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

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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.

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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? There is no doubt that healthcare is the middle of an evolution not seen in over 30 years.

Marketing 253
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FDA clears GE Healthcare AI algorithm for patient intubation

pharmaphorum

An artificial intelligence algorithm developed by GE Healthcare that helps with the placement of endotracheal tubes (ETTs) has been approved by the FDA. The new tool – part of GE’s Critical Care Suite 2.0 – helps bedside staff and radiologists assess patients before intubation – for example prior to ventilation in patients with critical COVID-19 – and make sure their ETTs are positioned correctly.

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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.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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

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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. A client launched an Oncology drug based on extensive research with physicians, but the results were not that good during a post-launch evaluation.

Drugs 238

More Trending

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EU nears decision on Novavax COVID-19 vaccine

BioPharma Reporter

The European Medicines Agency (EMA) could issue an opinion on Novavaxâ Conditional Marketing Authorization for its COVID-19 vaccine âwithin weeksâ.

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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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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. patent system to fend off competitors and increased the price of Humira to $77,000 for a year’s supply, while the price of its cancer drug Imbruvica was raised to $181,529 per year.

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AZ, Moderna say mRNA drug is promising in heart failure

pharmaphorum

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. At the American Heart Association (AHA) congress, the two partners presented results from the phase 2a EPICCURE trial that showed that injecting their AZD8601 candidate directly into the heart muscle of patients undergoing coronary artery bypass graft (CABG) surgery seemed to improve heart functio

Drugs 121
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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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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.

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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.

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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 117
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Respira Labs’ wearable device listens for lung diseases

pharmaphorum

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. The Sylvee wearable uses an artificial intelligence (AI) algorithm to interpret sounds that may indicate trapped air in the lungs, which can be a sign of ill health, using acoustic resonance – similar to the way an ultrasound machine creates visual images.

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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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Vertex receives CHMP positive opinion for Kaftrio in children with cystic fibrosis

Pharma Times

Those eligible will have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene

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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 300
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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).

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Merck Celebrates Another Win for Blockbuster Keytruda

BioSpace

Merck’s Keytruda (pembrolizumab) keeps expanding the indications for which it’s approved. The company announced today that the FDA had approved the anti-PD-1 therapy for adjuvant treatment of renal cell carcinoma.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Under-18s with COVID-19 in UK advised to wait 12 weeks for vaccine dose

Pharma Times

The UKHSA have said that deferring the vaccine dose could help to reduce even further the small risk of heart inflammation following vaccination

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Gilead pays up to retain rights to Arcus cancer drugs

Bio Pharma Dive

The biotech will pay $725 million to opt into rights on four experimental medicines developed by Arcus, including ones that could challenge Merck's Keytruda in lung cancer.

Medicine 279
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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. She is from the University of Johannesburg’s (UJ) campus in […].

Drugs 99
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Avrobio’s Small Trials Hint at Cure for 3 Big Lysosomal Diseases

BioSpace

Avrobio’s ex vivo lentiviral gene therapy platform led to durable responses measured in years, and significant reductions in disease-related biomarkers that far exceed today’s standard of care.

In-Vivo 98
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Report: UK disposed of 600,000 AZ vaccine doses after they passed expiry date

Pharma Times

The data was obtained by a Freedom of Information request, according to The Independent

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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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Goodles Offers Adult Mac and Cheese Lovers a Better-for-You Alternative

XTalks

There’s a new macaroni and cheese on the market, and it claims to be “gooder” than the rest. Mac and cheese brand Goodles launched Tuesday after its parent company, Gooder Foods, raised $6.4 million in funding from various venture capital firms and private investors. So, how does Goodles differ from mac and cheese legends Kraft and Annie’s, and where will it fit into the $4.4 billion dry noodle category?

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Pathway or Perish: The Two-Pronged Hurdle to Ensuring Access in Oncology

Drug Channels

Today’s guest post comes from Carolyn Zele, Senior Manager of Solution Enablement at MMIT. Carolyn describes how oncology pathways were developed to help standardize treatment and ensure quality care. She argues, however, that these pathways often shut manufacturers out of the market. Click here to learn more about MMIT's Pulse Analytics solution , which provides insight into payer- and pathway-driven barriers to access.

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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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New NHS stroke treatment drug agreement could save 5,000 a year

Pharma Times

This deal will see more patients having access to treatment which could prevent 21,700 strokes and 5,400 deaths

Drugs 123
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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.

Scientist 273
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NBA Rookie Jared Butler and Bristol Myers Squibb Partner on HCM Awareness Campaign

XTalks

Utah Jazz rookie Jared Butler is sharing his diagnosis of hypertrophic cardiomyopathy (HCM) by partnering with Bristol Myers Squibb (BMS) for its new HCM awareness campaign. Butler said he received the diagnosis during a routine health exam when he was 18; it caught him off guard as he had no symptoms. “The first time I heard the term hypertrophic cardiomyopathy, I was in the doctor’s office in the room getting diagnosed.

Doctors 98
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CVS, Walgreens, Walmart, and Supermarkets Keep Position in 2022 Part D Preferred Networks—With a Little Help from 340B

Drug Channels

In Consolidation and Preferred Pharmacy Networks in 2022’s Medicare Part D Plans , I highlighted how those networks have hijacked the world of stand-alone Medicare Part D prescription drug plans (PDP) and become a major presence in Medicare Advantage prescription drug (MA-PD) plans. Today, I examine the largest retail chains’ participation in the 21 major 2022 Part D preferred networks that the eight largest plan sponsors will offer.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.