Mon.Nov 11, 2024

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STAT+: The end of 23andMe’s drug discovery dream

STAT

23andMe, the genetics startup that has repeatedly captured the public imagination and then faced nearly fatal business challenges, announced Monday that it would halt its efforts to develop new medicines and lay off 40% of its workforce, focusing instead on selling genetic tests to consumers and using the resulting data for research. In closing its therapeutics division and laying off 200 people, 23andMe ended an audacious bet it made nearly a decade ago — that it could use the genetic da

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Spravato is just the beginning in a new wave of depression meds

PharmaVoice

Psychiatry is getting more targeted as drugmakers develop a new range of treatments for depression.

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STAT+: Schizophrenia drug AbbVie picked up in $9 billion acquisition fails in key trials

STAT

AbbVie said Monday that its experimental treatment for schizophrenia failed to significantly help patients in two trials, a blow to the company, which got the drug through its recent $9 billion acquisition of Cerevel Therapeutics. In Phase 2 studies, patients on different doses of the drug, called emraclidine, did not experience significant improvements on a test called the Positive and Negative Syndrome Scale (PANSS) compared with the placebo group.

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On Wall Street, ‘flat out’ failure of AbbVie schizophrenia drug leaves analysts stunned

BioPharma Dive

Negative drug results cost AbbVie billions of dollars in market value and convinced analysts that Bristol Myers had placed a better bet in buying Karuna Therapeutics.

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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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Cardiovascular health disparities persist in puzzling ways, studies find

STAT

Last week’s election results may signal political winds sweeping attention away from diversity, equity, and inclusion, but new research papers again make the case that people in different socioeconomic groups have differing health outcomes of concern.

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FDA’s Proposal to Remove Oral Phenylephrine from the OTC Monograph Isn’t a Surprise but What is Left “Over-the-Counter”?

FDA Law Blog: Biosimilars

By Deborah L. Livornese & JP Ellison — On November 8, 2024, FDA issued a proposed order to remove the oral decongestant ingredient phenylephrine (including both phenylephrine hydrochloride and phenylephrine bitartrate) (collectively, PE) from the OTC monograph on the basis of a lack of effectiveness. FDA also noted that it has concluded that no safety signal was identified for oral PE at doses permitted under the monograph.

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RSV and norovirus circulating at high levels for time of year

The Pharmacist

Respiratory syncytial virus (RSV) is circulating above baseline levels with particularly pronounced increases in those under five years old, surveillance figures show. Emergency department attendances for acute bronchiolitis have also increased nationally, NHS figures show. And the UK Health Security Agency has warned that norovirus activity in the last two weeks of October was 16% […] The post RSV and norovirus circulating at high levels for time of year appeared first on The Pharmacist.

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AI tool spots long COVID in electronic health records

pharmaphorum

Mass General Brigham researchers have developed an AI that can spot hidden cases of long COVID from electronic health records

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CPhO 'optimistic' about opportunities for community pharmacy

The Pharmacist

England's chief pharmaceutical officer (CPhO) David Webb is 'optimistic' about community pharmacy given the new government's priorities for healthcare, he told the Royal Pharmaceutical Society (RPS) conference on Friday. ''I was quite pleased when the government started talking about the three strategic shifts. sickness to prevention, analogue to digital, acute to community and primary - […] The post CPhO 'optimistic' about opportunities for community pharmacy appeared first on T

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FDA approves new CAR-T competitor to Gilead’s Tecartus

BioPharma Dive

Developer Autolus set a list price of $525,000 for its new cell therapy, which it will sell for a type of leukemia under the brand name Aucatzyl.

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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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Alteogen and Daiichi Sankyo sign license deal for ADC development

Pharmaceutical Business Review

ALT-B4 will be used for developing the subcutaneous formulation ENHERTU. As per the agreement, Daiichi Sankyo will gain global rights to utilise Alteogen’s ALT-B4, a human recombinant hyaluronidase enzyme. Furthermore, Alteogen is entitled to receive an upfront payment and milestone payments upon the achievement of certain development, regulatory, and sales-based goals from Daiichi Sankyo.

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FDA lifts pause on Novavax flu vaccine trials

BioPharma Dive

After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and unrelated to vaccination.

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Purple Life Sciences launches PSOCARE, a new psoriasis healing oil leveraging natural extracts

Express Pharma

Purple Life Sciences, a company focused on harnessing natural ingredients for medical treatment, launched PSOCARE, a healing oil for psoriasis, at an event today. This product marks one of the initial offerings from the research-led organisation, developed to manage psoriasis symptoms, including red patches, dry and cracked skin, itching, burning, flaking, scaling, and plaque formation.

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Unicycive eyes June FDA verdict for hyperphosphataemia drug

pharmaphorum

FDA starts review of Unicycive's drug for hyperphosphataemia in patients with chronic kidney disease on dialysis, aiming to improve on onerous phosphate binder therapy

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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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Autolus secures FDA approval for CAR-T cell therapy use in ALL  

Pharmaceutical Technology

Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a risk evaluation mitigation strategy (REMS) programme.

