Mon.Oct 09, 2023

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FDA denies expanded approval for Alnylam RNA drug

Bio Pharma Dive

The agency rejected Alnylam’s application for approval of its medicine patisiran in people with a rare heart condition, setting back the company’s plans.

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GSK and Zhifei sign deal for shingles vaccine in China

Pharmaceutical Technology

GSK and Chongqing Zhifei have signed an exclusive agreement for co-promoting the former’s shingles vaccine, Shingrix, in China.

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GSK partners with Chinese pharma to expand Shingrix sales

Bio Pharma Dive

The purchase agreement with Chongqing Zhifei Biological Products is part of GSK’s plan to double sales of the shingles vaccine by 2026.

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Islet transplantation for type 1 diabetes: Do regulators have it right?

Pharmaceutical Technology

Diabetes researchers oppose the regulation of islet transplantation as a biologic, following the approval of CellTrans’ Lantidra.

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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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Want to Cut Heart Disease Risk? Here’s How Many Flights of Stairs to Climb Daily

AuroBlog - Aurous Healthcare Clinical Trials blog

Getting up at least 50 steps a day is associated with a more than 20 percent cut in the risk of cardiovascular disease, new research shows – so you may only need to climb five flights of stairs per day to significantly boost your heart health.

Research 246
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October 9, 2023: Registration Opens for Pragmatic Trials Workshop at AcademyHealth Dissemination & Implementation Conference

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 16th Annual Conference on the Science of Dissemination and Implementation in Health in Arlington, Virginia. The workshop, “Dissemination & Implementation in Embedded Pragmatic Trials: Raising the Bar for Real-World Research,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on methods relevant to health

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More Trending

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Using real-world data to improve patient access to oncology therapies

Bio Pharma Dive

Oncology manufacturers can improve access by using claims, labs, pathway and policy data to address misalignment.

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UK pharma industry hits out at plans to rework statutory payment scheme

Pharmaceutical Technology

More than 20 pharmaceutical companies across the UK have hit out against a proposed measure in the UK's regulation of medicines.

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Gates Foundation spends $40M to boost mRNA vaccine production in Africa and beyond

Fierce Pharma

Following similar initiatives to bolster mRNA vaccine production and access in Africa, the Bill & Melinda Gates Foundation is providing new funding to a clutch of drugmakers. | Following similar initiatives to bolster mRNA vaccine production and access in Africa, the Bill & Melinda Gates Foundation is providing new funding to a clutch of drugmakers.

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Novartis expands Cosentyx reach for rheumatic diseases with IV version approval

Pharmaceutical Technology

The approval marks the first intravenous (IV) formulation treatment in adults with rheumatic diseases in six years.

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

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Elligo Health Research expands Study Marketplace with Syneos Health

Pharma Times

The agreement builds on the companies’s existing partnership - News - PharmaTimes

Research 135
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BMS signs agreement to buy Mirati Therapeutics for $5.8bn

Pharmaceutical Technology

Bristol Myers Squibb (BMS) signed a definitive agreement to acquire all outstanding shares of Mirati Therapeutics for $5.8bn.

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New University of Bristol study to aid strep A vaccine development

Pharma Times

The study will offer new insights into the immune system's response to iGAS - News - PharmaTimes

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Semaglutide: a price and HTA comparison between US and top European markets

Pharmaceutical Technology

Semaglutide: compared to key European markets, its higher price and that of other diabetes/obesity drugs in the US could impact on healthcare

Marketing 147
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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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Alongside diagnosis: AI’s role in shaping health transformation outcomes

pharmaphorum

Alongside diagnosis: AI’s role in shaping health transformation outcomes Mike.

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Ultimovacs bags orphan drug tag for mesothelioma vaccine

Pharmaceutical Technology

The FDA decision follows a similar designation for the vaccine UV1 against malignant melanoma in December 2021.

