Mon.Mar 08, 2021

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America’s healthcare costs are in deep crisis

World of DTC Marketing

SUMMARY: The media loves to blame pharma companies for high healthcare costs, but unless we start to invest in healthy lifestyles, we’re headed for a healthcare crisis the likes of which we have never experienced. The media have targeted pharmaceutical companies for a long time because sensational headlines lead to clicks. Forget the fact that prescription drugs only account for $.10 of every healthcare dollar spent and that hospital chains are raking in cash with PBM’s and insurers

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Crucial data on AstraZeneca's vaccine are coming. Here's what we may learn.

Bio Pharma Dive

Results from previous trials have raised questions about the vaccine and how well it works. Data from a large U.S. study could help clear up the confusion.

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The drug Fenbendazole can make tumors sensitive to radiotherapy just like agents of chemotherapy

Pharma Mirror

Likewise, it was demonstrated by actualizing high throughput screening in-vitro framework that the drug fenbendazole is successful, not just against standard non-small cell lung cancer, NSCLC, yet in addition against the KRAS-mutant malignancy which seems, by all accounts, aggressive, barely accessible by chemotherapy and very normal (thirty percent of total cases of NSCLS) in people. [1] It became continually challenging in targeting KRAS transformation bearing tumors in view of the unclear con

In-Vitro 246
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Merck gives an early peek at COVID-19 drug results

Bio Pharma Dive

Initial results from a mid-stage study indicate the antiviral drug, molnupiravir, is safe. But whether it's hitting the study's main goal remains unclear.

Drugs 311
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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New Drug Approval Could Be on Horizon for Alzheimer’s after 17-Year Drought

BioSpace

A drug to halt the progression of Alzheimer’s disease will likely be approved within the next three years, and Alzheon’s ALZ-801 might be the leading candidate.

Drugs 144
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Spurred by FDA review, Roche pulls Tecentriq for bladder cancer use

Bio Pharma Dive

Four years after negative study results, the pharma withdrew the indication as the FDA's "industry-wide evaluation" of accelerated approvals progresses.

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Technological adoption, or the human connection? Finding the balance in clinical trials

Bio Pharma Dive

While technology can push trials ahead, in-person interactions and site relationships are, and always will be, the key to success in delivering patient-centric trials on time.

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New COVID-19 vaccine candidate leveraging nanotechnology is ‘promising’

BioPharma Reporter

Researchers from Cleveland Clinic's Global Center for Pathogen Research & Human Health, who have developed the nanotechnology based vaccine, say it has shown strong efficacy in preclinical disease models.

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VirTrial and uMotif Partner to Further Expand Decentralized Clinical Trial Capabilities

VirTrial

Scottsdale, AZ – (March 9, 2021) – VirTrial , the leading provider of telemedicine technology, and uMotif , the patient-centric data capture platform provider, are joining forces to combine their Decentralized Clinical Trial (DCT) technologies in one seamlessly integrated solution. VirTrial’s telemedicine platform provides robust and compliant video consultation capabilities to effortlessly connect site and patient.

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Austrian safety officials suspend batch of AZ vaccines after death

pharmaphorum

Austrian health officials have withdrawn a batch of Oxford University/AstraZeneca’s COVID-19 vaccine after two cases of severe coagulation, one of which was fatal. Both patients were treated from the same batch, codenamed ABV 5300, in the district of Zwettl. In a statement the Austrian Federal Office for Safety in Health Care (BASG) said a 49 year-old woman died as a result of severe coagulation disorders, while another women aged 35 developed a pulmonary embolism and is on the way to recovery.

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The New Age of Decentralized Clinical Trials

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

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INTCR 2021 invites the best and brightest from all corners of the globe to enter

Pharma Times

The PharmaTimes International Clinical Researcher of the Year is calling on the most talented clinical researchers to try their hand and reap the rewards in the 2021 competition.

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Top 10 Most Expensive Drugs on the Market

BioSpace

Prescription drug watchdog GoodRx compiled a list of the 10 most expensive drugs on the market. The list includes drugs that can be acquired at the neighborhood pharmacy, as well as those only administered in a hospital setting.

Marketing 113
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Focus on Rare: the invisible burden of rare diseases

pharmaphorum

Emma Sutcliffe from NexGen Healthcare Communications looks at how patient insights can bring the invisible challenges of living with a rare condition into plain view. Over the past decade there has been considerable investment by pharma into research for rare disease as the patient voice and advocacy movement have done an outstanding job of raising awareness of the needs of the one in 17 who has a rare condition.

Research 111
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CARB-X Places $22 Million Bet on Affinivax Staph Vaccine

BioSpace

Less than two months after bacterial vaccine company Affinivax’s Series C financing, the company is getting a $22 million boost from infectious disease consortium CARB-X to push forward a vaccine for tough-to-treat preclinical Staphylococcus aureus

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Using mRNA technology to develop vaccines for HIV and beyond

BioPharma Reporter

ConserV Bioscience and eTheRNA immunotherapies are to collaborate on development of mRNA vaccines for infectious diseases.

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Industry Veterans Jump Ship in Favor of Smaller Biotechs

BioSpace

It didn’t take long for Jason Campagna to find a new role after departing Intercept Pharmaceuticals last month. Campagna will take on the role of chief medical officer for Q32 Bio.

