Tue.May 30, 2023

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Sacklers win appeal that shields them from opioid lawsuits, clearing way for bankruptcy settlement

STAT

A federal appeals court ruled Tuesday Purdue Pharma can shield its owners — members of the wealthy Sackler family — from thousands of lawsuits over the role the company played in the opioid crisis in exchange for a contribution of up to $6 billion to a proposed bankruptcy settlement. The Sackler family members insisted a bankruptcy deal would not be possible unless they were released from all future liability related to the harm caused by Purdue’s OxyContin painkiller.

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CVS is exiting clinical trials. Does this spell trouble for retail-based research?

PharmaVoice

Walgreens leaders are not deterred and hope to fill the holes left behind by the pharmacy giant.

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Opinion: In defense of being ‘Cali sober’

STAT

The phenomenon of being “Cali sober” is taking the recovery world by storm. It is defined as dedicating oneself to a life free of drugs and alcohol — except for cannabis and other psychedelics. (Though many consumers don’t think of cannabis as a psychedelic, policy experts often consider it one because of its effects.) Hardcore proponents of abstinence-based recovery, such as Alcoholics Anonymous, dismiss the Cali sober approach as dangerous and “not really rec

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EU regulator recommends revoking approval for Novartis’ sickle cell disease drug

Pharma Times

The EMA's human medicines committee concluded that the benefits of Adakveo did not outweigh its risks

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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

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STAT+: Lured by a bigger payday, a medical device maker sold fake plastic parts. Many were implanted in chronic pain patients

STAT

Stimwave’s pitch was alluring. As a startup tackling chronic pain with nerve-stimulating devices, it promised to release patients from the stranglehold of addictive painkillers. And unlike its competitors, whose devices required patients to have clunky batteries implanted in their bodies, Stimwave’s system came with a sleek, wearable battery attached to thin wires under the skin.

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STAT wants to know your pick for a great summer read or listen

STAT

S TAT is putting together a list of books and podcasts that deal with health, medicine, and the life sciences that would be great to check out this summer. We invite our readers to fill out the form below, and you may see your pick in our upcoming annual roundup. To get a little inspiration, check out our past lists from 2022 , 2021 , and 2019.

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Amylyx’s ALS drug could face rejection in Europe

BioPharma Dive

The biotech said a committee advising the European Medicines Agency is “trending” toward issuing a negative opinion of its drug Relyvrio, which was approved in the U.S. last year.

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Opinion: More hospitals are offering child care. But they shouldn’t have to

STAT

Since the pandemic began, thousands of child care locations have closed , exacerbating an already acute shortage. But health care worker Jada Carter was lucky. Her two children went to Hospitots, one of the few places to stay open during the early days of the pandemic, when, by one estimate , two-thirds of child care centers closed.

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SK Bioscience gains UK authorisation for SKYCovion Covid-19 vaccine

Pharmaceutical Technology

SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. SKYCovion is intended for the prevention of Covid-19 resulting from SARS-CoV-2 infection in individuals aged 18 years and above. The authorisation allows the distribution of the vaccine in Scotland, Wales and England.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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STAT+: Just how vulnerable is Medicare drug negotiation to legal challenges?

STAT

WASHINGTON — Drugmakers have already hinted at suing Medicare over its new efforts to negotiate prescription drug prices. A new report by nonpartisan congressional researchers suggests there are at least some parts of the law that can’t be challenged — but they caution it would ultimately be up to the courts to decide. When they laid out the new rules for Medicare drug price negotiation, Democrats tried to get the program up and running before a future Republican administrat

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Pfizer says hemophilia drug succeeded in Phase 3 study

BioPharma Dive

The drug, called marstacimab, outperformed factor treatment in the study, and wasn’t associated with the kind of safety signals that have dogged other medicines in its class.

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STAT+: Pharmalittle: Pfizer touts study data for hemophilia drug; former Novartis execs cleared of bribery in Greece

STAT

Good morning, everyone, and how are you today? We are doing fine, thank you, especially since we had an extended holiday weekend on this side of the pond. Whether you were off or not — depending upon where you may be — we hope you are feeling refreshed and energized this morning as we all prepare for the usual routines. To cope, yes, we are brewing cups of stimulation.

