Sat.Nov 28, 2020 - Fri.Dec 04, 2020

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iRhythm digital heart monitoring service backed by NICE

pharmaphorum

A heart monitor developed by iRhythm has become the first product to be endorsed by NICE in a pilot project covering digital health technologies. In new guidance, the health technology assessment (HTA) agency has recommended iRhythm’s Zio XT service for detecting abnormal heart rhythms – provided NHS organisations that deploy it collect evidence of its benefits.

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COVID-19 collaboration to study patient risk via blood

Outsourcing Pharma

Health tech specialists GoodCell are working with the New York Blood Center to identify COVID-19 patients with elevated risk of adverse clinical outcomes.

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What Can Supplements Really Do For Health and Beauty?

Pharma Mirror

Taking a health supplement can positively impact your health and beauty if you choose the right one for your needs. According to Mayo Clinic, the benefits of supplements specifically apply to pregnant people (subject to doctor’s recommendation), over the age of 50, who have food allergies or digestive conditions or miss large food groups in their diet.

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Varenicline Clinical Pearls

Med Ed 101

Cigarette smoking is a difficult problem that pharmacists and other healthcare professionals can play an important role in. Varenicline is one of the main medications that can be used to help curb this addiction. In this post, I will lay out my most important varenicline clinical pearls that I have learned from my practice as […]. The post Varenicline Clinical Pearls appeared first on Med Ed 101.

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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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A history of Pfizer

pharmaphorum

Few companies embody the term ‘pharma giant’ as much as Pfizer. Here we take a look at the colourful history of one of the biggest drugmakers in the world. Pfizer was founded in 1849 by two recent German immigrants to the USA, Charles Pfizer and Charles Erhart. Both in their mid-twenties, the two men set up what was initially a fine chemicals business in a Brooklyn factory, using a loan from Pfizer’s father as capital.

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COVID-19 fueling decentralized trial surge: Oracle survey

Outsourcing Pharma

A recent survey conducted by Oracle reveals trial professionalsâ thoughts, feelings and behavior around decentralized research in the face of the pandemic.

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Drugs That Worsen Urinary Incontinence

Med Ed 101

There are a few drugs that I remember when reviewing issues associated with urinary incontinence. Here’s my list of common drugs that worsen urinary incontinence. First, we must discuss the term incontinence. In general, it is a pretty vague term and can be associated with different medical processes. Incontinence simply means any involuntary or accidental […].

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Valneva accelerates Lyme disease vaccine R&D project with Pfizer

pharmaphorum

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. Subject to approval from regulators the vaccine specialist said it plans the trial known as VLA15-221 as a randomised, observer-blind phase 2 study including around 600 healthy people aged 5-65 years of age.

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Dive into the digital evolution of clinical trials

Outsourcing Pharma

Taking place December 9, the Digital Advances in Clinical Trials webinar covers notable advances in clinical trial technology, and the future of the field.

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Vaccine nationalism, CDMO expansion, AMR and dual sourcing predicted in 2021

Pharma Mirror

The new report looks ahead to a post-pandemic 2021 with pharma manufacturing capacity and payment structures shifting as new sourcing strategies emerge Amsterdam: A new report from CPhI explores the potential implications in 2021 of impending vaccine approvals, a new administration in the White House and a return to dual supply chain strategies. The report – which summarises expert analysis into 12 key findings – foresees a particularly positive outlook for the pharma manufacturing supply chain

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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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Colchicine added to UK’s COVID-19 ‘RECOVERY’ trial

Pharma Times

Commonly used anti-inflammatory drug added to list of potential treatments

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Healthware Group buys Finnish digital agency Make Helsinki

pharmaphorum

Healthcare agency, consultancy and digital health group Healthware Group has acquired Finland-based digital service development and creative agency Make Helsinki. The acquisition builds on prior collaborations between the two organisations, including in best-in-class full-service agency offerings, digital transformation, technology/enterprise solutions and corporate venturing.

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Latest FDA COVID-19 news

Outsourcing Pharma

As the pandemic continues to impact the globe, the agency has kept busy issuing EUAs for potential treatments, and cited sellers of unapproved treatments.

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Vectura signs agreement to support the development of VR588 to treat asthma

Pharma Mirror

Chippenham, UK: Vectura Group plc, an industry leading inhalation CDMO, today announces that it has signed a global out licence and development agreement with Kinaset Therapeutics Inc. for the development and commercialisation of VR588, a preclinical novel inhaled pan-JAK inhibitor for the prevention and treatment of severe asthma. Pan-JAK inhibitors have been developed and tested in clinical trials, approved and commercialised for many different indications but mainly for the treatment of chron

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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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PureTech launches phase II ‘long COVID’ drug trial

Pharma Times

LYT-100 will be evaluated in patients with persistent symptoms caused by COVID-19

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Pfizer cut vaccine production targets because of raw material shortage – reports

pharmaphorum

Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of 100 million doses. That’s enough to inoculate 25 million people as the dosing schedule involves two shots three weeks apart.

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NIAID kicks off fourth iteration of COVID-19 trial

Outsourcing Pharma

The division of the National Institutes of Health has begun enrolling hospitalized patients in a trial investigating various potential COVID-19 treatments.

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FIP publishes Position Statement on emerging technologies and pharmacy practice

Pharma Mirror

The Hague — The digital era is radically changing how technology is used, and new technologies are set to have major impacts on how people live and work. How pharmacists and pharmacy organisations can rise to the challenge of these technologies and embrace them is set out in a new Position Statement on emerging technologies and pharmacy practice released by the International Pharmaceutical Federation (FIP) today.

