Sat.Feb 19, 2022 - Fri.Feb 25, 2022

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Big day for AZ, Daiichi as Enhertu aces HER2-low breast cancer trial

pharmaphorum

Already making inroads as a treatment for HER2-positive breast cancer, AstraZeneca and Daiichi Sankyo’s Enhertu has now shown efficacy in tumours that express lower levels of HER2 – potentially making it an option for a much broader group of patients. It’s a key moment for the two companies, as expansion into HER2-low breast cancer has been held up as a key requirement for Enhertu (trastuzumab deruxtecan) if it is to achieve its multibillion-dollar sales expectations.

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Report shines a light on unique challenges of rare disease patients

Outsourcing Pharma

In its latest diversity, equity and inclusion report, Global Genes offers insight into obstacles faced by rare-disease patients from minority communities.

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Data from first DMT-assisted clinical trial revealed

Pharma Times

No sign of significant negative effects on anxiety and wellbeing following pioneering Small Pharma trial

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A Re-cap of The Year Ahead: Insights from Pharma Executives

Pharma Marketing Network

“ Being more focused, more narrow in terms of the meeting objectives, making sure the right people are there, and making sure that you have quick hit type of interventions during the course of the week to keep track of status is serving us very well. I would suggest that even if and when things return to normal, a lot of those practices and a lot of those mindsets of ways of working will probably continue even after.” – Jeff Fayer, Novartis.

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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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EU clears Bayer’s chronic kidney disease drug Kerendia

pharmaphorum

Bayer has claimed EU approval for Kerendia, its new drug for chronic kidney disease (CKD) in people with type 2 diabetes, as the company tries to build a role of the drug alongside rival therapies from AstraZeneca and Johnson & Johnson. The approval is based on the phase 3 FIDELIO-DKD trial, in which Kerendia (finerenone) reduced the risk of kidney disease progression or renal death by 18% when added to the highest tolerated dose of standard therapy.

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Genomenon forges rare-disease partnership with advocacy group

Outsourcing Pharma

The AI-centered genomics company is joining with Donât Forget Morgan, a group for patients with BPAN, to explore treatments for the neurodegenerative condition.

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Abzena, Alira Health and Oncodesign launch DRIVE Biologics to support access to specialist services from discovery to clinical development for oncology and inflammation

Pharma Mirror

Cambridge, UK, Framingham, MA (USA), and Dijon, France, Abzena, a partner research organization for integrated services from discovery through to clinical and commercial manufacturing for biologics and bioconjugates, Alira Health, an international patient-centric and technology-enabled advisory firm whose mission is to humanize healthcare, and Oncodesign (ALONC -FR0011766229), a biopharmaceutical company dedicated to precision medicine, announce today that, with the launch of DRIVE™-Biologics,

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Could Facebook monitoring predict sudden epilepsy death?

pharmaphorum

A study has suggested people with epilepsy may show patterns of activity and behaviour on social media that could serve as an early warning signal for sudden death – a rare but much feared complication of the disease. The study was carried out in six individuals who suffered sudden unexpected death in epilepsy (SUDEP), with the researchers analysing hundreds of Facebook posts for each subject in the six months leading up to their death, with the consent of surviving family members.

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For rare disease patients, ‘every day is Rare Disease Day’

Outsourcing Pharma

On February 23, five days ahead of the day of rare-disease awareness, OSPâs Rare and Orphan Diseases webinar will share insights from top industry experts.

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Accelerating Oligonucleotide Demand: A Force Driving The Contract Manufacturing Market

Roots Analysis

Since the approval of the first antisense therapy in 1998, oligonucleotides have been in light for their capabilities as therapeutic agents. Oligonucleotides are short synthetic nucleotide chains with immense potential in the diagnosis and treatment of a myriad of disease indications. In addition to therapeutics, these complex molecules act as a significant resource in various research applications.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Ways to Access Affordable Mental Health Services

Pharma Mirror

Taking care of your mental health can be affordable. All you will have to do is choose therapy options that fit in your budget. In this article, we have outlined the most affordable therapy options. While the options fall in the lower price range, they are all capable of delivering your expected results. The post Ways to Access Affordable Mental Health Services appeared first on Pharma Mirror Magazine.

