Fri.Dec 01, 2023

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People with congenital heart disease are living longer — but facing new threat of heart failure

STAT

When Jennifer Case was living in Los Angeles in her early 30s, she was hospitalized 11 times. She had been born with two rare heart abnormalities, Ebstein anomaly and Wolff-Parkinson-White syndrome. Her parents were told that she probably wouldn’t live.

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3 standout digital innovations in pharma this year

PharmaVoice

IDEA Pharma just released its Digital Innovation Index. Here are the top companies they identified and some of the standout advances the industry made.

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Life-extending epilepsy surgery performed less often in Black children, study finds

STAT

Children with drug-resistant epilepsy who are Black or insured through Medicaid may be less likely than white and privately insured patients to receive surgical treatments that can end or minimize their seizures and extend their lives, according to new research being presented Monday at the American Epilepsy Society’s annual meeting in Orlando, Fla.

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ASBM Exhibits at ACR Convergence 2023

Safe Biologics

From November 12-14, ASBM exhibited at Booth #2612 at ACR Convergence 2023 in San Diego, CA. ACR Convergence is hosted annually by the American College of Rheumatology and is considered the premier meeting for rheumatology professionals globally. ASBM was represented at the booth by Executive Director Michael Reilly, Advisory Board Chair Philip Schneider, and Programs Director Ray Patnaude.

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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+: Pfizer to halt development of its twice-daily oral obesity drug, following disappointing trial

STAT

Pfizer on Friday said it was stopping development of a twice-daily oral obesity medication after an underwhelming clinical trial, a blow to the company’s efforts to compete in the booming field of weight-loss medications. The medicine, danuglipron, met its primary target in a placebo-controlled Phase 2b trial, leading to a statistically significant amount of weight lost, the company said.

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AbbVie agrees $10 billion oncology acquisition

European Pharmaceutical Review

AbbVie has agreed to acquire ImmunoGen and its first-in-class antibody-drug conjugate (ADC) ELAHERE ® (mirvetuximab soravtansine-gynx), for a total of approximately $10.1 billion. The antibody-drug conjugate is the first to be approved for platinum-resistant ovarian cancer (PROC) and show meaningful survival benefit for this form of the disease. As a folate receptor alpha (FRα) with a maytansinoid payload DM4, a potent tubulin inhibitor, the biologic medicine offers expansion opportunities in e

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Don’t Get Distracted By AI, Instead Focus on Intellectual Property

PharmExec

Artificial intelligence is making it quicker to get drug candidates to the clinic, but it isn’t addressing the fundamental need to marry the right candidate and the right target to the right disease.

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STAT+: Patients wants test results now, and radiologists need time to explain. Can they meet in the middle?

STAT

One of the hardest parts about getting an X-ray or a CT scan is the wait. Sometimes it takes days, or even weeks, for medical imaging results to be analyzed by a radiologist, transferred to a primary doctor, and then delivered to the patient — good news or bad. Today, that hand-wringing delay has been nearly eliminated. In 2021, provisions from the 21st Century Cures Act kicked in that require health centers to provide patients with access to their health information on request — i

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NHS England releases PGDs for Pharmacy First service

The Pharmacist

Drafts of the 23 patient group directions (PGDs) and one protocol for the Pharmacy First service have now been published by NHS England. This follows the release earlier in the week of service specifications and the clinical pathways for the seven common conditions included in the scheme – uncomplicated urinary tract infection (UTI) in women, […] The post NHS England releases PGDs for Pharmacy First service appeared first on The Pharmacist.

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Johnson & Johnson bets heavy on AI-driven drug discovery

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Today we talk about Pfizer’s obesity woes, how J&J is leaning heavily into artificial intelligence, chat about how ADCs are having a heyday, and ponder the zombie microcap.

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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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FDA Priority Review Granted to Keytruda/Padcev Combo for Locally Advanced, Metastatic Urothelial Carcinoma

Pharmaceutical Commerce

In clinical trials, Keytruda plus Padcev lowered the risk of disease progression or death by 55% compared with chemotherapy in adult patients with locally advanced or metastatic urothelial carcinoma.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.   That’s right.  Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Prostate cancer focal therapy could improve costs and patient outcomes

Pharma Times

Every year, over 44,000 men are diagnosed with prostate cancer in England - News - PharmaTimes

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STAT Virtual Event – Decoding Clinical Trials: Venture Capitalists Talk Early Biotech R&D

STAT

Editor’s note: A livestream of the event will be embedded below at 1 p.m. ET. After a few go-go years, the early-stage biotech market has cooled considerably. Two VCs will weigh in on what distinguishes great science from bad investments.

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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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European regulators want to know more about the risks of GLP-1 drugs

BioPharma Dive

The EMA's safety committee has more questions for makers of the in-demand therapies as it reviews whether the drugs are linked to the risk of suicidal thoughts.

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STAT+: Pharmalittle: Pfizer halts development of twice-daily obesity pill; Supreme Court to review Purdue bankruptcy deal

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is rather modest. We plan to promenade with the official mascots, tidy up the leafy grounds, and maybe have a listening party with Mrs. Pharmalot. The rotation will likely include this , this , this and this.

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Celebrating Creativity and Resilience: EveryLife Foundation’s Rare Artist Program

Putting Patients First Blog

Celebrating Creativity and Resilience: EveryLife Foundation’s Rare Artist Program December 1, 2023 By: Stephanie Riordan, Director of Patient Programs, EveryLife Foundation for Rare Diseases In the heart of every challenge lies a unique opportunity for expression and empowerment. At the EveryLife Foundation for Rare Diseases, we firmly believe in the transformative power of art, especially in the lives of those affected by rare diseases.

