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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More Trending

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Tetra and Cellvera partner to develop oral Covid-19 treatment

Pharmaceutical Technology

Tetra Bio-Pharma and Cellvera have entered an agreement to jointly develop ARDS-003 as an oral combination therapeutic candidate with 400mg Qifenda (Favipiravir) for Covid-19. A first-in-human drug product, ARDS-003 contains the active pharmaceutical agent, Onternabez. Onternabez is a selective full agonist of the type 2 cannabinoid receptor (CB2R).

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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+: Gilead drug prolongs survival of women with common form of breast cancer

STAT

Gilead Sciences said Wednesday that its cancer drug Trodelvy prolonged the survival of women with the most common form of breast cancer by just under 30% — a clinical trial result that could lead to a better treatment option for patients with advanced disease and strengthen the drug’s commercial outlook. In the study, called TROPICS-02, Trodelvy showed a median overall survival of 14.4 months compared to 11.2 months for comparator chemotherapy.

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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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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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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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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+: 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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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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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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Driving drug innovation: developments in pharmaceutical capsules

European Pharmaceutical Review

The second most commonly used pharmaceutical dosage form, capsules, are anticipated to be a $5.2 billion market by 2030, growing from a 2020 value of around $2.4 billion. 1 Here experts Torkel Gren of Recipharm and Dr Jnanadeva Bhat of ACG-Worldwide share key developments in capsules by answering four key questions. What are the major trends in capsule development?

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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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Fentanyl test strips could help save lives. In many states, they’re still illegal

STAT

Nothing has made the nation’s addiction epidemic more deadly than fentanyl’s infiltration of the drug supply. Yet in more than a dozen states, tools used to detect the ultra-potent synthetic opioid are still classified as drug paraphernalia — making it a crime to possess or distribute them. The practice of “drug-checking” — essentially, testing illicit drugs to see if they contain unknown toxins — has remained controversial even as the crisis of f

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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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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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AstraZeneca on the hunt for new acquisitions

Pharmaceutical Technology

Following AstraZeneca’s success in vaccine development during the Covid-19 pandemic , the pharmaceutical giant is now looking to expand its scope through acquisitions across a range of indications, says CEO Pascal Soriot. “We want to be a sustainably growing company. Until 2025, we have strong growth ahead of us, but we also believe we can continue to grow very strongly post-2025 and it’s all about innovation in the pipeline.”.

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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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Opinion: Dying of a disease I never knew existed

STAT

By this time next year, if the medical forecasts are correct, I will probably be dead, another casualty of a fatal illness that most people have never heard of: idiopathic pulmonary fibrosis (IPF). This condition has been described by Michael J. Stephen in his 2021 book “Breath Taking” as the “most frustrating and disheartening of all the diseases in pulmonary medicine.

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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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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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NICE says no to Lynparza in prostate cancer, creating UK access divide

pharmaphorum

NICE has said it is unable to recommend NHS use of AstraZeneca’s Lynparza for some patients with prostate cancer, after failing to reach an agreement on price with the drugmaker. The health technology assessment (HTA) authority said that the PARP inhibitor “is not cost-effective at its current price” as a treatment for BRCA-positive prostate cancer that has spread to other parts of the body and relapsed after prior hormonal therapy.

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Valneva and VBI announce partnership for hepatitis B vaccine

Pharma Times

Collaboration involves the marketing and distribution of PreHevbri across Europe

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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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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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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.