September, 2022

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The dangers of expanding the TRIPS waiver

PhRMA

World Trade Organization (WTO) members, including the United States, are considering waiving commitments to honor certain intellectual property (IP) rights on COVID-19 treatments, following a harmful and unnecessary decision to do the same for COVID-19 vaccines. This is referred to as the TRIPS waiver.

Vaccines 306
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How has the evolution of data changed independent pharmacy?

Drug Topics

Big data and analytics are everywhere—including in independent pharmacy. But is the collected information being used to help with documentation, care planning, and reimbursement?

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Trending Sources

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Three Keys to Implementing Artificial Intelligence in Drug Discovery

Pharmacy Times

AI-based technologies are increasingly being used for things such as virtual screening, physics-based biological activity assessment, and drug crystal-structure prediction.

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Opinion: Doctors who knowingly spread Covid-19 lies should be held accountable

STAT

The California State Legislature has sent a bill to Gov. Gavin Newsom that strengthens discipline for doctors who knowingly spread Covid-19 misinformation. Legislation like this is sorely needed across the country. More than two years into the pandemic, Covid-19 misinformation still runs rampant. Some comes from doctors spreading lies about unproven — and actually harmful — “treatments” for Covid-19 and promoting anti-vaccine conspiracy theories.

Vaccines 145
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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Novo Nordisk partners with Microsoft for AI-driven drug discovery

Pharmaceutical Technology

Novo Nordisk has signed a new strategic partnership with Microsoft to expedite the discovery and development of drugs leveraging big data and artificial intelligence (AI). Under the deal, Microsoft's computational services, Cloud and artificial intelligence (AI) will be merged with the drug discovery, development and data science expertise of Novo Nordisk.

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The discovery of a new and compounding cybersecurity threat to pharmacies

pharmaphorum

Sam Crowther, founder and CEO of cybersecurity company Kasada, tells us about a recent discovery his company made that revealed tens of thousands of accounts with prescription drug attachments in major online pharmacies had been compromised. While performing analysis for a client of online accounts for sale, Kasada uncovered a new and illegal way bots are being used – to steal pharmacy customers’ accounts and resell prescriptions on a secondary market for in-demand substances, such as Oxyc

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Potential Impact of Inflation Reduction Act on Biosimilars

Drug Topics

Several provisions in the law are designed to protect and foster the biosimilar market. But some representatives of the sector see CMS drug price negotiation as a threat to profit margins.

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Study: Programs to Limit Prescription Opioids May Spur Illegal Drug Use

Pharmacy Times

Prescription drug monitoring programs have decreased prescription opioids in the United States but resulted in unintended spikes of illegal drug use and heroin-related deaths.

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STAT+: USDA starts cracking down on companies that ship animals without timely inspections

STAT

Earlier this year, a leading animal rights group asked U.S. authorities to investigate medical research labs for allegedly violating federal law after finding numerous instances where nearly 2,000 monkeys were shipped between facilities without required veterinary inspections. Now, the federal government appears to be acting.

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Micro-robots, smart toilets, and 3D bioprinted organs: the future of healthcare

Pharmaceutical Technology

It is the year 2030. You have just received the results from your whole genome sequencing test, offered through your public health provider, and discovered that you have a 75% chance of developing a rare form of cancer. But you are not panicking; your genomic data was automatically uploaded, with your permission, to your electronic health record (EHR), which is fully secured with blockchain technology.

Vaccines 137
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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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FDA drops PreCert report, new digital health guidances

pharmaphorum

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report. The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

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Recognizing National Sickle Cell Awareness Month

PhRMA

September is National Sickle Cell Awareness Month and a time for us to underscore the biopharmaceutical industry’s ongoing commitment to improve the lives of patients, families and communities affected by sickle cell disease.

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2022-2023 Flu Season Vaccination Recommendations for Children and Adolescents

Drug Topics

Keep your pharmacy vaccine-ready for your youngest patients with the most current influenza vaccination information from the American Academy of Pediatrics.

Vaccines 201
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Genomic Testing Framework for Chronic Kidney Disease Continues to Grow

Pharmacy Times

Investigators combine research discovery with technological development to determine whether the role of genomics in nephrology should remain with subspecialists or be integrated into general nephrology.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Pfizer isn’t sharing Covid vaccines with researchers for next-gen studies

STAT

WASHINGTON — Researchers studying next-generation vaccines to fight an evolving Covid-19 threat are running into problems getting existing vaccines to use in their research. Because Pfizer and Moderna hold the patents for the current vaccines, researchers would likely have to get the companies’ permission to use them for research into products like nasal or pan-coronavirus vaccines.

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The Manufacturing Edge on Path to Market

PharmExec

FDA backs the benefits of adopting continuous manufacturing, a strategy which has accelerated approval and launch timelines, and its Emerging Technology Program could be a helpful tool.

FDA 130
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The future of AI drug discovery & development in immunology and GPCR research

pharmaphorum

Alphabet subsidiary and precision health company Verily recently announced a breakthrough in its AI drug discovery GPCR research collaboration with Sosei Heptares. A mere six months ago Verily launched the study with Sosei Heptares – a global leader in GPCR structure-based drug design – with an aim to “prioritise protein targets for therapeutic targeting in immune-mediated disease”.

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Timely reauthorization of PDUFA and BsUFA is vital to the FDA’s review of medicines

PhRMA

As we’ve discussed on this blog before, timely reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) is critical to sustaining the U.S. Food and Drug Administration’s (FDA) ability to keep pace with the number of innovative drugs, biologics and biosimilars entering the regulatory review pipeline.

