Mon.Aug 03, 2020

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Lilly to test COVID-19 antibody drug in unorthodox nursing home study

Bio Pharma Dive

Seeking fast answers in a pandemic, Lilly will use mobile RVs to set up infusion clinics at assisted living facilities, which have become COVID-19 hot spots.

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Will people line up for a COVID-19 vaccine?

World of DTC Marketing

QUICK READ: As COVID-19 vaccines enter Phase III trials one has to wonder just how transparent pharma companies will be with the data. Personally I would want to know as much as I can before I ask for the vaccine but I also know that greed can make people do stupid things and there is a lot of money at stake here. The rush to develop a COVID-19 vaccine is well underway because there are billions of dollars in profits at stake.

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Big pharma alliance recruits first patients for unusual COVID-19 study

Bio Pharma Dive

The trial is testing whether drugs from Amgen, Takeda and AbbVie can combat the life-threatening immune overreaction some COVID-19 patients experience.

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US government secures 100m doses of GSK and Sanofi vaccine for $2.1bn

BioPharma Reporter

In return for capital for development and manufacturing scale-up help, Sanofi and GSK agree number of doses of potential COVID-19 vaccine.

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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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Bausch Health to pay $45M to settle US charges over Valeant-era accounting

Bio Pharma Dive

The agreement comes four years after an accounting scandal led to the unraveling of then-Valeant's image as a new breed of drugmaker.

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Otrivine Extra Dual Relief – 8 facts YOU must know

Druggist

Otrivine Extra Dual Relief is a pharmacy only medication and the only over the counter product containing ipratropium bromide for the management of congestion and runny nose caused by colds. This post summarises the essential information about Otrivine Extra Dual Relief nasal spray. 1. Otrivine Extra Dual Relief indicated use Otrivine Extra spray is used for the management of congestion and rhinorrhoea caused by colds. 2.

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6 Key Takeaways from HBA’s “Virtual Best Practices: Clarity, Collaboration and Connecting”

Pharma Marketing Network

Recently, the Healthcare Businesswomen’s Association (HBA) held a webinar entitled, Virtual Best Practices: Clarity, Collaboration and Connecting , which dove into the topic of “Zoom fatigue,” a new, commonly used term defined by the draining feeling you experience after a day of long, unnecessary meetings. We are all facing new challenges in the rapidly changing work environment.

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Cosentyx wins EU approval for first-line paediatric psoriasis

Pharma Times

Low-dose and high-dose Cosentyx is effective in rapidly improving skin symptoms and quality of life

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Research partnership delves into opioid alternatives

Outsourcing Pharma

Neurasic Therapeutics is borne from a collaborative effort intended to advance development of opioid-alternative pain relief.

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Genmab/Janssen’s Darzalex combo hits the mark in phase 3 study

Pharma Times

Subcutaneous formulation of Darzalex in combination with pomalidomide and dexamethasone meets primary endpoint

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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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Fujifilm to produce COVID-19 vaccines, BARDA speeds up capacity boost

BioPharma Reporter

US BARDA drafts Fujifilm Diosynth into its vaccine production effort, offering to also accelerate capacity expansion.

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Emergency Department Visits and Hospital Admissions in the First Months of the COVID-19 Pandemic in the US

JAMA Internal Medicine

This cross-sectional study examines trends in emergency department visits and visits that led to hospitalizations during a 4-month period leading up to and during the COVID-19 outbreak in the US.

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Sangamo and Novartis partner on gene therapies for autism

BioPharma Reporter

The two companies will develop three neurodevelopmental targets, using the formerâs zinc-finger technology.

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Home Health Care Worker Experiences in NYC During the COVID-19 Pandemic

JAMA Internal Medicine

This qualitative analysis using grounded theory describes the experiences of home health care workers caring for older adults and for patients with chronic illnesses in New York City during the coronavirus disease 2019 pandemic.

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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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Clinical Research Patient Recruitment Made More Efficient and Remotely With Deep Lens Co-Founder

Clinical Trial Gurus

Artificial intelligence is expected to enter the clinical research industry and provide support for the way many tasks are performed. One such task is enrollment which might experience a revolutionary new away of prescreening patients. Sites who successfully implement such technology can expect that their coordinators will have more time to focus on screening patients who are more likely to qualify for a study.

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Sanofi, GSK in advanced discussions with EU for COVID-19 vaccine

Pharma Times

Supply deal could include up to 300 million doses of vaccine

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As Clinical Trials Go Digital, Complexity Grows Along with the Risk to Data Integrity

BioSpace

Data security risks are growing as more and more clinical trials embrace telemedicine and other digital technologies.

