Wed.May 04, 2022

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How patient-on-a-chip tech could be the future of drug discovery

pharmaphorum

Testing drug compounds on a chip designed to mimic human organs sounds closer to science fiction than reality, yet the technology already exists and is already being put to use. Ben Hargreaves discovers how the technology could provide more accurate safety predictions and even discover new treatments. The limits of animal models in drug discovery are well known.

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US pharma hubs: The rising stars to watch

Outsourcing Pharma

CPhI North America 2022 host city Philadelphia is set to become one of the worldâs biggest cell and gene therapy manufacturing hubs. But itâs just one of many centers of innovation that are helping drive the US pharma and biopharma industry.

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UK study finds evidence for brain fog after severe COVID

pharmaphorum

Cognitive problems affecting memory and attention can be substantial and long-lasting in patients who suffer severe COVID-19 infections, according to a study by researchers in the UK. The study used computerised cognitive assessments to follow-up 46 people who were hospitalised with COVID-19 at the Addenbrooke’s Hospital in Cambridge over a three-month period in 2020, comparing the results with 460 matched control subjects.

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Continuous manufacturing adoption continues to rise: Pharmatech

Outsourcing Pharma

An expert from Pharmatech Associates offers a glimpse into the evolution of CM and previews a lively discussion during the upcoming CPhI North America event.

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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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Digital health firm Hello Heart raises $70m

pharmaphorum

Hello Heart has raised $70 million in fourth-round financing to help grow its smartphone-based technology for people seeking to improve their heart health. Hello Heart blood pressure monitor. Hello Heart’s digital platform is based on a blood pressure monitor and smartphone app. It deploys artificial intelligence to help users track their blood pressure, pulse rate, weight and activity levels – as well as any medications taken – and give feedback and advice on how to adopt healthy practice

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Overview of FDA Expedited Development and Approval Programs for Serious Conditions

Impact Pharmaceutical Services

May 4, 2022 | Nathaniel DiTommaso, MS, Regulatory Affairs Manager. In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. Image courtesy of qimono at pixabay.com.

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Overview of FDA Expedited Development and Approval Programs for Serious Conditions

Impact Pharmaceutical Services

May 4, 2022 | Nathaniel DiTommaso, MS, Regulatory Affairs Manager | Regulatory Affairs | Drug Development Consulting In May of 2014 and February of 2019, the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening […].

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Pre-Filled Syringes San Francisco Conference 2022

pharmaphorum

SAE Media Group’s 3rd Annual Conference. Pre-Filled Syringes San Francisco. September 19 – 20, 2022 | San Francisco, CA, USA. ————————————————————————-. The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to aid self-administration and deliver biologics, high concentration, a

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Future drugs will need novel excipients: IPEC

Outsourcing Pharma

An expert from the organization discusses ahead of his CPhI North America presentation how tomorrowâs drugs canât all be formulated with yesterdayâs excipients.

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Kymriah is first CAR-T cleared for follicular lymphoma in EU

pharmaphorum

Novartis’ CAR-T Kymriah has become the first therapy in the category to be approved for the treatment of relapsed/refractory follicular lymphoma, ahead of Gilead Sciences’ rival Yescarta. Follicular lymphoma is the second most common form of non-Hodgkin lymphoma (NHL), and is a slow developing but incurable disease that represents around 22% of NHL cases.

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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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Pharma growth, partnerships focus of 2022 CPhI North America

Outsourcing Pharma

A leader from the organizer of the pharmaceutical event discusses whatâs in store for the upcoming conference, and for the drug development industry itself.

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AZ eyes Q3 FDA decision for Imfinzi in biliary tract cancer

pharmaphorum

The FDA has kicked off a priority review of AstraZeneca’s checkpoint inhibitor Imfinzi for biliary tract cancer (BTC), setting up what could be approval for an immunotherapy for the group of rare and aggressive gastrointestinal tumours. The six-month review means that PD-L1 inhibitor Imfinzi (durvalumab) could get a verdict from the US regulator in the third quarter of the year.

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Adderall and Vitamin C – How To Address This Interaction?

Med Ed 101

As you may or may not be aware, Adderall and vitamin C can interact with each other. The primary issue for this drug interaction involves an alteration of Adderall’s gastrointestinal absorption. Having a more acidic gut environment can reduce the absorption of Adderall. Here’s my take on the Adderall vitamin C interaction and some questions […].

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Isla Visual Record for Surveillance to aid post-surgery wound assessment

Pharma Times

Platform will enable patients to monitor and share updates of their post-surgical wound healing

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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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Novartis Kymriah receives EC approval for lymphoma treatment

Pharma Times

Approval for Kymriah follows a positive CHMP opinion and is applicable to all 27 EU member states

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