Mon.Aug 12, 2024

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What’s in a drink? U.S. regulators consider new alcohol label, but health advocates want even more

STAT

If you twirl a bottle of alcohol and squint, you might see a text box with a warning. Usually in black and white, with letters two to three millimeters high, it reads: GOVERNMENT WARNING: (1) According to the Surgeon General, women should not drink alcoholic beverages during pregnancy because of the risk of birth defects. (2) Consumption of alcoholic beverages impairs your ability to drive a car or operate machinery, and may cause health problems.

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M&A is ready to explode, and that’s good news for pharma layoffs

PharmaVoice

Deals driven by obesity meds are fueling an M&A comeback.

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Opinion: The FDA should withdraw approval of more than 400 tainted medicines

STAT

When the FDA learned that a testing facility in India had submitted fraudulent data for more than 400 drugs (most of them generics), the agency should have withdrawn them from the market. Instead, it has allowed these drugs to continue to be prescribed and distributed for at least a year as the pharmaceutical companies retest them for equivalency to the original brand-name drugs.

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Study suggests COVID-19 vaccination lowers incidence of arterial thromboses

Pharma Times

A second dose of the vaccine lowered the incidence of conditions such as heart attack or stroke

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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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Opinion: Some ‘inconvenient’ truths about pharmacy benefit managers

STAT

Pharmacy benefit managers have been in the crosshairs of late, as the focus of media scrutiny, government investigations and reports, and proposed federal legislation. A few recent examples make the point: A New York Times story in June 2024 bore the headline, “Pharmacy benefit managers are driving up drug costs for millions of people, employers and the government.

More Trending

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A tough week for MDMA-assisted psychotherapy

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Morning. A hard weekend for those backing MDMA-assisted psychotherapy: First, the FDA rejects a treatment from Lykos Therapeutics. Now a journal is retracting three MDMA papers, citing data integrity issues. Also, a nasal epinephrine spray gets an FDA approval, and more.

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FDA approves Ascendis drug for rare endocrine condition

BioPharma Dive

The clearance of Yorvipath for hypoparathyroidism was some time coming for Ascendis, which had resubmitted after receiving a rejection last year.

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STAT+: Pharmalittle: We’re reading about FDA rejecting MDMA; a nasal spray for allergic reactions, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of phone calls, online meetings, and deadlines has predictably returned. But you knew this would happen, yes? After all, we can only move forward. So what better way to cope than with a refreshing cup or two of stimulation?

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Following FDA rejection, a journal retracts papers on MDMA-assisted therapy

BioPharma Dive

Editors at Psychopharmacology cited "unethical conduct" that the study authors didn't disclose when submitting the papers. Lykos Therapeutics says it filed a complaint with a third party to review the way the journal came to its decision.

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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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Morning Rounds: Getting healthier in the checkout aisle and the alcohol aisle

STAT

Want to stay on top of health news?  Sign up  to get our Morning Rounds newsletter in your inbox. It’s Brittany subbing for Theresa this fine Monday. Thank you for all of the excellent song recommendations over the weekend. If you want to check out my road trip playlist, you can find it here.

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The politics of health: How elections will impact life sciences

pharmaphorum

Explore how the recent and upcoming elections may impact the field of life sciences and medical technology. Stay informed about the intersection of politics and health advancements.

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Support DPPs with protected learning time, RPS urges

The Pharmacist

Prescribers must get the support they need to train, supervise and support trainees as designated prescribing practitioners (DPPs), the Royal Pharmaceutical Society (RPS) has urged. This comes as the RPS and the National Pharmacy Association (NPA) have together published a roundtable report discussing the barriers and solutions to providing prescribing training for pre-registration pharmacists.

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MSD adds bispecific cancer antibody via $1.3bn Curon deal

pharmaphorum

MSD adds a bispecific antibody for blood cancers and autoimmune diseases to its pipeline via a $1.3bn licensing deal with Curon Biopharma.