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UK approves Pfizer/BioNTech’s COVID-19 vaccine

Pharma Times

First doses for emergency use will be delivered 'immediately'

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Healthcare that no longer leaves out the patient

pharmaphorum

For so long the US healthcare system was built around the provider, with appointments and services set by the provider (along with insurance reimbursement systems). This structure relies on in-person visits of patients to operate and become profitable. But when the industry suddenly shifted due to COVID-19, so too did the power dynamics of the patient-provider relationship.

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Janssen partners with Koa Health on digital depression treatments

Outsourcing Pharma

The global pharma firm will work with the digital mental health solutions specialist on solutions for treatment-resistant depressive order patients.

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(BEST) over the counter ANTIBIOTIC cream

Druggist

In today’s post, I will review over the counter antibiotic creams in the UK. Some over the counter creams, gels and ointments available in the UK, have an ‘antibiotic’ properties however most of them are not genuinely classified as antibiotics, due to their limitations in terms of elimination of infections. The main focus of this post is to review use and the effectiveness of ‘antibiotic’ creams, supported any existing evidence.

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Bayer inks deal with Blackford Analysis to develop radiology AI platform

Pharma Times

Agreement will aim to develop a platform to support radiologists' decision-making

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‘Knowledge is power’ for rare diseases and NAbs

pharmaphorum

Cure Rare Disease’s Rich Horgan discusses the importance of preclinical NAbs screening and helping rare disease patients better understand their eligibility for gene therapies. Neutralising antibodies (NAbs) present a unique challenge to researchers looking to treat patients with AAV treatment. As AAV is a virus derived from the common cold, the immune system can easily have levels of pre-existing NAbs that will recognise and neutralise AAV, rendering it ineffective.

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People on the Move: December 2020

Outsourcing Pharma

This monthâs news about industry hires, promotions, acquisitions and other events includes Signant, PRA, Lonza, Bora Pharmaceuticals and other top firms.

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The urgent need for education and awareness about mitochondrial disease

pharmaphorum

Delayed diagnosis, misdiagnosis, and no cure or disease modifying treatments – children living with mitochondrial disease face all the issues often associated with rare diseases. It’s a problem that Michelle Bamber, whose two little girls both have the life-limiting condition, knows only too well. Lily was a happy, contented baby, and her parents had no cause for concern until she went for her two-year check and was put on a pathway to diagnosis.

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Merck KGaA signs DNA damage response cancer deal with Artios Pharma

pharmaphorum

Germany’s Merck KGaA has joined with UK-based Artios Pharma in a potential multi-billion dollar deal to investigate novel DNA damage response targets in cancer. The principle of DNA damage response is already being exploited by AstraZeneca and other companies with their poly (ADP-ribose) polymerase (PARP) inhibitor drugs. These target the inherent genetic instability in certain cancer cells, which have switched to a backup mechanism to repair damage to their DNA code.

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J&J files lung cancer bispecific amivantamab for FDA approval

pharmaphorum

Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC). J&J’s Janssen unit is seeking approval of the drug in a specific patient group – those with exon 20 insertion mutations whose disease has progressed despite first-line chemotherapy.

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Kayentis raises €7m for its digital trial engagement platform

pharmaphorum

French tech company Kayentis has raised €7 million in private funding that will be invested in its digital platform for clinical trials. The Grenoble-based company operates in the electronic Clinical Outcome Assessment (eCOA) market, which covers areas like patient and clinician reported outcomes, automatic remote testing, and patient diaries through a combination of web and mobile tools.

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Navigating the NHS as a digital start-up

pharmaphorum

We speak to finalists from the Greater Manchester Future of Health accelerator to find out how digital start-ups can overcome the challenges small companies face in bringing their technologies into the NHS. Right now the NHS is embracing digital to an extent no one could have foreseen a year ago – but that doesn’t mean it’s a smooth journey for digital health start-ups looking to gain traction in the health service.

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Pfizer/BioNTech to deliver COVID-19 vaccine to UK after approval

pharmaphorum

Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world to approve it. As predicted by pharmaphorum, the regulator was able to move faster than its counterparts from the European Medicines Agency, who are also conducting a separate review of the data. Pfizer and BioNTech have an agreement to supply the UK with 40 million doses of the vaccine, which is called BNT162b2 and was shown to be 95% effectiv

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PureTech begins trial of potential ‘Long COVID’ drug as cases mount

pharmaphorum

As the pandemic drags on there are increasing concerns about “Long COVID” – where symptoms persist long after the initial infection has been fought off. PureTech has joined the effort to find ways to treat the scarring and inflammation that are thought to cause the ongoing symptoms such as shortness of breath and fatigue. After promising results in an early stage study, the company has begun a phase 2 trial of its LYT-100 (deupirfenidone) in Long COVID respiratory complications and related seque

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Pfizer/BioNTech say COVID-19 vaccine could be approved in Europe by year-end

pharmaphorum

Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the year. The filing for a conditional marketing authorisation completed the rolling submission process that began on October 6. The companies initially filed the nonclinical data and other technical data, followed by emerging clinical trial results.

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UK appoints COVID-19 vaccine rollout minister as country preps for launch

pharmaphorum

The UK has appointed Nadhim Zahawi as vaccine rollout minister as the country prepares for a potential approval of Pfizer/BioNTech’s ground-breaking COVID-19 vaccine. According to press reports, the UK’s drug regulator, the Medicines and Healthcare products Regulatory Authority (MHRA) could become one of the first bodies to approve the vaccine. According to the Financial Times, the MHRA could approve the vaccine by 7 th December after the companies announced supportive data from a phase 3 trial