Sun.Apr 11, 2021

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Lilly gene-targeted drug shows potential for use across cancers

Bio Pharma Dive

Study results presented at AACR showed Retevmo shrank tumors in nine different cancers, building a case for the type of tissue-agnostic label that only three other medicines have secured.

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COVID-19: Some ignored facts

World of DTC Marketing

QUICK THOUGHT: People believe the COVID-19 vaccine was developed in less than a year but that’s not true. Coronaviruses were first encountered in April 1930, when a strange respiratory disease ravaged poultry farms across North Dakota and Minnesota, killing tens of thousands of baby birds. Further scientific research into the virus and recognition that it was not like influenza A, a flu virus known to cause bronchitis, would transpire over the next 30 years. .

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mRNA Tech Used in COVID-19 Vaccines Could be Used to Cure HIV, Cancer and More

BioSpace

Researchers are leveraging the messenger RNA (mRNA) technology used to develop the Pfizer-BioNTech and Moderna COVID-19 vaccines for possible treatments for a range of other diseases, including HIV and cancer.

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Shift in diet allowed gray wolves to survive ice-age extinction

Scienmag

Credit: Julius Csotonyi April12, 2021 – Gray wolves are among the largest predators to have survived the extinction at the end of the last ice age around11,700 years ago. Today, they can be found roaming Yukon’s boreal forest and tundra, with caribou and moose as their main sources of food. A new study led by […].

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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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Large-Scale Study Finds One-Third of COVID-19 Patients Suffer Neurological Damage

BioSpace

Six months after a COVID-19 diagnosis, more than 33% of people exhibited some form of brain damage, according to a study appearing in Lancet Psychiatry.

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MD Anderson researchers highlight advances in clinical studies at the AACR Annual Meeting 2021

Scienmag

Credit: MD Anderson Cancer Center HOUSTON — Early phase clinical trials conducted by researchers from The University of Texas MD Anderson Cancer Center show promising results for patients with RET fusion-positive cancers, high-grade (HGG) and low-grade glioma (LGG) and ovarian cancer. The results, presented today at the virtual American Association for Cancer Research (AACR) Annual […].

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NIH training grant enhances opportunities for biomedical graduate students at AU

Scienmag

Credit: Kim Ratliff, Augusta University Augusta University has received a $1.5 million grant from the National Institutes of Health to help support the graduate education of future scientists whose focus is cardiometabolic diseases — like hypertension and diabetes — which disproportionally affect minorities. The training grant (1HL155011-01A1) will support four graduate students in its first […].

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Sanofi Continues Site Expansions, Preparing for Future Pandemics

BioSpace

The new factory will include cutting-edge technology, allowing production of three to four vaccines simultaneously, a massive improvement on the current limitation of one vaccine in an industrial site.

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Study snapshot: How do weighted funding formulas affect charter school enrollments?

Scienmag

Study: “How Do Weighted Funding Formulas Affect Charter School Enrollments?” Author: Paul Bruno (University of Illinois at Urbana-Champaign) This study was presented today at the American Educational Research Association’s 2021 Virtual Annual Meeting. Main Findings: The adoption of a school funding system in California that increased revenues for schools enrolling higher-need students led to an […].

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Biogen and Sage’s Movement Disorder Therapy Reduces Tremor Score in Study

BioSpace

Recently announced topline results from a Phase II study show SAGE-324, Sage Therapeutics’ investigational oral neuroactive steroid GABAA receptor positive allosteric modulator, significantly reduced tremor score in adult patients with essential tremor.

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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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Time-Limited Trials Among Patients With Advanced Illness and Reduction of Nonbeneficial ICU Treatments

JAMA Internal Medicine

This quality improvement study uses data from medical intensive care units to investigate the association between time-limited trials and nonbeneficial treatments.

Trials 75
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Taysha Dishes Out $5.5 Million for Rare Disease Gene Therapy

BioSpace

Taysha Gene Therapies has acquired exclusive global rights to TSHA-120, an intrathecally dosed AAV9 gene therapy designed to treat giant axonal neuropathy.

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Can you take amoxicillin and metronidazole together?

Druggist

Amoxicillin is one of the most prescribed antibiotics in the UK. On the contrary, metronidazole is significantly less prescribed by GPs, mainly because of preferred use in dental infections. Prescriptions which are fulfilled in the pharmacy for a combination treatment with amoxicillin and metronidazole are almost always issued by a dentist rather than GP.

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AACR: BMS Checkpoint Inhibitor Flexes Muscle in Early-Stage Lung Cancer and Other Highlights

BioSpace

In a flurry of weekend activity, oncology companies showcased the latest clinical and preclinical data for cancer therapies during the virtual American Association for Cancer Research meeting.

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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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Twitch partners with University of Chichester to examine esports through scientific study

Scienmag

Steaming service will be embedded into academic modules of University’s new BA (Hons) Esports degree Credit: University of Chichester Twitch-Chichester agreement will equip students with skills and experience necessary to participate in global esports and gaming industry Steaming service will be embedded into academic modules of University’s new BA (Hons) Esports degree Students will get […].

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Clinical Catch-Up: April 5-9

BioSpace

It was a relatively quiet week for clinical trial announcements, but there were a few standouts. Read on for more.

