Mon.Dec 04, 2023

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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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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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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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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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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+: How sickle cell became the first disease treated by CRISPR

STAT

Nearly a decade ago, consultants delivered to Rodger Novak a kind of Sears catalog of human malady: 200 pages, listing dozens of different diseases, each annotated with — from a business standpoint — their best and worst attributes.  The document was supposed to help Novak, then the chief executive of CRISPR Therapeutics, navigate a pressing quandary.

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SAEM Clinical Images Series: Penile Lesion with a Poor Prognosis

ALiEM - Pharm Pearls

A 49-year-old male presented to the emergency department of an academic hospital with the chief concern of penile pain. Prior medical history is notable for end-stage renal disease on hemodialysis three times per week, but the patient has not been dialyzed in the past four days, hypertension, insulin-dependent diabetes mellitus, heart failure with reduced ejection fraction (59% two months prior), seizure disorder, prior pulmonary embolism (eight months prior), a left nephrectomy seven months ago

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The fortunes and flops of pharma M&A

PharmaVoice

Hindsight offers a better perspective on why some deals are fruitful and others fail.

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STAT+: Official: FDA needs staff influx to meet gene therapy needs

STAT

WASHINGTON — The Food and Drug Administration needs dozens more reviewers if it wants its so-called Operation Warp Speed for rare disease therapies to take off, the agency’s biologics chief said Monday. The administration launched the rare disease pilot program, dubbed START and modeled after the record race for a Covid-19 vaccine, this September.

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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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STAT Morning Rounds: Six health news stories you need to start your day

STAT

Understand how science, health policy, and medicine shape the world everyday. Sign up for our Morning Rounds newsletter here. How sickle cell became the first CRISPR’d disease Nearly a decade ago, consultants delivered to Rodger Novak a kind of Sears catalog of human malady: 200 pages, listing dozens of different diseases, each annotated with — from a business standpoint — their best and worst attributes.

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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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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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STAT+: FDA efforts to oversee foreign drug manufacturing remain inadequate to ensure safety, analysis finds

STAT

In the wake of the Covid-19 pandemic, the Food and Drug Administration inspected far fewer domestic and foreign pharmaceutical facilities, even though manufacturing activity did not decline, according to a new analysis. Meanwhile, FDA budgeting and staffing held steady, although resources allocated for each inspection surged and more plants were cited for serious violations.

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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

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STAT+: Pharmalittle: Roche to buy obesity-drug developer for $2.7 billion; Novo Nordisk paid U.S. doctors $26 million over a decade

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and refreshing, because that oh-so familiar routine of online meetings, phone calls, and deadlines has predictably returned. But you knew this would happen, yes? After all, the world, such as it is, somehow keeps spinning. So time to nudge it in a better direction with a fresh cup of stimulation.

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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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Industry and academia should work together to combine discovery biology and translational research

Express Pharma

How has your work on the biology of G-protein coupled receptors (GPCRs) helped pharma companies increase the efficacy of medicines for common diseases like diabetes, hypertension etc.? About half of the currently prescribed medicines work through GPCRs by turning them on or off. However, the signaling mechanism downstream of GPCRs is very complexes and involves multiple pathways operating in parallel.

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Supreme Court wrestles with OxyContin maker’s bankruptcy deal

STAT

WASHINGTON — The Supreme Court on Monday wrestled with a nationwide settlement with OxyContin maker Purdue Pharma that would shield members of the Sackler family who own the company from civil lawsuits over the toll of opioids. The justices seemed by turns relucant to break up an exhaustively negotiated agreement, but also leery of somehow rewarding the Sacklers.

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New £20m NIHR project announced to combat HIV in England

Pharma Times

In England, an estimated 4,500 people are living with undiagnosed HIV - News - PharmaTimes

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Novartis is building a new radioligand plant in China

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hiya. Today, we explore how traditionally underserved sickle cell patients became early recipients of a futuristic gene-editing therapy, see another generative AI drug discovery deal forged, and more.

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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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I reversed my type 2 diabetes. Here’s how I did it | Neil Barsky

The Guardian - Pharmaceutical Industry

Modern medicine makes it seem as if drugs are the only way to deal with diabetes. But what if diet can be a solution? One gray Sunday in the middle of the Covid lockdown, I received an unwelcome call from my family doctor. Until then, for virtually my entire life, I had managed to stay out of a doctor’s office, except for routine checkups. My luck had run out.

