Sat.Sep 03, 2022 - Fri.Sep 09, 2022

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STAT+: In reversal, FDA advisers vote to support approval of Amylyx’s drug for ALS

STAT

At the end of an unusual and dramatic meeting on Wednesday, an independent panel of advisers to the Food and Drug Administration recommended the approval of a new drug to treat people with ALS developed by Amylyx Pharmaceuticals. The vote was 7-2, a substantial margin of support for the Amylyx drug called AMX0035 and a reversal of the same group’s vote against the drug last March.

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The 2022 PharmaVoice 100

PharmaVoice

From standout executives to R&D pioneers — this year’s class of honorees is defining the next era of leadership.

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Trending Sources

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Brainomix and Bridge Biotherapeutics enter artificial intelligence partnership

Pharma Times

Link up will utilise Brainomix’s AI software for the assessment of idiopathic pulmonary fibrosis

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The discovery of a new and compounding cybersecurity threat to pharmacies

pharmaphorum

Sam Crowther, founder and CEO of cybersecurity company Kasada, tells us about a recent discovery his company made that revealed tens of thousands of accounts with prescription drug attachments in major online pharmacies had been compromised. While performing analysis for a client of online accounts for sale, Kasada uncovered a new and illegal way bots are being used – to steal pharmacy customers’ accounts and resell prescriptions on a secondary market for in-demand substances, such as Oxyc

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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

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Pfizer isn’t sharing Covid vaccines with researchers for next-gen studies

STAT

WASHINGTON — Researchers studying next-generation vaccines to fight an evolving Covid-19 threat are running into problems getting existing vaccines to use in their research. Because Pfizer and Moderna hold the patents for the current vaccines, researchers would likely have to get the companies’ permission to use them for research into products like nasal or pan-coronavirus vaccines.

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Entrepreneurs: Vincent Keunen

PharmaVoice

With his unique platform, the has built a bridge between patients, physicians and researchers around the world.

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More Trending

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Stada launches prostate cancer treatment across 21 European countries

Pharma Times

Company is introducing abiraterone film-coated tablets for treating metastatic prostate cancer

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STAT+: Relay Therapeutics drug shows promise in early trial

STAT

A daily dose of Relay Therapeutics’ experimental drug for cholangiocarcinoma, a rare cancer of the bile ducts, led to tumor shrinkage of a third or more in 15 of 17 patients with metastatic disease, the company said Wednesday. The results were released in an abstract at the annual meeting of the European Society of Molecular Oncology, where they will be presented in full on Sunday.

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Woman of the Week: Foresite Capital’s Cindy Mesaros

PharmaVoice

The longtime marketing pro details her fascinating career journey and how she’s positioning early stage health companies to thrive.

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Bridge Bio will use Brainomix AI in lung fibrosis trial

pharmaphorum

Brainomix has reeled in another pharma partner for its artificial intelligence-powered biomarker software, used to track the performance of therapeutic interventions in clinical trials. South Korea’s Bridge Biotherapeutics has signed up to use the UK medtech firm’s e-ILD software package in a phase 2 trial of BBT-877, its experimental therapy for serious lung disease idiopathic pulmonary fibrosis (IPF).

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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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PhoreMost in drug target discovery collaboration with Roche

Pharma Times

PhoreMost will use Siteseeker platform to identify novel targets for Roche’s discovery programmes

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STAT+: Why Illumina has a merger mess of its own making

STAT

For Illumina, the leading maker of DNA sequencing equipment, there was bad news and worse news Tuesday. The bad news: The European Commission said it was blocking Illumina’s $8 billion acquisition of Grail, a firm focused on the early detection of cancer. The worse news? In its press release on the ruling, Illumina acknowledged that, although it will appeal, that may not prevent the European Commission from forcing it to divest Grail, which it purchased before regulatory approvals were in

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Disrupters: Trishna Bharadia

PharmaVoice

As a patient advocate, The Spark Global’s owner is transforming how pharma companies approach patient centricity.

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Novo Nordisk, Kry partner on digital programme for obesity

pharmaphorum

Digital health specialist Kry has teamed up with pharma group Novo Nordisk on the development of resources that can help people with obesity manage their condition and adhere to treatment. The partners anticipate that the digital obesity programme will launch later this autumn in Sweden, ahead of a broader rollout in other European markets before the end of the year.

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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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Sanofi and Regeneron’s Dupixent shows consistent safety profile

Pharma Times

Study involving children aged six to 11 years with moderate-to-severe asthma reveals positive data

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As masks are shed, a routine visit to a medical office can pose Covid risks for some patients

STAT

In May, Sarah Fama had to get blood work done before refilling a prescription for an autoimmune disorder. Because her condition put her at high risk for Covid-19, and she lives with her parents, both in their 80s, she checked the lab’s website, which stated that masks were required inside. When she arrived, she was reassured by a sign on the door that said the same thing.

