European Pharmaceutical Review

JUNE 24, 2022

The Greek state has filed a lawsuit against Novartis , asking for € 214 million in compensation for non-pecuniary damages* the country may have suffered due to alleged illegal payments to government officials and healthcare providers. Commenting on the lawsuit , Greece’s Health Minister Thanos Plevris, stated that the country is seeking compensation for the damage it has suffered “from the actions that Novartis itself has admitted to in the USA that concerns payments to doctors.”.

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MedCity News

JUNE 24, 2022

State bans would mean sensitive patient data, such as interactions with a telehealth provider to obtain abortion drugs, could be used against someone as a threat. One expert warned that the value of such data will “skyrocket.

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Pharmaceutical Technology

JUNE 24, 2022

As regulatory agencies gear up for another round of Covid-19 vaccine deliberations centered on emerging variants, Moderna has released data on its booster’s efficacy against Omicron subvariants. In addition to providing protection against the Omicron BA.1 variant, on 22 June, Moderna said its booster also showed a “potent” antibody response against Omicron subvariants BA.4 and BA.5.

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MedCity News

JUNE 24, 2022

An Intellia Therapeutics therapy that uses CRISPR to perform in vivo genomic edits has clinical data showing that the therapeutic effects continue for a year in patients. The biotech now plans to speak with regulators about the design for a pivotal clinical trial testing this therapy, a potential one-time treatment for a rare inherited disease.

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Distribution

Pharmaceutical Technology

JUNE 24, 2022

Novavax has obtained emergency use authorization (EUA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), from the Taiwan Food and Drug Administration for use in people of the age 18 years and above. The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain. Developed utilising Novavax’s recombinant nanoparticle technology to generate antigen obtained from the coronavirus spike (S) protein, the vaccine is also formulated with the company’s saponin-

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MedCity News

JUNE 24, 2022

The Future of Virtual-First Care eBook, sponsored by Wheel, explores some of the challenges and trends in virtual-first care. It also offers clues as to how healthcare stakeholders envision the future of virtual health.

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Healthcare Healthcare 105

MedCity News

JUNE 24, 2022

The decision about whether to allow the procedure now falls to individual state governments, and only 16, plus the District of Columbia, have passed laws to preserve the option, while two others have state constitutional protections that have been cited by state courts as protections for abortion.

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Government 86

European Pharmaceutical Review

JUNE 24, 2022

BioNTech has initiated construction of its first vaccine production facility in Africa. Located in Kigali, Rwanda, the mRNA manufacturing facility will be the first of three planned sites across the continent, with further factories to come in Senegal and South Africa. Together this network of factories will supply therapies and vaccines solely for people residing in member states of the African Union.

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pharmaphorum

JUNE 24, 2022

Last year, AstraZeneca reported that a new drug to treat Wilson disease developed by its Alexion rare diseases unit had hit the mark in a phase 3 trial, setting it on course for regulatory filings. Now, the data has been revealed – and according to investigators could transform treatment. Wilson disease is a rare and progressive genetic condition in which the body’s process for removing excess copper is broken, allowing it to build to toxic levels and damage the liver, brain and other vita

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Side effects Doctors Patients Medical 73

Copyright Clearance Center

JUNE 24, 2022

The post ALA Annual Conference Returns to Washington appeared first on Copyright Clearance Center.

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Safety

pharmaphorum

JUNE 24, 2022

Shares in Sarepta came under pressure after the biotech said it had temporarily halted a clinical trial of its new-generation Duchenne muscular dystrophy candidate, after a patient had a serious safety incident. The FDA has ordered a clinical hold on Sarepta’s SRP-5051 (vesleteplirsen) drug candidate after one patient in the study developed very low levels of magnesium, a condition known as hypomagnesaemia, that can lead to muscle weakness and tremors, seizures, and irregular heart rhythms

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Pharmaceutical Technology

JUNE 24, 2022

invoX Pharma has signed a definitive agreement for the acquisition of all issued and outstanding shares of clinical-stage biopharma firm F-star Therapeutics, in a deal valued at nearly $161m or $7.12 for each share in cash. invoX Pharma is a fully owned Sino Biopharmaceutical subsidiary. The latest deal will expedite the strategy of invoX to develop the International Biopharmaceutical R&D Platform of Sino Biopharm outside of China to transform the lives of patients globally.

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PharmaTimes

JUNE 24, 2022

MHRA extends UCB’s therapy for the treatment of partial-onset seizures

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Pharmaceutical Technology

JUNE 24, 2022

GlaxoSmithKline (GSK) has announced plans to invest $1.2bn (£1bn) over a decade to expedite research and development (R&D) for infectious diseases in lower-income countries. New vaccines and therapies for the prevention and treatment of malaria, tuberculosis, human immunodeficiency virus (HIV), neglected tropical diseases (NTDs) and anti-microbial resistance (AMR) will be the focus of this research.

