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By Brian Buntz | December 9, 2025

China’s biopharma sector enters ‘innovation 2.0’ era

Western drug executives long treated China as little more than a sales target. Think more than a billion potential customers, a gold mine for revenue, but nothing special in terms of fresh ideas. Lately, that thinking has changed fast. China now ranks as the world’s second-biggest pharmaceutical market. The country’s sales hit $112.8 billion in…

By Julia Rock-Torcivia | December 8, 2025

HPV vaccine shrinks cervical tumors in mice

A nasal HPV vaccine has been shown to shrink cervical cancer tumors in mice, researchers reported in Science Translational Medicine last month. The vaccine targets HPV16 E7, a protein made by the human papillomavirus (HPV) that targets a tumor suppressor and causes uncontrolled cell growth. Unlike most vaccines, which are preventative, this medicine could be…

By Brian Buntz | December 8, 2025

Recursion’s AI-selected MEK drug cuts FAP polyp burden in small trial

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Recursion Pharmaceuticals dropped phase 1b/2 results Monday for REC-4881, a MEK inhibitor it flagged through AI screens. In 12 older patients (55 years old and older) with familial adenomatous polyposis, the drug trimmed total polyp burden a median 43% after three months. The gains stuck around: 12 weeks off treatment, the median drop climbed to…

By Julia Rock-Torcivia | December 5, 2025

How bioprospecting revealed a scorpion venom that kills breast cancer cells

Researchers at the University of São Paulo’s Ribeirão Preto School of Pharmaceutical Sciences (FCFRP-USP) in Brazil have found a molecule in the venom of Brotheas amazonicus, a species of scorpion native to the Amazon, which appears to attack breast cancer cells in a way similar to a widely used chemotherapy medication. Their findings were presented…

By Julia Rock-Torcivia | December 5, 2025

Does your cat need Ozempic? GLP-1s in veterinary medicine

Portrait of a funny beautiful red fluffy cat with green eyes in the interior, pets

Okava Pharmaceuticals, a clinical-stage company developing medicines for cats and dogs, announced a new clinical trial testing a GLP-1 implant for cats on Tuesday. The trial is appropriately named MEOW-1 (ManagEment of Over Weight cats).  OKV-119 is Okava’s long-release GLP-1 implant, designed to slowly release the drug over six months. The implant is from Vivani…

By Kelly Broster, Ph.D. | December 3, 2025

Ensuring the safety and efficacy of GLP-1 drugs: How mass spectrometry powers the next wave of metabolic therapeutics

Therapeutic peptides, as well as broader biologics and biotherapeutics, are rapidly reshaping the treatment landscape for chronic diseases, offering precision, potency and specificity that small molecules often can’t match. Among peptide-based therapeutics, such as, Glucagon-Like Peptide-1 (GLP-1) receptor agonists – including semaglutide and liraglutide – have emerged as game changers in managing type 2 diabetes,…

By Julia Rock-Torcivia | December 1, 2025

First FDA-approved treatment for lymphoma (CTCL) in seven years

On Monday, Citius Oncology announced the U.S. launch of Lymphir (denileukin diftitox-cxdl), the first FDA-approved immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) since 2018.  Lymphir is an IL-2 receptor-directed fusion protein that kills cancer cells by binding to the IL-2 receptors found on the regulatory T-cells and releasing a toxin that inhibits protein…

By Angie Maurer | November 26, 2025

The FDA’s AI ambitions depend on better data practices

In June 2025, the Food and Drug Administration rolled out Elsa, an agency-wide generative AI assistant that officials say is already helping to speed the review of new drugs and devices and shrink weeks of paperwork into minutes. It is a vision that could reshape how lifesaving therapies reach patients, but Elsa’s first six months…

