Sat.Oct 10, 2020 - Fri.Oct 16, 2020

5 questions ahead of next week's FDA meeting on coronavirus vaccines

Bio Pharma Dive

Normally staid affairs, next Thursday's advisory committee meeting could be historic and set expectations for how the FDA will approach any future vaccine approval

Get ready for HUGE healthcare changes

World of DTC Marketing

There is going to be more coverage for virtual doctors’ visits in new employee health plans along with expanded mental health benefits and access to on-site health clinics. Of course, this comes at an increased cost even though health insurers are making a lot of money.

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Single-Arm Trials Using Real-World Evidence for Rare Disease Product Development

Camargo

As a sponsor designs clinical studies, the respective comparison control groups become a critical factor to consider.

Zeptoseconds: new world record in short time measurement

Scienmag

Physicists from Frankfurt, Hamburg and Berlin track the propagation of light in a molecule Credit: Sven Grundmann, Goethe University Frankfurt FRANKFURT. In 1999, the Egyptian chemist Ahmed Zewail received the Nobel Prize for measuring the speed at which molecules change their shape.

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Early signs of survival benefit raise optimism around a small biotech's ALS drug

Bio Pharma Dive

Newly published data show that, after joining a clinical trial, patients who were given a drug from Amylyx Pharmaceutcials lived a median 6.5 months longer than those who didn't

Pharma and insurers raking in the cash

World of DTC Marketing

HEY NOW : Most companies struggled in the second quarter as the coronavirus pandemic froze the economy, but health insurers like UnitedHealth heavily benefited as people held off on going to the doctor or hospital, resulting in fewer medical claims that needed to be paid. In addition, pharma profit margins remain very high. UnitedHealth Group registered more than $6.6

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The rise of ‘zoom towns’ in the rural west

Scienmag

J&J halts studies of coronavirus vaccine due to participant's illness

Bio Pharma Dive

The company did not disclose details, nor could it confirm whether the participant had received its shot. But J&J is now the second vaccine developer, along with AstraZeneca, to suspend testing for a safety review

Remdesivir Fails to Prevent Covid-19 Deaths in Huge Trial

NY Times

An antiviral widely used to treat hospitalized patients did not lower the mortality rate in a multinational trial

Trials 114

U.S. Government Inks Antibody Cocktail Deal with AstraZeneca

BioSpace

AstraZeneca signed a deal with Operation Warp Speed, the U.S. government program to advance COVID-19 vaccines and therapeutics, for a monoclonal antibody cocktail

Could BCG vaccine protect against COVID-19? UK recruitment begins

Scienmag

A largescale global trial designed to test the theory that the widely-used BCG vaccine could help protect against COVID-19 will soon recruit healthcare staff and care home workers in the UK.

Gilead's COVID-19 drug doesn't prevent deaths, large WHO study finds

Bio Pharma Dive

The results could weaken the case for widely using Veklury, also known as remdesivir, just as the company is asking for full approval from the FDA

Drugs 219

A Dose of Optimism, as the Pandemic Rages On

NY Times

The months ahead will be difficult. But the medical cavalry is coming, and the rest of us know what we need to do

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Relief Therapeutics and NeuroRx Release Promising Data for Potential COVID-19 Treatment

BioSpace

Relief Therapeutics and NeuroRx released results on Tuesday from their open-label prospective study looking into RLF-100 (aviptadil) as a potential treatment for COVID-19 and respiratory failure

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The ur-Iris likely had purple flowers, pollinated by insects for nectar

Scienmag

There is value to patients when independent sites offer clinical trials

Bio Pharma Dive

We observe that the COVID-19 crisis shines a light on the benefits to patients and industry stakeholders of bringing clinical trials closer to patients' homes

Pfizer to apply for COVID-19 vaccine EUA after mid-November safety data milestone

BioPharma Reporter

Pfizerâs CEO says the company will apply for Emergency Use Authorisation (EUA) for its COVID-19 vaccine candidate âsoon afterâ a safety milestone is reached in the third week of November. Bio Developments

