Sat.Aug 14, 2021 - Fri.Aug 20, 2021

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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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Google says health projects will continue even as it unwinds dedicated health division

Fierce Healthcare

Google says health projects will continue even as it unwinds dedicated health division. hlandi. Fri, 08/20/2021 - 19:08.

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Latest COVID-19 updates from the FDA

Outsourcing Pharma

The US Food and Drug Administration continues to review potential preventatives and treatments for the virus, and to offer advice to life-sciences professionals and civilians alike.

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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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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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Merck kicks off oral COVID-19 antiviral filing in Canada

pharmaphorum

Health Canada has started a rolling review of Merck & Co’s molnupiravir, an oral antiviral therapy treatment for COVID-19 partnered with Ridgeback Biotherapeutics. The Canadian regulator will start reviewing early safety, quality and efficacy data for the drug while late-stage clinical trials are still underway, in the hope of approving the drug quickly of results are positive.

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Physician pay remained stagnant while productivity slumped in 2020, new survey finds

Fierce Healthcare

Physician pay remained stagnant while productivity slumped in 2020, new survey finds. agliadkovskaya. Thu, 08/19/2021 - 19:00.

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COVID-19: Booster Doses – Part 2

The Infectious Pharmacist

Photo by Skitterphoto on Pexels.com. In Booster Doses – Part 1 I wrote about some of the basics of booster doses and the need for “additional” doses (not booster doses) in patients with compromised immune systems. Today I’m going to talk about some of the rationale behind booster doses in patients with healthy immune systems. At the bottom of this post is a list of some background posts and definitions that may be useful.

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NICE says yes to Novartis’ Rydapt for rare blood disorder

pharmaphorum

Novartis’ Rydapt has become the first and only licensed treatment for rare and life-threatening blood disorder systemic mastocytosis (SM) to be cleared for routine NHS use, after getting a green light from NICE. The decision means around 170 people with advanced SM in England and Wales will be eligible for treatment with oral, twice-daily drug, which since 2018 has also been cleared for NHS treatment of a form of acute myeloid leukaemia.

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Biden administration to invest $19M to expand telehealth in rural, underserved areas

Fierce Healthcare

Biden administration to invest $19M to expand telehealth in rural, underserved areas. hlandi. Wed, 08/18/2021 - 08:15.

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Trial complexity, info explosion driving data management evolution

Outsourcing Pharma

A leader from Veeva Systems shares perspective on what factors are impacting clinical trial data management, and how the industry can adapt to the changes.

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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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COVID-19: Booster Doses – Part 1

The Infectious Pharmacist

Photo by George Becker on Pexels.com. The most recurring question I get is a variant (see what I did there?) of “What about booster doses?”. A lot of complexity and potential for misunderstanding is built into that seemingly simple question. As my initial writing on this topic got longer and longer, I realized it was time for another 1980s style mini-series of blog posts.

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Global regulators seek permanent working group on AI

pharmaphorum

Rapid advances in the use of artificial intelligence (AI) in healthcare and medicines development are at risk of outstripping current regulatory frameworks, according to a new report. The International Coalition of Medicines Regulatory Authorities (ICMRA) has recommended that a new permanent working group be set up to keep tabs on the use of AI and make sure that regulations can accommodate new developments.

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Maven Clinic nabs $110M funding round and a boost from Oprah to reach unicorn status

Fierce Healthcare

Maven Clinic nabs $110M funding round and a boost from Oprah to reach unicorn status. hlandi. Tue, 08/17/2021 - 12:50.

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Secure pharma supply chain requires connections, information

Outsourcing Pharma

A representative from Clarivate explains how supply chain vulnerabilities can hurt stakeholders, including patientsâand how one solution can close the gap.

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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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The Art of Applying to Medical School (The Pharmacy Student Edition)!

The Physician Pharmacist

Applying to medical school is no easy task, but neither is making it through pharmacy school! If you are reading this right now, then you are investigating the same calling I experienced several years ago. Every pharmacy student plays with the fantasy of going to medical school and unfortunately most will never get further than that. I am here to share my insider tips and tricks to optimize your application.

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Organicell on regenerative medicine: the pharmaphorum podcast

pharmaphorum

In the latest episode of the podcast Dominic Tyer speaks with Dr Maria Ines ‘Mari’ Mitrani, chief science officer at the clinical-stage biopharmaceutical company Organicell Regenerative Medicine. They looked at the development of regenerative medicine and where Organicell hopes to add to that field. Then, with the company pivoting to try and help tackle Covid, they also discussed how that change was made possible and where Organicell’s focus will be.

