Thu.Mar 10, 2022

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Mallinckrodt pays $260m to settle kickback, rebate fraud charges

pharmaphorum

Mallinckrodt’s liability problems in the US have been lightened slightly, after it agreed a $260 million deal to resolve allegations of Medicare rebate fraud and payment of illegal kickbacks. The Ireland-domiciled company was accused of illegally paying smaller drug rebates to Medicaid than were due, as well as using a charitable foundation to cover co-pays for its Acthar Gel (corticotropin) epilepsy treatment – which is not allowed under US law.

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International collaboration - building strong and resilient health and care systems through evidence-based decision making

NICE

Following the launch of the international strategy for NICE , I’m keen to reflect on the importance of international collaborations and partnerships. The COVID-19 pandemic, the extraordinary pace of healthcare innovation, rising costs and the need for accessible, reliable, up-to-date information, are just a few examples highlighting the importance of shared learning on a global scale.

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Scenic Bio raises $31m for genetic modifier platform

pharmaphorum

18 months after signing its first partnering deal with Genentech, Scenic Biotech has raised $31 million in first-round financing that it will use to take its own genetic modifier-targeted medicines into clinical trials. The Netherlands-based biotech, which is putting together a pipeline of genetic modifier drugs for cancer and rare diseases, said the new funding would also allow it to double its headcount to add clinical capabilities and move to a larger facility.

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Pfizer kicks off Phase II/III study for pediatric COVID-19 treatment

Outsourcing Pharma

The pharma company is evaluating its Paxlovid oral treatment, intended for high-risk patients who have tested positive for the virus, in pediatric subjects.

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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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Investing in biologics excellence

pharmaphorum

In little over three decades, advances in biotechnology have noticeably disrupted the development landscape of small molecule drugs. Yet, despite the immense potential of the field, biologics have remained largely untapped. Now, amid a wave of innovation, investors and drugmakers are putting their weight behind the drug class. “Biologics have revolutionised treatments for several serious diseases, some of which had no therapeutic alternatives until now,” says Antonio Magnelli, head of the Chiesi

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App taps into patient data to explore human side of cancer

Outsourcing Pharma

Patient-centric company Belong.life has developed an app designed to inform cancer research by offering a holistic view of the lives of people with cancer.

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UK COVID-19 cases rising among those aged 55 and older

Pharma Times

Certain areas in the UK have been experiencing a significant increase in COVID-19 cases in recent days

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Chasing rivals, Bayer files Nubeqa for new prostate cancer use

pharmaphorum

Bayer has filed for approval to extend the use of its prostate cancer therapy Nubeqa as it tries to achieve labelling parity with rival drugs from Pfizer/Astellas and Johnson & Jonson, and fulfil its aim of €3 billion in peak sales for the drug. Nubeqa is already making headway in the market as a treatment for non-metastatic, castration resistant prostate cancer (nmCRPC), with sales of €219 million last year, but will need to expand into new forms of the disease if it is to meet its commerc

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The NHS: Prevention, Personalisation and Performance

Pharma Times

The government’s planned ‘Road to Recovery’ will have a new focus on prevention

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Welcome to the 2nd Chronic HBV Drug Development Summit

pharmaphorum

Advance Combination Therapies, Outline Clinical Endpoints & Understand the Immunology Perspective to Achieve Functional Cures for Chronic Hepatitis B. With a tight lens on late translational through to phase II clinical progress; the 2nd Chronic HBV Drug Development Summit is dedicated to advancing direct antiviral and immunotherapy pipelines in combination therapy paradigms.

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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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Electronics giant LG makes health play with Amwell alliance

pharmaphorum

Consumer electronics giant LG has made a big foray into the digital health arena via a partnership with US telehealth player Amwell. The two companies say they intend to develop “device-based service solutions designed to make it easier for patients to access care, whether in a hospital or at home.” South Korean LG – which makes a huge range of devices from TVs and refrigerators to cell phones and computer monitors – will create devices that will be able to host services from Amwell&