Sat.Sep 11, 2021 - Fri.Sep 17, 2021

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After talks with FDA, a biotech prepares to submit its closely watched ALS drug

Bio Pharma Dive

Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will ask for approval of AMX0035 — likely within the next six months.

Drugs 360
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How pharmacists can partner with health coaches

Pharma Mirror

What is a health coach? A health coach is someone with expertise in wellness who assists people achieve good health by being a mentor and educator on lifestyle and nutritional changes. It is important to understand that health coaching is not only about nutrition, but instead, health coaches offer people a holistic approach to creating and sustaining healthy habits.

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DTC messages need to evolve

World of DTC Marketing

SUMMARY: With patients staying away from their doctors because of COVID, DTC messages need to add incentives and better messaging to get people to take action rather than wait. No one message will do this, however. Messages need to evolve in these special times. My doctor’s office recently sent me an email that they had plenty of telehealth appointments available for patients who didn’t want to come to the office.

Doctor 199
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FDA Approves First Human Trial for Potential CRISPR-Led HIV Cure

BioSpace

?The FDA's IND approval sets the stage for the very first Phase I/II trial to evaluate EBT-101 as a functional cure for chronic HIV based on the endpoints of safety, tolerability, and efficacy.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Fourth trial volunteer dies in Astellas gene therapy study

Bio Pharma Dive

The study, which was suspended following three deaths last year, had been restarted in February after Astellas lowered the treatment dose used.

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Regulatory Strategy Considerations for Working with the FDA vs the EMA, Part 2

Camargo

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during development.

More Trending

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Pfizer UK, Entia partner on home blood monitoring device for breast cancer patients

Pharma Times

Through Entia’s virtual oncology platform, patients are able to perform their own blood tests

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FDA advisers support booster dose of Pfizer vaccine in older or high-risk adults

Bio Pharma Dive

In a back-and-forth meeting Friday, the committee opposed clearing a third shot widely for use in people older than 16, but agreed the benefits outweighed the risks for adults over 65 or those at risk of severe COVID-19.

Vaccine 351
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The tech revolution reshaping European healthcare

pharmaphorum

The European health tech industry has made a “quantum leap” into using digital health technology due to the pandemic with the help of a growing number of trailblazing entrepreneurs, according to AlbionVC. The London-based venture capital firm provides a useful overview of how healthcare has changed over the last decade, and where digital health is expected to make the most impact in the future, in their first Health Tech primer for Europe report.

Radiology 135
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Opioid use for pain relief increased as a result of the Covid-19 pandemic

Pharma Mirror

The use of opioids for pain relief in patients awaiting hip and knee replacement surgery increased dramatically during the pandemic according to new research from the University of Aberdeen. Published in the BMJ Quality & Safety, the study found that the numbers of patients using opioids while waiting for surgery increased by 40% compared to pre-pandemic levels.

Research 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Research identifies possible link between antibiotic use and breast cancer growth

Pharma Times

Researchers discovered that treating mice with broad-spectrum antibiotics increased the rate at which their breast cancer tumours grew

Research 122
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Theravance to lay off 75% of employees alongside larger restructuring

Bio Pharma Dive

The move, which will affect an estimated 270 positions, follows a review by the company's board, and comes just weeks after one of its most advanced drugs failed a key test.

Drugs 345
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Digital health approach improves neurosurgery care, says study

pharmaphorum

Deployment of digital health technologies during the pandemic improved patient satisfaction, expanded the delivery of care and augmented training of staff at a leading neurosurgery provider in the US, according to a new study. Faced with the disruption caused by the COVID-19 crisis, Cleveland Clinic centres implemented a number telehealth and audio-visual technologies to compensate for the difficulties in having face-to-face interactions with patients.

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Legend Capital Led a New Round of Investment of Etana

Pharma Mirror

HONG KONG, Legend Capital led a new round of investment of PT Etana Biotechnologies Indonesia (Etana), along with Innovent Biologics, Inc. (Innovent) (HKEX: 01801), and a consortium led by UOB Venture Management (UOBVM). This round of funds will be used to further strengthen the company’s production, registration, clinical and commercialization capabilities, promote the company’s extensive and in-depth cooperation with biopharmaceutical companies, and lead the development of the Indo

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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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Phony Diagnoses Hide High Rates of Drugging at Nursing Homes

NY Times

At least 21 percent of nursing home residents are on antipsychotic drugs, a Times investigation found.

