Sat.Sep 12, 2020 - Fri.Sep 18, 2020

AstraZeneca, Oxford vaccine study allowed to restart in UK

Bio Pharma Dive

Six days after a worrisome illness in a U.K. study participant led to a worldwide pause in vaccinations, the country's drugs regulator and an independent committee allowed testing to resume

Our healthcare has failed us

World of DTC Marketing

IN SUMMARY: American healthcare is failing. Not only has the FDA become a political pawn but almost half the population is now obese. While there are lots of reasons for this the silence of healthcare providers is a huge reason.

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In the News: August Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explore how those changes could impact your program. Fitbit developing algorithm COVID-19 early detection.

Benefits of Getting Counseling

Triage Cancer

Like many people, I thought fighting cancer was a physical battle and that recovering from surgery was the victory. Looking back now, seven years later, I see that the battle had two fronts: the physical and the emotional. I neglected the latter.

Pfizer says coronavirus vaccine study still on track for October readout

Bio Pharma Dive

Importantly, the study committee hasn't had reason to pause vaccinations in the trial, something AstraZeneca and the University of Oxford recently reported in tests of their vaccine

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Oncology DTC: Opportunities

World of DTC Marketing

IN SUMMARY: According to a Takeda Oncology report “for people diagnosed with multiple myeloma, there can be an abundance of information, which can lead to confusion around the next steps in their diagnosis and treatment plan.

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Giving the forgotten generation of cancer patients a voice

Pharma Phorum

Young people with cancer need a “seat at the table”, but instead they are often side-lined and voiceless. That’s according to advocate Megan-Claire Chase, who has been blogging about her experiences since she was diagnosed with invasive lobular breast cancer in her early 30s.

Moderna, in bid for transparency, discloses detailed plan of coronavirus vaccine trial

Bio Pharma Dive

The biotech, among the furthest along in coronavirus vaccine development, is the first developer to share the so-called study protocol of its large Phase 3 trial

AbbVie doesn’t care about employees

World of DTC Marketing

THE BASICS: A “critical part” of pharmaceutical company AbbVie ‘s success is “face-to-face” interaction, CEO Richard Gonzalez explained in an Aug. 27 email outlining its process for bringing thousands of U.S.-based based employees back to work.

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Vaxart's oral COVID-19 tablet vaccine to enter clinical trials

BioPharma Reporter

Vaxart will start a Phase 1 clinical trial for its oral COVID-19 vaccine candidate, having received Investigational New Drug (IND) clearance. Bio Developments

iBio’s FastPharming® Platform Produces Decoy Therapeutic to Bind to SARS-CoV-2

BioSpace

Recently licensed from Planet Biotechnology, the candidate is a recombinant protein made from human angiotensin converting enzyme 2 (ACE2) fused to a human immunoglobulin G Fc fragment

Lilly offers first evidence that its antibody drug may help treat COVID-19

Bio Pharma Dive

The results, from a mid-stage study of Lilly's drug, suggest treatment helped lower virus levels, but the degree to which patients benefited remains unclear

Online ads: Creative vs. media

World of DTC Marketing

TO THE POINT: When it comes to online advertising the creative is more important than the money you’re spending on media. DTC marketers need to create a “hook point” to lead to action. Consumers today are bombarded with so much information you have to grab their attention quick.

Epilepsy gene therapy candidate moves closer to clinical study phase

BioPharma Reporter

Gene therapy developer, CombiGene, and CDMO, Cobra Biologics, have signed off on a deal to secure Good Manufacturing Practice (GMP) production of two essential plasmids needed for the manufacture of CombiGene's gene therapy, CG01. Upstream Processing

Study connects hormones we’re born with to lifetime risk for immunological diseases

Scienmag

Credit: Michigan State University Differences in biological sex can dictate lifelong disease patterns, says a new study by Michigan State University researchers that links connections between specific hormones present before and after birth with immune response and lifelong immunological disease development.

