August, 2021

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F.D.A. Aims for Full Approval of Pfizer Covid Vaccine on Monday

NY Times

Federal regulators are winding down the process of licensing Pfizer’s two-dose coronavirus vaccine, setting up an approval possibly by Monday and possibly kicking off a wave of new mandates.

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Around 250 digital health apps are launching every day, says IQVIA

pharmaphorum

There was a dramatic increase in the launch of health-related mobile applications last year, taking the total number on offer in app stories to 350,000 – and while average quality is currently “middling” it is on the rise, according to a report from IQVIA. The pandemic contributed to another 90,000 apps being introduced in 2020 – an average of 250 per day – and this coupled with rising number and functionality of wearable devices “provides evidence of digital health’s acc

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Trending Sources

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Artificial intelligence stands to ‘revolutionize’ research: Bioclinica

Outsourcing Pharma

A leader from the clinical research tech specialist explains how the use of AI is increasing in the field and outlines the many ways it could SOMETHING.

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UK trial to assess Sativex for the treatment of ‘aggressive’ brain tumours

Pharma Times

Sativex is a complex botanical formulation that contains the principal cannabinoids THC and CBD

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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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Upcoming workshop on generic portfolio management

Drug Patent Watch

I’ll be leading a workshop on generic portfolio management, and also giving a talk, at the 14th annual Marcus Evans event on Portfolio Planning and Partnerships for Generics. The event…. The post Upcoming workshop on generic portfolio management appeared first on DrugPatentWatch - Make Better Decisions.

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SAVE THE DATE: PMN Fall 2021 Summit: Pharma-Marketing Innovations & Trends of 2021 – Sep. 16th

Pharma Marketing Network

SAVE THE DATE – PMN Fall 2021 Summit: Pharma-Marketing Innovations & Trends of 2021 | SEP. 16th, 12:00PM – 1:30PM EST. SAVE YOUR SEAT TODAY. Telehealth: Is It Here to Stay? Once considered a novelty, over the past 18 months, Telehealth has risen to a prominent position in the continuum of care. Pharmaceutical brands must adapt to this new modality and pivot their promotional efforts to ensure that they can leverage the Telehealth channel effectively.

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SMA Awareness Month: How pharma and digital solutions can improve patient care

pharmaphorum

Spinal Muscular Atrophy (SMA) is a rare disease affecting the motor nerve cells in the spinal cord. It’s a debilitating condition that affects 1 per 8,000 to 10,000 people worldwide , impacting their ability to walk, eat, and breathe. SMA Type 1 represents an estimated 50% of all cases, for which life expectancy is less than 18 months without treatment. .

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Virtual reality technology transforming COVID-19 drug discovery

Outsourcing Pharma

Nanomeâs virtual reality tech is being put to use by Oak Ridge National Laboratory and top pharma firms to study COVID-19 and explore drug candidates.

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Welireg approved in US for rare VHL-associated cancers

Pharma Times

VHL is a rare genetic disease which puts patients at risk of developing benign blood vessel tumours and several cancers

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New patent for Gilead Sciences drug EPCLUSA

Drug Patent Watch

Annual Drug Patent Expirations for EPCLUSA Epclusa is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from one supplier. There are twenty-six…. The post New patent for Gilead Sciences drug EPCLUSA appeared first on DrugPatentWatch - Make Better Decisions.

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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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Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Pharma in Brief

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. The proposed amendments are intended to modernize the Canadian therapeutic product regulatory system at every stage of products’ lifecycles from authorization to post-market.

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Ivermectin Demand Surges Though It Doesn’t Work for Covid-19

NY Times

Prescriptions for ivermectin have jumped to more than 88,000 per week, some pharmacists are reporting shortages and people are overdosing on forms of the drug meant for horses.

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Older people ‘more likely to engage with digital physiotherapy care’

pharmaphorum

Researchers in the US have found that older people are far more likely to engage with digital physiotherapy programmes digitally than those in younger age groups. Gen Xers, working-age baby boomers and retirees – collectively the over-41 age bracket – were more likely to start a musculoskeletal (MSK) programme delivered via digital channels than Gen Zers and millennials, according to Hinge Health, whose back and joint pain programme was used in the study.

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Revive Therapeutics reports progress with Phase III COVID-19 trial

Outsourcing Pharma

A leader from the rare and infectious disease treatment specialist talks about ongoing research into a potential treatment for mild-to-moderate COVID-19.

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NICE’s health technology assessment methods and processes to be evaluated

Pharma Times

Public consultation launches on proposed changes aiming to provide earlier access to new treatments

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New patent for Boehringer Ingelheim drug SYNJARDY

Drug Patent Watch

Annual Drug Patent Expirations for SYNJARDY Synjardy is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from one supplier. There are six patents…. The post New patent for Boehringer Ingelheim drug SYNJARDY appeared first on DrugPatentWatch - Make Better Decisions.

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Ep. 014 – RJ Lewis and Diane Bartoli of ePocrates Discusses the State of eCME – August 9, 2021

Pharma Marketing Network

Tune in with the Pharma Marketing Network for an insightful conversation with R.J. Lewis and Diane Bartoli, VP and General Manager of epocrates, as she shares her background with eCME, how COVID-19 has been driving it’s rapid growth, the other digital channels that have come into play, the term “snackable eCME” and how we can expect eCME to trend in a post-COVID sense.

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Covid Vaccines Produced in Africa Are Being Exported to Europe

NY Times

Johnson & Johnson is sending shots from South Africa to other parts of the world. African countries are waiting for most of the doses they’ve ordered.