Nurses 122
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New data from Israel, Pfizer show potent effect from third coronavirus shot

Bio Pharma Dive

The much-anticipated data arrive two days before an important FDA advisory meeting to discuss authorization of a booster dose for Pfizer's coronavirus vaccine.

Vaccine 336
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Coalition formed to represent patient interests in digital health

pharmaphorum

Not enough is being done to ensure that patient voices are included in policymaking around digital health, says a new patient organisation in the UK, which aims to set that situation right. The Patient Coalition for AI, Data and Digital Tech in Health has brought together members of patient organisations, medical colleges and health charities to tackle issues such as ensuring equitable access to digital health services.

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NHS England launches large-scale trial of ‘revolutionary’ cancer test

Pharma Times

The Galleri test is able to identify the ‘earliest’ signs of cancer in the blood

Trials 112
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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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Gates Foundation, Exscientia enter $70m agreement to develop COVID-19 treatments

Outsourcing Pharma

The pharma tech firm has forged a four-year partnership with the foundation to develop antivirals for COVID-19 and other viruses with pandemic potential.

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Departing FDA officials, WHO leaders argue against broad rollout of COVID-19 booster shots

Bio Pharma Dive

Marion Gruber and Philip Krause, two top FDA vaccine reviewers who are unexpectedly departing this fall, joined senior WHO officials in saying booster vaccine doses are not yet widely needed.

Vaccine 334
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EU ‘negotiating with Valneva’ over COVID-19 vaccine contract

pharmaphorum

The European Commission is reportedly in advanced discussions with French biotech Valneva about picking up the contract to supply COVID-19 vaccines that was terminated by the UK government this week. A French government source told Reuters that the EU is considering using the VLA2001 vaccine as part of its booster campaign plans, along with a shot from Sanofi and GlaxoSmithKline.

Vaccine 116
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Keytruda made available on the NHS for certain oesophageal cancer patients

Pharma Times

Approximately 1,000 people will be eligible for the treatment in England

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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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Growing Glioblastomas in a Laboratory: 3D Bioprinting a Better Brain Model

BioSpace

This newfound ability to take tumor cells directly from a patient and incorporate them into a more clinically accurate glioblastoma model could lead to greater patient personalization in cancer therapeutics.

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FDA staff tight-lipped on booster shot views ahead of consequential meeting

Bio Pharma Dive

In a briefing document released Wednesday, agency reviewers did not make a strong case either for or against the broad authorization of boosters for the general public.

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Taking stock of NHS medicines optimisation

pharmaphorum

Given the rising cost of medicines as a share of the NHS budget in England, the establishment of ICSs provides a timely opportunity to take stock on delivering medicines optimisation at local level, says NHS Gloucestershire CCG’s Ellen Rule. Medicines optimisation aims to improve health outcomes, service quality, and sustainability by ensuring patients are taking their prescribed medicines as recommended to derive the intended benefits and avoid incurring harms.

Medicine 113
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Moderna to collaborate with AbCellera

Pharma Times

Partnership aims to develop mRNA-encoded antibody therapeutics

Antibody 107
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA approves IND application for peanut allergy drug candidate

Outsourcing Pharma

The US agency has given the go-ahead to Cour Pharmaceuticals to evaluate the safety and efficacy of CNP-201, a drug intended to treat peanut allergies.

Allergies 105
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Biotech funder Lightstone raises another $375M for life sciences investing

Bio Pharma Dive

The venture firm, which previously invested in Disarm Therapeutics, Ra Pharma and Tizona Therapeutics, said its third fund surpassed its target.

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AI aims to prevent unneeded treatment for deep vein thrombosis

pharmaphorum

Researchers in the UK are working on an artificial intelligence (AI) algorithm to help diagnose deep vein thrombosis (DVT) from ultrasound images – and potentially prevent patients from receiving drugs unnecessarily. The team from Oxford University, Imperial College London and the University of Sheffield are working with German tech company ThinkSono on the smartphone-based app, called AutoDVT, and estimate it could cut the cost to health services of each examination by up to $150.

Research 111
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Eli Lilly Pursues RNA Editing in New Partnership with ProQR

XTalks

With RNA therapies being the next hot thing in genetic medicine, Eli Lilly is joining the RNA editing race by partnering with Netherlands-based ProQR Therapeutics NV (Nasdaq: PRQR), a biotech company developing RNA-based therapies for rare genetic diseases with a focus on blinding disorders of the retina. ProQR announced yesterday that it had landed a global licensing and research collaboration with Eli Lilly and Company “focused on the discovery, development and commercialization of potential n

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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.