Sat.Jul 24, 2021 - Fri.Jul 30, 2021

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Rapid COVID immune status test launched in UK, Ireland

pharmaphorum

You’ve had your two COVID-19 jabs, but are you actually protected against infection? That’s a question that a fingerprick test launched today in the UK and Ireland could help to answer. The test – originally developed by US manufacturer Chembio Diagnostics – has been introduced into the UK and Irish markets by Guilford-based Luas Diagnostics and tests for the presence of SARS-CoV-2-targeting antibodies in the blood.

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Pharma industry, CROs adapting to COVID-19 impacts: survey

Outsourcing Pharma

A recent check-in with several biopharma and CRO companies, conducted by Life Science Strategy Group, indicates adjustment to pandemic-related challenges.

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The “Amazon Effect” – Pharmacies, Healthcare, and Disruption

Fuld

CVS, Walgreens, and Walmart control over 20,000 bricks & mortar stores, or some 40% of all U.S. retail pharmacies. But Amazon has sent shock waves through these incumbents’ corporate offices with its recent move into the healthcare market via PillPack, Amazon Pharmacy and Amazon Care. Suddenly, the old guard are faced with the “Amazon Effect” – a highly disruptive, user-friendly virtual care model that bundles telehealth, big data, and free and fast mail order delivery directly to patient ho

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EU backs approval of Moderna’s COVID-19 vaccine in 12-17 year-olds

Pharma Times

Study in adolescents met it primary endpoint, successfully bridging immune responses to those observed in an efficacy study in adults

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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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Google’s DeepMind puts human proteome online for free

pharmaphorum

The most complete database of protein structures ever assembled, developed with the help of Google’s artificial intelligence unit DeepMind, has been made freely available to researchers around the world. DeepMind partnered with the European Molecular Biology Laboratory (EMBL) to come up with the AlphaFold database, which predicts the three-dimensional structures of the human proteome – nearly all (98.5%) of the 20,000 or so proteins expressed by the human genome.

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BMS, BridgeBio partner to study drug combo for lung cancer

Outsourcing Pharma

The two pharma firms will partner to study the efficacy of Opdivo, paired with a SHP2 inhibitor, to treat non-small cell lung cancer with KRAS mutations.

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Researchers find extending the time between Pfizer doses boosts antibodies

Pharma Times

Eight weeks between doses is the 'sweet spot' according to researchers

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Why digital doctors are crucial for the future of primary care

pharmaphorum

Our primary care system is weathering a storm on several fronts. Demand is skyrocketing, with GPs delivering millions more appointments than in previous years and workload far outstripping pre-Covid-19 levels. Dr Dan Bunstone explores how innovation can help GPs overcome the current capacity squeeze in primary care and tackle patient backlog. Despite the misconception that general practice has been ‘closed’ during the pandemic, practice staff are supporting a growing number of patients whose l

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New eLearning program aimed at enabling faster clinical adoption and improving patient access to ATMPs

Outsourcing Pharma

A new UK eLearning program is targeted at healthcare and academic professionals to support their learning on advanced therapy medicinal products (ATMPs).

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Pharma Marketing USA 2021 | November 8-10 | Virtual

Pharma Marketing Network

Delivering a flawless customer journey is no longer beyond your reach. With precision analytics as an anchor behind data-driven decision-making, new advancements in data quality and access, plus rising cultural acceptance to innovation – we’re finally moving towards digital maturity. It’s time to enable more personalized touchpoint identification, channel selection and agile content needed to succeed in the hybrid future.

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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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Four-drug combo therapy shows benefit for newly-diagnosed myeloma patients

Pharma Times

Combo therapy includes carflizomib administered alongside lenalidomide, dexamethasone and cyclophosphamide

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Tackling the ‘disease of systemic racism’ in clinical trials

pharmaphorum

A lack of racial diversity in clinical trials is a long-standing, well-documented problem that contributes to the stark health inequalities that have been brought into sharp focus by COVID-19. Tackling it, however, has not been easy, thanks in no small part to the reasons being as complex as they are multi-faceted. But, according to the Pharmaceutical Research and Manufacturers of America (PhRMA), the country’s biopharmaceutical companies are “committed to learning and leading” in a bid to “addr

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Personalized medicine requires complex supply chains: Marken

Outsourcing Pharma

A clinical trial logistics expert discusses specialized concerns involved in transporting cell and gene products and other personalized medicine items.

