Tue.Nov 19, 2024

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Taking its best shot at Roche, Merck scores in phase 3 trial of subcutaneous Keytruda

Fierce Pharma

Two months after Roche scored FDA approval for its subcutaneous ve | Two months after Roche scored FDA approval for its subcutaneous version of PD-LI inhibitor Tecentriq, Merck has achieved a key milestone in lining up its checkpoint inhibitor Keytruda to follow suit. On Tuesday, the company revealed that its subcutaneous formulation of Keytruda has aced a phase 3 trial, demonstrating non-inferiority to the immunotherapy’s intravenous version.

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Scientists Say This One Particular Diet May Slow The Decline of The Brain

AuroBlog - Aurous Healthcare Clinical Trials blog

(Flavio Coelho/Moment/Getty Images) While it’s not possible to stop the brain from aging – at least not yet – there might be ways to slow down its decline, and a new study shows the vital role blood sugar levels play in how rapidly the brain ages.

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Diversity Action Plans (DAPs) in Clinical Trials Are No Longer a “Nice-to-Have” — Are You Ready?

XTalks

In clinical research, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinical trial outcomes. The integration of diverse patient populations ensures that therapeutic interventions are effective across different demographics, reflecting real-world settings. The need for adequate representation has given rise to several initiatives, the most notable and recent among which is the US Food and Drug Administration

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Under-the-skin Keytruda comparable to infused version in Phase 3 study, Merck says

Bio Pharma Dive

Merck plans to discuss the data with regulators as it lags rivals Roche and Bristol Myers in bringing forward a subcutaneous form of its cancer drug.

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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AHA 2024: CV effectiveness of GLP-1RA + Empagliflozin therapy in adults with T2D

Pharmaceutical Technology

SGLT-2I therapies reduce the risk of heart failure and this study clearly demonstrates the benefit of adding them onto GLP-1RA therapy.

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Incyte shares sink on setback for drugs acquired in $750M buyout

Bio Pharma Dive

The company paused testing of one candidate acquired in its April deal for Escient and scrapped another in a blow to its diversification plans.

Drugs 167

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Astellas application rejected by FDA; Cytokinetics strikes licensing deal with Bayer

Bio Pharma Dive

The agency turned back Astellas’ attempt to update its drug Izervay’s labeling. Elsewhere, former NCI director Ned Sharpless founded a new startup and Novartis licensed another radiopharma drug.

Licensing 144
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FDA shares additional draft guidance on CGTs

Pharmaceutical Technology

The FDA has released a draft of new guidance addressing common FAQs about the development of potential CGT treatments.

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New PAGB research highlights importance of self-care for easy-to-treat conditions

Pharma Times

The census found that 56% of people visit their GP for a UTI and 27% for thrush

Research 128
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Does Southeast Asia have a growing role in vaccine development?

Pharmaceutical Technology

The upcoming clinical trial conferences will host talks on supply chain resilience, AI’s growing role and forging industry partnerships.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Henrick Watz, MD, PhD, Leads Ahrensburg, Germany Site as Top Enroller in Global COPD Trial

Velocity Clinical Research

Another outstanding achievement for Henrik Watz, MD, PhD, and our team in Ahrensburg, Germany! They led enrollment for a global chronic obstructive pulmonary disease (COPD) trial, more than doubling the enrollment of the next highest-performing site. Congratulations to Dr. Watz and our Ahrensburg team! Learn more about our respiratory capabilities > The post Henrick Watz, MD, PhD, Leads Ahrensburg, Germany Site as Top Enroller in Global COPD Trial appeared first on Velocity Clinical Researc

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Regenxbio eyes 2026 filing for Duchenne muscular dystrophy gene therapy

Pharmaceutical Technology

Regenxbio’s plans toward a BLA filing in 2026 after positive data from the Phase I/II AFINITY DUCHENNE trial.

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FDA approves first-ever gene therapy to be directly administered to the brain

BioPharma Reporter

PTC Therapeutics has received FDA approval for a gene therapy to treat AADC deficiency, a rare genetic disorder that impairs the normal function of neurons.