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Specialization

Pharmacy Times

JUNE 24, 2022

Amy Cadwallader, PhD, director of Regulatory and Public Policy Development at US Pharmacopeia (USP), discusses how medicine quality and the medicines supply chain can affect antimicrobial resistance (AMR).

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European Pharmaceutical Review

JUNE 24, 2022

RECENTLY, there has been a spate of withdrawals caused by nitrosamine drug substance-related impurities (NDSRIs). The latest recalls have centred on Orphenadrine Citrate ER Tablets 1 and Quinapril HCl/Hydrochlorothiazide 2 due to the presence of N -nitroso Orphenadrine and N -nitroso Quinapril, respectively. These NDSRIs can form during manufacturing or subsequent storage of the drug product.

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Food and Drug Administration Manufacturing Food FDA 52

Pharmaceutical Commerce

JUNE 24, 2022

The Health System Owned Specialty Pharmacy (HOSP) Alliance‘s Melissa Goff responds to the news of the FTC investigation into PBM practices news and outlines the alliance‘s vision for the integrated specialty pharmacy industry.

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Legacy MEDSearch

JUNE 24, 2022

Typically, career advice is written for the Job Seeker, and rarely for the gainfully employed. Likewise, it is much easier (and more ideal) to find a new position while employed, and similarly, it is much easier to build an enticing personal brand and professional portfolio while actively engaged in a career. So, for those who wish to remain marketable and primed while employed, here are a few tips for becoming a Prepared Passive Candidate. 1.

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Safety

Pharma Marketing Network

JUNE 24, 2022

This content is password protected. To view it please enter your password below: Password: The post Protected: Approaches to Reach, Recruit and Retain Atopic Dermatitis Patients for Clinical Trials appeared first on Pharma Marketing Network.

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pharmaphorum

JUNE 24, 2022

pharmaphorum editor in chief Jonah Comstock talks to Philip Gomez, CEO of Siga Technologies, about how his company’s antiviral drug can play a crucial role in addressing monkeypox cases. Although the World Health Organization is still rating the current monkeypox outbreak as a moderate threat , the disease has continued to spread , with 2,103 cases in 42 countries and one confirmed death, according to the latest WHO data.

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Pharmacy Times

JUNE 24, 2022

The impact of the pandemic on the mental health of health care workers, including pharmacists and pharmacy staff, has been well documented.

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pharmaphorum

JUNE 24, 2022

Fujifilm’s Irvine Scientific unit has licensed rights to an artificial intelligence-powered technology developed to improve the success rate of in vitro fertilisation (IVF) techniques. The cell culture specialist, a player in assisted reproductive technologies (ART), has licensed the platform from Brigham and Women’s Hospital and Massachusetts General Hospital, where it was developed.

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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

Management

Pharmacy Times

JUNE 24, 2022

Abemaciclib (Verzenio; Eli Lilly and Company) is an FDA-approved kinase inhibitor being investigated for new indications in individuals with hormone-sensitive prostate cancer and castration-resistant prostate cancer.

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FDA 59

PharmaTimes

JUNE 24, 2022

COVID-19 Beta-containing vaccine provides 75.

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Pharmacy Times

JUNE 24, 2022

Breast cancer screening guidelines using mammography vary among guiding bodies, including the American Cancer Society and the American Academy of Family Physicians.

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Physicians 61

PharmExec

JUNE 24, 2022

Takes aim at actions that limit access to lower-cost drugs, calls for revamp of M&A-impact guidelines.

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Competition Pharma 52

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Leads

Pharmacy Times

JUNE 24, 2022

This is the first RSV vaccination candidate to show clinically meaningful and statistically significant efficacy in adults aged 60 years and older.

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pharmaphorum

JUNE 24, 2022

Digital health company Happify has signed a partnership with another biopharma company, joining forces with Biogen on a toolkit to help people with multiple sclerosis manage their illness. The digital toolkit is designed to keep patients informed of new treatments, help them adhere to their prescribed therapies, encourage behaviours aimed at improving their wellbeing and connect to experts as well as other people with MS.

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Pharmacy Times

JUNE 24, 2022

Analysis results expand understanding of the impact of the company’s medicines in early stages with the goal or providing patients with durable and robust outcomes from their first treatment.

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Penrod

JUNE 24, 2022

The post Encourage User Adoption of a New Salesforce Implementation appeared first on Penrod.

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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

Patients