pharmaphorum

JULY 26, 2021

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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Immunization Vaccines FDA 137

Outsourcing Pharma

JULY 27, 2021

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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Fuld

JULY 27, 2021

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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Health and Personal Care Stores Specialty Pharmacies Insurance Medical Records 83

Pharma Marketing Network

JULY 28, 2021

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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Pharmaceutical Companies Pharmaceutical Companies 52

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.

pharmaphorum

JULY 26, 2021

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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Documentation Hospitals 116

Outsourcing Pharma

JULY 27, 2021

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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McCreadie Group

JULY 27, 2021

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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Communication 52

pharmaphorum

JULY 29, 2021

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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Specialty Pharmacies FDA 111

Outsourcing Pharma

JULY 26, 2021

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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Psychadelic Pharmacist

JULY 26, 2021

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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Labelling 52

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.

FDA

Pharma Times

JULY 27, 2021

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

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Immunization Vaccines 66

pharmaphorum

JULY 27, 2021

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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Outsourcing Pharma

JULY 26, 2021

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

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Med Ed 101

JULY 28, 2021

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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Pharmacy Management Software

Pharma Times

JULY 28, 2021

Rate of rare blood clots with low platelets after the second dose is comparable to background rates observed in unvaccinated populations

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pharmaphorum

JULY 29, 2021

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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FDA 105

Outsourcing Pharma

JULY 26, 2021

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

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pharmaphorum

JULY 27, 2021

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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Vaccines 100

pharmaphorum

JULY 29, 2021

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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FDA 98

pharmaphorum

JULY 29, 2021

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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pharmaphorum

JULY 29, 2021

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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FDA 98

pharmaphorum

JULY 29, 2021

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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Vaccines FDA 98

pharmaphorum

JULY 27, 2021

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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Hospitals Vaccines 98

pharmaphorum

JULY 30, 2021

US telehealth group Amwell has agreed to buy two digital health specialists – SilverCloud Health and Conversa Health – as it looks to expand its services amid a boom in virtual healthcare delivery. SilverCloud specialises in digital cognitive behavioural health programmes aimed at people with mental health issues like anxiety and depression, while Conversa offers a telehealth-based patient engagement platform.

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Hospitals 95

pharmaphorum

JULY 28, 2021

A new analysis has suggested that the rare blood clot side effects linked to AstraZeneca’s COVID-19 vaccine Vaxzevria don’t occur after a second dose. The study in The Lancet examined cases of thrombosis with thrombocytopenia syndrome (TTS) from an AZ database encompassing around 5.62 million people who had received two doses of Vaxzevria in the EU and UK.

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Vaccines 81

pharmaphorum

JULY 30, 2021

Biogen and partner Eisai have said they will run a large-scale observational study of Alzheimer’s drug Aduhelm in the US to build evidence for the drug’s efficacy following its controversial approval. The ICARE AD-US study will provide information on the long-term effectiveness and safety of Aduhelm (aducanumab) as prescribed in routine clinical practice within the US label, monitoring long-term changes in in cognition, function and neuropsychiatric status in around 6,000 patients ta

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FDA Labelling 75

pharmaphorum

JULY 27, 2021

We’ve all got used to hailing healthcare staff as heroes over the past year. Of course they deserve every ounce of admiration, even though many are uncomfortable with the adulation. But the bigger question is whether this heroic status really represents a healthy situation? Someone once advised me that, when conducting due diligence on a business, it’s important to find the hero.

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pharmaphorum

JULY 28, 2021

A £6.6 million ($9.2 million) cash injection for UK digital health company Peppy will be used to scale up its business-to-business platform and expand its reach and range of services. The Series A financing, led by Felix Capital, will help the company reach more organisations and people in the UK, and also allow it to explore international expansion, according to Dr Mridula Pore, co-founder and co-chief executive of the startup.

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Outsourcing Pharma

JULY 29, 2021

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

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FDA 65

pharmaphorum

JULY 30, 2021

With a string of new drugs for Alzheimer’s disease making their way through late-stage clinical testing, the demand for suitable subjects to enrol into trials is running at an all-time high – and threatens to outstrip supply. Now, the National Institute on Aging (NIA) – part of the US National Institutes of Health (NIH) – has developed an online recruitment tool to reach out to potential trial candidates through a range of communication channels, including websites, handouts, videos, and

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Communication 59

pharmaphorum

JULY 28, 2021

AbbVie and Alphabet spin-out Calico Life Sciences have agreed to fund their seven-year-old partnership seeking treatments for diseases of ageing with another $500 million apiece. The collaboration with Google sister company Calico – formed in 2014 with $1.5 billion in funding and extended in 2018 with another $1 billion top up – has already resulted in three clinical trial-stage projects for immuno-oncology and neurological diseases, and 20 early-stage programmes.

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Immunization 59

pharmaphorum

JULY 28, 2021

Merck & Co’s Keytruda has just picked up its 30th approval from the FDA, and it is a good one – early-stage triple-negative breast cancer (TNBC), a particularly hard-to-treat form of the disease. The FDA has given a green light to the use of Keytruda (pembrolizumab) pre-surgery alongside chemotherapy in the neoadjuvant setting, as well as in the post-surgery (adjuvant) setting as a monotherapy, to prevent tumours from recurring.

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Chemotherapy FDA 59

pharmaphorum

JULY 30, 2021

Takeda has decided development of its norovirus vaccine candidate outside Japan will be more efficient if it is spun out into a dedicated company. The Japanese drugmaker has partnered with venture capital company Frazier Healthcare Partners to form HilleVax, which comes into being with full and exclusive ex-Japanese development and commercial rights to TAK-214 (now HIL-214) which has cleared a phase 2b trial.

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Vaccines 52

pharmaphorum

JULY 30, 2021

Ask people in most western nations to think back to 2019 and consider what they would have said then about the potential impact of a pandemic on their everyday lives and my guess is that the vast majority of us would have had little insight into what would happen. Residents of Southeast Asia who had experienced the SARS outbreak in 2002-04 would likely have had a much better understanding, but even they could not have imagined just how disorganised the response would be in many other parts the w

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Vaccines 52