Disruptive Technologies and Mature Regulatory Environment Vital for Cell Therapy Maturation

BioSpace

Immuno-oncology and CAR T cells energized the field of regenerative medicine, but for cell and gene to deliver on their promises, new, disruptive technologies and new modes of operation are needed

Gene 101

Engineers print wearable sensors directly on skin without heat

Scienmag

An international team of researchers developed a novel technique to produce precise, high-performing biometric sensors Credit: Ling Zhang, Penn State/Cheng Lab and Harbin Institute of Technology Wearable sensors are evolving from watches and electrodes to bendable devices that provide far more precise biometric measurements and comfort for users.

Roche, aiming to make better gene therapies, turns to an emerging startup

Bio Pharma Dive

The Swiss pharma is the third large drugmaker to partner with Harvard spinout Dyno Therapeutics, a small biotech aiming to improve gene therapy technology

Boehringer, Yale trial digital tech in heart failure

Pharma Phorum

Patients with heart failure often have a dismal prognosis as the condition usually worsens over time, but a new study aims to see if digital health technologies can improve their prospects.

CDC Finalizes COVID-19 Vaccine Distribution Plan as Vaccine Authorization Nears

BioSpace

With multiple COVID-19 vaccines in development, the CDC is confident that any vaccines the FDA authorizes or approves will be safe because they are based on the FDA’s usual stringent protocols. The greater question, after a vaccine is approved, is how it will be distributed

Carnivores living near people feast on human food, threatening ecosystems

Scienmag

Credit: Phil Manlick. Photo credits (Left to Right): Flickr/Tambako the Jaguar/Renee Grayson and Wikimedia Commons/United States National Park Service/United States Fish and Wildlife Service.

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Vertex faces first notable setback as it pushes beyond cystic fibrosis

Bio Pharma Dive

Safety signals in a mid-stage study led Vertex to stop work on one of its experimental drugs for the inherited disorder alpha-1 antitrypsin deficiency

Drugs 211

Accelerating the digital approval process

Pharma Phorum

The boom in digital tech over COVID means that pharma can move faster than ever – but the industry’s traditional processes for asset approval are still holding timelines back. David Reily examines how pharma companies are responding to the increased burden of asset approval with new ways of working.

Operation Warp Speed Boss Projects COVID-19 Vaccine EUA by Thanksgiving

BioSpace

Moncef Slaoui, the head of Operation Warp Speed, suggested the first Emergency Use Authorization for a COVID-19 vaccine will likely be around Thanksgiving

COVID-related delays to CRC screening causing 11.9% rise in death rates, research reveals

Scienmag

Based on survival rates at 5 years for stage III-IV CRC, the results showed a significant 11.9%

FDA approves Regeneron antibody drug as first Ebola virus treatment

Bio Pharma Dive

Research for the drug, now cleared as Inmazeb, helped Regeneron jumpstart its fast development of an antibody therapy for COVID-19

Pharmacovigilance in times of COVID-19

Cloudbyz

The COVID-19 pandemic is ravaging the world in so many ways. It has affected and hit hard how clinical trials were done and managed in pre-COVID times.

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Research Roundup: COVID-19 Neurological Damage and More

BioSpace

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones

Immunotherapy combo halts rare, stage 4 sarcoma in teen

Scienmag

Pfizer won't seek FDA clearance of coronavirus vaccine until mid-November, CEO says

Bio Pharma Dive

An unusual letter from Pfizer chief Albert Bourla confirms that the drugmaker won't file for an approval of its experimental shot, assuming positive results, before the U.S. presidential election

UK joins global trial to test BCG vaccine against COVID-19

BioPharma Reporter

A global trial, designed to test the theory that the BCG vaccine could help protect against COVID-19, will soon start recruitment in the UK. Bio Developments

Pfizer CEO Anticipates EUA for COVID-19 Vaccine in Late November

BioSpace

Pfizer will not seek Emergency Use Authorization for its COVID-19 vaccine until the end of November even if the readout from a Phase III study expected later this month is positive