February, 2022

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'The music stopped': Biotech rout leaves drug startups grounded as demand slumps for IPOs

Bio Pharma Dive

For the first time in years, biotechs no longer have an easy path onto Wall Street, a market reversal that could change what the next generation of young drugmakers looks like.

Drugs 364
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Lung cancer deaths decline but.

World of DTC Marketing

The mortality rate from lung cancer has dropped in recent decades—by 56% in men from 1990 to 2019 and by 32% in women from 2002 to 2019. In recent years, early detection and treatment improvements have helped boost the 3-year survival rate for lung cancer from 21% in 2004 to 31% in 2015 through 2017. The 5-year survival rate has increased by 6% for distant-stage lung cancer, 33% for a regional-stage disease, and 60% for localized disease.

Medicine 271
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Simons Foundation gives $4 million to CUNY Graduate Center to diversify astrophysics education

Scienmag

NEW YORK, February 9, 2022– Astrophysics is one of the most popular science fields, igniting the imaginations of many as they learn about it from television shows or news of space exploration. Like many other STEM fields, though, it lags in attracting students of color. Studies have shown the benefits of diversity in STEM fields, […].

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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 130
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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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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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J.&J. Pauses Production of Its Covid Vaccine Despite Persistent Need

NY Times

A crucial Johnson & Johnson plant has stopped making its Covid vaccine, though the company says it has millions of doses in inventory.

More Trending

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Biogen continues to sink

World of DTC Marketing

Board members and senior executives are bailing out of Biogen but will there be enough life vests? What has/is happening at Biogen is a train wreck, and the only way to correct this disaster is to tear it down and rebuild the company from the top down. According to Endpoint News” We’ve seen Biogen’s CSO exit under pressure in recent weeks, and senior marketing execs leave in an exodus as the company recoiled from a fierce backlash against the FDA’s ultra controversial app

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NJIT reaffirmed as an elite research university, retains R1 classification

Scienmag

New Jersey Institute of Technology (NJIT) has reaffirmed its status among the nation’s most elite and productive research institutions by once again achieving an R1 status — the highest designation — by the Carnegie Classification. Credit: NJIT New Jersey Institute of Technology (NJIT) has reaffirmed its status among the nation’s most elite and productive research […].

Research 129
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Cancer vaccines: providing the edge in oncology

pharmaphorum

In this article, Ben Hargreaves looks into the promise of cancer vaccines and how this treatment modality may offer advantages over existing immunotherapies in the oncology sector. According to a report by IQVIA last year, there were 3,500 oncology-focused therapeutic candidates in the pipeline, which represents a 75% increase on figures seen in 2015.

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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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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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Plant-based COVID-19 vaccine approved in Canada

BioPharma Reporter

Medicago and GlaxoSmithKline (GSK) have gained approval for Covifenz, the companiesâ plant-based COVID-19 vaccine, from Health Canada.

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BioMarin says gene therapy hold will endure as FDA questions cancer risk

Bio Pharma Dive

According to BioMarin, the regulator has requested additional data to assess the "theoretical" cancer risk to the treatment, information that will take "several quarters" to collect.

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When it comes to telehealth it’s not numbers

World of DTC Marketing

Business Insider formed a relationship with eMarketer for so-called “intelligence.” Their report on telehealth has numbers, but that’s not what’s important. We need to understand “why” people are using telehealth and for what purposes versus an in-office visit. In-office visits also have more benefits. Here is a quote from the report that is debatable at best “over the next few years, telehealth will remain the domain of the younger digital natives.

Doctors 247
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Your microbiome shapes your life. But where did it come from?

Scienmag

Baltimore, MD— The gut microbiome is an ecosystem of hundreds to thousands of microbial species living within the human body. These populations affect our health, fertility, and even our longevity. But how do they get there in the first place? Credit: By Navid Marvi, courtesy of the Carnegie Institution for Science. Baltimore, MD— The gut […].

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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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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 117
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Scientists discover immune cell surveillance mechanism

Pharma Times

Francis Crick Institute and King’s College London collaborate to identify specialist cells which protect DNA

Scientist 131
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Valneva and Pfizer to take Lyme disease vaccine into Phase 3 trial this year

BioPharma Reporter

Valneva and Pfizer have reported further positive Phase 2 data for their Lyme disease vaccine candidate, VLA15, with a Phase 3 trial set to start in Q3, 2022.

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FDA sends signal with tough questions of Lilly at cancer drug meeting

Bio Pharma Dive

The agency criticized Eli Lilly for using a trial run in China to seek approval of an immunotherapy it licensed from Innovent Biologics. Outside advisers agreed in a decisive vote that could have repercussions for several other drugmakers.

Licensing 340
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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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How agencies can help pharma DTC

World of DTC Marketing

The way people make treatment decisions is changing because of COVID. Agencies are responsible for working with clients to implement changes that support brand objectives. It won’t be easy and means changing the mindset from a vendor to a strategic partner. If you work in an agency, your job is not to develop a website or TV spot. You need to work with pharma clients to educate them on the complicated path from awareness to requesting an Rx.

Marketing 247
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Even the smallest pollution particles change the rainfall regime in the Amazon

Scienmag

Even the finest particles of pollution influence the process of cloud formation and the rainfall regime. A study conducted in Manaus, the capital of Amazonas state in Brazil’s North region, shows that oxidation leads small aerosols expelled by factories and car exhausts, for example, to grow very rapidly, reaching up to 400 times their original […].

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Dr Reddy’s jumps on medical cannabis train, buying Nimbus Health

pharmaphorum

India’s Dr Reddy’s Laboratories has joined the growing list of pharma companies that are looking to tap into the market for medical cannabis, buying German developer Nimbus Health for an undisclosed sum. While the regulatory framework for cannabinoid products remains fragmented and hard to navigate around the world, Germany has emerged as an early-mover.

Licensing 113
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Data day: Trial results deliver hope for prostate cancer patients

Pharma Times

New combination treatment can significantly reduce the risk of death among prostate cancer patients

Trials 138
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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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AI can be a powerful tool in drug development, discovery: Tellius

Outsourcing Pharma

A leader from the artificial intelligence insights specialist talks discusses how the effective use of advanced analytics can lead to a number of benefits.

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Sarepta reveals gene editing alliance with biotech exploring alternative delivery methods

Bio Pharma Dive

The collaboration with GenEdit, a South San Francisco startup developing new ways of delivering gene editing tools into the body, dates back to December 2020, but has recently begun to advance.

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Mental health apps can be useless

World of DTC Marketing

According to the Lancet, a medical journal, the incidence of depression and anxiety has soared in the pandemic—by more than 25% globally in 2020. That, combined with more people using online services, has led to a boom in mental-health apps. But are they safe and effective? Now that big companies prioritize employees’ mental health, some apps work with them to help entire workforces.

Marketing 241
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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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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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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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Pfizer sets out strategy to win in mRNA

BioPharma Reporter

Having built up its mRNA expertise with its COVID-19 vaccine, Pfizer now sets out its strategy for the future. âGoing forward, we plan to continue to capitalize on the leadership we have built in both mRNA R&D and manufacturing.".

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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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J&J, Legend cell therapy approved by FDA for multiple myeloma

Bio Pharma Dive

The CAR-T treatment is the second to be approved in the U.S. for the blood cancer, following Bristol Myers Squibb and 2Seventy bio's Abecma.

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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.