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The benefits of adopting a truly digital mindset for pharmaceuticals

pharmaphorum

The benefits of adopting a truly digital mindset for pharmaceuticals Mike.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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STAT+: European regulatory panel weighing against approval of Amylyx’s ALS therapy, company says

STAT

LONDON — A European regulatory panel has taken a negative view of whether an ALS treatment from Amylyx Pharmaceuticals should win approval, the company said Tuesday, threatening the drug’s chances of entering the European market. In a statement, Amylyx said it had learned that a European Medicines Agency’s committee “is trending toward a negative opinion” on the drug, AMX0035, after its May meeting last week.

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Parkinson’s wearable matches experts in clinical trial

pharmaphorum

Parkinson’s wearable matches experts in clinical trial Phil.

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Addressing Mental Health: A conversation with Barry Greene, CEO of Sage Therapeutics

PhRMA

As we recognize Mental Health Awareness Month, I had the opportunity to connect with PhRMA board member Barry Greene, CEO of Sage Therapeutics, about the company’s efforts to address mental health.

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UK funds extended reality projects for mental health

pharmaphorum

UK funds extended reality projects for mental health Phil.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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Lexicon Receives FDA Stamp of Approval for New Heart Failure Treatment

PharmExec

Inpefa to support multiple cardiovascular issues.

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Elizabeth Holmes due to start prison sentence today

pharmaphorum

Elizabeth Holmes due to start prison sentence today Phil.

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Sun Pharma gets China NMPA approval for ILUMETRI to treat moderate-to-severe plaque psoriasis

Express Pharma

Sun Pharmaceutical Industries announced that the New Drug Application (NDA) for tildrakizumab injection under the brand name ILUMETRI has been approved by the National Medical Products Administration of the People’s Republic of China (NMPA). ILUMETRI is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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Short-term crucial to future of AI drug discovery

pharmaphorum

Short-term crucial to future of AI drug discovery Mike.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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How do you solve a problem like community pharmacy IT systems?

The Pharmacist

The NHS primary care recovery plan promised ‘interoperable digital solutions’ to support pharmacists to deliver clinical services and ‘significantly improve’ the digital infrastructure between general practice and community pharmacy. This would include streamlined referral processes, giving community pharmacy additional access to relevant clinical information from GP records, and allowing community pharmacy to update GP records […] The post How do you solve a problem like community pharmac

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Amplo Biotechnology receives NIH-NIAMS grant for gene therapy AMP-201

Pharmaceutical Technology

Amplo Biotechnology has received a fast track phase I/II STTR grant from the NIH-NIAMS [National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases] for its gene therapy AMP-201. The company will receive substantial funding to advance AAV-ColQ gene therapy. AMP-201 addresses the severe congenital myasthenic syndrome (CMS) caused by collagen Q (ColQ) deficiency.

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NHS workforce plan ‘delayed again due to cost concerns’

The Pharmacist

The government’s long-awaited NHS workforce plan appears to have been delayed as rumours circulate that it is too expensive. According to deputy chief executive of NHS Providers Saffron Cordery, the plan, which was expected for publication imminently, has been delayed further. Speaking on BBC Radio 4’s Today programme, Ms Cordery said the plan will require ‘a very […] The post NHS workforce plan ‘delayed again due to cost concerns’ appeared first on The Pharmacist.

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Overcoming common pitfalls in lentiviral cell and gene therapies

BioPharma Dive

See how ddPCR technology can take your lentiviral cell and gene therapies to the next level.

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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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European Commission approves haematology biosimilar

European Pharmaceutical Review

The European Commission (EC) has granted a marketing authorisation for EPYSQLI , a biosimilar to Soliris (eculizumab) for adults and children patients with paroxysmal nocturnal haemoglobinuria (PNH). “The approval of EPYSQLI , Samsung Bioepis’ first haematology biosimilar, reflects our ongoing endeavours to introduce more treatment options for PNH patients in Europe,” stated Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis.

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How transparent is the VPAS?

pharmaphorum

How transparent is the VPAS? Mike.

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Sun Pharma, Philogen sign pact to commercialise specialty product, NIDLEGY in Europe, Australia and New Zealand

Express Pharma

Sun Pharmaceutical Industries and Philogen have entered into a licensing agreement for commercialising Philogen’s specialty product, Nidlegy (Daromun) in the territories of Europe, Australia and New Zealand. Nidlegy, currently in Phase III clinical trials, is a new anti-cancer biopharmaceutical which is being developed by Philogen for the treatment of melanoma and non-melanoma skin cancers.

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