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Waste Problem Shows COVID-19 Vaccines Aren’t Just a Dime a Dozen

Drug Topics

When it comes to the COVID-19 vaccine, independent pharmacies are being set up to fail by federal health partners.

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Monkeypox in Populations Presenting with Neurologic Syndromes Require Diagnosis

Pharmacy Times

Included in the literature review were the known neurologic complications of smallpox, including encephalitis, transverse myelitis, and acute disseminated encephalomyelitis.

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STAT+: In reversal, FDA advisers vote to support approval of Amylyx’s drug for ALS

STAT

At the end of an unusual and dramatic meeting on Wednesday, an independent panel of advisers to the Food and Drug Administration recommended the approval of a new drug to treat people with ALS developed by Amylyx Pharmaceuticals. The vote was 7-2, a substantial margin of support for the Amylyx drug called AMX0035 and a reversal of the same group’s vote against the drug last March.

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Mass producing biodegradable stem cell therapy microrobots

European Pharmaceutical Review

Professor Hongsoo Choi’s team at The Department of Robotics and Mechatronics Engineering at the Daegu Gyeongbuk Institute of Science & Technology (DGIST), Korea, developed revolutionary technology that produces over 100 microrobots per minute. The collaboration with Professor Sung-Won Kim’s team at Seoul St. Mary’s Hospital, Catholic University of Korea and Professor Bradley J.

Hospitals 126
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Bridge Bio will use Brainomix AI in lung fibrosis trial

pharmaphorum

Brainomix has reeled in another pharma partner for its artificial intelligence-powered biomarker software, used to track the performance of therapeutic interventions in clinical trials. South Korea’s Bridge Biotherapeutics has signed up to use the UK medtech firm’s e-ILD software package in a phase 2 trial of BBT-877, its experimental therapy for serious lung disease idiopathic pulmonary fibrosis (IPF).

Packaging 121
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Navigating the patient experience: Burdens and barriers standing between patients and their care

PhRMA

Health care affordability is not the only hurdle facing patients, according to PhRMA’s third Patient Experience Survey (PES). The latest PES report exposes another crucial problem: the frustration and confusion people have around how to use their coverage. Administrative hurdles and other barriers imposed by health insurers and pharmacy benefit managers (PBMs), such as time-consuming paperwork or prior authorization, are a challenge for many insured Americans, including more vulnerable communiti

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How Pharmacists Can Address Vaccine Hesitancy for the Flu and Beyond

Drug Topics

Address vaccine hesitancy at your pharmacy to encourage patients and their families to get vaccinated against COVID-19, flu, and more.

Vaccines 201
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New Bivalent Omicron-Containing Booster Vaccine May Elicit Higher Antibody Response Against COVID-19

Pharmacy Times

Patients could have a better immune response against the omicron variant of COVID-19 with a second booster of the bivalent mRNA-1273.214 vaccine at a 50 ?g dose.

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Where caregiving is a family affair, Alzheimer’s places a heavy burden on children and spouses

STAT

HARLINGEN, Texas — Here in the Rio Grande Valley almost everyone knows, or cares for, someone with dementia. It’s not a surprise. The region has some of the nation’s highest rates of the disease. But what’s less appreciated is the enormity of the burden carried by the mostly Mexican American caregivers. In a culture where caregiving is a family affair, it’s almost unthinkable for children and spouses to place loved ones in nursing facilities or ask for outside

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NF Community Day 9th Oct 2022

NF2 BioSolutions

We have been very busy organising the NF Community Day in Manchester with other NF organisations and in particular NF Patients United. Registration for the NF Community Day is now open from Sept 20th 2022! You MUST register & sign up via this link: [link]. There is a maximum of 100 registration places available. Location: Mercure Manchester Piccadilly Hotel, £5 Per person attending.

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Majority of retail pharmacists fear losing Medicare-eligible patients

Drug Store News

Seventy percent of pharmacists who responded to EnlivenHealth's survey said that a third or more of their pharmacy's revenue comes from Medicare-eligible patients.

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New Report: Nearly 800 medicines in development to treat chronic condition

PhRMA

Chronic conditions impose a substantial health and economic burden that affects millions of patients, families and communities across the United States each day. While these conditions come with different origins, symptoms and treatments, they each can have a negative impact on a person’s physical and emotional well-being, quality of life and productivity.

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Cannabis Treatment for Sleep Disorders Warrants Further Investigation

Drug Topics

Encouraging outcomes in recent studies have researchers calling for more analysis of the effect of cannabinoids on sleep disorders.

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Study: Medical Cannabis May Have Far-Reaching Benefits for Neurological Disorders

Pharmacy Times

Research suggests cannabis can improve quality of life for patients who suffer from pain and neurological disorders.

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Ebola experimental vaccine trial may begin soon in Uganda

STAT

A clinical trial of one or perhaps two experimental vaccines designed to protect against the Ebola Sudan virus could soon begin in Uganda, as long as the country agrees to allow the research to take place, an official of the World Health Organization said Wednesday. The trial could get underway within a couple of weeks and definitely before the end of October, said Ana Maria Henao-Restrepo, who heads WHO’s R&D Blueprint effort to develop drugs, diagnostics, and vaccines to respon

Vaccines 141
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Novartis probed by Swiss authorities over ‘unlawful’ patent use

pharmaphorum

The competition authorities in Switzerland said this morning they have carried out a raid on a pharma company – now confirmed to be Novartis – as part of an investigation into a “possible unlawful use of a patent to reduce competitive pressure.” The Swiss Competition Commission (COMCO) arrived unexpectedly at Novartis at dawn on Tuesday morning, to gather information on an unidentified dermatology drug, as part of a wider investigation into the drugmaker by the European Commission.

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