Pharmaceutical Technology

SEPTEMBER 5, 2022

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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FDA Approval Clinical Trials Clinical Trials Development 287

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 5, 2022

The latest TikTok trend has us listening to brown noise. According to TikTok, this has multiple benefits including helping you relax and quickly fall into a deep sleep. Getting insufficient sleep, and insomnia are common. Skip advert So it’s no wonder many people are looking for ways to improve their sleep. But can brown noise […].

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Clinical Trials Clinical Trials Clinical Research Trials 200

Pharmaceutical Technology

SEPTEMBER 5, 2022

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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AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 5, 2022

The National AIDS Control Organization (NACO) has resumed one-month dispensation of HIV medicines nationwide following intervention by the Union ministry of health and family welfare. A group of HIV-positive people led by Delhi Network of Positive People staged a 40 days dharna in Delhi protesting shortage of antiretroviral drugs at NACO centres pan India.

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Medicine Drugs Clinical Trials Clinical Trials 134

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

Clinical Research

Pharmaceutical Technology

SEPTEMBER 5, 2022

Factors such as increasing access to health information, the introduction of new medical treatments and technologies and the spike in birth rate are increasing the need for payers in the pharmaceutical industry. Payers ensure the delivery of the best possible health outcomes to the patients from their financial plan. Finding the top payers in the pharmaceutical industry.

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NPR Health - Shots

SEPTEMBER 5, 2022

Updated COVID boosters are now available for anyone age 12 or older. The CDC is urging anyone who is eligible to sign up but some vaccine experts say some people might want to wait. (Image credit: Rogelio V.

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Vaccination Vaccine 143

STAT News

SEPTEMBER 5, 2022

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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Medicine 139

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical wholesalers act as intermediaries between pharmaceutical manufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs. Wholesalers can be either full-line wholesalers, who purchase the complete product line of a company, or specialised companies, which purchase speciality drugs to sell to clinics and h

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Packaging Packaging Compliance Manufacturing 130

pharmaphorum

SEPTEMBER 5, 2022

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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Pharmaceutical Technology

SEPTEMBER 5, 2022

The US Food and Drug Administration (FDA) has approved the expanded usage of Vertex Pharmaceuticals ’ Orkambi (lumacaftor/ivacaftor) to treat cystic fibrosis (CF) in children aged 12 months to under 24 months. The treatment is indicated for CF patients who are homozygous for the F508del mutation (F/F genotype) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

NPR Health - Shots

SEPTEMBER 5, 2022

Though the CDC said the specific source of the outbreak hasn't been confirmed, many of the people who got sick reported eating sandwiches with romaine lettuce at the fast food chain.

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pharmaphorum

SEPTEMBER 5, 2022

Greater use of telehealth services forced by COVID-19 seems to have benefitted people with opioid use disorder (OUD), leading to longer times on treatment and reduced risk of overdose, according to a new study. The researchers examined data from two groups of Medicare patients, one treated for OUD before the pandemic, and another who were treated after COVID-19 took hold, with greater use of telehealth support to complement in-person care.

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Containment Research Drugs 98

Antidote

SEPTEMBER 5, 2022

Because Hunter syndrome is a rare, inherited disorder that mostly impacts children, it can lead to many questions from the parents and caregivers of those that are affected.

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Pharma Times

SEPTEMBER 5, 2022

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

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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.

Clinical Supply

pharmaphorum

SEPTEMBER 5, 2022

Shares in PolyPid have been under pressure after the Israeli biotech reported its antibiotic for surgical site infections failed a phase 3 trial, although there may still be a way forward for the programme. The SHIELD I trial of D-PLEX 100 – a new formulation of the well-established antibiotic doxycycline – found that giving the drug wasn’t able to improve on regular care in preventing infections in people undergoing abdominal surgery.

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Pharma Times

SEPTEMBER 5, 2022

Warning comes from NHS leaders as new Prime Minister prepares to move into Number 10

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pharmaphorum

SEPTEMBER 5, 2022

The UK Competition and Markets Authority (CMA) is seeking to disqualify Peter Butterfield, currently chief executive of Alliance Pharma, from serving as a company director. Butterfield is one of seven company directors from Alliance, Lexon, Focus Pharma, and Medreich in the financial regulator’s sights, in connection with allegations that they colluded to raise the NHS price of widely-used nausea drug prochlorperazine, raking in millions of pounds in excess profits.