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Coronavirus: New 90-minute tests for Covid-19 and flu 'hugely beneficial'

The Pharma Data

Image copyright. DnaNudge 2020. Image caption. Thousands of DNA test machines will be rolled out in hospitals from September. New 90-minute tests that can detect coronavirus and flu will be rolled out in hospitals and care homes from next week. The “on-the-spot” swab and DNA tests will help distinguish between Covid-19 and other seasonal illnesses, the government said.

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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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Disruption and Innovation During a Crisis

Client Pharma

In 2008, Salesforce.com grew revenues from $497mn USD to $749mn. In just 10 years, by the end of 2018, it had reached over $10bn, winning major market share from the likes of Oracle and SAP. Before the last global financial crisis, software was distributed through a user licence agreement model. As liquidity dried up and service user budgets were slashed, the door was opened for a different model, known as SaaS (Software as a Service).

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Testing 'may not prevent new coronavirus wave' when schools reopen

The Pharma Data

Image copyright. Getty Images. Current testing and contact tracing is inadequate to prevent a second wave of coronavirus after schools in the UK reopen, scientists have warned. Increased transmission would also result from parents not having to stay at home with their children, they say. Researchers said getting pupils back to school was important – but more work was needed to keep the virus in check.

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Important factors to consider when working with CRFs

pharmaphorum

What’s the background on CRFs? A traditional paper case report form is known as a CRF (or paper CRF). An electronic case report form (eCRF) is the same as a CRF, except that it’s electronic. Both abbreviations tend to be used interchangeably, and are also referred to as forms. CRFs and eCRFs are used for gathering patient data during clinical trials.

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Premier Research: ePRO data improves upon paper-based reporting

Outsourcing Pharma

Use of electronic patient-recorded outcome data can lead to more accurate trial data, and a better patient experience, according to the CRO.

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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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New speaker session with Kiniksa Pharmaceuticals at Pre-filled Syringes East Coast 2020

pharmaphorum

SMi Reports: new speaker session with Paul Roussel, Senior Director, Combination Products, at the Pre-filled Syringes East Coast 2020 conference. I am pleased to inform you that Paul Roussel, Senior Director, Combination Products, Kiniksa Pharmaceuticals, has confirmed his position as speaker at the conference. Paul’s presentation is as follows: Development of a Combination Product- A case study.

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ERT expands its cognitive assessment capabilities

Outsourcing Pharma

Partnering with Cogstate, the company is seeking to enhance its eCOA solution, with the goal of ultimately boosting the speed and effectiveness of trials.

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Disruption and Innovation During a Crisis

Client Pharma

In 2008, Salesforce.com grew revenues from $497mn USD to $749mn. In just 10 years, by the end of 2018, it had reached over $10bn, winning major market share from the likes of Oracle and SAP. Before the last global financial crisis, software was distributed through a user licence agreement model. As liquidity dried up and service user budgets were slashed, the door was opened for a different model, known as SaaS (Software as a Service).

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Coronavirus: Is risk from Covid-19 higher during pregnancy?

The Pharma Data

Image copyright. Getty Images. As a precaution, pregnant women have been told to be particularly strict about avoiding social contact, so they reduce their risk of catching coronavirus. But what do we know about its impact on pregnancy? Is coronavirus a problem during my pregnancy? Although there is still much that doctors don’t know about how pregnancy can be affected by the virus, pregnant women do not appear to become more unwell than other healthy adults who contract it. “If ther

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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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Lilly’s antibody for COVID-19 protection starts nursing home trial

pharmaphorum

While the world waits an effective coronavirus vaccine, Eli Lilly has started late-stage human testing an antibody drug as an alternative way to prevent viral transmission in high-risk locations. The US drugmaker is testing the antibody – called LY-CoV555 and developed in collaboration with Canadian biotech AbCellera – in a phase 3 trial to see if it can prevent the spread of the coronavirus among residents and staff in US nursing homes.

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Scientists Worry About Political Influence Over Coronavirus Vaccine Project

NY Times

Operation Warp Speed has moved along at a rapid clip. But some people involved in the process fear pressure to deliver an October surprise for President Trump.

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NASP 2020 Annual Meeting & Expo Virtual Experience

Drug Channels

NASP 2020 Annual Meeting & Expo Virtual Experience. September 14-18, 2020 | Virtual Experience www.naspmeeting.com/registration. Utilizing innovation and cutting-edge technology, the National Association of Specialty Pharmacy (NASP) is hosting its 2020 Annual Meeting & Expo, September 14-18, as a full-scale virtual conference experience that includes all that attendees have come to expect and love from the live event.