World of DTC Marketing

FEBRUARY 7, 2022

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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Pharma Companies Marketing Sales Clinical Trials 253

Bio Pharma Dive

FEBRUARY 7, 2022

The FDA's clearance of Enjaymo for cold agglutinin disease means Sanofi has a new marketed product to show for its 2018 buyout of Biogen's former spinoff.

Production 246

Production Drugs Marketing 246

BioPharma Reporter

FEBRUARY 7, 2022

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.

Vaccination 116

Vaccination Vaccine Trials Development 116

Bio Pharma Dive

FEBRUARY 7, 2022

Read how private equity investment helps scale the push towards healthcare digitization.

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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

Clinical Research

Outsourcing Pharma

FEBRUARY 7, 2022

The HIV-focused pharma company announced the agency has approved Cabenuva for administration as few as six times a year for adults living with the virus.

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FDA Approval Pharma Companies Regulation Marketing 107

Bio Pharma Dive

FEBRUARY 7, 2022

Despite tumbling biotech valuations, however, several said they still prefer smaller-sized "bolt-on" deals to larger, potentially more disruptive, transactions.

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XTalks

FEBRUARY 7, 2022

Health technology company InBody has released its new BP170 consumer at-home blood pressure monitor that allows individuals to track their blood pressure in real time. This is important because blood pressure can significantly fluctuate throughout the day. Inbody’s BP170 real time blood pressure monitoring device can capture these oscillations and generate reports that the individual and their healthcare provider can assess.

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Development Marketing 98

BioPharma Reporter

FEBRUARY 7, 2022

Mission Bio says it is paving the way for the routine use of its technology in clinical trials on materials to support the next wave of life-saving CGT treatments.

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Clinical Trials Clinical Trials Trials Development 97

Scienmag

FEBRUARY 7, 2022

PULLMAN, Wash. – A discovery that blocks the normal transition of semen from a thick gel to a liquid shows promise for development of a new form of non-hormonal, over-the-counter contraception. Credit: Washington State University PULLMAN, Wash. – A discovery that blocks the normal transition of semen from a thick gel to a liquid shows […].

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Hormones Development Medicine 91

Pharma Times

FEBRUARY 7, 2022

Institute for Cancer Research highlights missed opportunity for NICE to reform its cancer drug assessment processes

Drugs 110

Drugs Research 110

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

Scienmag

FEBRUARY 7, 2022

PLYMOUTH MEETING, PA [February 7, 2022] — New research in the February 2022 issue of JNCCN—Journal of the National Comprehensive Cancer Network confirms that mRNA vaccine for COVID-19 are just as safe for people with cancer as they are for cancer-free individuals. Researchers from Fox Chase Cancer Center tracked short-term side-effects from more than 1,753 […].

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Vaccination Vaccine Research Medicine 89

pharmaphorum

FEBRUARY 7, 2022

The last three years in pharma have seen a growing awareness of and dissatisfaction with a trend that has plagued the industry for its whole life: Nondiverse and unrepresentative clinical trials, which lead to incomplete data and compounded health disparity for minority populations. It’s been more than a year since the US Food and Drug Administration released its final guidance on diversifying clinical trials in November 2020.

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Clinical Trials Clinical Trials Trials Pharma Companies 81

Scienmag

FEBRUARY 7, 2022

In a recent study, investigators showed that a culturally tailored patient navigation program can improve the rate of colorectal cancer screening among Hispanic adults and potentially help eliminate historical gender disparities in such screening. The findings are published by Wiley online in CANCER, a peer-reviewed journal of the American Cancer Society.

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Pharma Times

FEBRUARY 7, 2022

Extensive research into pharmacy responses across Europe during the pandemic yields several recommendations

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Pharmacy Research 107

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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.

Clinical Supply

Scienmag

FEBRUARY 7, 2022

Mechanical hearts spur some regeneration in dormant parts of failing hearts, according to a UT Southwestern pilot study that shows promise for developing regenerative heart therapies. Credit: UT Southwestern Medical Center Mechanical hearts spur some regeneration in dormant parts of failing hearts, according to a UT Southwestern pilot study that shows promise for developing […].

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Development 87

Drug Channels

FEBRUARY 7, 2022

Drug Pricing Transparency Congress. Hybrid Event March 28-29, 2022 | Philadelphia, PA www.informaconnect.com/drug-pricing-transparency. Don’t miss the Drug Pricing Transparency Congress on March 28-29, 2022! You'll be part of the important discussions on how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices.

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Drugs Compliance Regulation Production 71

Scienmag

FEBRUARY 7, 2022

The word “robot” would probably conjure up images of hard metallic bodies that are invulnerable to attacks. In modern day-to-day life, however, robots are hardly needed for defending against enemy attacks. Instead, they are required to perform more mundane tasks such as handling delicate objects and interacting with humans. Unfortunately, conventional robots perform poorly at […].