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BioPharma Reporter

SEPTEMBER 5, 2022

The Asia-Pacific (APAC) region was the largest contributor to the global clinical trial landscape from 2017 to 2021, accounting for more than 50% of conducted trials during the analysis period, found research by GlobalData.

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Clinical Trials Clinical Trials Trials Research 59

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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

Clinical Trials

NPR Health - Shots

SEPTEMBER 5, 2022

When rural hospitals go out of business, they're frequently gone for good. But now, some comebacks are a welcome sign for communities that have been without easy access to health care.

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BioPharma Reporter

SEPTEMBER 5, 2022

Biotimize has announced the opening of a $30m Series A fundraising round: with the investment set to enable Biotimize to build the first biological CDMO in Brazil and to become the first end-to-end biological CDMO in South America.

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Drug Discovery World

SEPTEMBER 5, 2022

The University of California, Davis, has received over $12 million from the National Institutes of Health for the third and final five-year phase of the Knockout Mouse Phenotyping Project (KOMP2). ‘Knockout’ mice are bred in a laboratory with specific genes silenced or ‘knocked out’. They have been valuable tools for research on a wide range of diseases and conditions, used in 4,676 published papers so far.

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Gene Silencing Gene Genetics Genome 52

Drug Patent Watch

SEPTEMBER 5, 2022

Annual Drug Patent Expirations for BYLVAY Bylvay is a drug marketed by Albireo and is included in one NDA. There are eight patents protecting this drug. This drug has one…. The post New patent expiration for Albireo drug BYLVAY appeared first on DrugPatentWatch - Make Better Decisions.

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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.

Clinical Supply

Drug Discovery World

SEPTEMBER 5, 2022

GSK will present its latest gynaecological cancer research at the European Society for Medical Oncology (ESMO) Congress 2022 (September 9-13). The company will share positive trial data on its gynaecological cancer treatments Zejula (niraparib) and Jemperli (dostarlimab), as well as early-stage research in immuno-oncology and real-world evidence assessing treatment patterns and outcomes.

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Drug Patent Watch

SEPTEMBER 5, 2022

Annual Drug Patent Expirations for DEXYCU+KIT Dexycu Kit is a drug marketed by Eyepoint Pharms and is included in one NDA. There are six patents protecting this drug. This drug…. The post New patent expiration for Eyepoint Pharms drug DEXYCU KIT appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

SEPTEMBER 5, 2022

The results of the survey were revealed ahead of CPHI Korea, which will be held in Seoul, September 28-30. South Korea recovered from the pandemic earlier than many other Asian countries and reported rapid growth in its contract manufacturing industry in the last two years. . In fact, the government is targeting over $50 billion in exports by 2030 and many international companies are accelerating efforts to deepen local supply networks.

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Contract Manufacturing Manufacturing Sales Marketing 52

BioPharma Reporter

SEPTEMBER 5, 2022

Digital transformation is fundamental to the growth of the UK and Ireland's biopharma sector, according to a new study by Siemens.

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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.

Clinical Trials

Drug Discovery World

SEPTEMBER 5, 2022

At this year’s Tech Theatre at ELRIG Drug Discovery Martin-Immanuel Bittner, CEO & Co-Founder Arctoris will discuss The Remote Lab: Is This the Future? . Sponsored by DDW, the Tech Theatre will feature a series of seminars focused on automation and technology for drug discovery. . Martin-Immanuel Bittner, CEO & Co-Founder Arctoris. Martin-Immanuel Bittner MD DPhil FRSA is a clinician-scientist by background.

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BioPharma Reporter

SEPTEMBER 5, 2022

As the EU heads towards the winter months, authorities have given Pfizer/BioNTech and Modernaâs COVID-19 Omicron vaccines the green light.

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Vaccination Vaccine Regulation Marketing 52

Drug Discovery World

SEPTEMBER 5, 2022

An experimental combination of two drugs halts the progression of small cell lung cancer, the deadliest form of lung cancer, according to a recent study. The discovery was made by researchers at Washington University School of Medicine in St Louis, Grenoble Alpes University in Grenoble in France, and The University of Texas MD Anderson Cancer Center in Houston.

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Protein Drugs Medicine Research 52

Drug Patent Watch

SEPTEMBER 5, 2022

LONHALA MAGNAIR KIT (glycopyrrolate) Sunovion resp Patent: 7,316,067 Expiration: Sep 6, 2022 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact…. The post Drug Patent Expirations for the Week of September 4, 2022 appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs 40

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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.

Clinical Trials