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Anticipated Challenges of Decentralized Clinical Trials: Part Two of the R’Kes Starling Interview

McCreadie Group

August 2021 | Jennifer Drabing, Senior Marketing Communications Manager McCreadie Group is pleased to present the second part of the interview with R’Kes Starling, CEO and founder of Reveles Clinical Services. In the first blog, we began discussing the future of decentralized trials, and now we will continue the conversation by focusing on specific challenges.

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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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UK genomics market valued at over £5bn, according to new report

Pharma Times

‘Genomics Nation’ report launched in a bid to showcase the thriving UK genomics sector

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How tech-driven hubs in specialty pharmacy can improve the patient experience

pharmaphorum

The use of specialty drugs in the U.S. has skyrocketed in recent years driven primarily by an increase in chronic condition diagnosis and the number of new medications on the market. Krishnanjan Alaparthi explores how tech-driven hub services can help manage the complexities of specialty pharma. It’s estimated specialty medications account for 75% of the approximately 7,000 prescription drugs currently in development, and by 2022, more than 60% of the 600 drugs expected to gain FDA approval will

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Personalized medicine supply chain highly complex: Marken

Outsourcing Pharma

A clinical trial logistics expert discusses specialized concerns involved in transporting cell and gene products and other personalized medicine items.

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Comparison of DPP4 Inhibitors

Med Ed 101

While Dipeptidyl Peptidase-4 (DPP4) inhibitors aren’t used incredibly often, we wanted to provide a comparison of DPP4 inhibitors. DPP4 inhibitors are used in the treatment of diabetes and function by inhibiting the breakdown of endogenous incretin hormones GLP-1 and GIP, increasing their concentrations in the bloodstream. This will then stimulate insulin release and inhibit glucagon […].

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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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Early data shows CanSinoBIO’s inhaled COVID-19 vaccine triggers immune response

Pharma Times

No serious side effects were observed in the Phase I trial

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Aptar makes digital health play, agreeing deal to buy Voluntis

pharmaphorum

Drug delivery specialist Aptar Group has agreed a deal to take a near two-thirds share in Voluntis, a French developer of digital therapeutics (DTx), with a view to taking full control of the company later this year. Illinois-headquartered Apar – which makes inhalers, syringe components, eye drop bottles and other delivery systems for pharmaceuticals, cosmetics and other sectors – is paying €8.70 per share in the initial deal, which will give it a 64.6% stake in the company.

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FDA grants Breakthrough Device designation to digital therapeutic

Outsourcing Pharma

The BiovitalsHF, from Biofourmis, is intended to augment decision-making in clinical environments, and to supplement traditional pharmaceutical therapies.

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Top Psychedelic Research Papers of the Psychedelic Renaissance

Psychadelic Pharmacist

In no particular order: Psilocybin with Psychological Support for Treatment-Resistant Depression Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study (2016). Carhart-Harris RL, Bolstridge M, Rucker J, Day CM, Erritzoe D, Kaelen M, Bloomfield M, Rickard JA, Forbes B, Feilding A, Taylor D, Pilling S, Curran VH, Nutt DJ.

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New study provides insight into the pharma industry’s reputation in the UK

Pharma Times

Findings come from a year-long study into the perceptions of the pharma sector in the UK

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FDA clears Medtronic AI algorithms for cardiac monitoring

pharmaphorum

Two artificial intelligence (AI) algorithms designed to diagnose people with heart rhythm abnormalities have been approved by the FDA for use with Medtronic’s LINQ II cardiac monitor. The AccuRhythm algorithms can be used to improve the accuracy of detecting atrial fibrillation (AF) – an irregular or rapid rhythm in the upper chambers of the heart – and asystole, a long pause between heartbeats.

