Bio Pharma Dive

MAY 25, 2022

The regulator agreed to assess the companies' data under priority review, setting up a decision on approval of the hemophilia B treatment in six months.

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Gene Therapy Gene Regulation 286

pharmaphorum

MAY 25, 2022

US pharma giant Pfizer has said it will sell some of its patented medicines at non-profit prices to 45 of the world’s poorest countries – including new launches. The initiative will focus on infectious diseases, cancer, inflammation, rare diseases and women’s health, and will include its BioNTech-partnered COVID-19 vaccine Comirnaty as well as oral antiviral therapy Paxlovid (nirmatrelvir/ritonavir).

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Medicine Vaccination Vaccine Sales 115

Bio Pharma Dive

MAY 25, 2022

The pharma has been criticized for not doing enough to make its COVID-19 vaccine and pill available globally. The new initiative commits Pfizer to supplying current and future branded medicines at lower cost to 45 countries.

Medicine 244

Medicine Sales Branding Vaccination 244

XTalks

MAY 25, 2022

Fibromyalgia is a chronic condition that causes widespread pain, difficulty concentrating, sleep problems, fatigue, mood disorders and other symptoms. People with fibromyalgia have abnormal pain perception processing, so they may be more sensitive to pain compared to people without the condition. Fibromyalgia affects approximately 4 million adults in the US, which is about 2 percent of the US adult population.

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FDA Approval Clinical Trials Clinical Trials Drugs 105

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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

Bio Pharma Dive

MAY 25, 2022

With the market for biotech stocks constrained, Genocea Biosciences plans to delist from Nasdaq and lay off the its remaining employees.

Marketing 141

Marketing 141

pharmaphorum

MAY 25, 2022

The move to online international meetings has left pharma companies with uncertainty around contact compliance. But new joint guidance, from the IFPMA, EFPIA, and PhRMA, provides clarity. To say the world of work has changed is something of an understatement in the pharma and biopharma industry. Since COVID-19 reared its head more than two years ago, the traditional hustle and bustle of in-person annual congresses have largely been consigned to the history books.

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Regulation Compliance Manufacturing Medicine 105

XTalks

MAY 25, 2022

Driscoll’s, a global producer of fresh berries, is bringing back its popular Rose Berries, along with a new high-flavor strawberry innovation, Tropical Bliss. The new flavor will join Rose Berries and Sweetest Batch, making Driscoll’s the first fresh berry company to offer three different high-flavor strawberries mapped to a proprietary sensory wheel. .

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Genetics Packaging Packaging Scientist 98

Fossil Remedies

MAY 25, 2022

Are you going to launch a new business by partnering with a new PCD Pharma Company ? Or do you want to expand your business by adding one more company? In both situations, you should be careful and selective while choosing a company. There are several companies around when you search for it. But it is always good to associate with the best one. Why should you prefer the best company?

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Pharma Companies Packaging Packaging Production 97

BioPharma Reporter

MAY 25, 2022

Inceptor Bio, a biotechnology company advancing cell therapies for difficult-to-treat cancers, recently closed a US$37m Series A financing round led by Kineticos Ventures.

Regulation 98

Regulation Marketing 98

Scienmag

MAY 25, 2022

One day more than 3000 years ago, someone lost a shoe at the place we today call Langfonne in the Jotunheimen mountains. The shoe is 28 cm long, which roughly corresponds to a modern size 36 or 37. The owner probably considered the shoe to be lost for good, but on 17 September 2007 it […].

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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

pharmaphorum

MAY 25, 2022

Around 100 patients in England and Wales with triple negative breast cancer (TNBC) that has spread to other parts of the body could soon access treatment with Merck & Co/MSD’s Keytruda, on the recommendation of cost-effectiveness agency NICE. The health technology assessment (HTA) body has published draft guidance supporting routine NHS use of Keytruda (pembrolizumab) along with chemotherapy in patient with metastatic TNBC whose tumours express the biomarker PD-L1 with a combine positi

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Drugs Regulation Trials Marketing 64

Scienmag

MAY 25, 2022

For the first time since its discovery 130 years ago one of the most mysterious fossil vertebrates has finally been classified, increasing our possible understanding of the first animals to crawl on Earth. Credit: Tatsuya Hirasawa / RIKEN For the first time since its discovery 130 years ago one of the most mysterious fossil vertebrates […].

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pharmaphorum

MAY 25, 2022

Pfizer placed a $6.7 billion bet on the outcome of two phase 3 trials of Arena Pharmaceuticals’ etrasimod in ulcerative colitis (UC) when it acquired the company earlier this year, and the gamble seems to have paid off. Yesterday, the company reported the results of the two trials of the S1P receptor modulator in patients with moderately-to-severely active UC at the Digestive Disease Week congress, with the data suggesting it could mount a strong challenge against rival Zeposia (ozanimod)

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Trials Sales Drugs Production 59

Scienmag

MAY 25, 2022

In the early 20th century scientists began to record brain activity using electrodes attached to the scalp. To their surprise, they saw that brain activity is characterized by slow and rapid ascending and descending signals which were subsequently called “brain waves” Credit: Tal Dalal In the early 20th century scientists began to record brain activity […].

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Scientist Research 89

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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

BioPharma Reporter

MAY 25, 2022

Northway Biotech, a contract development and manufacturing organization (CDMO) based out of Vilnius, Lithuania, is set to open a facility in Boston, US.

