Sat.Nov 13, 2021 - Fri.Nov 19, 2021

FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

Bio Pharma Dive

The decision comes as at least 10 states have already begun opening up booster dose eligibility, with cases remaining at high levels across the country

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It’s getting harder to launch a new drug to physicians

World of DTC Marketing

SUMMARY: Physicians are tired and overwhelmed with medical information on new drugs. They don’t have the time to sit in the office and search for more information, and they feel that pharma is giving them “too much” information. An exciting development presented itself.

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In the News: October 2021 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 explores how those changes could impact your program. FDA Guidance Addresses Real-World Evidence Data Standards.

Why drinking water needs monitoring for HIV drugs

Scienmag

Years ago, there was a time that kids from a rural village in South Africa still wanted to swim in the rivers nearby. But when they got out of the water, those with sensitive skins would have the worst rash ever, says Prof Philiswa Nomngongo.

Drugs 87

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

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.

Years later, a first-of-its-kind treatment shows the power, and limits, of gene therapy

Bio Pharma Dive

Luxturna, approved four years ago as the first gene therapy for an inherited disease in the U.S., is improving sight and quality of life for several of the patients who received it

Omnichannel marketing is the answer but what’s the question?

World of DTC Marketing

SUMMARY: Omnichannel marketing employs the simultaneous implementation of channels across personal, non-personal, and media and addresses the integrated needs of multiple stakeholders – consumers/patients, healthcare professionals, and payers. Sounds good but is that the answer?

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Antihypertensive drugs are effective in hereditary cerebral small vessel disease

Scienmag

Niigata, Japan – Our brains have small arteries that perform a unique function. Aging and high blood pressure can damage these arteries, leading to gait disturbances and dementia. This disease is known as cerebral small vessel disease (CSVD).

Drugs 86

European drugs regulator signals rejection likely for Biogen's Aduhelm

Bio Pharma Dive

A European Medicines Agency panel tasked with reviewing drugs voted against the biotech's controversial Alzheimer's medicine, signaling an approval is unlikely next month

AbbVie continues to be what’s wrong with big pharma

World of DTC Marketing

SUMMARY: AbbVie continues to profit from Americans by repeatedly raising U.S. prices on its widely-used Humira rheumatoid arthritis drug while cutting the price abroad. AbbVie exploits the U.S.

FDA clears GE Healthcare AI algorithm for patient intubation

Pharma Phorum

An artificial intelligence algorithm developed by GE Healthcare that helps with the placement of endotracheal tubes (ETTs) has been approved by the FDA.

Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

Suffering from psoriasis? Blame this trio of proteins

Scienmag

LA JOLLA—About 7.5 million Americans suffer from psoriasis, an autoimmune disease that shows up as patches of red, inflamed skin and painful, scaly rashes. Although there are effective treatments for psoriasis, not everyone responds to these therapies—and for many, the relief is temporary.

A startup emerges with $125M and plans to edit the epigenome

Bio Pharma Dive

Chroma Medicine's launch is the latest step in a decadeslong quest by drugmakers to capitalize on research into epigenetics, a way of controlling gene expression without altering DNA

Biogen receives ‘negative trend vote’ for aducanumab in the EU

BioPharma Reporter

Biogen says it is disappointed with feedback received from a European Medicines Agency committee on its aducanumab Marketing Authorization Application: but pledges to continue to engage with the regulator as it considers its next steps. Markets & Regulations

The Covid cash cow – a look at the Covid vaccine sales figures

Pharma Phorum

The race to find and bring vaccines to market to fight Covid was impressive. So too are the sales figures. Katrina Megget reports. It’s been almost a year since the first Covid vaccine was authorised for use.

Sales 107

Monkeys, guinea pigs and native English speakers have very similar brain responses to speech sounds

Scienmag

PITTSBURGH, November 19, 2021 – Speech sounds elicit comparable neural responses and stimulate the same region in the brain of humans, macaques and guinea pigs, a multidisciplinary group of University of Pittsburgh researchers reported in the journal eNeuro today.

Anticipating Aduhelm's costs, Medicare plans big jump in premiums

Bio Pharma Dive

While CMS is still weighing whether to authorize wide coverage of Biogen's pricey Alzheimer's drug, administrators are planning to build reserves in case costs skyrocket

Drugs 239

Major Insurers Weigh in on “Medical Necessity” of Biogen’s Aduhelm

BioSpace

In a Bloomberg News survey of 25 large insurers, none described the drug as “medically necessary,” and said Aduhelm was still experimental

Drugs 101

Boost for Amazon’s telehealth business, as Hilton signs up

Pharma Phorum

Amazon’s push into the provision of remote healthcare services has been rewarded with a top-tier corporate client – the Hilton hotel chain.