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Novel generalised myasthenia gravis treatment approved

European Pharmaceutical Review

The European Commission (EC ) has authorised ZILBRYSQ ® (zilucoplan)▼ as the first once-daily subcutaneous (SC), targeted peptide inhibitor of complement component 5 (C5) inhibitor for generalised myasthenia gravis ( gMG ). It is also the only C5 inhibitor approved for self-administration by adult patients who are AChR antibody-positive with this disease.

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Vibcare Healthcare opens pharma manufacturing facility in Panchkula, Haryana

Express Pharma

Vibcare Healthcare has inaugurated a manufacturing facility in Panchkula, Haryana, built with an investment of Rs 40 crores. The company informed, spanning over five acres, the facility adheres to international standards, including EU GMP, PIC/S and UKMHRA GMP. Siddharth Singhal, CEO of Vibcare Healthcare said, “This groundbreaking facility affirms our dedication to excellence in pharma.

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Elevating pharmaceutical manufacturing processes with real-time insights

European Pharmaceutical Review

The (bio)pharmaceutical industry is currently facing numerous hurdles in its path to high-efficiency production that are more complex and pressing than ever before. One of the most significant perceived challenges is the ability to implement new innovations and increase productivity while adhering to stringent regulatory demands. The race to develop new drugs and therapies demands rapid drug discovery, testing and time-to-market.

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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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Takeda signs MoU with BIRAC to support healthcare start-ups

Express Pharma

Takeda announced the signing of a three-year MoU with the Biotechnology Industry Research Assistance Council (BIRAC), a public sector enterprise set up by the Department of Biotechnology, Government of India. The MoU was announced in the presence of Dr Jitendra Singh, Union Minister of State for Science & Technology, Minister of State for the Prime Minister Office, Government of India, and senior government and industry leaders.

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EyePoint sees stock surge on AMD drug trial data

BioPharma Dive

The biotech said Phase 2 study results showed its experimental medicine for age-related macular degeneration was "non-inferior" to Regeneron's Eylea.

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AIMp survey suggests dissatisfaction with CPE representation

The Pharmacist

Nearly three-quarters of respondents to a survey by the Association of Independent Multiple Pharmacies (AIMp) expressed the view that Community Pharmacy England (CPE) is not currently representative of community pharmacies in England. Among almost 380 responses, 73.8% opted for ‘no’ in answer to the question of, ‘Do you think CPE is currently representative of community […] The post AIMp survey suggests dissatisfaction with CPE representation appeared first on The Pharmacist.

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Roche joins obesity drug chase with $2.7B deal for startup Carmot

BioPharma Dive

The acquisition of Carmot, which had been planning an IPO, will hand Roche three weight loss medicines in early clinical testing.

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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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Pharmaceutical excipients market to witness expansion

European Pharmaceutical Review

A report published by MarketsandMarkets has estimated that the pharmaceutical excipients market will value $14.9 billion by 2028, growing at a CAGR of 6.8 percent between 2023 to 2028. This is compared to the expected revenue for the market in 2023 reaching $10.7 billion. Excipients market opportunities and limitations Major contributing factors regarding growth of the pharmaceutical excipients market are: increasing demand for generic drugs and drug products, increased investment in R&D for

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Pfizer announces topline Phase 2b results of oral GLP-1R agonist, danuglipron, in adults with obesity

World Pharma News

Pfizer Inc. (NYSE: PFE) announced topline data from the Phase 2b clinical trial (NCT04707313) investigating its oral Glucagon-like peptide-1 receptor agonist (GLP-1RA) candidate, danuglipron (PF-06882961), in adults with obesity and without type 2 diabetes. The study met its primary endpoint demonstrating statistically significant change in body weight from baseline.

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Akums’ acquires new formulation facility in Baddi

Express Pharma

Akums Drugs and Pharmaceuticals announced the acquisition of a new formulation facility located in Baddi, Himachal Pradesh. This marks the twelfth formulation facility under Akums, and the second in Baddi. The newly acquired facility, sprawling across approximately six acres, is currently undergoing upgrades and is slated to become operational in the year 2024.

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Overcoming scalability challenges in real-world data processing for transformative patient care

BioPharma Dive

Accurate and timely processing of data is imperative to create robust analytical datasets that can be used in the RWE setting.

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Brain waves found in sleep shown to protect against epileptic activity

Pharma Times

The neurological condition affects around 50 million people worldwide - News - PharmaTimes

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