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New Year’s Resolutions Trends: What Doctors Resolve To Do

Board Vitals - Pharmacist

With 2024 rapidly approaching, there comes the question of New Year’s Resolutions. Are they to be made or ignored? Many physicians use them to refocus their efforts on meaningful initiatives. Under the guise of a new year’s resolution, some clinicians take the opportunity to remind influencers and stakeholders of efforts that need to be redoubled for the benefit of patients and patient 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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Challenging applications of capillary electrophoresis in biopharmaceutical analysis

European Pharmaceutical Review

Since its introduction in 1980, capillary electrophoresis (CE) has been one of the most powerful techniques applicable as a choice method in the biopharmaceutical industry for the characterisation and quality control (QC) testing of biomolecules such as proteins, peptides as well as monoclonal antibodies (mAbs) and high molecular weight polysaccharides. 1 In addition to the intrinsic advantages of CE, such as high separation efficiency, high resolution, low sample volume requirements, short sepa

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Radiotherapy boost shown to reduce treatment times for breast cancer patients

Pharma Times

Every year, around 55,000 women in the UK are diagnosed with the condition - News - PharmaTimes

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Survey reports on falsification of medical devices

European Pharmaceutical Review

A new report by the Committee of Experts on minimising the public health risks posed by falsified medical products and related crimes (CD-P-PH/CMED) shares insight on how authorities perceive and address the falsification of medical devices. The report details findings from survey completed by 21 of the 46 Council of Europe member states on counterfeit medical devices.

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Expanded contraception and hypertension pharmacy services go live

The Pharmacist

Pharmacists can now initiate oral contraception and trained members of the pharmacy team can deliver blood pressure checks, with the expansion of the Pharmacy Contraception Service and the Hypertension Case-Finding Service coming into force from today (1 December 2023). As well as initiating oral contraception, pharmacists can continue to provide ongoing management of oral contraception […] The post Expanded contraception and hypertension pharmacy services go live appeared first on The Pha

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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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Drug development trends: insight from Thermo Fisher’s Anil Kane

European Pharmaceutical Review

During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drug development. Dr Kane leads a team of subject matter experts at Thermo Fisher, covering drug products in both sterile injectable dosage and oral solid dosage forms.

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AZ drops two trials aimed at expanding Lokelma’s label

pharmaphorum

AstraZeneca has decided to abandon two phase 3 trials of its drug to reduce high levels of potassium in the blood (hyperkalaemia) – Lokelma – in patients with kidney disease. The STABILIZE-CKD and DIALIZE-Outcomes studies – part of AZ’s CRYSTALIZE programme for the drug – have been shelved because patients were being enrolled into them more slowly than hoped for, and clinical events were occurring at a lower rate than expected.

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Orchard secures FDA fast track designation for Hurler syndrome gene therapy

Pharmaceutical Technology

Hot on the heels of the designation, Orchard Therapeutics is pressing ahead with a multi-centre trial for the candidate with a start date in December.

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Plan now for upcoming valproate prescribing rule changes, instructs MHRA

The Pharmacist

New regulatory measures tightening the rules around valproate prescribing are set to come into force from January 2024, and the Medicines and Healthcare products Regulatory Agency (MHRA) is urging healthcare organisations to adequately prepare. From the new year, the first phase of the new measures will curb the use of valproate in new male or […] The post Plan now for upcoming valproate prescribing rule changes, instructs MHRA appeared first on The Pharmacist.

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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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Lupin launches Turqoz (Norgestrel and Ethinyl Estradiol) Tablets USP in the US

Express Pharma

Lupin announced the launch of Turqoz (Norgestrel and Ethinyl Estradiol) Tablets USP, 0.3 mg/0.03 mg, after having received an approval from the United States Food and Drug Administration (US FDA). Turqoz (Norgestrel and Ethinyl Estradiol) Tablets USP, 0.3 mg/0.03 mg is the generic equivalent of Lo/Ovral-28 (Norgestrel and Ethinyl Estradiol) Tablets, 0.3 mg/0.03 mg of Wyeth Pharmaceuticals LLC and is a contraceptive drug indicated to prevent pregnancy.

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AstraZeneca’s durvalumab recommended for bile duct cancers

Pharmaceutical Technology

The SMC and NICE have recommended the use of AstraZeneca’s durvalumab to treat advanced biliary tract cancers in England and Scotland.

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Syngene concludes acquisition of biologics facility from Stelis Biopharma

Express Pharma

Syngene International announced the conclusion of the acquisition of a multi-modal biologics manufacturing facility from Stelis Biopharma as announced on July 4, 2023. The acquisition of the ‘Unit 3’ biologics manufacturing facility was concluded at a revised gross value of Rs 617 crores adjusted from the earlier gross value of Rs 702 crores. The reduction in gross value reflects the retention of certain equipment not currently installed in the facility by Stelis Biopharma.

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Biocon integrates Viatris biosimilars in 31 European countries

Pharmaceutical Technology

Biocon subsidiary Biocon Biologics has successfully integrated Viatris' biosimilars business in 31 countries in Europe.

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We are committed to delivering excellence across the pharma supply chain

Express Pharma

How does Körber contribute to safe and efficient processes in the manufacture, inspection, and packaging of pharma products? Can you share some examples of innovative solutions or technologies that your company has developed for the pharma industry? In the dynamic landscape of pharma manufacturing, we are standing as a beacon for safe and efficient processes.