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NICE says no to AZ’s Lynparza for prostate cancer

pharmaphorum

NHS patients in England will not be able to get access to AstraZeneca’s PARP inhibitor Lynparza if they have BRCA-positive advance prostate cancer, according to draft guidance from NICE. The cost-effectiveness agency is assessing use of Lynparza (olaparib) in patients with tumours that carry BRCA1 or BRCA2 mutations who have previously been treated with the hormone therapies abiraterone and enzalutamide but have relapsed.

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Takeda Inks Deal to Go After Solid Tumors with Maverick T-Cell Engager Technology

BioSpace

The pair’s lead candidate, TAK-186 (formerly MVC-101), a first-in-class conditionally active T-cell engager, has recently entered the clinic in a Phase I/II study for the treatment of EGFR-expressing solid tumors such as those found in head and neck cancers.

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The New Age of Decentralized Clinical Trials

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.

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Insatiable demand for cannabis has created a giant carbon footprint

Scienmag

Colorado State University researchers provide the most detailed accounting to date of the industry’s greenhouse gas emissions Credit: Hailey Summers/Colorado State University It’s no secret that the United States’ $13 billion cannabis industry is big business. Less obvious to many is the environmental toll this booming business is taking, in the form of greenhouse gas […].

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Gilead’s HIV therapy Biktarvy demonstrates long-term sustained efficacy

Pharma Times

Data from two Phase III studies demonstrated durable viral suppression in HIV-1 patients

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Cheap, nontoxic carbon nanodots poised to be quantum dots of the future

Scienmag

Credit: Photo by L. Brian Stauffer CHAMPAIGN, Ill. — Tiny fluorescent semiconductor dots, called quantum dots, are useful in a variety of health and electronic technologies but are made of toxic, expensive metals. Nontoxic and economic carbon-based dots are easy to produce, but they emit less light. A new study that uses ultrafast nanometric imaging […].

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Connecting Excipients with Drug Patents – New DrugPatentWatch module

Drug Patent Watch

New DrugPatentWatch module connects excipients and drug patents In response to user requests, DrugPatentWatch has added a new database of excipients (inactive ingredients) in drugs, and integrated it with our…. The post Connecting Excipients with Drug Patents – New DrugPatentWatch module appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 95
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Accelerating Clinical Supply Through Integrated Drug Development

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.

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Greater tobacco use linked to higher levels of inflammation in HIV-positive people

Scienmag

UMass Amherst study points to health benefits from reducing cigarette smoking Credit: UMass Amherst Inflammation in the body has been linked to the intensity of tobacco smoking among people with HIV, according to a team of University of Massachusetts Amherst researchers. Krishna Poudel, associate professor of community health education in the School of Public Health […].

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COVID-19 Vaccine Makers Top List of 2021’s Most Innovative Biotechs

BioSpace

In a list of the most innovative companies in 2021, Fast Company has outlined 10 biotech companies that continue to revolutionize the drug-discovery landscape.

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Paw hygiene no reason to ban assistance dogs from hospitals

Scienmag

Assistance dogs’ paws are cleaner than their users’ shoe soles, Utrecht University researchers discover Credit: Private photo of Iris and Sandy – may be re-used. Over 10,000 people in Europe use an assistance dog; think of guide dogs for people with a visual impairment, hearing dogs for people with a hearing impairment, medical response service […].

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Potential Blockbuster Drugs for 2021 – Alzheimer’s, Prostate Cancer and More

BioSpace

Clarivate published its annual “Drugs to Watch” list, and cited four drugs that it expects to be blockbusters—projected to bring in $1 billion in sales annually.

Drugs 97
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How Machine Learning Drives Clinical Trial Efficiency

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.

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New CAR T-Cell therapy extends remission in heavily relapsed multiple myeloma patients

Scienmag

Credit: UT Southwestern Medical Center DALLAS – March 8, 2021 – A new type of CAR T-cell therapy more than triples the expected length of remission for multiple myeloma patients who have relapsed several times, according to an international clinical trial with UT Southwestern as the lead enrolling site. Results of the trial, published recently […].

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New CDC Guidance for Fully Vaccinated People Brings Hope (and Criticism)

BioSpace

In the wake of an increasingly accelerated COVID-19 vaccine rollout, the CDC has released new guidance statements that give fully vaccinated individuals more freedom to socialize and participate in pre-pandemic activities.

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Oceans were stressed preceding abrupt, prehistoric global warming

Scienmag

Shelled organisms helped buffer ocean acidification by consuming less alkalinity from seawater Credit: Northwestern University Microscopic fossilized shells are helping geologists reconstruct Earth’s climate during the Paleocene-Eocene Thermal Maximum (PETM), a period of abrupt global warming and ocean acidification that occurred 56 million years ago.

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Novartis’ Autoimmune Drug Not Up for the Challenge in Phase III Cancer Trial

BioSpace

The drug was being evaluated in 237 adults with locally advanced or metastatic non-small cell lung cancer whose disease progressed while on or after previous platinum-based chemotherapy and checkpoint inhibitor immunotherapy.

Drugs 91
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.