Tue.Nov 12, 2024

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The recovery community says it offers refuge from opioid addiction. But it’s still hostile to lifesaving addiction medications 

STAT

The last time Mark Palinski went to a Narcotics Anonymous meeting, he was asked to leave and never come back. He stills remembers the argument: All he had done was advocate for the use of the “gold standard” treatment opioid addiction, a common medication called buprenorphine.  To Palinski, buprenorphine is a godsend.

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Pfizer and Lilly’s telehealth prescribing platforms draw Senate scrutiny for ‘potential fraud’

PharmaVoice

As Big Pharma embraces telehealth to sell medicines directly to patients, lawmakers wonder whether the programs skirt anti-kickback rules.

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Trending Sources

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STAT+: DOJ sues to block UnitedHealth takeover of home health giant Amedisys

STAT

The Department of Justice on Tuesday sued to prevent UnitedHealth Group from buying Amedisys, one of the largest home health and hospice chains in the country. The DOJ’s lawsuit, which is joined by the attorneys general from Maryland, Illinois, New Jersey, and New York, is one of the agency’s most aggressive actions to halt UnitedHealth from moving further into the delivery of health care.

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Tabloid changes Pharmacy First antibiotics headline following sector concern

The Pharmacist

A national newspaper headline about obtaining antibiotics through Pharmacy First has been changed following concerns raised by the sector's negotiator, The Pharmacist can reveal. The article, published yesterday (11 November) on the Mail Online, was originally headlined 'Revealed: What you need to say to a pharmacist to get antibiotics for your sore throat'.

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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+: A scrap of data on Amgen’s obesity drug candidate wipes out $12 billion in market value

STAT

On Tuesday, a tiny shred of data on Amgen’s lead obesity candidate — not yet verified — erased $12 billion in market value. The data, spotted by an analyst at Cantor Fitzgerald, focused on concerns about potential side effects with the drug, called MariTide. Once they were shared widely in an investor note, the company’s shares fell 7%, a reminder that its stock is in a highly precarious position ahead of a critical readout of the therapy.

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Rice University’s ROGUE device implants a ‘living pharmacy’ to combat diabetes and obesity

Express Pharma

Diabetes has emerged as a significant health challenge in India, affecting millions across both urban and rural areas. According to the National Family Health Survey (NFHS-5) 2019-21, the prevalence of diabetes among adults aged 15 years and above is substantial, with urban areas reporting higher rates compared to rural regions. The International Diabetes Federation (IDF) estimated that there were 72.9 million people with diabetes in India in 2017, projected to rise to 134.3 million by 2045.

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STEERLife and Callidus Research Laboratories partner to accelerate drug development

Express Pharma

STEERLife, and Callidus Research Laboratories have forged a strategic partnership to accelerate drug development for global markets. The collaboration combines STEERLife’s advanced hot melt extrusion (HME) and continuous processing technologies with Callidus’ Pharmaceutical drug development expertise, to address the global demand for innovative drug formulations and development.

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Opinion: How ADHD wired me for scientific discovery

STAT

Imagine a mind that’s constantly buzzing, leaping from one thought to the next, struggling to filter out the noise of a world that feels perpetually turned up to 11. That’s the experience of living with attention deficit hyperactivity disorder, a reality I know intimately. It has profoundly shaped my journey as a scientist, from the setbacks of my early years to the discoveries I’ve made in my laboratory.

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Pharma’s grip on cancer R&D is having unintended consequences

PharmaVoice

A pair of studies paint a complicated picture of funding and missed research opportunities.

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STAT+: How Pfizer used wearables to tap into the promise of an experimental drug

STAT

Pfizer’s promising research on a treatment for a dangerous cancer-related condition is also helping prove out the value of wearables in clinical trials. In September, the pharma giant reported results showing that an experimental antibody could positively impact people with cachexia, a complication sometimes called “wasting syndrome” that can cause people with cancer to lose weight and make it harder for them to tolerate treatments.

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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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'Much bigger' Pharmacy First awareness campaign needed

The Pharmacist

NHS England (NHSE) has relaunched its Pharmacy First advertising campaign with minor tweaks, but sector leaders are concerned it still does not go far enough. Community Pharmacy England (CPE) chief executive Janet Morrison said the campaign – which includes TV, radio and social media adverts – needs to be part of ‘a much bigger, ongoing […] The post 'Much bigger' Pharmacy First awareness campaign needed appeared first on The Pharmacist.

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STAT+: Despite setback, AbbVie’s big bet on neuroscience has yet to play out

STAT

For AbbVie, the good news this week is that the failure of a high-profile schizophrenia drug in two key trials hardly marks its last opportunity to make strides in neuroscience. The bad news is that the effort might not get any easier. The company has had high hopes for the schizophrenia treatment, called emraclidine, which was the centerpiece of its $9 billion acquisition of Cerevel Therapeutics.

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Daiichi and AZ pull Dato-DXd filing with FDA and try again

pharmaphorum

Daiichi Sankyo and AstraZeneca give up on their NSCLC application for Dato-DXd, and refile seeking a narrower label

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STAT+: AstraZeneca, Daiichi Sankyo change strategy on closely watched cancer drug

STAT

LONDON — AstraZeneca said Tuesday it has had to resubmit a closely watched medicine for U.S. approval in a different form of lung cancer, a step that will delay the drug’s arrival on the market and that will add to questions about how widely it could be used.  The medicine, datopotamab deruxtecan, or Dato-DXd, is a type of next-generation chemotherapy called an antibody-drug conjugate that AstraZeneca and other companies have been pouring investments into.