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GSK strikes $3B Shingrix partnership with China powerhouse Zhifei. Is a deal for RSV shot next?

Fierce Pharma

GSK has forged a partnership with vaccine powerhouse Chongqing | GSK has forged a partnership with vaccine powerhouse Chongqing Zhifei Biological Products to distribute Shingrix in China. Zhifei will pay £2.5 billion ($3.05 billion) for exclusive rights to distribute the shingles shot in China from 2024 through 2026. The deal could be a precursor to similar arrangement between the companies for GSK’s new respiratory syncytial virus (RSV) vaccine Arexvy, the London-based drugmaker said.

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Alnylam abandons plans for RNAi drug Onpattro after FDA hits the brakes

Pharmaceutical Technology

The FDA CRL cited insufficient evidence to approve the use of Onpattro for treating cardiomyopathy of ATTR amyloidosis.

Drugs 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Curio DTx hits mark in postpartum depression trial

pharmaphorum

Curio DTx hits mark in postpartum depression trial Phil.

Trials 115
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AstronauTx wins £48m in funding for developing Alzheimer’s therapies

Pharmaceutical Technology

The Series A funds will help advance a pipeline, which includes drugs that provide both symptomatic and disease-modifying benefits.

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Reviving an R&D Pipeline

Drug Patent Watch

The article titled “Reviving an R&D Pipeline: A Step Change in the Phase II Success Rate” discusses Pfizer’s efforts to improve its research and development (R&D) productivity. The pharmaceutical industry… The post Reviving an R&D Pipeline appeared first on DrugPatentWatch - Make Better Decisions.

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Janssen seeks approval from EMA for NSCLC combo therapy

Pharmaceutical Technology

Janssen has submitted an application seeking approval from the EMA for the NSCLC combo therapy, RYBREVANT plus chemotherapy.

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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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Roche preps for filings after subcutaneous Ocrevus matches up to IV formulation in phase 3 study

Fierce Pharma

Roche preps for filings after subcutaneous Ocrevus matches up to IV formulation in phase 3 study zbecker Mon, 10/09/2023 - 18:07

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Amgen acquires Horizon Therapeutics for $27.8bn

Pharmaceutical Technology

Amgen has acquired Horizon Therapeutics in a deal valued at $27.8bn following approval from the US Federal Trade Commission.

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Alnylam abandons Onpattro expansion in US as FDA spurns rare heart disease bid

Fierce Pharma

Despite an endorsement from an advisory committee, the FDA has come to a different conclusion on the benefit-risk profile for Alnylam’s Onpattro in the rare heart disease transthyretin amyloidosis | Despite an endorsement from an advisory committee, the FDA has come to a different conclusion on the benefit-risk profile for Alnylam’s Onpattro in the rare heart disease transthyretin amyloidosis cardiomyopathy (ATTR-CM).

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Signal: LimmaTech raises $37m for antimicrobial resistance research

Pharmaceutical Technology

Limmatech, a GSK spinoff focused on combatting antimicrobial resistance, had sought series A funding seven years after foundation.

Research 130
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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

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BMS swoops on Mirati with $5.8bn takeover offer

pharmaphorum

BMS swoops on Mirati with $5.8bn takeover offer Phil.

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Which pharmaceutical companies have the most drug patents in Mexico?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Mexico. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is… The post Which pharmaceutical companies have the most drug patents in Mexico? appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 105
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Scotland first in Europe to back MSD drug for VHL tumours

pharmaphorum

Scotland first in Europe to back MSD drug for VHL tumours Phil.

Drugs 108
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Navigating a fragmented marketing landscape with DeepIntent

Fierce Pharma

The way we consume and engage with content is changing all the time. | How can marketers leverage AI to make sense of the masses of data they have access to? Chris Paquette, Founder and CEO of DeepIntent, explores the issues of fragmentation and outlines some of the tools designed to overcome it.

Marketing 102
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How Machine Learning Drives Clinical Trial Efficiency

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.