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Beckley Psytech raises $80m for psychedelic meds development

pharmaphorum

UK psychedelic medicine specialist Beckley Psytech has raised an impressive £58 million (around $80 million) in an oversubscribed second-round financing that will help fund clinical development of its psilocybin-based therapies. The Oxford-based company had originally hoped to raise $50 million from the series B, and the scale of the financing is further evidence that repurposing psychedelic compounds as potential therapies for neuro-psychiatric disorders is a hot topic in biopharma.

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Pharmaceutical industry must fix broken supply chain: Phlow

Outsourcing Pharma

A leader from the company says to ensure medicines keep reaching the patients that need them, the industry must revamp outdated technologies and techniques.

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Gov’t launches study on COVID-19 vaccine dose interval for pregnant women

Pharma Times

The study will be the largest clinical trial of its kind in the UK, involving over 600 pregnant women

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New patent for Boehringer Ingelheim drug SYNJARDY XR

Drug Patent Watch

Annual Drug Patent Expirations for SYNJARDY+XR Synjardy Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are five…. The post New patent for Boehringer Ingelheim drug SYNJARDY XR appeared first on DrugPatentWatch - Make Better Decisions.

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Why GoodRx—Not Amazon—May Be the True PBM Disrupter

Drug Channels

The generic prescription market is being disrupted—but not by the big, bad spaceman from Seattle. Instead, consider how GoodRx is affecting patients, payers, and PBMs. Below I summarize the latest financial results for GoodRx’s discount card business. We estimate that the company accounted for $4.1 billion in U.S. prescription revenues for 2021. That’s about six times its 2016 figure.

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Ivermectin Should Not Be Used to Treat Covid, F.D.A. Says

NY Times

“You are not a horse,” the Food and Drug Administration said. “Stop it.”.

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Gene therapy specialist bluebird exits “untenable” European market

pharmaphorum

Europe market has proved so hostile to gene therapies when it comes to pricing and reimbursement for gene therapies that bluebird bio has decided to quit the market altogether, according to Andrew Obenshain, president of its severe genetic diseases unit. On the firm’s second-quarter results call, Obenshain said the biotech will start “an orderly wind-down” of its activities in Europe and seek “strategic alternatives” to make its therapies available to patients there

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Psychedelics research institute launches in Australia

Outsourcing Pharma

The Psychae Institute, established by a global team of scientists, will conduct pre-clinical and clinical research around psychedelic medicine development.

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Finalists announced for CROY 2021

Pharma Times

The finalists have been confirmed for the 2021 Clinical Researcher of the Year – The Americas competition.

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New patent for Boehringer Ingelheim drug JARDIANCE

Drug Patent Watch

Annual Drug Patent Expirations for JARDIANCE Jardiance is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from four suppliers. There are six patents…. The post New patent for Boehringer Ingelheim drug JARDIANCE appeared first on DrugPatentWatch - Make Better Decisions.

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PMPRB excessive price decision quashed by Federal Court of Appeal

Pharma in Brief

The Federal Court of Appeal has quashed an excessive-price decision of the Patented Medicine Prices Review Board ( PMPRB ) in a proceeding concerning the drug SOLIRIS. The matter has been remitted to the PMPRB for redetermination. Procedural background. The PMPRB issued a decision in 2017 finding that Alexion Pharmaceuticals Inc. sold SOLIRIS (eculizumab) at an excessive price in Canada and ordering Alexion to remit excess revenues earned between 2009 and 2017.

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Sacklers Threaten to Pull Out of Purdue Pharma Opioids Settlement

NY Times

In a rare court appearance, David Sackler said he and his family would withdraw their pledge to pay $4.5 billion, unless they are granted broad legal immunity.

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Funding round swells digital health firm Whoop’s value to $3.6bn

pharmaphorum

Fitness wearable company Whoop has raised another $200 million in funding that will help fund its expansion into international markets – and take on deep-pocketed rivals like Amazon, Apple and Google. The sixth-round financing was led by SoftBank’s Vision Fund 2, taking the total raised by the company to date to around $400 million, and catapults Whoop’s valuation to a massive $3.6 billion.

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Treg cell therapy showing promise in ALS trials: Coya Therapeutics

Outsourcing Pharma

According to the neurodegenerative-disease-focused biotechnology firm, their research could bring hope to patients with amyotrophic lateral sclerosis.

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Study finds protection against COVID-19 ‘waning’ in fully vaccinated people

Pharma Times

The ZOE COVID Study app assessed data on positive COVID-19 PCR test results between May and July 2021

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New patent for Boehringer Ingelheim drug GLYXAMBI

Drug Patent Watch

Annual Drug Patent Expirations for GLYXAMBI Glyxambi is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are eleven patents…. The post New patent for Boehringer Ingelheim drug GLYXAMBI appeared first on DrugPatentWatch - Make Better Decisions.

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A Video History of Pharmacies and Prescription Prices: From Soda Fountains to GoodRx

Drug Channels

Charlotte Morabito at CNBC has put together “Why Pharmacies Overcharge,” an entertaining and provocative video on the pharmacy industry and its generic prescription pricing. It’s definitely worth your time. I especially enjoyed the cool visualizations of Drug Channels Institute’s industry data. Links below. The video covers the history of pharmacy, from the “Soda Fountain Era” to “Lick, Stick, and Pour” to the rise of PBMs and GoodRx. .

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