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New data bolsters Sarepta gene therapies for two deadly muscle diseases

Bio Pharma Dive

The results disclosed at a medical meeting on Monday show that all patients tested have seen their motor skills stabilize or improve when history suggests they wouldn't

Ageism within pharma

World of DTC Marketing

WHAT”S HAPPENING? As more and more pharma companies merge and the industry consolidates good jobs are going to shrink, Unfortunately, what I’m hearing and seeing is that the industry is passing on older candidates with experience in favor of younger candidates who may be perceived as more technology literate. Kathy was someone who impressed me from the first time I met her. Her knowledge of all aspects of pharma marketing was like an encyclopedia.

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FDA sets back Novartis plans to expand use of SMA gene therapy

Bio Pharma Dive

The agency has asked Novartis to run a new study of the Zolgensma formulation that Novartis aims to bring to older patients with spinal muscular atrophy

How Are Biopharma Companies Evaluating Partnerships in the Rare Disease Space?

Camargo

Panel Summary from the World Orphan Drug Congress 2020. Last month, executives from leading international biopharma companies came together at the World Orphan Drug Congress 2020 to discuss how they are evaluating new opportunities in the rare disease space.

The Themes of The World Pharmacists Day 2010-2020

Pharma Mirror

Pharmacists are healthcare professionals who have enough knowledge about the effective uses of medications. World Pharmacist Day is celebrated on 25th September every year since 2010 on the day FIP (International Pharmaceutical Federation) started their journey.

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Quantitative Biomarkers in Clinical Research Imaging Trials

ERT

Quantitative imaging techniques are defined by the Radiologic Society of North America’s Quantitative Imaging Biomarkers Alliance (RSNA QIBA) as ”… the extraction of quantifiable features from medical images for the assessment of normal, or the severity, degree of change, or status of a disease, injury, or chronic condition relative to normal.”

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Provide shady spots to protect butterflies from climate change, say scientists

Scienmag

Credit: Andrew Bladon Researchers have discovered significant variations in the ability of different UK butterfly species to maintain a suitable body temperature. Species that rely most on finding a suitably shady location to keep cool are at the greatest risk of population decline.

First UK patient given GSK’s experimental arthritis drug in COVID-19 trial

Pharma Times

Drug is being investigated in up to 800 hospitalised patients nationwide

Risk Assessment Tool Identifies Diabetic Patients that Benefit Most from SGLT2 Inhibitor Treatment

XTalks

A new study shows that the diabetic drug canagliflozin reduces the risk of adverse cardiovascular and kidney outcomes in individuals with type 2 diabetes, particularly for those at higher risk of kidney failure.

Keys to success when interacting virtually with health authorities

Bio Pharma Dive

Due to COVID-19, health authority meetings are now virtual. Learn how you can flourish in this arena

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Could a COVID-19 breath test help UK out of lockdown?

Pharma Phorum

A potential COVID-19 breath test has been unveiled in the UK, as the country desperately searches for alternatives to crippling lockdown measures to prevent the disease from spreading.

Lipids, lysosomes, and autophagy: The keys to preventing kidney injury

Scienmag

A team of researchers led by Osaka University unravel a tangle of pathways involving calcium, lipids, and the degradation of damaged lysosomes that is essential for preventing crystal-induced kidney injury Credit: Osaka University Osaka, Japan – Human cells need to work like well-oiled machines to keep our bodies running as they should.

Novavax Begin Phase III Study of COVID-19 Vaccine Candidate in the U.K.

BioSpace

The late-stage study is part of an agreement struck between the company and the U.K. government last month that includes providing 60 million doses of the vaccine, should it be approved

Fitbit Wins Another Approval for AFib App

XTalks

The San Francisco-based tech giant, Fitbit, has received clearance from the US Food and Drug Administration (FDA) and the Conformité Européenne (CE) in the European Union for its electrocardiogram (ECG) app. The application is used to assess heart rhythm for atrial fibrillation (AFib).

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After setback in the US, Galapagos' main drug finds success elsewhere

Bio Pharma Dive

A month after the FDA surprisingly rejected the rheumatoid arthritis drug, known as filgotinib, and more recently, Jyseleca, it's been cleared by regulators in Europe and Japan

FDA launches Digital Health Center of Excellence

Pharma Phorum

The FDA has launched its Digital Health Center of Excellence (DHCoE), as the agency continues with its commitment to advancing use of technology such as mobile health devices, software and wearables to create medical products.

New insights into colorectal cancer: Growth factor R-spondin suppresses tumor growth

Scienmag

Researchers have found a surprising effect of the stem cell-regulating growth factor R-spondin in intestinal cancer. Credit: Marianne Lähde Colorectal cancer constitute the third most common cancer in the Western world.

