Wed.May 18, 2022

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Google gives ex-FDA digital health head Bakul Patel strategic role

pharmaphorum

FDA veteran Bakul Patel has joined Google as its new senior director of global digital health strategy, ending a stint at the regulator that lasted more than 13 years. Bakul Patel. Patel – who is currently director for digital health at the FDA – said on social media that he is “looking forward to learning from the teams in health across Google and Alphabet and helping build a unified digital health and regulatory strategy.” He was also involved in the creation of the FDA’s Dig

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Artificial intelligence stands to transform precision medicine: AiCure

Outsourcing Pharma

An expert from the AI-focused technology company shares insights as to how it can be harnessed to better interpret, and even predict, patient behavior.

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SwanBio raises $56m for rare neurological disease gene therapy

pharmaphorum

SwanBio Therapeutics has raised $56 million in a second-round financing that will be used to advance its lead gene therapy candidate for adrenomyeloneuropathy (AMN) into clinical testing later this year. The Series B takes the total raised by the Philadelphia-based biotech to $133 million and is earmarked for a phase 1/2 trial of the gene therapy – codenamed SBT101 – in the second half of this year.

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Machine learning can unlock potential of EEG data: Beacon Biosignals

Outsourcing Pharma

A leader from the neurobiomarker platform provider tells how use of ML and other advanced analytical tools can help make better use of complex information.

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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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AstraZeneca buys into startup RQ Bio’s COVID antibodies

pharmaphorum

Brand new UK startup RQ Biotechnology has been thrust into the spotlight after signing a $157 million licensing deal with AstraZeneca for monoclonal antibodies intended to protect vulnerable and immunosuppressed people from COVID-19. The deal covers a portfolio of early-stage antibodies targeting SARS-CoV-2, adding to the pipeline of COVID drugs following AZ’s already available Evusheld (tixagevimab/cilgavimab) therapy, which has been approved for pre-exposure prophylaxis of COVID-19.

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Lilly deploys AI-powered tech to expedite drug approval process

Outsourcing Pharma

The pharmaceutical company is partnering with Yseop to install the software companyâs Augmented Analyst, designed to elevate and accelerate data analysis.

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Closed Loop Medicine wraps DTx trial for hypertension treatment

Outsourcing Pharma

The digital therapeutics specialist has announced the last patient has ended participation in a study investigating a precision solution for hypertension.

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Recent advances in neurological disorders

pharmaphorum

Considerable scientific progress across neurological diseases and disorders was reported at the recent 74th American Academy of Neurology (AAN) Annual Meeting. What may be important for healthcare professionals certainly makes encouraging news for patients waiting for effective solutions. One research-driven company with a strong patient focus in neurology is UCB.

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Nicotine Patch Clinical Pearls

Med Ed 101

Nicotine patches are a useful tool in the management of smoking cessation. The success and tolerability of this form of nicotine replacement does require some pharmacology knowledge. I lay out my most important nicotine patch clinical pearls below. Nicotine Patch Clinical Pearls – Dosing Let’s start with the dosing of nicotine patches. A clinician must […].

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Merck snaps up cancer drug from China’s Kelun in $1.4bn deal

pharmaphorum

Merck & Co has quietly added another drug to its immuno-oncology pipeline via an agreement with China’s Sichuan Kelun Pharmaceutical, and is keeping the details close to its chest. The US pharma group is paying $47 million in upfront payments to license rights to the undisclosed drug outside China, Hong Kong, Macao, and Taiwan, with another $1.36 billion in potential milestone payments plus royalties on sales.

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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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Curebase and Flow Neuroscience launch clinical trial to test at-home headset for depression

Pharma Times

Device delivers currents to the brain to restore activity usually lowered in depression patients

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NICE endorses Magtrace diagnostic to detect breast cancer spread

pharmaphorum

Women with breast cancer in England and Wales will soon be able to access a new diagnostic based on an injectable magnetic marker liquid called Magtrace that will identify if the disease has spread around the body. The diagnostic developed by UK firm Endomag can be used to detect ‘sentinel’ lymph nodes – the first lymph node to which cancer cells are most likely to spread from a primary tumour – showing if the cancer has progressed beyond the breast tissue.

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Digitize to curb staffing challenges

Pharma Manufacturing

Modern manufacturing solutions can spare pharma the worst of ongoing labor shortages

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KOL Validation: An Opportunity To Benchmark Mindset

pharmaphorum

The benefits of conducting a regular KOL validation exercise to refresh your KOL list are well established. Such exercises implemented on a regular basis ensure you avoid the dangers that come from working continuously with the same people while keeping your KOL list refreshed and relevant. But the risk of becoming myopic in your view of the KOL landscape, and possibly even your KOL decision-making, extends beyond just the actual list of your KOLs.

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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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EpiEndo successfully completes phase 1 study into respiratory treatment

Pharma Times

Orally available EP395 has met all endpoints in safety and is now undergoing phase 2 planning

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Fearing the burn: A critical market is on fire

Pharma Manufacturing

The state of the antibiotics market should alarm the world

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Unlocking the potential of healthcare data in research

pharmaphorum

Health data research in the UK is rapidly evolving, with new capabilities emerging through the rise of hybrid engagement and the accelerated adoption of digital technologies. At the height of the COVID-19 pandemic, these capabilities were put to the test, being used to compare hospital caseloads to research activity in real-time and enabling COVID-19 clinical trials to rapidly recruit participants across the UK.