Fri.Dec 17, 2021

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Biogen’s Alzheimer’s drug Aduhelm is rejected by EU advisors

pharmaphorum

The EMA’s human medicines committee has said it cannot approve Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, saying it was unconvinced by the data submitted for the drug. The companies had already indicated that the CHMP looked likely to turn down their marketing application for Aduhelm (aducanumab), but the decision nevertheless is a heavy blow, coming as take-up of the drug has pretty much stalled in the US.

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A software vulnerability is threatening the internet. Experts explain why a fix for healthcare is not easy

Fierce Healthcare

A software vulnerability is threatening the internet. Experts explain why a fix for healthcare is not easy. agliadkovskaya. Fri, 12/17/2021 - 15:26.

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2022 Predictions From the Front-Lines of Pharma Digital Advertising

Pharma Marketing Network

The pharma industry has been slower to embrace digital technologies than other less-regulated sectors but the COVID-19 pandemic has greatly changed this long-standing mindset. In 2020 and 2021, we saw pharma forced to become more flexible and open-minded than ever before. In this article, R.J. Lewis, Founder & CEO of eHealthcare Solutions and Tap Native, offers his top ten predictions for what’s ahead for pharma in 2022.

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As Omicron cases rise, EMA backs early use of Pfizer’s Paxlovid

pharmaphorum

The EMA’s human medicines committee has said that EU member states can start to offer Pfizer’s oral antiviral Paxlovid as a treatment for people with COVID-19 outside hospital, ahead of a formal approval for the drug. The decision comes amid rising rates of infection and deaths due to COVID-19 across the EU, and with 529 new cases of the worrisome Omicron variant reported in member states yesterday, taking the total number to 3,158.

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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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Getting Creative with Sustainability | How Pharma Engages

Pharma Marketing Network

Big pharma has compelling reasons to change the way business gets done. The wave of interest in sustainability follows the value chain from top-tier pharmaceutical companies to their suppliers of every size. Leaders are hard at work focusing their efforts on how to use sustainability as a platform for innovation. Step one is to assess your corporate social responsibility (CSR) policies and ensure actions are integrated across the organization.

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Judge rejects Purdue opioid settlement over Sackler family immunity

pharmaphorum

A judge in the US has rejected the bankruptcy plan proposed by Purdue Pharma to settle legal action over its role in the opioid crisis , because of the protection from civil litigation it includes for the Sackler family that owns the drugmaker. Judge Colleen McMahon has thrown out the plan in a New York court, in a move that would remove the shield handed to the Sackers in return for a $4.5 billion payout to projects intended to support victims of the opioid crisis over a nine-year period.

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Deep Dive: Digital Health 2021

pharmaphorum

There is no doubt that the COVID-19 pandemic has accelerated the adopt of digital health. As this issue’s contributors discuss, the rapid transition to digital has showcase the potential of technology across the industry, but how can we continue this momentum beyond the pandemic? Read on for a look at some of the biggest stories from Frontiers Health, how digital is making healthcare more patient-friendly and key ways to optimise decentralised clinical trials.

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Oracle in talks to buy Cerner in potential $30B deal: WSJ

Fierce Healthcare

Oracle in talks to buy Cerner in potential $30B deal: WSJ. hlandi. Fri, 12/17/2021 - 07:56.

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NICE gives Keytruda parity with Opdivo for adjuvant melanoma

pharmaphorum

After three years of availability via the Cancer Drugs Fund (CDF), MSD’s checkpoint inhibitor Keytruda has now been approved for routine NHS use after surgery for people with melanoma to prevent the cancer returning. PD-1 inhibitor Keytruda (pembrolizumab) has been recommended by NICE for adjuvant treatment of adults with stage 3 melanoma that has spread to the lymph nodes, aiming to remove any cancer left behind after surgery.

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CMS: Insurers paid out $2B in medical loss ratio rebates for 2020 claims

Fierce Healthcare

CMS: Insurers paid out $2B in medical loss ratio rebates for 2020 claims. rking. Fri, 12/17/2021 - 16:06.

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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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Patient engagement processes: the pharmaphorum podcast

pharmaphorum

This episode of the pharmaphorum podcast is the second in a limited series focused on patient engagement that’s being led by clinician, consultant and patient advocate, Mark Duman. Joining him to discuss the importance of patient engagement are Johnson & Johnson’s global patient engagement leader Katherine Capperella, Novartis’ head of patient engagement Mark Boutin, and Astellas Pharma’s senior vice president and head of patient centricity, Anthony Yanni.

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Most oncologists think RWD vital to advancing cancer research: COTA

Outsourcing Pharma

The company has released a survey of cancer doctors; 83% of those polled believe real-world data is crucial to accelerating cancer research and treatment.

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Hy-Vee latest retailer to enter telehealth and online pharmacy markets with RedBox Rx

Fierce Healthcare

Hy-Vee latest retailer to enter telehealth and online pharmacy markets with RedBox Rx. agliadkovskaya. Fri, 12/17/2021 - 12:48.

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Pharma Marketing’s Data-Driven Omnichannel Future: Four Interconnected Themes from Reuters Pharma Marketing USA 2021

Pharma Marketing Network

#1: Omnichannel engagement is the key to creating personalized customer experiences and relevancy, but it remains something of a holy grail within the pharmaceutical industry. Across several sessions at this year’s Reuters Pharma Marketing USA, leading marketers discussed why it’s been such an uphill struggle and shared possible solutions. Traditionally, pharmaceutical companies have been siloed to a degree that would be unthinkable in most other industries.

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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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Biden asks Supreme Court to back health worker vaccine mandate after legal challenges

Fierce Healthcare

Biden asks Supreme Court to back health worker vaccine mandate after legal challenges. rking. Fri, 12/17/2021 - 15:48.

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Ipsen places €480m bet on Genfit’s liver drug elafibranor

pharmaphorum

Genfit was hit hard last year when it abandoned a phase 3 programme for elafibranor in non-alcoholic steatohepatitis (NASH), but pledged to press on with the drug in other indications – and now has the help of fellow French pharma group Ipsen. Ipsen has taken rights to PPAR agonist elafibranor as a treatment for primary biliary cholangitis – a chronic, autoimmune disease in which bile ducts in the liver are gradually destroyed causing cirrhosis – in return for an upfront payment of €120 million

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Kineret receives positive CHMP opinion for treatment of COVID-19 pneumonia

Pharma Times

The European Medicines Agency has recommended approval for use of Kineret in COVID-19 to the European Commission, which will issue a final decision.

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Biogen updates on its confirmatory Aduhelm trial

pharmaphorum

Biogen and partner Eisai have said they will provide details next March for the confirmatory trial that will be needed to upgrade the drug’s accelerated approval for controversial Alzheimer’s drug Aduhelm to a full one. Aduhelm (aducanumab) was approved by the FDA in June, but has been held back by a glacial rollout as clinicians have questioned the data on which the decision to clear the drug was based, plus a $56,000 per year price tag, which has in turn led to pushback by payers.

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NICE recommends monotherapy for adjuvant treatment of stage 3 melanoma

Pharma Times

The approval follows a successful period of monitoring and patient access through the Cancer Drugs Fund.

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Biden admits social spending bill may not go to a vote until 2022 after objections from moderates

Fierce Healthcare

Biden admits social spending bill may not go to a vote until 2022 after objections from moderates. rking. Fri, 12/17/2021 - 13:33.

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