Effects of Time-Restricted Eating on Weight Loss and Other Parameters in Patients With Overweight and Obesity

JAMA Internal Medicine

This randomized clinical trial examines the effect of 16:8-hour time-restricted eating on weight loss and metabolic risk markers

FDA Plans New, More Stringent Guidance for COVID-19 Vaccine EUA

BioSpace

Although the updated guidance has largely remained under wraps, sources who spoke to The Washington Post hinted that the new rules would make it more difficult for an EUA to be granted to a vaccine ahead of Nov. 3, the day of the U.S. elections

FDA decision on Bristol Myers cell therapy could come down to the wire

Bio Pharma Dive

The FDA could decide the fate of Bristol Myers' multiple myeloma treatment ide-cel four days before a key deadline related to the pharma's buyout of Celgene passes

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MIT Scientists Develop Food Sensor That Can Detect Spoiled or Contaminated Food

XTalks

MIT engineers have designed a food sensor , made from an array of silk microneedles, that can pierce through the plastic packaging of foods to sample for bacterial contamination and spoilage.

Thousands of excess deaths from cardiovascular disease during the COVID-19 pandemic

Scienmag

Credit: University of Leeds A major new study has identified 2085 excess deaths in England and Wales due to heart disease and stroke during the peak of the COVID-19 pandemic. On average, that is 17 deaths each day over four months that probably could have been prevented.

New patent for Insmed Inc drug ARIKAYCE KIT

Drug Patent Watch

Annual Drug Patent Expirations for ARIKAYCE+KIT Arikayce Kit is a drug marketed by Insmed Inc and is included in one NDA. There are ten patents protecting this drug. This drug…. The post New patent for Insmed Inc drug ARIKAYCE KIT appeared first on DrugPatentWatch - Make Better Decisions.

GSK’s Nucala approved in the US for hypereosinophilic syndrome

The Pharma Data

Treatment becomes first and only biologic for HES in the US. GlaxoSmithKline’s Nucala has been approved by the US Food and Drug Administration (FDA) for the treatment of hypereosinophilic syndrome (HES), making it the first biologic approved in this indication.

J&J, beginning final test, shares first data on coronavirus vaccine

Bio Pharma Dive

The early study results were used to support the drugmaker's recent decision to start a large Phase 3 study that, unlike other large tests underway, will evaluate a one-shot regimen

LabCorp Backs Resolution Bioscience’s Liquid Biopsy Test for NSCLC

XTalks

Clinicians and patients alike have long been hoping for liquid biopsy tests for cancer screening and diagnosis given their ease, convenience and ability to detect disease-specific mutations.

Computer model shows how COVID-19 could lead to runaway inflammation

Scienmag

Credit: Serkan Eldeleklio?lu lu PITTSBURGH, Sept. 29, 2020 – A study from the University of Pittsburgh School of Medicine and Cedars-Sinai addresses a mystery first raised in March: Why do some people with COVID-19 develop severe inflammation?

New patent for NOVO drug OZEMPIC

Drug Patent Watch

Annual Drug Patent Expirations for OZEMPIC Ozempic is a drug marketed by Novo and is included in one NDA. It is available from three suppliers. There are twenty-two patents protecting…. The post New patent for NOVO drug OZEMPIC appeared first on DrugPatentWatch - Make Better Decisions. Patent Added

Boehringer Ingelheim invests to further develop the pet care market in China

BioTech 365

Boehringer Ingelheim has acquired an equity stake in New Ruipeng Group (NRP Group) which operates digital and clinical pet services across China The partnership with NRP Group aims to expand health solutions, quality advice and professional care to the growing … Continue reading → Business Wire

Regeneron forges ahead in lung cancer, but will need more to unseat Merck

Bio Pharma Dive

The biotech's immunotherapy Libtayo looks headed for approval in lung cancer, but surpassing the bar set by Merck's Keytruda remains a challenge

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Cytel expands unique trial for early COVID-19 treatments in Global South

Journal for Clinical Studies

Two South Africa sites added to TOGETHER platform trials for the outpatient treatment of high-risk adults infected with SARS-CoV-2 Cytel… Europe news North America

3D biometric authentication based on finger veins almost impossible to fool

Scienmag

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Novel nasal spray reduces viral replication by up to 96%: according to COVID-19 challenge study

BioPharma Reporter

Ena Respiratoryâs preventative nasal spray treatment could reach human trials within four months, following results from an animal study released today which showed the spray reduced COVID-19 replication by up to 96%. Drug Delivery

MiNA Therapeutics Appoints Peter Bains as Chief Business Officer

BioTech 365

LONDON–(BUSINESS WIRE)–MiNA Therapeutics, the pioneer in RNA activation therapeutics, announced today the appointment of Peter Bains as Chief Business Officer (CBO), effective September 22, 2020.

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