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Navigating regulatory landscape tough for topical generics: MedPharm

Outsourcing Pharma

A leader from the topical solutions centered CDMO discusses the differences between approaches by the FDA and EMA, and how to deal with them effectively.

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Martin Shkreli’s $7.4m forfeit is paid, thanks to that Wu-Tang Clan album

pharmaphorum

The US government has sold off the one-of-a-kind Wu-Tang Clan album famously bought by ‘pharma bro’ Martin Shkreli, with the proceeds enough to wipe out his $7.4 million fine for defrauding investors. Shkreli , the pharma entrepreneur who became notorious in 2015 for hiking the price of a lifesaving drug, bought the Once Upon a Time in Shaolin album for $2 million in 2015, but surrendered it to the US authorities in 2018 after his conviction.

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BioNTech’s mRNA vaccine drive now includes malaria, TB shots

pharmaphorum

Flushed with the success of its COVID-19 vaccine, BioNTech has pressed the accelerator on the development of shots for other infectious diseases, and now plans to take malaria and tuberculosis candidates into the clinic next year. Human testing of the malaria shot should get underway by the end of 2022, according to the German biotech, which says it is working with the World Health Organization (WHO), European Commission and other organisations on the malaria project.

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FDA starts review of Roche’s eye disease drug, setting up 2022 verdict

pharmaphorum

The FDA has started a priority review of Roche’s bispecific antibody faricimab for two major causes of blindness, preparing for a market showdown with Bayer and Regeneron’s market-leading Eylea. The US regulator will review the drug for both neovascular or ‘wet’ age-related macular degeneration (AMD) and diabetic macular oedema (DME), as well as diabetic retinopathy under a standard review.

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UK fines Advanz £100m for raising thyroid drug price tenfold

pharmaphorum

The UK has levied another big fine for anticompetitive activity in the pharma market in a fortnight, with Advanz Pharma and former owners on the hook for more than £100 million ($140 million) after increasing the price of a thyroid disease drug by 1,110% over an eight-year period. The Competition and Markets Authority (CMA) said the fine “sends a clear message” to the pharmaceutical industry that breaking the law will not be tolerated.

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FDA okays Mylan insulin drug as first ‘interchangeable’ biosimilar

pharmaphorum

Generic drugmaker Mylan has become the first company to secure FDA approval for a biosimilar product that is considered completely interchangeable with the reference product – namely Sanofi’s once-daily insulin Lantus. Mylan’s Semglee has been approved for over a year as a regular biosimilar to Lantus (insulin glargine), meaning that it could be used in place of Sanofi’s drug, but only if specifically prescribed for a patient.

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AZ’s COVID-19 jab sales top $1.2bn, but come at a loss

pharmaphorum

AstraZeneca said this morning that it has made $1.2 billion in sales from its COVID-19 vaccine Vaxzevria in the first half of this year, but making it available at no profit had weighed on its profit margins. R&D expenses leaped 28% in the period, an increase that AZ said was “primarily” a result of its continued investment in the COVID-19 vaccine and other potential medicines to prevent and treat the coronavirus.

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Boehringer takes alteplase to phase 3 for COVID, but drops antibody

pharmaphorum

Boehringer Ingelheim’s latecomer antibody therapy for COVID-19 has been side-lined, as the company focuses its attention on its thrombolytic drug alteplase, heading into a phase 3 programme later this year. The decision to discontinue development of BI 767551, an inhaled antibody, has been taken because of the “evolving landscape” in managing the pandemic including the success of vaccination programmes, the availability of multiple antibody therapies and the emergence of SARS-C

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First published data backs CanSino’s inhaled COVID vaccine

pharmaphorum

Early-stage clinical data with CanSino Biologics’ inhaled COVID-19 vaccine show that it was able to stimulate neutralising antibodies against SARS-CoV-2 at a dose well below that required with intramuscular administration. Published in The Lancet , a phase 1 study conducted in China showed that a two-dose regimen of aerosolised Ad5-nCoV was similar to that achieved with a single, intramuscular dose of the same vaccine.