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

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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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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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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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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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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+: 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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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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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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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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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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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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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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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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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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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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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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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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Dolutegravir shows promise in pregnancy

European Pharmaceutical Review

Comparing the use of common antiretroviral therapy (ART) regimens in pregnancy suggests that dolutegravir-based regimens have a higher probability of human immunodeficiency virus type 1 (HIV-1) viral suppression at delivery. In a study published in the New England Journal of Medicine , researchers compared the effectiveness and safety of dolutegravir-based ART to five ART regimens recommended for use in pregnancy in the US and Europe: atazanavir–ritonavir, darunavir–ritonavir, oral rilpivirine,

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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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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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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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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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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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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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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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UV-based PAT could enable continuous protein purification

European Pharmaceutical Review

Researchers have developed a simple, fast and cost-effective ultraviolet (UV) spectroscopy-based method that could act as a process analytical technology (PAT) to enable integrated or continuous downstream protein purification operations. As the industry works to establish continuous bioproduction/bioprocessing in hopes of realising the benefits of reduced process costs and increased flexibility to cope with demand, the development of PAT tools that can provide real-time measurements and support

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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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Bayer agrees to pay $40m to resolve claims on three drugs

Pharmaceutical Technology

Bayer has agreed to make a payment of $40m for settling claims over the alleged violations of the False Claims Act linked to three drugs, Trasylol, Avelox and Baycol, the US Department of Justice said in a press statement. The settlement comes after a former Bayer employee, Laurie Simpson, filed two 'whistleblower' lawsuits against the company. These litigations were filed under the qui tam or whistleblower provisions of the False Claims Act, which facilitate private citizens to file lawsuits ag

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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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Epilepsy rescue therapy significantly increases time between seizure clusters

European Pharmaceutical Review

“The most exciting finding of the study is the robustness of the signal in the cluster-interval data,” noted co-author and Assistant Professor of Neurology at Harvard Medical School, US, Dr Jurriaan Peters. “The results consistently showed a clinical and statistical increase in the time between use of intranasal diazepam, Valtoco, over time.

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Push to double up on Covid booster and flu shot may have a downside, experts caution

STAT

“I really believe this is why God gave us two arms — one for the flu shot and the other one for the Covid shot.” — Ashish Jha, White House Covid coordinator, Sept. 6, 2022. As the promotional push to get people vaccinated with one of the updated, bivalent Covid vaccines heats up, federal health authorities are urging Americans to consider getting their Covid shot and their flu shot at the same time.

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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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India grants approval for Bharat Biotech’s intranasal Covid-19 vaccine

Pharmaceutical Technology

Indian company Bharat Biotech International has secured approval from Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for its intranasal Covid-19 vaccine, iNCOVACC (BBV154), for usage in people aged 18 years and older. A recombinant replication-deficient adenovirus vectored vaccine, iNCOVACC has a prefusion stabilised spike protein and is claimed to be the first intranasal vaccine globally to obtain primary two-dose schedule approvals.

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Assessing HCP-Visit Fallout: COVID’s Ultimate Impact on New Drug Entrants

PharmExec

Tracking the pandemic’s influence on brand awareness and prescribing efforts in light of decline in physician visits and fewer diagnoses—and what these dynamics, still unsettled post-pandemic, might mean for future launches.

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