Sat.Dec 02, 2023 - Fri.Dec 08, 2023

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The weight loss market looks unstoppable. How high could it go?

PharmaVoice

Market expectations for obesity drugs are soaring and competition is heating up. But hitting the heights will require overcoming payer and other issues.

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In historic decision, FDA approves a CRISPR-based medicine for treatment of sickle cell disease

STAT

The Food and Drug Administration on Friday approved the world’s first medicine based on CRISPR gene-editing technology, a groundbreaking treatment for sickle cell disease that delivers a potential cure for people born with the chronic and life-shortening blood disorder. The new medicine , called Casgevy, is made by Vertex Pharmaceuticals and CRISPR Therapeutics.

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CRISPR therapy for sickle cell approved by FDA in gene editing milestone

BioPharma Dive

In addition to clearing Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy, the FDA also granted an early OK to Bluebird bio’s sickle cell treatment Lyfgenia.

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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog: Biosimilars

By Larry K. Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. On October 10th, based on ability to pay, the U.S. District Court for the Western District of Texas imposed a $275,000 civil penalty on Zarzamora Healthcare LLC, in San Antonio, and its pharmacist-owner.

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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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Transforming blood cancer care to make a difference for patients

PharmaVoice

AstraZeneca’s Gemma Satterthwaite talks to the company’s ambition to transform the entire care experience for patients with blood cancers.

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New gene therapies confront many sickle cell patients with an impossible choice: a cure or fertility

STAT

As a teenager, Marie Tornyenu was always having to explain herself. If it wasn’t the chronic absences that had her doing homework from a hospital bed, it was the quilted blanket she carried with her on the days she could attend class. “It was a running joke that I was like 80 years old,” she said. “I would usually just laugh it off because the alternative was too depressing.

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More Trending

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AbbVie to buy Cerevel in $8.7B bet on brain drugs

BioPharma Dive

The deal hands AbbVie a portfolio of psychiatric medicines that originated within Pfizer, among them a closely watched schizophrenia treatment that’s in late-stage testing.

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4 historic FDA approvals from 2023

PharmaVoice

This year’s many firsts included a vaccine for RSV and a drug that slows Alzheimer’s disease.

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Sweeping bill to fight opioid addiction will be considered by Senate health committee

STAT

The Senate health care committee will consider a sweeping bill next week meant to combat the opioid epidemic, according to four lobbyists and a congressional aide familiar with the legislation.  The proposal would reauthorize a number of programs first created by the SUPPORT Act, an addiction-focused bill that Congress first passed in 2018. Many of those programs’ authorizations expired earlier this year, however, leading addiction treatment advocates to fret that lawmakers —

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FDA Grants Breakthrough Designation to Johnson & Johnson’s Novel Treatment for HR-NMIBC

PharmExec

TAR-200 has a novel targeted releasing system for the treatment of patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer who are ineligible for bladder removal surgery.

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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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Radiopharma startup Artbio raises $90M in sign of field’s momentum

BioPharma Dive

The funding is indicative of investor interest in an area of drug research that involves at least a dozen startups and multiple publicly traded companies.

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Phase III data for novel telomerase inhibitor released

European Pharmaceutical Review

Results from Geron’s Phase III IMerge trial evaluating its first-in-class investigational telomerase inhibitor imetelstat, have shown long-term and durable response in participants with a rare haematologic malignancy. Efficacy of the treatment was compared to placebo in patients with lower risk myelodysplastic syndromes (MDS) relapsed/refractory or ineligible for erythropoiesis stimulating agents (ESAs).

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Opinion: Big Weed today is a whole lot like Big Tobacco in the 1950s

STAT

OK, marijuana is now legal. So where’s the public health approach? Strictly speaking, marijuana use isn’t fully legal across the U.S. yet. But when Montana and Missouri have legalized recreational use and the Senate is debating legal banking for cannabis companies, you know it’s all over but the shouting.

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Artificial Intelligence Changing the Landscape for Healthcare Social Media Marketing

PharmExec

Experts from Hootsuite noted that the primary social media ROI concern for healthcare companies is the time and money it takes to maintain a multi-platform presence.

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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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Pricey new gene therapies for sickle cell pose access test

BioPharma Dive

Casgevy, the first CRISPR therapy approved by the FDA, will cost $2.2 million, while a competing genetic medicine also cleared Friday is priced at $3.1 million.

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AbbVie swoops on Pfizer spin-out Cerevel with $8.7bn offer

pharmaphorum

AbbVie has announced its second major takeover deal in the space of a few days, offering $8.7 billion to buy central nervous system drug specialist Cerevel Therapeutics which spun out of Pfizer in 2018.

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New England Journal of Medicine reckons with its racist past and complicity in slavery

STAT

The New England Journal of Medicine, the world’s oldest continually published medical journal, publicly reckoned with its history and complicity surrounding slavery and racism Wednesday, publishing the first of a series of essays by independent historians on the role the prestigious publication has played in perpetuating racist thinking in medicine that continues to this day.