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Clinical registry data, a valuable source of real-world data

PharmaVoice

Real-world data (RWD) from clinical drug registries can and should be used throughout the drug development lifecycle. At all stages, registries ensure that assumptions about the current standard of care are accurate and evidence-based.

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Roche to acquire biopharma firm Good Therapeutics for $250m

Pharmaceutical Technology

Roche has signed a definitive merger agreement for the acquisition of US-based biopharmaceutical company Good Therapeutics for an upfront payment of $250m in cash. Good Therapeutics focuses on the development of PD-1-regulated IL-2 drugs that are based on innovative conditionally active drug technology. With the takeover, Roche will attain rights to a conditionally active, PD-1-regulated IL-2 programme of Good Therapeutics.

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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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Positive phase 3 data for Sanofi’s Dupixent

Pharma Times

Research showed significant improvements in signs and symptoms of prurigo nodularis

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Google debuts a new AI tool in the global fight against tuberculosis

STAT

Tuberculosis kills 1.4 million people every year, primarily in places where poverty and deprivation conspire to make people uniquely vulnerable, and unable to get lifesaving care in time. Google is now joining a global fight to snuff out the disease, using AI to automate its detection — and expedite treatment — in communities where physicians are in short supply.

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Drug recalls are ticking upwards — here’s how to avoid costly pitfalls

PharmaVoice

Supply chain challenges, labor shortages and increased FDA inspections are boosting recall risks — but careful planning can keep companies in the clear.

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Ypsomed brings Sidekick on board to fight self-injection anxiety

pharmaphorum

Asking patients with chronic conditions to regularly inject themselves can be challenging, causing needle anxiety and worry that they may not carry out the procedure correctly, which can reduce compliance. Now, a partnership between Ypsomed and Sidekick Heath aims to tackle that problem. Ypsomed is a top developer of injection and infusion systems, so knows a lot about the difficulties that patients can face when getting to grips with these medical devices, particularly when they are just starti

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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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UCB reveals new Bimzelx ‘complete skin clearance’ data

Pharma Times

Positive data represents a boost for patients with moderate to severe plaque psoriasis

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Opinion: Open access to research can close gaps for people with disabilities

STAT

In a long-overdue move, the federal Office of Science and Technology Policy has issued guidance on making federally supported research and publications available to all without delay or embargo. This remarkable announcement about open access has the potential to remove information barriers that have long held back social and scientific progress. Even with immediate open access to research results, however, people with disabilities face unique barriers to information access.

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Innovators: Dr. Stephen Dale

PharmaVoice

The CMO at Kura Oncology, a clinical-stage biopharma company, is charting a new course to deliver on the promise of precision medicine in oncology.

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EU regulators release new workplan for accelerating clinical research

European Pharmaceutical Review

The 2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU ( ACT EU ) has been published by the European Commission (EC), Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA). Launched in January, ACT EU aims to transform how clinical trials are initiated, designed and run, building off of the Clinical Trials Regulation (CTR) and Clinical Trials Information System (CTIS) which became applicable in the same month.

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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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BioInnovation Institute reveals new cohort entering Venture Lab programme

Pharma Times

Group consists of nine ventures plus corporate-sponsored innovation projects from Novo Nordisk

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Opinion: Breaking the ‘corporate medical playbook’ that silences physicians’ reports of inequity

STAT

As a woman of color who was fortunate to be accepted to medical school 29 years ago, I thought that if I had the intelligence, grit, and credentials, I would succeed. I thought that the profession of medicine operated within a system of meritocracy: work hard and you will be rewarded. I learned the hard way that it isn’t like that. My post-graduate professional journey has spanned a general surgery residency, fellowships in hospice and palliative medicine and clinical medical ethics, all

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Disrupters: Dr. Tania Small

PharmaVoice

GSK’s medical oncology head is paving the way for patient-driven drug development and more equitable care.

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China NMPA grants approval for CanSinoBIO’s Covid-19 vaccine as booster

Pharmaceutical Technology

The National Medical Products Administration of China (NMPA) has approved CanSino Biologics ’ (CanSinoBIO) recombinant Covid-19 vaccine (Adenovirus Type 5 Vector) for inhalation, Convidecia Air, as a booster. This vaccine leverages the same adenovirus vector technological platform as Convidecia, the intramuscular version. Providing a non-invasive option, Convidecia Air utilises a nebuliser to convert liquid into an aerosol for inhaling through the mouth, the company noted.

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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.