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Does Southeast Asia have a growing role in vaccine development?

Pharmaceutical Technology

The upcoming clinical trial conferences will host talks on supply chain resilience, AI’s growing role and forging industry partnerships.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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J&J pill clears skin in two late-stage psoriasis studies

Bio Pharma Dive

The drug, called icotrokinra and developed together with Protagonist Therapeutics, is an oral peptide designed to tamp down the inflammation involved in psoriasis and other immune diseases.

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Aclaris Therapeutics secures global rights to Biosion’s antibodies

Pharmaceutical Technology

Aclaris Therapeutics has secured an exclusive license from Biosion for the global rights to two new antibodies.

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FDA approves first-ever gene therapy to be directly administered to the brain

BioPharma Reporter

PTC Therapeutics has received FDA approval for a gene therapy to treat AADC deficiency, a rare genetic disorder that impairs the normal function of neurons.

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Novartis strengthens radiopharma leadership with Ratio Therapeutics deal

Pharmaceutical Technology

Novartis has teamed up with Ratio Therapeutics in a $745m licensing and collaboration agreement to advance radiopharmaceutical therapies.

Licensing 130
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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GSK drug raises hopes for patients with PBC itch

pharmaphorum

GSK has reported promising phase 3 results with linerixibat in treating severe itching that plagues patients with primary biliary cholangitis

Drugs 98
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AHA 2024: Tirzepatide improves outcomes for major heart failure with HFpEF and obesity in SUMMIT

Pharmaceutical Technology

Tirzepatide is a long-acting dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist (GIP/GLP-1).

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J&J plots filings after psoriasis drug clears phase 3 test

pharmaphorum

Johnson & Johnson has moved a step closer to filing a potential first-in-class therapy for psoriasis after the drug hit the mark in a phase 3 trial

Drugs 98
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ReCode to secure funds for cystic fibrosis gene correction treatments

Pharmaceutical Technology

ReCode is set to secure up to $15m in funding from the Cystic Fibrosis Foundation to enhance its gene correction research programme.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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NIH algorithm matches patients to clinical trials

pharmaphorum

Researchers from the National Institutes of Health (NIH) are applying artificial intelligence to the recruitment of volunteers into clinical trials, aiming to solve a major obstacle in clinical research.Patient recruitment remains a major challenge for trial sponsors and can lead to delays and increased costs, and traditional methods can be time-consuming and inefficient.

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C Ray Therapeutics raises $100 million to develop radiopharmaceuticals

Outsourcing Pharma

The financing round will fund the improvement of the companyâs technology platform for the discovery and development of innovative radionuclide drug conjugates.

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With patent settlement, BeiGene defends blockbuster Brukinsa from MSN's generic threat until 2037

Fierce Pharma

As BeiGene works to grow the reach of its cancer offerings, the company inked a patent settlement with MSN over its star medicine Brukinsa.

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Eli Lilly announces positive Phase 2 results for Muvalaplin against heart disease

Outsourcing Pharma

Muvalaplin significantly lowered lipoprotein(a) levels, reducing the risk of cardiovascular events in high-risk adults.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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KnippeRx Transforms Patient Assistance Programs through Technology and Patient-Focused Solutions.

Fierce Pharma

KnippeRx Transforms Patient Assistance Programs through Technology and Patient-Focused Solutions.

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Eli Lilly announces positive Phase 2 results for Muvalaplin against heart disease

Outsourcing Pharma

Muvalaplin significantly lowered lipoprotein(a) levels, reducing the risk of cardiovascular events in high-risk adults.

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Pii Invests in Prefilled Syringe Capabilities

Pharmaceutical Commerce

The CDMO is investing $3.6 million toward boosting its advanced labeling, automated visual inspection, and fill-finish tech.

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C Ray Therapeutics raises $100 million to develop radiopharmaceuticals

Outsourcing Pharma

The financing round will fund the improvement of the company’s technology platform for the discovery and development of innovative radionuclide drug conjugates.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud