Wed.Jul 06, 2022

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Misjustice benefits pharma

World of DTC Marketing

Endpoint News reported “Three major drug distributors are off the hook for what may have been a $2.5 billion payment after a federal judge found them not liable for the opioid epidemic in parts of West Virginia, one of the hardest-hit areas of the country. This is beyond outrageous it’s a classic example of abuse of power. Despite distributing more than 51.3 million doses of oxycodone and hydrocodone to pharmacies in Cabell County and the city of Huntington over less than a decade, M

Pharma 238
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Is biotech facing a long bear market?

Pharmaceutical Technology

Talks of a bear market in the biotech sector do not seem to pass, with news of companies falling into administration and layoffs becoming a recurrence. Just last week, trading for 4D Pharma , a British biotech, was suspended on the London Stock Exchange’s Alternative Investment Market , and the company will be delisted from NASDAQ on July 7. Elsewhere, San Diego, California-based Heron Therapeutics announced restructuring and layoffs for 34% of its workforce.

Marketing 129
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Trending Sources

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How the agile in pharma trend is transforming drug development [Sponsored]

MedCity News

Emergn Principal Consultant Mario Moreira shared insights on how pharma companies can use the principles of Value, Flow and Quality to shorten drug development timelines and deliver better patient outcomes through improved ways of working.

Pharma 128
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EC approves Novavax’s Covid-19 vaccine CMA expansion for adolescents

Pharmaceutical Technology

The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain. The latest development comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive recommendation in

Safety 105
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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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How UCSF’s accelerator is helping health tech reach more low-income patients

MedCity News

The low-income patient populations who bear disproportionate disease burdens are the same populations who are most likely to face barriers in health technology use, according to Courtney Lyles co-founder of S.O.L.V.E. Health Tech, UCSF’s health equity accelerator. The program she co-founded seeks to address this problem by conducting research with digital health startups about how their products can better serve low-income patients.

Patients 120
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Europe is seeing a hiring boom in pharmaceutical industry data analytics roles

Pharmaceutical Technology

Europe was the fastest growing region for data analytics hiring among pharmaceutical industry companies in the three months ending May. The number of roles in Europe made up 11.8% of total data analytics jobs - up from 11.1% in the same quarter last year. That was followed by North America, which saw a -0.4 year-on-year percentage point change in data analytics roles.

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Are timely access and robust safety mutually exclusive?

pharmaphorum

The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely access with robust safety? Cancer patients in Europe wait an average of almost eight months longer for access to breakthrough medications than their American counterparts. A new cross-sectional study has found that the FDA green lit 95% of the 89 new oncology therapies approved between 2010 and 2019 before the EMA, with the Europeans trailing the Americans by a

Safety 92
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With new gene therapy data in hand, Sarepta talks with FDA about approval pathways

MedCity News

Sarepta Therapeutics has more clinical data showing the safety and efficacy of its experimental gene therapy for Duchenne muscular dystrophy. A pivotal Phase 3 test is already underway and could post data next year but the company is also talking with regulators about the possibility of a submission under the accelerated approval pathway.

Safety 117
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BioNTech bites back after CureVac patent challenge

pharmaphorum

BioNTech has responded to a patent infringement lawsuit filed by fellow German biotech CureVac over its COVID-19 vaccine, saying it will “vigorously” defend itself. CureVac revealed yesterday that had filed suit in the Düsseldorf Regional Court, claiming that mRNA technology used in BioNTech’s Comirnaty vaccine – partnered with Pfizer – infringes its intellectual property.

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OSF Ventures’ new leader will focus investments on alternative care modalities, workforce retention

MedCity News

OSF Ventures — the investment arm of Peoria, Illinois-based OSF HealthCare — gained a new leader last week when Mayank Taneja took the helm. In the role, Taneja oversees $250 million in assets across three funds. The venture capital arm is currently focused on investing in solutions to take care outside the four walls of a hospital and increase workforce retention, he said.

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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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FDA to decide on Roche’s lymphoma drug Lunsumio before year-end

pharmaphorum

The FDA has granted a priority review to Roche’s T-cell engager Lunsumio as a treatment for follicular lymphoma (FL), setting up a decision on the drug by 29 December. The first-in-class drug – which targets CD20 and CD3 – is being assessed by the regulator for relapsed or refractory FL, the most common slow-growing form of non-Hodgkin lymphoma (NHL), after two or more prior systemic therapies.

FDA 83
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Remote Therapeutic Monitoring (RTM): A gateway to hybrid musculoskeletal care

MedCity News

A new set of 5 CMS codes introduced for 2022, RTM allows physical therapists and other qualified healthcare professionals to bill for monitoring and managing a patient’s MSK care plan remotely.

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Woman of the Week: CinCor Pharmaceutical's Terry Coelho

PharmaVoice

From M&Ms to biotech, the chief financial officer's sweet tooth for taking risks is paying off.

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CureVac files patent lawsuit against BioNTech over mRNA technology

Pharmaceutical Technology

CureVac has filed a patent infringement lawsuit against BioNTech in Germany over intellectual property rights of messenger ribonucleic acid (mRNA) technology. The mRNA technology was used for the development of the Covid-19 vaccine. The lawsuit was filed against BioNTech and two of its subsidiaries in the German Regional Court in Düsseldorf. CureVac sought fair compensation for infringement of a portfolio of its intellectual property rights used to produce and sell BioNTech and Pfizer’s mRNA Cov

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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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How Big Pharma is prepping for the late 2020s patent cliff

PharmaVoice

Ratings agency Moody’s lays out the risk exposure for industry leaders.

Pharma 104
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Covid-19 induced immune response may damage brain, NINDS study finds

Pharmaceutical Technology

Scientists at the National Institutes of Health (NIH) unit National Institute of Neurological Disorders and Stroke (NINDS) have found that Covid-19-induced immune response could damage the blood vessels of the brain and may lead to short and long-term neurological symptoms. . NINDS team analysed changes in the brain of nine individuals who died following Covid-19 infection.

Leads 64
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Boehringer takes on antimicrobial resistance with Evotec, bioMérieux JV

pharmaphorum

A Franco-German joint venture company – Aurobac Therapeutics – has been formed to try to tackle the rising threat of antimicrobial resistant (AMR) infections. The JV has been formed German pharma companies Boehringer Ingelheim and Evotec with in vitro diagnostics specialist bioMérieux, with the objective of developing new antimicrobial drugs backed by diagnostics to quickly identify pathogens and their resistance patterns and guide treatment.

Pharma 59
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Big data hiring levels in the pharmaceutical industry rose in June 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for big data related positions rose in June 2022 compared with the equivalent month last year, with 68.4% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 65.7% of companies who were hiring for big data related jobs a year ago and the same as the figure of 68.4% in May 2022.

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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.

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Big three distributors claim win in $2.5bn WV opioid case

pharmaphorum

A court in West Virginia has ruled that US drug distributors McKesson, AmerisourceBergen and Cardinal Health are not responsible for fuelling the opioid crisis that has claimed thousands of lives in the state. District court judge David Faber rejected a call by prosecutors to force the distributors to pay $2.5 billion to fund an abatement plan to tackle an epidemic of deaths in Huntington and Cabell County – the hardest hit areas of the state – by shipping millions of opioid pills there.

Doctors 59
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Is biotech facing a long bear market?

Pharmaceutical Technology

Talks of a bear market in the biotech sector do not seem to pass, with news of companies falling into administration and layoffs becoming a recurrence. Just last week, trading for 4D Pharma , a British biotech, was suspended on the London Stock Exchange’s Alternative Investment Market , and the company will be delisted from NASDAQ on July 7. Elsewhere, San Diego, California-based Heron Therapeutics announced restructuring and layoffs for 34% of its workforce.

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Touchlight signs patent agreement with Pfizer

PharmaTimes

Deal involves the manufacturing of mRNA-based vaccines, therapeutics and gene therapies

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Sales Gamification: A Vital Feature for Sales Reps

Toolyt

Maintaining a long-lasting consistent performance from the sales team can be very complex. Sometimes motivation is all it takes to do something big! And, that’s the reason sales reps always tend to seek some extra motivation to close more deals. To enhance the extra zeal of motivation and the competitive edge, Gamification is the ideal process to win over your sales agents.

Sales 52
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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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NICE recommends Janssen’s treatment for active psoriatic arthritis

PharmaTimes

Clinical trial evidence suggests that Tremfya is effective when compared with a placebo

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annalise.ai appoints proven global healthcare leader as CEO, officially launches US team following FDA clearances

Legacy MEDSearch

annalise.ai, the global radiology AI company with rapidly growing presence in Asia- Pacific, Europe and the United Kingdom, today announced the appointment of accomplished healthcare technology executives Lakshmi Gudapakkam as Chief Executive Officer and clinical strategist Dr Rick Abramson as Chief Medical Officer. With the new appointments, annalise.ai expects to further accelerate its global market presence and entry into the US market following recent FDA approvals for part of its comprehens

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Traversing the Medtech Regulatory Landscape in the Interest of Patients

Impetus Digital

Dr. Bassil Akra , CEO of AKRA TEAM GmbH , sat down with me for a deep dive into the new approval process for medical devices in the EU. Among many other things, he shared his insights into how Medical Device and In Vitro Diagnostic companies can get safe, qualitative, and well-performing products onto the EU market with minimal delays. Here is a sneak peek of our conversation: Q: I’m curious if these new regulations relating to medical devices are also correlated with the private and pub

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Business optimism improves in June 2022: Poll

Pharmaceutical Technology

Business optimism improved in June 2022 compared to May 2022, even amid concerns over rising costs and slowing demand, revealed an analysis of an ongoing poll by Verdict. Verdict has been conducting the poll to study the trends in business optimism during COVID-19 as reflected by the views of companies on their future growth prospects amid the pandemic.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Sales Gamification: A Vital Feature for Sales Reps

Toolyt

Maintaining a long-lasting consistent performance from the sales team can be very complex. Sometimes motivation is all it takes to do something big! And, that’s the reason sales reps always tend to seek some extra motivation to close more deals. To enhance the extra zeal of motivation and the competitive edge, Gamification is the ideal process to win over your sales agents.

Sales 52
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Eisai/Biogen could get FDA verdict on new Alzheimer’s drug by 6 Jan

pharmaphorum

The FDA has started an accelerated review of Eisai and Biogen’s a new amyloid-targeting antibody lecanemab for Alzheimer’s disease, with a 6 January deadline that keep them ahead of closest rival Eli Lilly. The US regulator has been reviewing lecanemab as a treatment for patients with early-stage Alzheimer’s and amyloid plaques in the brain under a rolling biologics license application which completed in May.

FDA 52
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Get Ready for Shopfest

Verb

By now, you’ve probably heard about MARKET and the unique social shopping and selling experiences it offers to shoppers and sellers. For the past few months, we have been recruiting sellers to the MARKET platform, and sellers have had the opportunity to host a few live events to showcase the live experience. Individual storefronts are presenting their products at live events that are happening on the MARKET platform every couple of days.

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When & How to Ask For a Promotion at Work

MedReps

The time has come. You’ve been working hard, making your numbers, and going above and beyond what’s expected of you. However, you feel like you’re stuck in your current position with no room for advancement. Asking for a promotion at work can be a delicate balance – you don’t want to seem entitled or ungrateful, but you also know that you deserve more responsibility and compensation.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.