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Cambridge researchers redesign future mRNA therapeutics

Pharma Times

One-third of patients who received Pfizer’s COVID-19 vaccine had unintended immune responses - News - PharmaTimes

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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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FDA Approves Two Landmark Cell-Based Gene Therapies for Sickle Cell Disease

PharmExec

FDA approval of bluebird bio’s Lyfgenia and Vertex Pharmaceuticals' and CRISPR Therapeutics’ Casgevy marks significant milestone in the treatment of sickle cell disease.

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Breaking: Pharmacy supervision consultation launches

The Pharmacist

The Department of Health and Social Care (DHSC) has today launched its consultation into pharmacy supervision. It proposes to: enable pharmacists to authorise pharmacy technicians to carry out, or supervise others carrying out, the preparation, assembly, dispensing, sale and supply of medicines enable pharmacists to authorise any member of the pharmacy team to hand out […] The post Breaking: Pharmacy supervision consultation launches appeared first on The Pharmacist.

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STAT+: Pfizer plans to depart BIO

STAT

WASHINGTON — Pfizer has decided to leave the Biotechnology Innovation Organization, according to two sources familiar with the decision. The departure is a blow to BIO, which represents members ranging from small biotech startups to massive pharmaceutical companies. The group on Tuesday announced its new CEO, rare disease advocate and biotech executive John Crowley.

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Seattle Children’s Hospital launches BrainChild Bio for CNS therapies

Pharmaceutical Technology

Seattle Children's launched BrainChild Bio to focus on expediting the development of CAR T-cell therapies in central nervous system tumours.

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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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Merck suffers bad week as 3 Keytruda combination trials fail

BioPharma Dive

The setbacks for Merck demonstrate the challenge drug developers face in improving on Keytruda, which has brought in at least $18 billion so far this year for its maker.

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Common drug could facilitate “huge step-change” in managing type 1 diabetes

European Pharmaceutical Review

Results from a world-first human trial, published in the New England Journal of Medicine , has shown that a drug called baricitinib has promise as the first disease-modifying treatment of its kind for type 1 diabetes, that can be administered as a tablet.  baricitinib… [demonstrated an ability to] preserve the body’s own insulin production and suppress the progression of type 1 diabetes in people who initiated treatment within 100 days of diagnosis” The researchers noted that baricit

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Is the flu shot market a slam dunk for mRNA vaccines? Experts aren’t so sure

STAT

Here are two things that are true. The world needs more effective flu vaccines. And pharmaceutical companies that learned of the vaccine-making power of the messenger RNA platform during the Covid-19 pandemic need new markets for their technology.

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Roche makes obesity play with $2.7bn deal to buy Carmot

pharmaphorum

Roche has agreed a deal to acquire US biotech Carmot Therapeutics that if consummated will thrust it into the increasingly competitive market for incretin-based therapies for diabetes and obesity. The Swiss pharma group has agreed to pay $2.7 billion upfront in cash when the deal closes, with shareholders in the US company also in line for up to $400 million if the drug programmes covered by the agreement meet various milestones.

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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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Study reveals motor neuron region is affected in ALS

Pharma Times

The neurological condition currently affects one in 300 people in the UK - News - PharmaTimes

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Antibody-immunotherapy combination shows promise in lung cancer

European Pharmaceutical Review

In an early human study , US researchers have found that combining immunotherapy with dupilumab, an Interleukin-4 (IL-4) receptor-blocking antibody, boosted the immune system of lung cancer patients. Dupilumab is used widely as an allergy and asthma treatment, stated the authors of the corresponding research paper, which has been published in Nature.

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In pigs, researchers show ultrasound could be used for 3D printing inside the body

STAT

Imagine getting surgery without ever being cut open. Researchers at Duke University and Harvard Medical School have successfully demonstrated a proof of concept in new research published Thursday in Science using a 3D printer that uses ultrasound to print biomaterials inside an organ. Growing up, Junjie Yao, a bioengineer at Duke University and one of the primary investigators of the study, had heard stories about scientists coming up with great ideas over coffee or while chatting in the break r

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Bringing women’s health up to speed for 21st century human healthcare

pharmaphorum

In this latest instalment of the pharmaphorum podcast, web editor Nicole Raleigh speaks with David Solomon, CEO of Mithra Pharmaceuticals, about the current women’s health landscape and what Mithra is doing on an international scale to ameliorate that.

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Doubts raised over NHSE shared workforce guidance for pharmacists

The Pharmacist

NHS England (NHSE) has released optional guidance on shared workforce models for pharmacists, although the Company Chemists’ Association (CCA) has warned that complexity could hinder their uptake. The guidance, published last week, sets out optional workforce models that community pharmacies and hospital pharmacy departments may wish to consider in collaboration with primary care networks (PCNs). […] The post Doubts raised over NHSE shared workforce guidance for pharmacists appeared first