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Milken Institute, Baszucki Brain Research Fund launch fund for bipolar disorder research

Scienmag

Multimillion-dollar program dedicates funds to advance understanding of bipolar disorder treatment options. Initial letters of intent due May 14, 2021. Credit: Milken Institute The Milken Institute’s Center for Strategic Philanthropy and the Baszucki Brain Research Fund today announced the launch of a dedicated grant program aimed at advancing therapeutic discovery for bipolar disorder (BD).

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Regeneron's Antibody Cocktail Cuts Progression to Symptomatic COVID-19

BioSpace

Regeneron Pharmaceuticals announced the results from its Phase III trial of recently infected asymptomatic COVID-19 patients for its REGEN-COV (casirivimab with imdevimab) antibody cocktail.

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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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Retevmo® (selpercatinib) in Advanced RET Fusion-Positive Gastrointestinal and Other Cancers at 2021 American Association for Cancer Research (AACR) Annual Meeting

The Pharma Data

Confirmed Objective Response Rate of 47 Percent, with Responses Observed in Nine Unique Cancer Types Median Duration of Response Not Reached at 13 Months Median Follow-Up, with 11 of 15 Responses Ongoing Safety Consistent with Known Profile of Retevmo New Data Expands on Retevmo’s Established Data in Lung and Thyroid Cancers. INDIANAPOLIS, April 11, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced for the first time data from the Phase 1/2 LIBRETTO-001 trial show

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FDA Action Alert: Avenue, Merck, Sol-Gel, Protalix and Chiesi, and Ardelyx

BioSpace

The U.S. Food and Drug Administration’s schedule for April has several PDUFA dates scattered across the rest of the month. Here’s a look.

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New patent expiration for Almirall drug ALTABAX

Drug Patent Watch

Annual Drug Patent Expirations for ALTABAX Altabax is a drug marketed by Almirall and is included in one NDA. It is available from one supplier. There are three patents protecting…. The post New patent expiration for Almirall drug ALTABAX appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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AACR: OncoMyx Presents First Data Showing Myxoma Virotherapy Anti-Tumor Efficacy

BioSpace

The three posters OncoMyx Therapeutics presented at the virtual American Association for Cancer Research (AACR) Virtual Annual Meeting on April 10th provided the first data indicating its myxoma virotherapy approach to oncolytic therapeutics.

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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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New patent expiration for Vicuron drug ERAXIS

Drug Patent Watch

Annual Drug Patent Expirations for ERAXIS Eraxis is a drug marketed by Vicuron and is included in one NDA. It is available from one supplier. There are three patents protecting…. The post New patent expiration for Vicuron drug ERAXIS appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Workplace study during pandemic finds managers should talk less, listen more

Scienmag

Lessons learned during COVID-19 can aid workplace communication during crises and normal times Workplace communication often took a back seat this past year, as employees and employers rushed to work remotely, struggled with technology barriers and adjusted to physical distancing. But the pandemic has resulted in valuable lessons for communicating on the job, according to […].

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New patent expiration for Glaxosmithkline Llc drug REQUIP XL

Drug Patent Watch

Annual Drug Patent Expirations for REQUIP+XL Requip Xl is a drug marketed by Glaxosmithkline Llc and is included in one NDA. There are two patents protecting this drug and seven…. The post New patent expiration for Glaxosmithkline Llc drug REQUIP XL appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Those who view TV and social media as trustworthy sources of COVID news — less informed

Scienmag

People who trust television and Facebook to provide them with accurate news about the coronavirus pandemic are less knowledgeable about COVID-19, according to a new study, which assessed people’s knowledge of the virus in the earliest stages of the pandemic. The study, published today in the peer-reviewed journal Current Medical Research & Opinion, surveyed 5,948 […].

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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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Valbiotis Reveals Positive TOTUM•854 Preclinical Results in the Prevention of Hypertension at the Annual ESH-ISH Joint Meeting

BioTech 365

Valbiotis Reveals Positive TOTUM•854 Preclinical Results in the Prevention of Hypertension at the Annual ESH-ISH Joint Meeting Valbiotis Reveals Positive TOTUM•854 Preclinical Results in the Prevention of Hypertension at the Annual ESH-ISH Joint Meeting An acceleration of development in order … Continue reading →

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Study finds rapid evolution in foxgloves pollinated by hummingbirds

Scienmag

Researchers have found common foxgloves brought to the Americas have rapidly evolved to change flower length in the presence of a new pollinator group, hummingbirds. The findings are published in the British Ecological Society’s Journal of Ecology. Researchers from the University of Sussex, Universidad de Los Andes (Colombia) and Universidad de Costa Rica, studying the […].

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HEC Pharm Selects ABEC Large-Scale Fermenters to Increase Biopharmaceutical Production Capacity

BioTech 365

HEC Pharm Selects ABEC Large-Scale Fermenters to Increase Biopharmaceutical Production Capacity HEC Pharm Selects ABEC Large-Scale Fermenters to Increase Biopharmaceutical Production Capacity ABEC stainless steel fermentation solutions to enhance HEC Pharm’s manufacturing productivity and flexibility BETHLEHEM, Pa.

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Study shows tanning bed ban would reduce skin cancer rates in minors and cut healthcare costs

Scienmag

A recent study indicates that a U.S. ban on the use of tanning beds among minors would prevent thousands of cases of melanoma in adolescents and would save millions of dollars in healthcare costs. The findings are published early online in CANCER, a peer-reviewed journal of the American Cancer Society. Indoor tanning has been linked […].

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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.