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

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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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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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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 131
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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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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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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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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

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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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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 269
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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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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 110
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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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UK health leaders call for urgent mental healthcare plan

Pharma Times

The UK government is urged to be more mindful of children and young people who have mental health issues, following the publication of the NHS Elective Recovery Plan

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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.

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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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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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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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Moderna and Thermo Fisher Scientific announce 15-year mRNA manufacturing deal

BioPharma Reporter

Moderna and Thermo Fisher Scientific have announced a 15-year strategic collaboration agreement to enable dedicated large-scale manufacturing of COVID-19 vaccine Spikevax in the US, as well as other investigational mRNA vaccines and therapies.

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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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BioNTech Unveils the BioNTainer, a Modular mRNA Vaccine Factory to Help Production in Africa

XTalks

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. The BioNTainer is housed in shipping containers equipped with state-of-the-art technology for producing the mRNA vaccines from start to finish, except for the final fill-and-finish step that will be performed by local manufacturing partners.

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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 104
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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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Behavioral scientist will present findings from 25-year study of outcomes of juvenile justice-involved youth

Scienmag

Behavioral scientist will present findings from 25-year study of outcomes of juvenile justice-involved youth Credit: Northwestern Juvenile Project Behavioral scientist will present findings from 25-year study of outcomes of juvenile justice-involved youth Linda Teplin to speak at AAAS 2022 virtual meeting on Feb. 19, 2022 EVANSTON, Ill. — Northwestern University behavioral scientist Linda Teplin will […].

Scientist 100
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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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Victory Road: NHS successful in 11 year claim against Servier

Pharma Times

The European Commission finds that Servier committed a breach of competition over blood pressure drug

Drugs 126
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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

Trials 101
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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Looking for a Summer Internship? You’d Better Act Fast

Intouch Solutions

Internships are an ideal way to get real work experience and figure out if you’re a good fit for a particular industry, but how do you score one when much of the professional world is still working remotely? Who’s going to trust an untested employee to work unsupervised on their couch or at their dining room table? Intouch will. We’ve been doing it for the past two years, and we’ve learned that it’s not only possible, but that our interns do exceptionally well , even without ever setting foot in

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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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EverGrain’s Line of Barley-Based Products Scores Upcycled Certification

XTalks

EverGrain Ingredients, a barley protein and fiber solutions company, recently received certification from the Upcycled Food Association (UFA) for its entire portfolio of products. The first-of-its-kind certification , which launched last year, allows food and beverage manufacturers that use upcycled ingredients to place the claim on their packaging.

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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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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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Solving Regulatory Challenges: CSV for Cloud-based Clinical Applications

Cloudbyz

A comprehensive session exploring the regulatory challenges for clinical application. Rajendra Sadare, Head – Quality & Compliance from Cloudbyz goes deeper to explain the challenges, the expectation and the possible solutions.

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Sanofi and GSK, after delays, to seek clearance for COVID-19 vaccine

Bio Pharma Dive

The companies' vaccine provided strong protection against severe illness in a large clinical trial, a long awaited result that could position it as a booster for people who have received other shots.

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Partake Foods Goes Beyond Allergen-Friendly Treats to Create Opportunities for People of Color

XTalks

Cakes, cookies and brownies, among other confectionary delicacies, tend to be packed with the most common allergens, including cow’s milk, eggs and tree nuts. While we all deserve a treat, those with allergies can often be excluded from satisfying their sweet tooth without planning and forethought. That’s where Partake Foods comes in. . Founded in 2016 by Denise Woodard, Partake Foods was created out of necessity for allergen- and gluten-free cookies and baking mixes.

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PerkinElmer’s Sirion to develop new generation AAV vectors for diabetes gene therapy

BioPharma Reporter

PerkinElmerâs Sirion Biotech business is teaming up with the Centre for Genomic Regulation (CGR) to jointly develop new generation adeno-associated virus (AAV) vectors for type 1 and type 2 diabetes gene therapy in the pancreas.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.