Understanding how pathogenic fungi build their carbohydrate armor

Scienmag

In a new study published in Nature Communications, Associate Professor Tuo Wang and his research team from the Department of Chemistry at Louisiana State University revealed the molecular architecture of fungal cell walls and the structural responses to stresses, aiding the development of antifungal drugs targeting cell wall components.

Drugs 83

Pfizer asks FDA to authorize COVID-19 pill

Bio Pharma Dive

Study results released earlier this month showed the pill, when given soon after symptoms start, dramatically reduced the risk of COVID-19 hospitalization or death

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BioNTech Bags Fast-Track Status for Melanoma Treatment

BioSpace

BioNTech is on the Fast Track. This morning, the company announced it received Fast Track Designation from the U.S. Food and Drug Administration for its cancer immunotherapy candidate

Drugs 99

Respira Labs’ wearable device listens for lung diseases

Pharma Phorum

US company Respira Labs has developed a device worn on the chest that uses tiny speakers and microphones to project sound into the lungs and listen for signals that could indicate serious lung diseases.

Reading the mind of a worm

Scienmag

LA JOLLA—(November 19, 2021) It sounds like a party trick: scientists can now look at the brain activity of a tiny worm and tell you which chemical the animal smelled a few seconds before.

FDA approves Merck's Keytruda as first immunotherapy for early kidney cancer

Bio Pharma Dive

Immune-boosting drugs like Keytruda are increasingly being tested, and proven effective, alongside surgery before tumors spread widely

Pfizer, BioNTech and Zipline deliver COVID-19 vaccines by drone in Ghana

BioPharma Reporter

Pfizer and BioNTech have completed long-range drone deliveries of their mRNA COVID-19 vaccine: with partner Zipline claiming to be the first to deliver vaccines in this way at a national scale. Bio Developments

AZ, Moderna say mRNA drug is promising in heart failure

Pharma Phorum

Moderna is already riding high on the strength of its mRNA-based COVID-19 vaccine, but the broader potential of its technology has been shown in a new AstraZeneca-partnered candidate for heart failure.

New microscopy method offers 3D tracking of 100 single molecules at once

Scienmag

Since its invention over 400 years ago, the microscope has continued to evolve, peering ever deeper into nature’s mysteries at the smallest scales.

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Al Sandrock, Biogen's top scientist and Aduhelm defender, to retire in surprise exit

Bio Pharma Dive

Sandrock championed the controversial Alzheimer's drug, and was integral to the development of several other of Biogen's most important medicines during his 24 years at the biotech

Monoclonal Antibodies Shine in the Fight Against COVID-19

BioSpace

Monoclonal antibodies have proven to be an important therapeutic option in the ongoing battle against COVID-19

Parliamentary probe finds racism evidence in NHS sickle cell care

Pharma Phorum

Patients with sickle cell disease are facing racism in the NHS that is putting their lives a risk, claims a new report. .

Drugs 97

Urbanization not always bad for food and land use diversity

Scienmag

Widely accepted myths that urbanization negatively impacts food and land use biodiversity are incorrect, according to a team of researchers who developed a framework for evaluating this intersection. Their results could also affect nutrition and food insecurity in urban areas.

Pfizer will allow generic drugmakers to produce promising COVID-19 pill

Bio Pharma Dive

A licensing deal with a U.N.-backed backed patent group could expand supply of Pfizer's experimental drug Paxlovid in lower- and middle-income countries

Three Pharma Companies Seek to Address FDA Rejections

BioSpace

Iterum Therapeutics will head back into the clinic to meet regulatory requirements to refile a New Drug Application for oral sulopenem

Gene-edited cell replacement therapy for diabetes set to enter the clinic

BioPharma Reporter

CRISPR Therapeutics and ViaCyte, Inc. have received the green light from Health Canada for their Clinical Trial Application for VCTX210: an allogeneic, gene-edited, immune-evasive, stem cell-derived therapy for the treatment of type 1 diabetes (T1D). Clinical Development

Can defects turn inert materials into useful, active ones?

Scienmag

Demonstrating that a material thought to be always chemically inert, hexagonal boron nitride (hBN), can be turned chemically active holds potential for a new class of catalysts with a wide range of applications, according to an international team of researchers.