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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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Merck drug for rare tumour hits phase 3 target

pharmaphorum

Merck KGaA is shaping up to take on Daiichi Sankyo and Ono Pharma in the market for tenosynovial giant cell tumour (TGCT) therapies after its drug candidate pimicotinib cleared a phase 3 trial.The German group said the CSF-1R inhibitor given as a once-daily, oral dose hit its primary endpoint in the MANEUVER study, achieving an objective response rate (ORR) at week 25 of 54% compared to 3.2% for a matched placebo in patients with TGCT, a rare disease affecting the joints and tendons.

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STAT+: RNA startup Orna Therapeutics cuts more jobs

STAT

Biotech startup Orna Therapeutics has cut more jobs in its second round of layoffs in the last year, STAT has learned.  Orna was part of a buzzy cohort of companies established in the wake of the Covid pandemic, planning to create a new, more durable type of RNA-based medicines. It launched in 2021 and quickly garnered attention from Gilead subsidiary Kite Pharma, Bristol Myers Squibb, Novartis, and Merck.

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NHS England relaunches anti-smoking pill programme

pharmaphorum

'Game-changer' daily pill to quit smoking returns to NHS after three-year absence after a deal between Teva and NHS England

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OpenAI isn’t built for health care. So why is its tech already in hospitals, pharma, and cancer care?

STAT

The company behind ChatGPT didn’t set out to tackle health care.

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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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Neurogene shares fall on Rett syndrome gene therapy data

pharmaphorum

Neurogene says Rett syndrome gene therapy improves clinical symptoms, but a serious adverse event causes shares to fall

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STAT+: Pharmalittle: We’re reading about 23andMe retrenching, AstraZeneca reworking cancer drug plans, and more

STAT

Top of the morning to you. And a fine one it is. Lots of sunshine and clear blue skies are once again enveloping the Pharmalot campus, where the official mascots are bounding about the grounds in search of creatures to annoy. As for us, we are as busy as ever hunting and gathering items of interest. We trust you have your own hectic agendas. So join us as we hoist the ever-present cup of stimulation — our choice today is coconut rum — and attack the fast-growing to-do list.

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FDA clears Novavax to resume trials of Covid-19 and flu combo vaccine 

Pharmaceutical Technology

The FDA agreed for Novavax to continue trials of its vaccine combo after addressing a serious adverse event that paused trials.

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Biotech investors, including Third Rock, pump $100M into a startup’s genetic medicine for ALS

BioPharma Dive

Trace Neuroscience aims to advance an RNA-binding therapy designed to preserve — and potentially improve — muscle function in people living with the nerve-destroying disorder.

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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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Top 10 Challenges in Generic Drug Development

Drug Patent Watch

Generic drug development is a crucial aspect of the pharmaceutical industry, providing cost-effective alternatives to brand-name medications. However, this process is not without its challenges. Here are the top 10 challenges faced by generic drug developers: Generic drug development involves navigating complex regulatory frameworks, including the U.S.

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Alembic Pharma gains USFDA final approval for Ivabradine Tablets, 5 mg and 7.5 mg

Express Pharma

Alembic Pharmaceuticals announced that it has received Final Approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ivabradine Tablets, 5 mg and 7.5 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Corlanor Tablets, 5 mg and 7.5 mg, of Amgen. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated to reduce the risk of hospitalisation for worsening heart failure

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AstraZeneca, Daiichi revise approval plans for Enhertu successor

BioPharma Dive

Following mixed study results, the partners have backed away from seeking broad clearance of dato-dxd in lung cancer and instead are aiming for a narrower approval.

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Abbisko’s pimicotinib hits primary endpoint in phase 3 TGCT trial

Outsourcing Pharma

Abbiskoâs small molecule drug pimicotinib has smashed the primary goal of a phase 3 trial for the treatment of tenosynovial giant cell tumor (TGCT), taking the asset a step further to the market in China and elsewhere.

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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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Understanding the FDA's Exemption for DSCSA Compliance

Pharmaceutical Commerce

In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.

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Next gen wearables: Transforming remote patient care

pharmaphorum

Virtual wards (also known as hospital at home) allow patients to get the care they need at home safely and conveniently, rather than being in hospital. The NHS is increasingly introducing virtual wards to support people at the place they call home, including care homes. In today’s podcast, web editor Nicole Raleigh speaks with Dr Samuel Ewing, global head of pharma partnerships at Doccla, about the next generation of digital tools such as wearable medical devices, as well as remote patient monit

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Why Blockchain is Key to Enhancing Supply Chain Integrity

Pharmaceutical Commerce

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jonathan Colehower, managing director, global operations & supply chain practice at UST, explains how the use of blockchain technology will become more prominent moving forward.

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New $3.5b AstraZeneca investment to accelerate US R&D and manufacturing

European Pharmaceutical Review

To boost AstraZeneca’s research and manufacturing footprint by the end of 2026, it is dedicating $3.5 billion of capital investment in the US. Of this amount, $2 billion will generate over 1,000 new jobs, the company added. AstraZeneca highlighted its US footprint is expanding in multiple areas such as: • a state-of-the-art R&D centre in Kendall Square, Cambridge, Massachusetts • next generation biologics manufacturing facility based in Maryland • cell therapy manufacturing capacity on the W

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Chasing $80bn sales target, AZ unveils $3.5bn US investment

pharmaphorum

AstraZeneca plans to invest a whopping $3.5 billion to expand its R&D and manufacturing operations in the US by 2026 as part of a drive to raise its revenues to $80 billion by the end of the decade.The programme – part of the pharma group's Ambition 2030 effort – will include the construction of a new R&D centre at Kendall Square in the heart of the biopharma hub in Cambridge, Massachusetts, and a biologics manufacturing facility in Maryland.

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