so many years, not just with Ireland, with everybody.”

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Good morning. Let’s get straight into the news today.

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So, too, is the vast, unexplored drug-hunting territory of chemical space, waiting to be illuminated by data’s light.

Every AI model trained for biology only can see what’s illuminated by the data points it is trained on. AlphaFold succeeded in predicting protein structures because the 200,000 or so known protein structures in the Protein Data Bank covered enough of the limited ways amino acids can combine that the model was able to understand what almost the entire protein structure space looked like. But ask the PDB for only the structures where proteins are hugging other proteins or — even rarer — interacting with drug-like molecules, and there’s nowhere near enough illumination for AI biology models to understand what the topography of those plains look like, much less make useful predictions for drug discovery.

Life sciences data company Apheris on Thursday announced an effort to boost the capabilities of protein AI models by uniting several pharmaceutical companies’ proprietary data. Apheris’ consortium of pharma companies is partnering with OpenFold3 — Columbia professor Mohammed AlQuraishi’s open-source dupe of AlphaFold3 — to train the model on AbbVie and Johnson & Johnson’s vast stores of structural data. The collaboration will focus on structures relevant to drug discovery, such as small molecule-protein and antibody-antigen interactions. 

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Good morning. The MAHA movement is influencing not only the federal government, but also state legislatures across the U.S. We discuss all that and the key biotech news today.

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