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Manufacturing Development Regulation Marketing 59

Scienmag

MAY 25, 2022

ASTROPHYSICS Credit: Ola J. Joensen, Niels Bohr Institute, University of Copenhagen ASTROPHYSICS A team of University of Copenhagen astrophysicists has arrived at a major result regarding star populations beyond the Milky Way. The result could change our understanding of a wide range of astronomical phenomena, including the formation of black holes, supernovae and why galaxies […].

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Drug Discovery World podcast

MAY 25, 2022

This is the latest episode of the free DDW podcast, “Mini-library approach delivers an arsenal in drug development pipeline”. It covers a narrated article written for Volume 22, Issue 3 –Summer 2021 of DDW. In the article, Dr. Naganna Nimishetti, Chief of the Small Molecule Drug Discovery Division (SMDD) and Dr. Dun Yang, CEO/CSO of Anticancer Bioscience, a precision therapeutics company headquartered in Chengdu, China, explain how the company is identifying bioactive hits using libraries of l

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Development Drugs 52

Scienmag

MAY 25, 2022

Urban construction, especially the ongoing large-scale expansion and utilization of underground space, has resulted in massive excavated soil and rock (ESR) from buildings and subways. A novel solution suggests sintering utilization is a feasible method to recycle solid waste to construction products from the perspective of technology, environment, and policy through qualitative and quantitative methods […].

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Production Engineer 89

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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

Advarra

MAY 25, 2022

Compliant, efficient document management during the various phases of a clinical trial is essential. Yet, throughout a trial, as documents are added to different systems for the investigator/institution and the sponsor, a great deal of time is spent managing those documents; and, of course, as with any manual process, there’s risk of error. That’s why direct communication and integration between key technology systems like email, electronic institutional review board (eIRB) systems, clinical tri

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Compliance Clinical Trials Clinical Trials Trials 52

Scienmag

MAY 25, 2022

Breastfeeding duration is associated with improved cognitive scores at ages 5 through 14, even after controlling for socioeconomic position and maternal cognitive ability, according to a new study published this week in the open-access journal PLOS ONE by Reneé Pereyra-Elías, Maria Quigley and Claire Carson of the University of Oxford, U.K. Credit: Timothy Meinberg, Unsplash, […].

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Drug Patent Watch

MAY 25, 2022

Annual Drug Patent Expirations for CONTRAVE Contrave is a drug marketed by Nalpropion and is included in one NDA. It is available from three suppliers. There are nineteen patents protecting…. The post New patent for Nalpropion drug CONTRAVE appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

Scienmag

MAY 25, 2022

DENVER, May 25, 2022 – People with hearing aids and other assistive listening devices often struggle at crowded events, because the various sources of sound make it difficult to make out any one of them clearly. During the 182nd Meeting of the Acoustical Society of America, Ryan M. Corey, from the University of Illinois at […].

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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

pharmaphorum

MAY 25, 2022

Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims could be a game-changer in the treatment of the skin disorder. Vtama (tapinarof) – originally developed by GlaxoSmithKline – is a first-in-class, once-daily topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA) and has been approved by the US regulator with a broad label spanning mild, moderate, and severe psoriasis and an

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Drugs FDA Approval Licensing Licensing 52

Scienmag

MAY 25, 2022

The University of Louisville is creating a new campus in downtown Louisville to be known as the UofL Christina Lee Brown Envirome Institute – New Vision of Health Campus, where study will focus on health as a shared community resource, incorporating environmental and cultural factors. The campus will be both a world-class research center and a nexus for […].

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Research 86

Outsourcing Pharma

MAY 25, 2022

Michelle Keefe, formerly the president of medical affairs and commercial solutions, joined the company in 2017; she also had spent 20 years working for Pfizer.

Regulation 52

Regulation Marketing 52

Scienmag

MAY 25, 2022

From 1990 to 2019, deaths from suicide by firearm declined throughout the world, but some countries saw an increasing trend. Irena Ilic of the University of Belgrade, Serbia, and colleagues present these findings in the open-access journal PLOS ONE on May 25, 2022. Credit: Ilic et al., 2022, PLOS ONE, CC-BY 4.0 ([link] From 1990 […].

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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

BioPharma Reporter

MAY 25, 2022

The DATAcc has released a collection of open-access resources that are intended to help users build inclusivity into digital health measurement products.

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Production 52

Scienmag

MAY 25, 2022

UCLA researchers have taken the initial step in identifying what may be an effective way to detect gestational diabetes mellitus (GDM) earlier in pregnancy, potentially improving diagnosis and treatment for what is the most common disorder of pregnancy. Credit: UCLA Health UCLA researchers have taken the initial step in identifying what may be an effective […].

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Research 85

Drug Patent Watch

MAY 25, 2022

Annual Drug Patent Expirations for VEKLURY Veklury is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are ten…. The post New patent for Gilead Sciences drug VEKLURY appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 40

Scienmag

MAY 25, 2022

Some residents of Belmont County in eastern Ohio have long suffered from headaches, fatigue, nausea and burning sensations in their throats and noses. They suspected these symptoms were the result of air pollution from fracking facilities that dominate the area, but regulators dismissed and downplayed their concerns. Credit: Leatra Harper/Freshwater Accountability Project Some residents of […].

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Regulation 85

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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