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pharmaphorum

FEBRUARY 7, 2022

The UK government’s long-awaited plan to tackle the backlog in NHS care caused by the pandemic has been delayed, but one small part that aims to improve transparency has been revealed. Patients who need non-urgent surgery will be able to use a new platform on the NHS.UK website – called My Planned Care – to get information about waiting times for their trust.

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Development 59

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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.

Clinical Trials

Scienmag

FEBRUARY 7, 2022

Why some patients develop metastases and others do not is largely unclear. Researchers around ISTA professor Daria Siekhaus are now contributing to a better understanding of the process in certain types of cancer. They took a close look at the role of a protein called MFSD1 – the mammalian relative of a protein they had […].

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Protein Development Research Medicine 86

Drug Patent Watch

FEBRUARY 7, 2022

Annual Drug Patent Expirations for UKONIQ Ukoniq is a drug marketed by Tg Theraps and is included in one NDA. There are seven patents protecting this drug. This drug has…. The post New patent for Tg Theraps drug UKONIQ appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

Scienmag

FEBRUARY 7, 2022

New research finds that dogs being walked in nature reserves contribute a significant amount of nutrients to the environment through their faeces and urine, which researchers warn could negatively impact local biodiversity. The research is published in the British Ecological Society journal, Ecological Solutions and Evidence. Credit: Pieter De Frenne New research finds that dogs […].

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Research 86

pharmaphorum

FEBRUARY 7, 2022

Women in England with a specific type of endometrial cancer will be able to access an immunotherapy for the first time, after NICE backed use of GlaxoSmithKline’s PD-1 inhibitor Jemperli via the Cancer Drugs Fund (CDF). The health technology assessment (HTA) agency has given a temporary okay to the use of Jemperli (dostarlimab) for endometrial cancer patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) mutations, while additional evidence for the drug&#

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Sales Drugs Trials Antibody 52

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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.

Clinical Supply

Scienmag

FEBRUARY 7, 2022

A large-scale study has found that simulation-based surgical training produced an increase of surgeons’ skills for more complex surgeries. Credit: Takashige Abe A large-scale study has found that simulation-based surgical training produced an increase of surgeons’ skills for more complex surgeries. Practice makes perfect, but what if the practice can be life-threatening?

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Trials 85

Imperical Blog

FEBRUARY 7, 2022

This is the first in a series celebrating key roles in the clinical trials industry. The contract research organization’s clinical project manager (CPM) does not have a light workload. CPMs plan and… The post Clinical Project Managers: The CRO’s Secret Weapon appeared first on Imperial Clinical Research Services Blog; Trending Topics.

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Clinical Trials Clinical Trials Clinical Research Trials 52

Scienmag

FEBRUARY 7, 2022

For the first time in the world, researchers from Sagol Center for Regenerative Biotechnology at Tel Aviv University have engineered 3D human spinal cord tissues and implanted them in lab model with long-term chronic paralysis. The results were highly encouraging: an approximately 80% success rate in restoring walking abilities. Now the researchers are preparing for […].

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Engineer Research 85

pharmaphorum

FEBRUARY 7, 2022

Sanofi has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for the rare blood disorder in the US. The complement C1s-targeting antibody – given the brand name Enjaymo – has been cleared decrease the need for blood transfusions in patients with CAD, an autoimmune disease which results in destruction of red blood cells (haemolysis).

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Drugs Antibody FDA Approval Manufacturing 52

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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.

Clinical Trials

Scienmag

FEBRUARY 7, 2022

CLEVELAND—Case Western Reserve University announced today that alumnus Joel Roth has committed more than $20 million to support a leadership institute designed to prepare students to address the increasingly complex challenges facing the globe. Credit: Case Western Reserve University CLEVELAND—Case Western Reserve University announced today that alumnus Joel Roth has committed more than $20 million […].

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pharmaphorum

FEBRUARY 7, 2022

Bayer has abandoned development of its investigational P2X3 receptor antagonist eliapixant, despite promising efficacy data in clinical trials, on what appears to be safety grounds. The decision comes right on the heels of the FDA’s rejection of Merck & Co’s rival oral P2X3 antagonist gefapixant, which was also attributed to concerns about the safety of the drug.

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Clinical Trials Clinical Trials Licensing Licensing 52

Scienmag

FEBRUARY 7, 2022

Leicester space scientists have discovered a never-before-seen mechanism fuelling huge planetary aurorae at Saturn. Credit: NASA, Cassini, VIMS Team, University of Arizona, University of Leicester, JPL, ASI Leicester space scientists have discovered a never-before-seen mechanism fuelling huge planetary aurorae at Saturn. Saturn is unique among planets observed to date in that some of its aurorae […].

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Scientist 84

Outsourcing Pharma

FEBRUARY 7, 2022

An expert from the CRO discusses the role real-world data plays in developing therapies, with benefits ranging from speeding recruitment to decreasing costs.

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Development Drugs Clinical Development 52

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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.

Clinical Trials