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Advantage BMS as AbbVie drug fails schizophrenia trials

pharmaphorum

AbbVie's $8.7bn play for Cerevel looks like a poor bet as its lead schizophrenia drug flunks two phase 2 trials, but which rival stands to benefit?

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Managing Drug Patent Portfolios Effectively

Drug Patent Watch

Effective management of drug patent portfolios is crucial for pharmaceutical companies to maintain market exclusivity, protect revenue streams, and drive innovation. A robust patent strategy aligned with business goals is essential for maximizing value and staying competitive in the pharmaceutical landscape.

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Parkinson’s disease clinical research in 7MM focuses on disease-modifying agents: GlobalData

Express Pharma

Parkinson’s disease (PD) therapeutic landscape is heavily genericized, leaving substantial unmet needs in neuroprotective and disease-modifying therapies (DMTs). With current treatments largely focused on motor symptoms, the pipeline across the seven major markets (7MM*) highlights a growing emphasis on DMTs and non-motor symptom therapies, signalling a commitment to advancing PD treatments that address the full spectrum of patient challenges, says GlobalData.

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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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Autolus bags FDA approval for leukaemia cell therapy

pharmaphorum

Autolus gets its first product approval, an FDA green light for anti-CD19 CAR-T Aucatzyl for B-cell acute lymphoblastic leukaemia

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Scottish medicines consortium approves CAR T-cell therapy for blood cancer

Pharma Times

First car t-cell therapy accepted for second-line treatment in Scotland

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The evolving role of AI in drug submission and approval: An expert perspective

pharmaphorum

Discover an expert perspective on how artificial intelligence is transforming the drug submission and approval process in the pharmaceutical industry. Explore the evolving role of AI in drug development.

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Pharmaceutical Technology Excellence Awards 2024: BostonGene 

Pharmaceutical Technology

BostonGene is a winner in four categories in the 2024 Pharmaceutical Technology Excellence Awards.

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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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NHS England hopes to save thousands of lives with pill that helps smokers quit

The Guardian - Pharmaceutical Industry

Experts say once-a-day varenicline tablet reduces nicotine cravings and side-effects from cutting out tobacco Hundreds of thousands of smokers will be given a pill that increases people’s chances of quitting, in a move that NHS bosses believe will save thousands of lives. About 85,000 people a year in England will be offered the chance to use varenicline, a once-a-day tablet that experts say is as effective as vapes at helping people to kick the habit.

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Moderna’s mRESVIA vaccine gains Health Canada approval

Pharmaceutical Technology

Moderna has received Health Canada's approval for its respiratory syncytial virus messenger ribonucleic acid (mRNA) vaccine mRESVIA, designed to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals aged 60 and over.

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SMC recommends Yselty for treating uterine fibroids

Pharma Times

New treatment option approved for women in Scotland

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HP demonstrates its latest innovations in labels and packaging printing technology at Labelexpo India 2024

Express Pharma

HP India, in collaboration with Technova Imaging Systems, is set to present its comprehensive lineup of HP Indigo presses and solutions for the labels and packaging industry at Labelexpo India 2024. Taking place from November 14-17, 2024, at India Expo Mart in Greater Noida , this event offers visitors a unique opportunity to experience HP Indigo’s advanced digital printing solutions firsthand at Hall 10, Booth E20.

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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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Harnessing AI and Digital Tech for Health Plan Outcomes

assurecare

Revolutionizing Healthcare: How AI is Driving Efficiency, Cost Savings, and Better Outcomes Artificial intelligence (AI) is no longer just a buzzword in healthcare—it’s a game changer. From enhancing member engagement to creating personalized care plans, AI has moved to the forefront of healthcare innovation. What started as an experimental technology in the 1980s is now a critical part of modern healthcare strategies, thanks to recent advancements in processing power and tools like ChatGPT.

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CMS commences formal review for Topical Oxygen Therapy coverage

Pharmafile

11 November 2024 AOTI, INC. (AIM: AOTI), a medical technology group focussed on the durable healing of wounds and prevention of amputations, is pleased to note that the Centers for Medicare and Medicaid Services (CMS), through its Durable Medical Equipment (DME) Medicare Administrative Contractors (MACs), has scheduled a public Contractor Advisory Committee (CAC) meeting.

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AbbVie’s $9B bet collapses as closely watched schizophrenia drug fails studies

BioPharma Dive

Shares in AbbVie slumped Monday after the company disclosed its psychiatric medicine emraclidine didn’t best placebo in two Phase 2 trials.

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Theramex receives recommendation for YSELTY in Scotland

Pharmafile

Theramex, a dedicated women’s health company, have announced that the Scottish Medicines Consortium (SMC) have recommended YSELTY (linzagolix) for the treatment of moderate or severe symptoms of uterine fibroids (UFs) in adult women of reproductive age. The decision from the SMC will see YSELTY available on the NHS across Scotland. Dr Sigi Joseph, co-founder of The […] The post Theramex receives recommendation for YSELTY in Scotland appeared first on Pharmafile.

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Have clients say YES to Dentistry!

epicur

Gain more confidence in your understanding of the importance of pet dental care and be able to convey that to your clients, resulting in increased acceptance of the dental recommendations. Watch It Now The post Have clients say YES to Dentistry!

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