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Examining COVID’s impact on clinical research participant diversity

pharmaphorum

The clinical research industry has long struggled with participant diversity. One study found that only 5% of Black or Asian United Kingdom residents had ever participated in a clinical trial. A study of FDA-approved vaccine trials from 2011-2020 showed that 78% of participants were white, even though only 60% of the U.S. population was. . And then came COVID-19.

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Lilly planning $700m genetic medicine development center

Outsourcing Pharma

The pharmaceutical companyâs Lilly Institute for Genetic Medicine reportedly will focus on developing RNA-based therapeutics in a âstate-of-the-artâ facility.

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Next Generation Sequencing (NGS) Library Preparation Kits: Revolutionizing the Field of Genetic Sciences

Roots Analysis

NGS has emerged as an evolutionary technology in modern biotechnology and healthcare research, enabling researchers to develop a better understanding of the cause and consequences of disease. Over the past few years, several companies have started offering a diverse range of genome sequencing products and services using various second and third generation sequencing technologies.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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MBMV invests in international bio-tech startup Arcensus GmbH

Pharma Mirror

Hoboken, NJ, Rostock/Berlin, Germany, Based on Whole Genome Sequencing (WGS), Arcensus GmbH makes it possible to detect rare as well as frequent disorders such as cancer or heart diseases at the earliest stage in order to start preventive and personalized treatment. One year after Arcensus was founded, fresh capital is now being raised for further expansion.

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NHS gene testing missing half of people at cancer risk

pharmaphorum

A study has revealed that current NHS guidelines on testing for genetic alterations linked to cancer could be missing around half of people carrying them, says a new study. The work by scientists at the Institute for Cancer Research (ICR) suggests that access to genetic testing should be made easier because the guidelines as drawn up “would have excluded many people who had ‘actionable’ genetic alterations that could raise their risk of cancer.” Cancer is not usually inhe

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FDA clears Immune-Onc to start trial of Keytruda combo in solid-tumor patients

Outsourcing Pharma

The agency has given the go-ahead for a Phase I study of the companyâs IO-202 antibody (in combination with Merckâs Keytruda) to treat various tumor types.

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Rising Need of Autoinjectors

Roots Analysis

With the increasing global population, the incidence rates of several chronic disease indications, such as diabetes, anaphylaxis, rheumatoid arthritis and psoriasis, are on the rise. This has led to a rise in the demand for effective treatment options for patients suffering from these diseases. Further, in order to improve the quality of life in these patients, companies have developed novel devices capable of delivering a variety of formulations of different drugs / therapies, in an efficient a

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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MBMV invests in international bio-tech startup Arcensus GmbH

Pharma Mirror

Hoboken, NJ, Rostock/Berlin, Germany, Based on Whole Genome Sequencing (WGS), Arcensus GmbH makes it possible to detect rare as well as frequent disorders such as cancer or heart diseases at the earliest stage in order to start preventive and personalized treatment. One year after Arcensus was founded, fresh capital is now being raised for further expansion.

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Takeda grows in gene therapies again with $2bn Code Bio deal

pharmaphorum

Takeda has forged another alliance as it continues a push into gene therapy, agreeing a deal worth up to $2 billion with Code Biotherapeutics for opt-in rights to four candidates for rare diseases. The Japanese drugmaker will get access to Code Bio’s 3DNA non-viral genetic medicine delivery platform, initially for a liver-directed programme, and is also interested in deploying the technology for central nervous system disorders.

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Viiv weighs in on FDA approval of long-acting HIV treatment

Outsourcing Pharma

A representative from the HIV-centered pharmaceutical company shares thoughts and perspective on the every-two-month treatment and how it might help patients.

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Next Generation Sequencing (NGS) Library Preparation Kits Market: Current Scenario and Future Potential

Roots Analysis

Since the introduction of a gene sequencing method by Frederick Sanger in 1977, the field of genomic data collection and analysis has evolved significantly. Advancement in DNA sequencing technologies have resulted in noteworthy developments in various healthcare-related research fields, such as diagnostics and personalized medicine. However, the conventional nucleotide library preparation process has several challenges, including requirement of huge amount of starting materials, inadequate throu

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V-01 as a Sequential Booster Can Produce Good Protection against Omicron Latest Phase III Data of COVID-19 Vaccine by Livzon Pharma

Pharma Mirror

HONG KONG, Global pandemic control is still facing enormous challenges after more than two years since the outbreak of the COVID-19. Following the Delta and Beta variants, Omicron variant emerged at the end of 2021, and its enhanced infectivity has cast a shadow over the global COVID-19 control. Recently, Omicron quickly spread in Japan and South Korea, and the number of newly confirmed cases in South Korea has exceeded 90,000 for two consecutive days.

