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

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Moderna bets on booster demand, advancing new 'bivalent' COVID-19 shot

Bio Pharma Dive

The biotech will start trials in the U.S. and U.K. of a vaccine that targets both the original coronavirus strain and the omicron variant.

Vaccine 316
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The drug industry continues to dare regulation

World of DTC Marketing

Pfizer expects to make as much as $22bn from its new Covid pill this year, on top of $37bn it made in 2021 from the vaccine. Pfizer’s Paxlovid currently costs about $530 for a five-day course of the treatment. Merck’s molnupiravir, now approved for use in the U.K., costs about $700. Reportedly, the cost of production for molnupiravir stands at about $17.74.

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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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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.

Trials 132
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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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Copay accumulators, maximizers and the CMS best price rule: What you need to know now

Bio Pharma Dive

Copay accumulators, maximizers and best price concerns dominated the copay assistance landscape in 2021. Here is an update on the most prominent developments in this area over the last six months.

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BMS: Delayed new drug to avoid paying billions?

World of DTC Marketing

Bristol Myers Squibb Co was sued for $6.4 billion on Thursday for allegedly delaying its Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp, which the drugmaker bought in 2019. Was it a wise move or incompetence? According to a complaint in Manhattan federal court, Bristol Myers failed to use contractually required “diligent efforts” to win U.S.

Drugs 216

More Trending

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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 DRIVEâ„¢-Biologics,

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Lilly, Boehringer diabetes pill wins expanded use in heart failure

Bio Pharma Dive

The FDA OK greatly broadens the number of patients eligible for Jardiance, which first won approval in 2014 as a treatment for low blood sugar in people with diabetes.

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Frequency on pharma TV too high

World of DTC Marketing

Ninety-two percent of U.S. viewers surveyed in 2021 believe “they see the same advertisements too many times when watching TV,” according to a new study by Audience Project. Nowhere is this more evident than in pharma TV ads like Tepezza. Thyroid eye disease affects more women than men, although men are more likely to have severe illnesses.

Branding 210
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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.

Drugs 122
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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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AstraZeneca, Daiichi press rivals with new results for breast cancer drug

Bio Pharma Dive

Positive study results for the companies' drug Enhertu in patients whose only remaining option is chemo could open up a new treatment use, pressuring competitors Roche and SeaGen.

Drugs 278
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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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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.

Genetics 121
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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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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.

Genome 130
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Amicus' SPAC deal unravels, leading to layoffs and cost cuts

Bio Pharma Dive

The biotech is calling off plans to spin out its gene therapy business via a merger with a blank check company, citing unfavorable market conditions and a "challenging environment.

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Greater tolerance: Allergic reactions to COVID vaccine lower for second dose

Pharma Times

Researchers discovered that recipients experiencing an allergic response to second COVID vaccine dose are minimal

Vaccine 119
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A Guide for Culture Fit Assessment When Screening Pharma Applicants (Free Questionnaire)

XTalks

Have you ever considered using a culture fit assessment for your candidate screening process? A culture fit assessment is designed to assess the candidates true alignment with the organizational culture. Essentially, how well they “fit in” Organizational culture is a widely recognized business term that has been well studied when it comes to the effectiveness of all kinds of organizations.

Marketing 116
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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.

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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.

Genome 130
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Spark CEO Marrazzo, who led company to historic gene therapy approval, to step down

Bio Pharma Dive

Jeffrey Marrazzo has led Spark since its founding in 2013, through the historic FDA approval of Luxturna and the company's $4.3 billion buyout by Roche.

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Community pharmacies save 20,000 lives during initial vaccination phases

Pharma Times

Figures by National Audit Office estimate that programme prevented up to 262,000 hospitalisations

Pharmacy 115
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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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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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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.

Vaccine 130
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Meso Scale Discovery (MSD): An immunoassay platform with varied applications in the biopharmaceutical industry

Bio Pharma Dive

Learn how MSD is a one stop immunoassay platform that could be a time- and cost-effective alternative to the regularly used bio-molecule detection technologies in the laboratory.

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NHS gene testing fails half of people at cancer risk

Pharma Times

Study reveals that many with an increased risk of cancer were excluded from the potential for monitoring

Gene 114
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New simple method for surveying amphibians: A vital contribution to conservation efforts

Scienmag

An international collaborative research group consisting of members from 7 institutions has developed a method of determining which amphibious species (types of frog, newt and salamander) inhabit an area. They achieved this by amplifying extra-organismal DNA (environmental DNA) found in the water so that they could be analyzed. This DNA ends up in the water […].

DNA 108
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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.

Drugs 130
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Kodiak crashes on negative trial results for would-be Eylea competitor

Bio Pharma Dive

Data from a Phase 3 trial showed Kodiak's experimental treatment didn't match up to Eylea in wet AMD, spurring questions from analysts about its potential.

Trials 189
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Haleon days: GSK explains demerger decision

Pharma Times

New company Haleon will become standalone venture as GSK's strategy for the future unfolds

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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

Gene 105
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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.