Sat.Aug 13, 2022 - Fri.Aug 19, 2022

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3 ways pharma can prep for Biden’s sweeping drug pricing policies

PharmaVoice

Now that Medicare will be able to negotiate drug prices under the Inflation Reduction Act, the industry can expect to see some changes. Here are some tips on how to navigate the changing tide.

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MHRA approves Pluvicto® and Locametz® for prostate cancer

European Pharmaceutical Review

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for Pluvicto ® (lutetium [ 177 Lu] vipivotide tetraxetan), for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.

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Valneva’s Lyme disease vaccine faces final clinical test in a sparse landscape

Pharmaceutical Technology

On August 8, Pfizer and Valneva announced the initiation of a Phase III study with their Lyme disease vaccine , bringing the prospect of an injection to prevent the condition disease one step closer to reality. VLA15 is the only vaccine for Lyme disease in clinical development, according to GlobalData, the parent company of Pharmaceutical Technology.

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Leading by Example

The Honest Apothecary

It is my conviction that managers really do make all the difference in the world. Great managers get great results and build great teams. Bad managers don’t. But it is also my conviction that managers generally mirror the leadership culture created by those they report to. There is, if you will, a “trickle down” effect in the style and priorities of your management.

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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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Right under our noses: Could COVID-19 vaccines be better as nasal spray?

PharmaVoice

Nasal vaccines under development by Codagenix, Xanadu Bio and others have the potential to finally help reduce virus transmission and breakthrough infections.

Vaccines 265
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Copper coated surfaces found to reduce COVID-19 transmission

European Pharmaceutical Review

Research suggests copper (Cu) and silver (Ag) coated surfaces display significant differences in antiviral properties and that while copper is effective at reducing Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2; the cause of COVID-19) transmission, silver is not. As a result of corrosion, both copper and silver release positively charged ions into their environment, which can prevent bacterial growth or kill off the cells completely.

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More Trending

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Gilead to acquire global rights of Trodelvy from Everest

Pharmaceutical Technology

Gilead Sciences has entered an agreement with Everest Medicines to acquire complete rights to develop and market Trodelvy (sacituzumab govitecan) in Greater China, Singapore, South Korea, Philippines, Vietnam, Thailand, Indonesia, Mongolia and Malaysia. According to the deal, Everest is entitled to receive an upfront payment of $280m from Gilead. Furthermore, Gilead will make potential payments of up to $175m to Everest on meeting certain regulatory and commercial milestones.

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Woman of the Week: Takeda Oncology’s Teresa Bitetti

PharmaVoice

Upon joining Takeda Pharmaceuticals as president of the global oncology unit, Teresa Bitetti had two important goals: to transform the business and create greater synergies between commercial and R&D operations.

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UK approves Moderna’s bivalent COVID-19 vaccine

European Pharmaceutical Review

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Moderna’s COVID-19 vaccine, Spikevax, that targets two coronavirus variants as a booster. The regulator confirmed that the vaccine meets its standards of safety, quality and effectiveness. The decision was also endorsed by the government’s independent expert scientific advisory body, the Commission on Human Medicines, after a careful review of the evidence.

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FDA grants swift review to Lynparza in first-line prostate cancer

pharmaphorum

AstraZeneca and Merck & Co’s PARP inhibitor Lynparza is already used to treat prostate cancer associated with a specific genetic mutation, but could see its use broadened if a new marketing application is approved by the FDA. The US regulator has started a priority review of Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone as a first-line treatment for metastatic castration-resistant prostate cancer (mCRPC) based on the results of the PROpel trial.

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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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Scientists hope nasal vaccines will help halt Covid transmission

The Guardian - Pharmaceutical Industry

Unlike jabs, nasal vaccines target the respiratory tract, the body’s first line of defence against infection People who receive a Covid booster dose in the UK next month will be among the first in the world to receive Moderna’s dual-variant vaccine , which protects against two strains of the virus. But scientists say there is a misconception that this latest vaccine is an upgrade on what has come before.

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The CEO in the ophthalmologist’s coat

PharmaVoice

In balancing two roles — Lexitas CEO and practicing physician — George Magrath brings a patient-first perspective to developing and advancing eye treatments.

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Hashimoto’s and Graves’ Remission after Helicobacter Pylori Eradication

The Thyroid Pharmacist

While I have a lot of stories of people who recovered their health through removing reactive foods, adding in healing foods, and taking the appropriate supplements, I personally did not get my Hashimoto’s into remission by following those steps. Sure, I felt much better, and my thyroid antibodies significantly dropped with the help of nutrition, but eventually my health problems began creeping back in.

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GSK gets June 2023 FDA decision date for momelotinib

pharmaphorum

The clock is now ticking on the FDA’s review of GSK’s momelotinib for myelofibrosis patients with anaemia – the centrepiece of its $1.9 billion acquisition of Sierra Oncology which completed last month. The US regulator is due to make a decision on momelotinib by 16 June, 2023, on the basis of phase 3 results reported in January, said GSK.

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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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Industry 1VQ Solutions: Change of Lot or Extension of Shelf-life of Reference Standard

PharmaTech

Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.

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Inventing the COVID vax pill: a matter of convenience and durability

PharmaVoice

Recent data from Vaxart’s phase 1 trial of its COVID-19 inoculation pill shows potential.

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FDA grants approval for bluebird’s Zynteglo to treat beta-thalassemia

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for bluebird bio ’s Zynteglo (betibeglogene autotemcel, beti-cel) for the treatment of the underlying genetic cause of beta?thalassemia in adult and paediatric patients. A custom-made, one-dose gene therapy, Zynteglo is indicated for such patients who need red blood cells (RBCs) transfusions on a regular basis.

