Mon.Jun 20, 2022

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Lilly’s Verzenios gets NICE blessing for early-stage breast cancer

pharmaphorum

Thousands more people with breast cancer in England look set to be eligible for routine treatment with Eli Lilly’s Verzenios, after new guidance from NICE backed use of the drug after surgery for early-stage tumours. The new advice means that around 4,000 people with hormone receptor-positive, HER2-negative, node-positive early breast cancer who are considered at high risk of recurrence after surgery can receive Verzenios (abemaciclib) in combination with standard hormone therapy, said the

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3 ASCO Insights for Pharma Communicators

PharmExec

The world’s largest cancer research meeting, the American Society of Clinical Oncology (ASCO) Annual Meeting, recently convened in person in Chicago after two years of being held virtually. Sara Baker and Kristine Austria Fan of Marina Maher Communications provide their takeaways from the meeting.

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Is Merck planning a $30bn-plus move for Seagen?

pharmaphorum

Speculation that Merck & Co may be preparing a $30 billion takeover bid for Seagen – bolstering its oncology ambitions – has the biopharma community aflutter. The rumour was first published in the Wall Street Journal, which suggests that a takeover is just one option on the table, along with a marketing deal that would bind the two companies together without the risk of antitrust issues holding up or blocking a merger.

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#DIA2022: How the industry's top regulator views the future of healthcare

PharmaVoice

In the evolution of healthcare, data is the linchpin to making drug development more efficient.

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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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Pfizer takes stake in French Lyme disease jab partner Valneva

pharmaphorum

Pfizer has acquired an 8.1% stake in French vaccines developer Valneva at a cost of €90.5 million (around $95 million) and rejigged the terms of their alliance to develop a shot for Lyme disease. The deal gives Valneva a cash injection that it will be able to use to advance Lyme disease candidate VLA15 towards the market, but the revised licensing terms means that the French biotech will shoulder more of the financial cost of the development programme.

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epocrates Appoints New Leaders to Guide Commercial Strategy, Consulting, and Customer Experience

PharmExec

Additions of Andrew Johnson and Bridget Seay strengthen epocrates’ evolution as a commercial organization with best-in-class market intelligence and products.

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NF Young Adult International Summit 2022

NF2 BioSolutions

The NF Young Adults Summit this year is taking place LIVE from New York on 27th and 28th August 2022, put the date in your diary if you are aged between 18 and 30 and want to join in. Organised by Littlest Tumour foundation, Childhood Tumour Trust, NF2 BioSolutions UK & NF Patients United. If you would like to register for this event please do so here [link].

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DEA Electronic Forms

OctariusRx

DEA electronic forms are now required for registration and all renewals. Are you opening a facility and looking to obtain a new registration, or do you have an existing registration that needs to be renewed? Read this week’s post to be prepared to comply with the DEA’s new requirements. As of May 11, 2022, whether you are registering for the first time, or renewing an existing DEA registration, you will need to do so though the secure online portal.

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Healing States or Serotonin Toxicity?

The Spirit Pharmacist

How can the effects of psychedelics be differentiated from adverse effects or serotonin toxicity? It’s a good question! This one I wanted to address in both a video and written blog post. It’s an important discussion both in terms of psychedelic safety and in terms of persons understanding what happened to them in certain experiences or whether to proceed on the psychedelic healing path.

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Alimetry nabs FDA okay for gastric disorder-diagnosing wearable

pharmaphorum

New Zealand medical tech startup Alimetry has claimed an FDA approval for a wearable device that can be used to diagnose gastric disorders non-invasively. The Gastric Alimetry device will be marketed and distributed in the US by a new Minneapolis-based subsidiary, said the company, which has also secured approval for the product in New Zealand as well as the UK.

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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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The Future of Managing Regulatory Intelligence

Pharmaceutical Commerce

IQVIA’s Jens-Olaf Vanggaard discusses the challenges of managing regulatory intelligence on a global scale.

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FDA panel turns down Acadia’s Nuplazid for Alzheimer’s psychosis

pharmaphorum

Acadia Pharma’s attempts to extend the indications of its Nuplazid drug in the US to include Alzheimer’s disease-related psychosis have suffered another major setback. Nuplazid (pimavanserin) is already FDA-approved to treat psychosis caused by Parkinson’s disease, but Acadia’s hope to expanding that use to the Alzheimer’s population were shot down by a complete response letter (CRL) from the regulator last year.

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Blood vessel breakthrough is major step towards Alzheimer’s treatment

Pharma Times

The discovery may lead to development of drugs that halt disease progression and stop memory loss

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Evaluate’s Orphan Drug Report 2022

pharmaphorum

Paul Verdin, VP of consulting and analytics, and Andreas Hadjivasiliou, managing analyst at Evaluate, tell us about the company’s Orphan Drug Report 2022, which highlights activities within the orphan drug market and forecasts what the future of the industry holds based on data. Evaluate provides commercial intelligence to the pharma and life sciences sectors through annual publications.

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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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DeepIntent Outcomes Hits 65% of Campaign Impressions

PharmExec

Matterkind uses DeepIntent Outcomes’ patented technology to improve audience quality and script performance.

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Exothera Forms AAV Manufacturing Collaboration

Pharmaceutical Commerce

Partnership aims to compare reproducibility and comparability between different suspension bioreactors.

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Shortening the equipment qualification path

Pharma Manufacturing

Advanced automation can speed the validation process, helping pharma projects come online faster

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RMI’s COVID-19 vaccine partnership with Acacium proves a success

Pharma Times

The joint aim of the companies was to provide vaccines to vulnerable communities