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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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Pfizer builds case for RSV shot with data from immunocompromised adults

BioPharma Dive

Results from a Phase 3 study could help Pfizer broaden use of its vaccine Abrysvo to younger adults whose medical history puts them at higher risk.

Vaccines 111
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Pfizer announces top-line results of ABRYSVO® for RSV in immunocompromised adults

World Pharma News

Pfizer Inc. (NYSE: PFE) today announced positive top-line safety and immunogenicity results from substudy B of the ongoing pivotal Phase 3 clinical trial ( NCT05842967) MONeT (RSV I Mmunizati ONStudy for Adul Ts at Higher Risk of Severe Illness), evaluating two doses of ABRYSVO vaccine in immunocompromised adults aged 18 and older at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD).

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Article retractions muddy MDMA waters after FDA denial

pharmaphorum

Journal retracts three articles on MDMA-assisted psychotherapy, shortly after FDA blocks approval of @Lykos_PBC's therapy for PTSD

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UKBPA welcomes single route to register internationally qualified pharmacists

The Pharmacist

The president of the UK Black Pharmacist Association (UKBPA) has welcomed the change in proposed training routes for internationally qualified pharmacists. This comes as the General Pharmaceutical Council (GPhC) has scrapped its proposals for a three-route system that had come under fire for potentially being unfair. Instead, the GPhC has now proposed a single, one-year […] The post UKBPA welcomes single route to register internationally qualified pharmacists appeared first on The Pharmaci

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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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NICE updates on controversial multiple myeloma decisions

pharmaphorum

Three controversial decisions by NICE on NHS use of new multiple myeloma therapies are heading for the end of comment and appeals processes.

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Era of ADCs: Pharma companies innovate to stand out in a buzzing market

Pharmaceutical Technology

As antibody drug conjugate (ADC)-centred deals dominate the oncology space, biotechs are using newer targets and linkers to differentiate themselves.

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Pharmacy Deserts are Becoming a National Problem

Pharmaceutical Commerce

A lack of access could shut out patients in need of maintenance drugs for complex conditions.

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FDA clears first anaphylaxis nasal spray at second attempt

pharmaphorum

ARS Pharma gets FDA approval for epinephrine nasal spray neffy, the first needle-free alternative to EpiPen-style autoinjectors for serious allergic reactions.

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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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Pharma Pulse 8/12/24: Balancing Profitability and Mission, Minority Groups Remain Underrepresented in Vitiligo Trials & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Another AIM defection as BiVictriX plans to delist

pharmaphorum

BiVictriX is the latest UK biotech to say it wants to cancel its AIM-listed shares and go private in pursuit of better financing opportunities.

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Maintaining a Specialty Medication Regimen

Pharmaceutical Commerce

In this part of his Pharma Commerce video interview, Josh Marsh, Vice President and General Manager of Cardinal Health Sonexus Access and Patient Support, discusses the impact technology has in relation to patients sticking to their medication plan.

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PLAIO raises €4.3M to revolutionize pharma supply chains with AI-driven planning platform

Outsourcing Pharma

In a landmark move for the pharmaceutical industry, PLAIO, a pioneering Icelandic tech firm, has secured â4.3 million in an oversubscribed funding round to accelerate its AI-driven sales and operations planning platform designed specifically for the pharmaceutical sector.

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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 touts positive topline data for RSV vaccine Abrysvo

Pharmaceutical Technology

Abrysvo was found to be safe in immunocompromised adults at risk for developing RSV-associated lower respiratory tract disease.

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Lykos’ heartache over FDA setback as new trial for groundbreaking PTSD treatment ordered

Outsourcing Pharma

In a blow to millions of Americans battling post-traumatic stress disorder (PTSD), Lykos Therapeutics announced today that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its new drug application (NDA) for midomafetamine capsules.

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Startup Halda raises $126M to advance new type of targeted cancer therapy

BioPharma Dive

Technology emerging from Yale researcher Craig Crews’ labs will be used to target prostate and breast cancer in early clinical trials.

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