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Phase III trial shows tislelizumab improves outcomes for liver cancer patients

European Pharmaceutical Review

The Phase III RATIONALE 301 study evaluated the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. . Hepatocellular carcinoma, or HCC, is the sixth most common type of cancer worldwide. HCC accounted for more approximately 85 percent of the 900,000 new liver cancer cases in 2020, according to the Globocan 2020 database. .

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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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Monkeypox Vaccine Emergency Use Authorization

Digital Pharmacist

On August 9th, 2022, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the JYNNEOS vaccine. Here is what you need to know about the monkeypox vaccine emergency use authorization. . JYNNEOS Vaccine Authorization Details . This authorization allows healthcare providers to administer the vaccine by intradermal injection for high risk individuals that are 18 years of age or older.

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The FDA is mulling an OTC approval for a birth control. Will politics factor in?

PharmaVoice

Analysts are watching how cultural and political debates around reproductive rights may impact HRA Pharma's OTC birth control application.

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Atomwise and Sanofi partner for drug discovery using AI

Pharmaceutical Technology

Atomwise and Sanofi have entered a strategic and exclusive research partnership to use the former’s artificial intelligence (AI)-driven AtomNet platform to discover and research up to five drug targets computationally. The approach of Atomwise makes the process of drug discovery more logical and efficient by moving away from serendipitous discovery and toward a search that is structure-based.

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Tackling the silent pandemic: AMR Industry Alliance sets the Standard

European Pharmaceutical Review

Antimicrobial resistance (AMR) is a growing concern worldwide. Recognised as one of the top 10 global health changes by the World Health Organization (WHO), 1 it was found to have played a role in 4.95 million deaths in 2019 and been the direct cause of 1.27 million of these, 2 meaning drug-resistant infections killed more people than HIV/AIDS (864,000 deaths) or malaria (643,000 deaths). 3 Just six resistant bacteria accounted for almost 80 percent of the direct deaths, with antibiotic-resistan

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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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Positive appraisal for Eisai’s Kisplyx in combination with MSD’s Keytruda

Pharma Times

NICE approval is for first-line treatment of intermediate and advanced renal cell carcinoma

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From nasal vaccines to pills: the next defences against Covid

The Guardian - Pharmaceutical Industry

Analysis: a bivalent vaccine has been approved and research is being carried out into possible pan-coronavirus vaccines When the autumn booster programme begins next month, many people are likely to receive Moderna’s new bivalent vaccine , designed to protect against the original Covid strain and the more transmissible Omicron variant. As Covid continues to evolve, so will vaccination strategies.

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IN FOCUS: Northgate Technologies

Pharmaceutical Technology

RANKINGS 2022 Excellence Innovation Commended Excellence Product Launch Commended Excellence Safety Commended. The Verdict. Northgate Technologies Inc. (NTI) is a Illinois based producer of medical devices and technologies for the healthcare sector, with a particular focus on surgical environments. The company is ranked in the 2022 Excellence Rankings in the INNOVATION , PRODUCT LAUNCH and SAFETY categories.

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4mn dose shortage of GSK’s childhood rotavirus vaccine expected

European Pharmaceutical Review

According to Reuters , Kenya, Tanzania, Senegal and Cameroon have either run out of or are close to running out of vaccines to protect children against the deadly rotavirus infection following undisclosed “manufacturing challenges” at GSK. Rotaviruses are the most common cause of severe diarrhoeal disease in infants and young children worldwide, according to the World Health Organization (WHO), which estimates that up to 200,000 children die each year of the highly contagious infection.

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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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Frequently Asked Questions About CCRN Certification 

Board Vitals - Pharmacist

CCRN certification is a special certification granted by the American Association of Critical Care Nurses (AACN). CCRN certification is valuable for nurses, as it allows RNs to care for patients in acute care and/or critical care setting. We’ve compiled some of the most frequently asked questions about CCRN certification to help you prepare for the exam and maintain your licensure.

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What I Packed for a Miami Bachelorette

The Luxe Pharmacist

Hello friends, I cannot wait for my girlfriends bachelorette this weekend in Miami! (Currently publishing this from the airport). I’m expecting a lot of heat given that it’s mid August, so I figured I may as well bring the heat as well! I’m sharing everything I packed and more if you need some inspiration for an upcoming bachelorette trip, date night, girls night out or tropical vacay.

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IBNCC – Approach to CNS infection

EMCrit Project

This chapter explores some general aspects of neurological infectious diseases, including important historical features and high-risk groups. It also includes a more general discussion of lumbar puncture performance and interpretation. The IBCC chapter is located 👉 here. The podcast & comments are below. Follow us on iTunes. EMCrit Project by Josh Farkas.

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FDA approves Zynteglo gene therapy for beta-thalassemia patients

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved bluebird bio’s Zynteglo (betibeglogene autotemcel; beti-cel), the first cell-based gene therapy for the treatment of adult and paediatric patients with beta-thalassemia who require regular red blood cell transfusions. . “Today’s approval is an important advance in the treatment of beta-thalassemia, particularly in individuals who require ongoing red blood cell transfusions,” commented Peter Marks, MD PhD, director of the FDA’s Center for Bio

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Which pharmaceutical companies have the most drug patents in Norway?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Norway. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Norway? appeared first on DrugPatentWatch - Make Better Decisions.