Merck pays Seattle Genetics $1.7B as antibody cancer drugs continue comeback

Bio Pharma Dive

Merck's deal for Seattle Genetics' antibody-drug conjugate comes as Gilead agreed to acquire rival developer Immunomedics in the biotech industry's largest buyout of 2020

Pfizer, BioNTech Say COVID-19 Vaccine Might Be Ready by End of October

BioSpace

In a weekend interview on CBS’ “Face the Nation,” Albert Bourla, chief executive officer of Pfizer indicated they may have key data from its Phase III trial of the vaccine to the U.S. Food and Drug Administration by the end of October

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Vaccine Makers Keep Safety Details Quiet, Alarming Scientists

NY Times

Researchers say drug companies need to be more open about how vaccine trials are run to reassure Americans who are skittish about getting a coronavirus vaccine

3 Ways Video Keeps Reps and HCPs Connected and Engaged

Pharma Marketing Network

Fast-tracking digital communication is now the new normal across many industries. The healthcare industry is no exception, and for pharma sales reps engaging with healthcare professionals, human connection is key.

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Takeda adds to cell therapy push with new manufacturing site

Bio Pharma Dive

The Japanese drugmaker has made cell therapy a focus, advancing three experimental cancer treatments into clinical testing with plans for two more

Stem Cells May Help COVID-19 and ARDS Patients Breathe Easier

BioSpace

One company working towards an ARDS treatment is Athersys, a biotech company focusing on regenerative medicine therapies for diseases with significant unmet need

‘Cellular compass’ guides stem cell division in plants

Scienmag

Credit: Andrew Muroyama The stem cells tasked with creating and maintaining biological tissues have a difficult job. They have to precisely divide to form new specialized cells, which are destined to different fates even though they contain identical DNA.

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Education as the solution to the rare disease ‘diagnostic odyssey’

Pharma Phorum

It took more than a year for Don Legere to receive a diagnosis of scleroderma, a rare disease that causes the skin and connective tissues to thicken and harden, robbing people of their jobs and passions.

Lilly says its arthritis drug helps speed COVID-19 recovery

Bio Pharma Dive

The benefit of adding Lilly's Olumiant to Gilead's antiviral Veklury appeared modest, reducing time to recovery by one day in a study of hospitalized patients

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Moderna CEO: COVID-19 Vaccine Safety and Efficacy Data Likely in November

BioSpace

He also said they would be able to deliver 100 million doses to the U.S. government in the “first few months of 2021

Rapid 90-minute COVID-19 test shown to be highly accurate

Scienmag

A 90-minute COVID-19 test has been shown to have over 94 per cent sensitivity, and 100% specificity in a new study Credit: Thomas Angus/Imperial College London A 90-minute COVID-19 test has been shown to have over 94 per cent sensitivity, and 100 per cent specificity in a new study.

Lilly’s antibody therapy cuts hospitalisation rates in COVID-19

Pharma Phorum

Eli Lilly has followed up supportive data from its Olumiant in COVID-19 with results of a study showing its antibody treatment could help prevent hospitalisation from the disease.

What to watch as the first late-stage coronavirus vaccine trials near potential readouts

Bio Pharma Dive

Predictions of results by the end of October look ambitious, as the number of COVID-19 cases needed to generate definitive data could still take months

Eli Lilly’s Antibody Therapy Against COVID-19 Reduced Hospitalization Rates

BioSpace

Eli Lilly and Company announced interim proof-of-concept data from its BLAZE-1 Phase II clinical trial of LY-COV555, its neutralizing antibody therapy for COVID-19

Virtual reality trains public to reverse opioid overdoses

Scienmag

Credit: Penn Nursing The United States has seen a 200% increase in the rate of deaths by opioid overdose in the last 20 years. But many of these deaths were preventable.

5 Ways a CTMS Can Help Study Coordinators Who Are Spread Too Thin

Forte Research Systems®

Learn how a CTMS can help study coordinators tackle a demanding workload. Clinical Research Technologies CTMS Study Coordination AMC Site

Arrowhead shares soar on liver disease data from four patients

Bio Pharma Dive

Encouraged by the early study results, Arrowhead plans to ask regulators to streamline its clinical trials, which could pressure rivals Vertex and Dicerna

NIH Raises Concerns About Potential Safety Issues Associated with AstraZeneca Vaccine

BioSpace

The National Institutes of Health is raising concern about the safety of AstraZeneca’s coronavirus vaccine, even as the U.S. FDA is weighing whether or not to resume testing in the United States following a global pause in the trial for safety reasons

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Biologists create new genetic systems to neutralize gene drives

Scienmag

Two active genetics strategies help address concerns about gene-drive releases into the wild Credit: Ana Silva In the past decade, researchers have engineered an array of new tools that control the balance of genetic inheritance.