Thu.Dec 09, 2021

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Anthem-backed Hydrogen Health rolls out virtual primary care services for insurers, employers

Fierce Healthcare

Anthem-backed Hydrogen Health rolls out virtual primary care services for insurers, employers. hlandi. Thu, 12/09/2021 - 09:01.

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Consumer health innovation – where passion and science meet

pharmaphorum

Heather Barnes, external innovation lead EMEA at Johnson and Johnson Consumer Health, is a scientist who is truly passionate about consumer health. With her background in biochemistry and eye for identifying innovation trends, the future is bright at Johnson & Johnson Innovation. After making her way from early-stage drug development research to her current role, Heather got straight to work on creating sustainable collaborations that made life better for people and their families.

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AHA, AMA sue Biden admin to challenge surprise billing arbitration process

Fierce Healthcare

AHA, AMA sue Biden admin to challenge surprise billing arbitration process. pminemyer. Thu, 12/09/2021 - 12:17.

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Post-Brexit medicines regulation must have international scope

pharmaphorum

Post-pandemic, post-Brexit Britain must create a regulatory framework that both defines and aligns with international standards, or risk being left behind. If the UK creates regulatory frameworks that drastically diverge from those of its “science allies”, it could become a late – or even no – launch market for new treatments. The need for companies to make multiple dossiers and submissions could lead to “profound implications for UK patients needing access to innovative and novel therapies”, sa

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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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CVS Health projects at least $304B in revenue for 2022

Fierce Healthcare

CVS Health projects at least $304B in revenue for 2022. pminemyer. Thu, 12/09/2021 - 15:57.

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HER2 Targeting Therapies Market: A Deeper Look into Therapy Developer Landscape and Future Opportunities

Roots Analysis

The epidermal growth factor receptor (EGFR is a tumor resistance biomarker which plays an essential role in the differentiation and proliferation upon activation through the binding of one of its ligands. A non-ligand-binding member of EGFR family, HER2 exerts its activity through heterodimerisation along with its other family members. HER2 is a transmembrane growth factor receptor present in the normal and malignant breast epithelial cells.

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Trial sets up filings for uniQure’s haemophilia gene therapy

pharmaphorum

Dutch biotech uniQure and partner CSL Behring are planning to file for approval of their gene therapy for haemophilia B, armed with new trial data that they say answers earlier concerns about the programme. The results are from the HOPE-B study, which was temporarily placed on a clinical hold by the FDA earlier this year after a case of liver cancer was seen in a patient treated with etranacogene dezaparvovec – subsequently deemed not to be linked to the gene therapy.

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Abu Dhabi to Strengthen its Capabilities as a Life Sciences Hub Through a Pharma Collaboration with Belgium

Pharma Mirror

UAE, Abu Dhabi , Abu Dhabi has set its sights on Belgium, as a leading global pharmaceutical hub, to establish a global distribution corridor to serve the world in vaccine delivery and future life science needs. The collaboration builds on the capabilities of Abu Dhabi’s healthcare sector as a leading life sciences hub and the efforts of the HOPE Consortium in providing vaccine solutions for the world.

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Shkreli’s former company pays $40m in price-gouging settlement

pharmaphorum

A pharma company formerly led by ‘pharma bro’ Martin Shkreli has settled a long-running lawsuit with the US federal government over massive price increases for an off-patent drug treatment for people with an HIV-related disease. Vyera Pharma – known as Turing Pharma when the scandal first emerged several years ago – will pay $40 million in settlement of the charges that it raised the price of Daraprim (pyrimethamine) for toxoplasmosis, a life-threatening parasitic infection that affe

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Distributed Control System Facilitates Expansion for New Drugs Produced by Contract Manufacturing Organization

Pharma Mirror

Combatting the pandemic has highlighted the importance of the partnership between biopharma organizations and the contract manufacturing organizations (CMOs) that must flexibly handle outsourced production, which can come suddenly and often must quickly be ramped up. For example, to meet the urgent need for COVID-19 related therapies and vaccines early in the pandemic, Thermo Fisher Scientific, a world leader in serving science with annual revenue of approximately $35 billion, had to expand its

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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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FDA advisors unconvinced by Reata’s kidney disease drug

pharmaphorum

An FDA advisory committee has delivered a blow to Reata Pharma, after voting unanimously that the drugmaker’s data on bardoxolone – a drug for kidney disease – did not show it is effective. Reata is seeking approval from the US regulator for bardoxolone as a treatment for CKD caused by Alport syndrome, a rare genetic disease, after earlier clinical trial failures with the drug in CKD and diabetic kidney disease.

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Time to take trial data analysis to the next level: ConcertAI

Outsourcing Pharma

A leader from the advanced data and artificial intelligence specialist suggests ways to advance data collection through new tools, techniques, and thinking.

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Identifying Rising Stars

pharmaphorum

The term ‘Rising Stars’ is often used throughout the pharma industry. In general, rising stars within a given field, are the emerging leaders that stand out amongst their peers, indicating a potential to become more influential KOLs in the future. Rising stars are also valued because they often bring fresh ideas and new approaches to medicine. The sooner that you can engage with such experts and support their work, the greater the benefit they can bring to all.

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UPS: Increasingly complex supply chain calls for action, collaboration

Outsourcing Pharma

A representative shares ways that COVID-19 has impacted the already intricate pharmaceutical supply chain and offers suggestions to stay ahead of the curve.

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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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Chutes & Ladders—NIH taps Tabak as acting director; Former Unilever CIO joins Mass General Brigham

Fierce Healthcare

Chutes & Ladders—NIH taps Tabak as acting director; Former Unilever CIO joins Mass General Brigham. hlandi. Thu, 12/09/2021 - 16:30.

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Former biopharmaceutical executives nabbed for insider trading

Outsourcing Pharma

The US Department of Justice has charged a former CFO and a former head of corporate communications for allegedly conducting an insider trading scheme.

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Cancer clinical trial recruitment drops by 60% during pandemic

Pharma Times

In a new report from The Institute of Cancer Research (ICR), data from cancer trials alongside assessments from clinicians and patients aims to provide guidance on how to improve services

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AZ’s antibody first to be cleared by FDA for COVID prevention

pharmaphorum

AstraZeneca’s antibody cocktail for COVID-19, now called Evushield, has become the first drug in the class to be authorised for prevention of infection by the US FDA. The long-acting antibody combination, formerly known as AZD7442 (tixagevimab and cilgavimab) has been cleared for pre-exposure prophylaxis (PrEP) of COVID-19 in adults and adolescents aged 12 and older who weigh at least 40kg and have compromised immunity.

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NICE publish final guidance recommending Aspaveli in adults with ultra-rare blood disorder

Pharma Times

The drug is additionally undergoing assessment with the Medicines and Healthcare products Regulatory Agency for a marketing authorisation in the UK

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Digital pill tracks HIV PrEP adherence with 98% accuracy

pharmaphorum

A digital pill that records when it is taken has been shown to be highly effective at helping patients adhere to pre-exposure prophylaxis (PrEP) treatment used to protect them from contracting HIV. A pilot study, which involved 16 men who have sex with men (MSM) and a history of substance use, found that the system was 98% effective at tracking adherence to a once-daily oral PrEP regimen.