By Julia Rock-Torcivia | November 25, 2025

Novo Alzheimer’s trial disappoints as amycretin shines

Novo Nordisk in the Drug Discovery & Development Pharma 50

On Monday, Novo Nordisk announced that the results from its Phase 3 trial investigating semaglutide as a treatment for Alzheimer’s “did not confirm the superiority of semaglutide versus placebo in the reduction of progression,” of the disease, according to the press release.  Monday’s announcement had a silver lining. That is, the treatment did result in…

By Julia Rock-Torcivia and Brian Buntz | November 25, 2025

Vaccines, autism and America: A stress test for public health standards

Vaccines, autism and America: A stress test for public health standards The CDC recently overhauled its “Autism and Vaccines” webpage, telling readers that the familiar claim that “vaccines do not cause autism” is not evidence based because studies have not ruled out the possible effect from infant vaccines. It goes on to note that “correlation…

By Brian Buntz | November 19, 2025

Outpatient clinics are becoming critical Infrastructure for drug trials

Researchers working in the clinical laboratory

Investors are pouring money into medical outpatient buildings just as pharma races to decentralize clinical research. The overlap is starting to look less like coincidence. When you look at the latest U.S. office numbers, it might appear that medical and pharmaceutical companies are retreating from real estate. Central business district towers are struggling with high…

By Drug Discovery Editor | November 18, 2025

Lifordi secures $112M from Sanofi Ventures, others ahead of first clinical data

Burlington, MA–based Lifordi Immunotherapeutics has secured a strategic investment from Sanofi Ventures, along with additional funding from existing backers ARCH Ventures, 5AM Ventures and Atlas Venture, bringing the company’s total capital raised to $112 million. The investment comes as the clinical-stage biotech prepares to report its first human data for LFD-200, a VISTA-targeted antibody-drug conjugate…

By Brian Buntz | November 17, 2025

Novo slashes US GLP-1 prices by up to 70%, but 2026 semaglutide revenue could hold steady or even grow

Novo Nordisk, which helped kickstart the GLP-1 craze by expanding a diabetes drug to obesity, is slimming down the prices of Ozempic and Wegovy. That won’t necessarily translate into steep revenue drops in 2026 though. Current projections still point to rising semaglutide sales next year, and a drop in price could lead to a boost…

By Drug Discovery Trends Editor | November 17, 2025

SAS launches clinical trial analytics software built on its Viya cloud native analytics platform

Cary, North Carolina–based analytics stalwart SAS has launched SAS Clinical Acceleration, a cloud based software platform designed to help manage clinical trial data, analyze results and prepare regulatory submissions. The modular system combines a content repository with a statistical computing environment so clinical development teams can manage, analyze, report and review clinical and medical data…

By Julia Rock-Torcivia | November 14, 2025

Pictor Labs’s new AI-powered ClearStain

Pictor Labs announced the release of ClearStain, an AI-powered virtual staining technology, on Thursday. ClearStain enables pathologists to visualize and annotate the exact tissue being sequenced with no adjacent slides and no chemical stains, the company said. The technology could accelerate turnaround time from days to minutes, according to Pictor Labs.  Pathologists compared tissues and…

By Elizabeth Madichie | November 12, 2025

Regulatory strategy reimagined: Three trends accelerating drug development

Cyber big data flow. Blockchain data fields. Network line connect stream. Concept of AI technology, digital communication, science research, 3D illustration music waves

Is AI a risk or an opportunity? Is regulatory divergence a barrier or a catalyst for innovation? The answer depends on how prepared and how agile your organisation is. As regulatory frameworks shift beneath our feet, the question facing every drug developer is not ‘if’ but ‘how’ these macro trends will disrupt their strategy. In…

By Julia Rock-Torcivia | November 10, 2025

Trump administration makes deal with Eli Lilly, Novo Nordisk to lower GLP-1 prices

On Thursday, the Trump administration announced agreements with Eli Lilly and Novo Nordisk to reduce the prices of the companies’ GLP-1 drugs for Americans. Under the agreements, Ozempic and Wegovy will be sold at $350 per month and Zepbound for an average of $346 per month, depending on dose, when purchased through TrumpRx, a platform…

By Julia Rock-Torcivia | November 7, 2025

Pfizer sues Novo Nordisk and Metsera in bidding war

Pfizer has filed two lawsuits against the metabolic-focused startup Metsera and Novo Nordisk as of Tuesday. The first suit, filed last Friday, claims that Novo Nordisk’s rival bid for Metsera is a move “to suppress competition,” Pfizer said in a press release.  Metsera could be a vital acquisition for either company. The company is developing…

By Dr. Marek Bieniek, M.D.; Anu Chaudhary, PhD and Joanna Pulawska, PhD | November 6, 2025

Shifting mindsets all around: clinical thinking about Alzheimer’s disease moves from symptoms treatment toward earlier intervention and prevention

Alzheimer’s disease remains one of the most complex and devastating neurodegenerative disorders, affecting over 55 million people globally. With projections estimating this number will rise to 139 million by 2050, the urgency to develop effective treatments has never been greater.  Historically, AD drug development has been marked by setbacks and limited therapeutic success due to…

By Yushi Redhead,  Maryam Youssef and Pooja Goyal | November 5, 2025

RSV at IDWeek 2025: Competitive expansion of preventive and therapeutic modalities

This year’s IDWeek (Oct 19-22, 2025) showcased a spectrum of therapeutics to protect against and treat Respiratory syncytial virus (RSV) infection across vulnerable populations: infants, older adults, and the immunocompromised. Once dominated by seasonal hospital surges and limited preventive options, RSV management is entering a new era characterized by durable vaccination strategies, next-generation monoclonal antibodies,…

By Brian Buntz | November 5, 2025

Sai Life Sciences to double process R&D capacity with new Hyderabad facility

New CMC Process R&D center will add peptide and oligo-intermediate capabilities, expand analytical and formulation labs and target completion by September 2026. Sai Life Sciences plans to build a 100,000-sq-ft CMC Process R&D center at its integrated R&D campus in Hyderabad, aiming to double its process R&D capacity by September 2026. The project adds dedicated…

By Julia Rock-Torcivia | November 4, 2025

FDA Drug Unit chief resigns as he is sued

George Tidmarsh, the head of the FDA’s drug division, resigned on Sunday after he was placed on leave Friday, “after the Office of the General Counsel and the Office of the Inspector General were notified of serious concerns about his personal conduct,” Emily Hilliard, an HHS spokeswoman, told ABC News in a statement. Tidmarsh said…

By Brian Buntz | November 4, 2025

Precision medicine made trials smarter. It also made recruitment harder.

In statistics and machine learning, there’s a tradeoff between precision and recall: tune a system to be more selective and you inevitably miss more true positives. Cancer clinical trials have stumbled into a similar trap. As oncology has shifted from tumor-type-centered studies to gene-directed approaches, eligibility criteria have grown exquisitely precise. Instead of enrolling patients…

By Julia Rock-Torcivia | November 3, 2025

Eli Lilly announces Q3 results, $3 billion new site, plans for oral GLP-1 approval

Quarter 3 results Eli Lilly reported a 54% increase in revenue in the third quarter, rising to $17.60 billion in 2025 from $11.439 billion in 2024, which the company largely credited to sales of Mounjaro and Zepbound, the company’s GLP-1 agonist weight-loss treatments.  Mounjaro revenue saw a 109% increase in revenue from the third quarter…

By Brian Buntz | November 3, 2025

Kimberly-Clark’s $48.7B Kenvue bet is to pay a premium amid Tylenol noise

Kimberly-Clark agreed to acquire Kenvue in a cash-and-stock deal valuing the Johnson & Johnson spin-off at about $48.7 billion in enterprise value. Kenvue holders are set to receive $3.50 in cash plus 0.14625 Kimberly-Clark shares per Kenvue share, equal to $21.01 per share based on October 31 pricing, a 46% premium to Kenvue’s prior close.…

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