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Bia Care starts NHS trial of its digital menopause platform

pharmaphorum

A virtual menopause clinic service developed by Bia Care is starting a randomised clinical trial within the NHS that will not only test how well it performs, but also attempt to tackle inequalities in women’s health. The trial has been announced shortly after Bia Care was awarded additional funding from the NHS to extend the rollout of its digital platform, which helps women book an appointment, have a group online consultation with a doctor, get a personalised plan for managing menopause

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Emmes contributes data service to pediatric COVID-19 research

Outsourcing Pharma

The CRO is helping out on a project exploring the effects of the virus in children; other members of the research team include experts from Duke University.

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Nanoparticles: Emerging Stars for Pharmaceutical Industry

Roots Analysis

Over the last decade, one of the major challenges faced by pharmaceutical players across the globe is low drug solubility. In fact, it has been observed that around 40% of the pharmaceutical products approved by regulatory organizations exhibit poor bioavailability / solubility. Further, every year, poor bioavailability is one of the prime reasons that leads to failure in obtaining approval authorization.

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QUOTIENT SCIENCES COMPLETES INTEGRATION OF DRUG SUBSTANCE INTO TRANSLATIONAL PHARMACEUTICS® PLATFORM

Pharma Mirror

NOTTINGHAM (UK) Quotient Sciences – a global drug development and manufacturing accelerator offering a suite of services to clients in the pharmaceutical and biotech industry – announces that it has integrated drug substance into its flagship Translational Pharmaceutics® platform. The newly integrated service unites drug substance, drug product and clinical testing activities all within a unified organization and under a single project manager.

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How new data capabilities can supercharge clinical research

pharmaphorum

The UK’s health research data capabilities are rapidly evolving. For example, during the height of the pandemic, NIHR’s integrated health research system was able to compare COVID-19 hospital caseloads to COVID-19 research activity in real time. This enabled rapid recruitment to multiple COVID-19 clinical trials throughout England/UK. . In a post-pandemic world, how can we use insights gained from healthcare and research activity data to inform commercial research planning and placement decisio

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Parexel, Medidata extend decentralized clinical trial partnership

Outsourcing Pharma

The two companies, which have been collaborating for 15 years, reportedly will focus on elevating decentralized trial solutions to develop new therapies.

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PANORAMIC view of World’s largest COVID study

Pharma Times

Study involving 10,000 patients will investigate a range of potentially ground-breaking oral antivirals

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Open Fracture Management: Antibiotics

Pharmacy Friday Pearls

Download PDF. Introduction. Open fracture wounds are considered high energy injuries that come with a high risk of infection due to the potential exposure of bone and tissue to environmental pathogens. The Gustilo- Anderson classification system grades open fractures and can be utilized to guide antimicrobial prophylaxis. For Type I fractures, which are clean wounds less than 1 centimeter long, gram positive coverage is recommended; cefazolin is usually the agent of choice.

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FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure

pharmaphorum

Eli Lilly and Boehringer Ingelheim’s blockbuster diabetes drug Jardiance (empagliflozin) has been granted approval by the US Food and Drug Administration (FDA) for a wider range of heart failure patients. . The approval builds upon previously secured indications, including the use of Jardiance to reduce the risk of cardiovascular death plus hospitalisation for heart failure with reduced left ventricular ejection fraction (LVEF), which the FDA greenlighted in 2021.

FDA 101
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MAOIs in Parkinson’s – Breakdown For Pharmacists

Med Ed 101

Pharmacists are no strangers to neurodegenerative disease. However, Parkinson’s cases present great difficulty to patients and clinicians, as our medical world lacks a solid understanding of the disease in comparison to other conditions. After Alzheimer’s disease, Parkinson’s is the second most prevalent neurodegenerative disease. It is estimated at least 1 million people in the U.S. […].

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