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AstraZeneca Invests $2 Billion in Summit Therapeutics for Next-Generation Cancer Drug Combinations

AstraZeneca Invests $2 Billion in Summit Therapeutics for Next-Generation Cancer Drug Combinations

AstraZeneca Invests $2 Billion in Summit Therapeutics for Next-Generation Cancer Drug Combinations

Eli Lilly's Jaypirca Approved for First-Line Treatment of CLL/SLL in U.S.

Eli Lilly's Jaypirca Approved for First-Line Treatment of CLL/SLL in U.S.

Eli Lilly's Jaypirca Approved for First-Line Treatment of CLL/SLL in U.S.

AstraZeneca Inaugurates New Global Strategic R Center in Kendall Square, Cambridge, Massachusetts

AstraZeneca Inaugurates New Global Strategic R Center in Kendall Square, Cambridge, Massachusetts

AstraZeneca Inaugurates New Global Strategic R Center in Kendall Square, Cambridge, Massachusetts

Regeneron Expands Global Immunology Alliance with Sanofi, Securing $1 Billion Upfront

Regeneron Expands Global Immunology Alliance with Sanofi, Securing $1 Billion Upfront

Regeneron Expands Global Immunology Alliance with Sanofi, Securing $1 Billion Upfront

CSL Licenses Anti-Claudin-1 Antibody from Alentis Therapeutics in $1.55 Billion Deal for Kidney and Liver Diseases

CSL Licenses Anti-Claudin-1 Antibody from Alentis Therapeutics in $1.55 Billion Deal for Kidney and Liver Diseases

CSL Licenses Anti-Claudin-1 Antibody from Alentis Therapeutics in $1.55 Billion Deal for Kidney and Liver Diseases

HHS Unveils AI Initiatives to Accelerate U.S. Clinical Trials

HHS Unveils AI Initiatives to Accelerate U.S. Clinical Trials

The U.S. Department of Health and Human Services (HHS) has announced a new program and three complementary projects aimed at significantly speeding up clinical trials through the integration of artificial intelligence (AI), advanced computational models, and real-time analysis. The core initiative, named SURPASS (Simulation-augmented, Real-time Platform Adaptive Seamless Trials), seeks to develop AI-powered platforms that will continuously and adaptively support clinical trial designs. This program includes the creation of a phaseless design engine to simulate trials for faster results with fewer patients, a continuous inference engine for real-time data analysis and trial adaptations, and an agentic AI operations layer to automate startup activities and data collection. These efforts are part of a broader strategy by HHS to transform U.S. clinical trials, building on previous initiatives like Operation TrialBlazer and the FDA's pilot program using AI for real-time clinical trial data monitoring. The goal ...

Factbox-Global healthcare companies invest billions to boost US presence

Factbox-Global healthcare companies invest billions to boost US presence

Oct 6 (Reuters) - Global healthcare firms have announced a wave of US investments, committing billions of dollars to expand manufacturing and research operations as they prepare for a shifting trade environment under the Trump administration.

CRISPR Gene Therapies Advance Towards Direct In-Body Genome Editing for Inherited Retinal Disease

CRISPR Gene Therapies Advance Towards Direct In-Body Genome Editing for Inherited Retinal Disease

CRISPR gene editing therapies are progressing from ex vivo (outside the body) modifications to direct in-vivo (inside the body) genome editing. A significant development in this area is the BRILLIANCE clinical trial, which in 2020 treated its first patient with EDIT-101, an experimental CRISPR/Cas9 therapy for Leber congenital amaurosis type 10 (LCA10). LCA10 is a rare inherited retinal disorder caused by mutations in the CEP290 gene. The treatment involves a subretinal injection designed to deliver the editing machinery directly to retinal cells. The eye is considered an ideal environment for such research due to its contained tissue, allowing for localized treatment delivery. While this represents a major step forward, researchers emphasize that these results should not be mistaken for an established human clinical therapy. The field is also exploring in-vivo approaches for other tissues, such as the liver, using lipid nanoparticles for systemic administration, with some experimental programs already in ...

AstraZeneca to invest over $1 billion in Massachusetts, boost workforce

AstraZeneca to invest over $1 billion in Massachusetts, boost workforce

Oct 5 (Reuters) - AstraZeneca said on Monday it would spend more than $1 billion in Massachusetts as part of its broader $50 billion US investment plan, a move expected to expand its workforce in the state by more than 50% in the coming years.

FDA Launches Expedited IND Pilot Program and Updates Non-Animal Testing Regulations

FDA Launches Expedited IND Pilot Program and Updates Non-Animal Testing Regulations

The U.S. Food and Drug Administration (FDA) has initiated an Expedited Investigational New Drug (IND) Pilot program, now accepting applications. This program aims to accelerate the drug development process by pairing drug sponsors with Qualified Research Institutions (QRIs) to support IND application preparation. The pilot allows for a rolling review of individual IND components during the pre-IND phase, rather than requiring a complete package upfront, with the goal of reducing clinical holds and shortening the drug-to-first-dose timeline. Applications for this pilot are due by October 30, and the FDA anticipates selecting 8–10 sponsor–QRI pairs for the initial cohort. Concurrently, the FDA has issued a direct final rule replacing 'animal tests' with 'nonclinical tests' in its drug and biologics regulations, explicitly allowing non-animal methods like human cell cultures, organs-on-chips, and computer models for pre-human safety assessment. This change does not eliminate animal studies but clarifies that ...

Orano Med Expands Lead-212 Production with New U.S. Facility for Cancer Therapies

Orano Med Expands Lead-212 Production with New U.S. Facility for Cancer Therapies

Orano Med, a clinical-stage biotechnology company and subsidiary of the Orano group, is expanding its global manufacturing capabilities for lead-212-based targeted alpha therapies (TATs) for cancer treatment. Following the inauguration of its ATLab Valenciennes in France, which is Europe's first industrial-scale pharmaceutical facility dedicated to producing these radioligand therapies, Orano Med is also commissioning a similar production site in Indianapolis, in the U.S. This U.S. facility is designed to serve the North American market, mirroring the European site's goal of large-scale production to meet patient needs. The company's TATs utilize lead-212 (212Pb), an alpha-emitting radioisotope, as a potent therapeutic payload against cancer cells. Orano Med's strategy involves developing several 212Pb-based radioligand therapies combined with various targeting agents, with four drug candidates currently in clinical development and a broad preclinical pipeline. The logistical demands for these treatments a...

Fenbendazole Not Approved for Human Cancer Treatment, Poses Risks

Fenbendazole Not Approved for Human Cancer Treatment, Poses Risks

Fenbendazole, an antiparasitic medicine used in veterinary medicine to treat certain worm infections in animals, is not approved for human use in the United States, particularly for cancer treatment. Despite online discussions and personal testimonials suggesting its efficacy against cancer, there is no reliable clinical evidence to support these claims. The drug works by interfering with microtubules in parasites, which are also present in cancer cells, leading to scientific interest. However, laboratory findings and animal studies do not translate directly to safe and effective human treatments. The U.S. Food and Drug Administration has not approved fenbendazole for any human use, and there is no established, clinically validated dosing regimen for human cancer. Individuals considering or currently using fenbendazole for cancer are strongly advised to consult their oncology team to discuss potential risks and available evidence-based treatments.