Fierce Pharma

NOVEMBER 19, 2024

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.

FDA Approval 122

FDA Approval Trials 122

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 19, 2024

(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.

Scientist 225

Scientist Clinical Trials Clinical Trials Trials 225

Bio Pharma Dive

NOVEMBER 19, 2024

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.

Regulation 173

Regulation Drugs 173

Pharmaceutical Technology

NOVEMBER 19, 2024

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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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

Medicine

Bio Pharma Dive

NOVEMBER 19, 2024

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 173

Drugs 173

Pharmaceutical Technology

NOVEMBER 19, 2024

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

Development 130

Development 130

Pharmaceutical Technology

NOVEMBER 19, 2024

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

Clinical Trials 130

Clinical Trials Clinical Trials Development Vaccine 130

Bio Pharma Dive

NOVEMBER 19, 2024

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.

Development 113

Development Drugs 113

Pharmaceutical Technology

NOVEMBER 19, 2024

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

Gene Therapy 130

Gene Therapy Gene Trials 130

BioPharma Reporter

NOVEMBER 19, 2024

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.

Gene Therapy 99

Gene Therapy FDA Approval Gene Genetics 99

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Clinical Supply

Pharmaceutical Technology

NOVEMBER 19, 2024

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

Clinical Trials 130

Clinical Trials Clinical Trials Development Vaccine 130

pharmaphorum

NOVEMBER 19, 2024

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

Drugs 98

Drugs 98

Pharmaceutical Technology

NOVEMBER 19, 2024

BMS's CFO David Elkins added it is “too soon to tell” what policies Trump’s new administration will bring.

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130

Pharma Times

NOVEMBER 19, 2024

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

Research 98

Research 98

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

Clinical Trials

Pharmaceutical Technology

NOVEMBER 19, 2024

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

Antibody 130

Antibody Licensing Licensing 130

Fierce Pharma

NOVEMBER 19, 2024

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

Medicine 98

Medicine 98

Pharmaceutical Technology

NOVEMBER 19, 2024

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

Licensing 130

Licensing Licensing 130

pharmaphorum

NOVEMBER 19, 2024

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Research 98

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Clinical Supply

Pharmaceutical Technology

NOVEMBER 19, 2024

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

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130

pharmaphorum

NOVEMBER 19, 2024

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

Drugs Trials 98

Pharmaceutical Technology

NOVEMBER 19, 2024

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

Gene 130

Gene Research 130

Outsourcing Pharma

NOVEMBER 19, 2024

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

Development 83

Development Drugs 83

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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.

Clinical Trials

Pharmaceutical Technology

NOVEMBER 19, 2024

EMA's CHMP has recommended AstraZeneca's Tagrisso for approval in the European Union to treat individuals with NSCLC.

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130

XTalks

NOVEMBER 19, 2024

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

Clinical Trials 64

Clinical Trials Clinical Trials Trials Production 64

Outsourcing Pharma

NOVEMBER 19, 2024

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

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81

BioPharma Reporter

NOVEMBER 19, 2024

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.

Gene Therapy 81

Gene Therapy FDA Approval Gene Genetics 81

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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

Clinical Research

Outsourcing Pharma

NOVEMBER 19, 2024

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

Clinical Development 81

Clinical Development Development 81

pharmaphorum

NOVEMBER 19, 2024

Astellas has suffered another major setback with geographic atrophy (GA) treatment Izervay, this time in the US. The company has received a complete response letter (CRL) from the FDA for a proposed update to the labelling for Izervay (avacincaptad pegol) that sought to include the results of the phase 3 GATHER2 trial and improve the drug's competitive profile against rival Syfovre (pegcetacoplan) from Apellis.

Drugs 81

Drugs Trials 81

Outsourcing Pharma

NOVEMBER 19, 2024

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

Development 77

Development Drugs 77

ACRP blog

NOVEMBER 19, 2024

A scholarship powered by the long-distance cycling adventures of some of the ACRP Community’s greatest equity champions and their backers has gone the distance on the other side of the globe this year, resulting in a completed prostate cancer project for Esther Samuel in Nigeria, who was among the initial recipients of ACRP Access for Students to Clinical Research Training (ASCRT) program support.

Clinical Research 59

Clinical Research Research 59

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Clinical Trials