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NextGen Healthcare founder Razin looks to shake up board to improve company's performance

Fierce Healthcare

NextGen Healthcare founder Razin looks to shake up board to improve company's performance. hlandi. Fri, 08/20/2021 - 12:58.

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Paige, Perspectum forge AI-centered clinical trial alliance

Outsourcing Pharma

The digital pathology firm and image-analysis software developer will partner on artificial intelligence based solutions to improve trial decision making.

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When Should We Use Icosapent Ethyl?

Med Ed 101

As one of the few significant new treatment options approved for reducing the risk of cardiovascular events since statins were approved about 30 years ago, when should icosapent ethyl (Vascepa) actually be used? Icosapent ethyl, sold as Vascepa by Amarin, is a purified form of the ethyl ester of eicosapentaenoic acid (EPA) that was approved […].

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Health Innovators: PureTech Health’s Daphne Zohar

pharmaphorum

In latest episode of our Health Innovators video interview series, Dr Paul Tunnah speaks to Daphne Zohar, the co-founder and CEO of PureTech Health. They discuss the publicly-listed biotech’s pipeline projects and focus on the BIG (brain-immune-gut) axis as well as PureTech’s interest in digital therapeutics. Daphne explains how she built an impressive team of board advisors for her company, plus the challenges and experience of fund raising.

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Insurers take cue from providers, begin requiring vaccines for employees

Fierce Healthcare

Insurers take cue from providers, begin requiring vaccines for employees. pminemyer. Thu, 08/19/2021 - 12:32.

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3D tablet printing needs the right excipient: DFE Pharma

Outsourcing Pharma

The excipients specialist shares findings from its research into the ins and outs of 3D powder bed printed tablets and how it can benefit drug development.

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August 2021 Update: Treatment of COVID-19 in the Hospital

Med Ed 101

Treatment for patients hospitalized with COVID-19 is continuously evolving. Some medications have proven beneficial over the past year, while others have fallen out of favor. Here we review the most recent guidelines as of August 2021. In short, it is recommended to continue home maintenance medications, provide supportive care for non-severe cases of COVID, and, […].

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Does draft RCT guide set the scene for future trials?

pharmaphorum

A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. The Good Clinical Trials Collaborative (GCTC) has published a draft guidance document, and is asking for the life sciences sector to make its views known. The publication, which is out for public consultation until 15 September, said RCTs played a central role in generating the evidence needed to inform the de

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Survey: Nurses largely on board with COVID-19 vaccines but want more info on boosters, long-term safety

Fierce Healthcare

Survey: Nurses largely on board with COVID-19 vaccines but want more info on boosters, long-term safety. dmuoio. Wed, 08/18/2021 - 15:32.

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Orally disintegrating tablets offer range of patient benefits: Roquette

Outsourcing Pharma

A leader from the excipients firm discusses how ODTs appeal to seniors and patients on the go, and the formulation-related challenges with such tablets.

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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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Pfizer, BioNTech file for FDA approval of COVID booster shot

pharmaphorum

Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the US prepares to get its booster campaign underway. The two companies have submitted data from a phase 1 trial in support of the booster dose to the US regulator, and will follow that with filings in Europe and elsewhere in the world in the coming weeks.

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GoodRx reports spike in drug discount subscribers driving 43% revenue growth in Q2

Fierce Healthcare

GoodRx reports spike in drug discount subscribers driving 43% revenue growth in Q2. hlandi. Thu, 08/19/2021 - 12:39.

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Uniting clinical research, healthcare can benefit both: Biofourmis

Outsourcing Pharma

An executive from the digital therapeutics specialist discusses the clinical trial landscape, and how clinical care can yield a number of important benefits.

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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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BMS buys into AI-designed immune drug from Exscientia

pharmaphorum

Bristol Myers Squibb has exercised an option on an immune-modulating drug candidate developed by UK artificial intelligence specialist Exscientia, paying $20 million for the buy-in as part of their $1.2 billion alliance. The unnamed drug candidate acts on an immunological kinase enzyme, which has proven hard to target using conventional drug discovery techniques because challenges relating to “potency, selectivity, and overall drug-like properties,” according to the partners.

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Memorial Health cancels surgeries, reverts to paper records as it responds to cyberattack

Fierce Healthcare

Memorial Health cancels surgeries, reverts to paper records as it responds to cyberattack. hlandi. Mon, 08/16/2021 - 17:20.

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Tech Innovations: August 2021

Outsourcing Pharma

This monthâs roundup of equipment, decentralized technology, partnerships and other items includes news from Medidata, PerkinElmer, Syneos and other firms.

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