Sun.Apr 18, 2021

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Adagio Raises $336 Million to Support Development of COVID-19 Antibody Candidate

BioSpace

The new financing round was led by RA Capital Management, in tandem with new investors Redmile Group, Federated Hermes, Foresite Capital, ArrowMark Partners, PremjiInvest, and another unnamed investor from the health care space.

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As plant/animal diversity wanes, is microbial life changing too? A perilously ‘profound Ignorance’

Scienmag

The unknown direction and pace of change in microbial — including viral — biodiversity may have deep consequences for all life on Earth Credit: Steven Wilbert, Gary Borisy, Forsyth Institute; Jessica Mark Welch, Marine Biological Laboratory With alarms sounding about the declining diversity of plants and animals, a related concern with equally profound implications is […].

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Clinical Catch-Up: April 12-16

BioSpace

It was a particularly busy week for clinical trial news, in part because of several big medical conferences. Here’s a look.

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Study aims to improve health of patients with CF across their increasing lifespan

Scienmag

Credit: Kim Ratliff, Augusta University People with cystic fibrosis are living better and longer, and now investigators want to further enhance quality and longevity by better understanding the role of nutrition, body composition and exercise in their health across an increasing lifespan. While CF may be viewed primarily as a lung disease, the abnormally thick […].

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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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Tonix Seeks to Advance OyaGen’s COVID-19 Treatment Under New Global Licensing Deal

BioSpace

The companies also plan to develop the candidate for the treatment of other potential future viral diseases.

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Online farmers’ markets valuable when crisis events like COVID occur

Scienmag

New research is shining light on the importance of farmers’ markets’ ability to mitigate potential disruptions to distribution networks in the face of system shocks like the COVID-19 pandemic New research is shining light on the importance of farmers’ markets’ ability to mitigate potential disruptions to distribution networks in the face of system shocks like […].

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Adverse Events Associated With the Addition of Aspirin to Direct Oral Anticoagulant Therapy

JAMA Internal Medicine

This cohort study evaluates whether dual therapy with acetylsalicylic acid and a therapeutically dosed direct oral anticoagulant increases rates of bleeding.

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J&J, Teva and Other Opioid Drugmakers Face $50 Billion Lawsuit in California

BioSpace

Johnson & Johnson, Endo International, AbbVie’s Allergan unit and Teva Pharmaceutical will head to court this morning in California over claims the companies engaged in deceptive marketing practices that fueled the opioid crisis in America.

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Rethinking Routine Peripheral Intravenous Line Placement

JAMA Internal Medicine

This Teachable Moment considers the routine insertion of peripheral intravenous catheters in hospital patients given that the harms sometimes outweigh the benefits.

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Bristol Myers’ Opdivo Receives FDA Approval for Gastric Cancer

BioSpace

Opdivo, the trade name for the generic Nivolumab, can now be used in combination with certain types of chemotherapy for initial treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.

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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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Common plants and pollinators act as anchors for ecosystems

Scienmag

Credit: Julian Resasco The next time you go for a hike, take an extra moment to appreciate the seemingly ordinary life all around you. A house fly, humble yarrow weed and other “generalist” plants and pollinators play a crucial role in maintaining biodiversity and may also serve as buffers against some impacts of climate change, […].

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Q&A with Acting FDA Commissioner Janet Woodcock on the Future of the FDA

BioSpace

Acting FDA Commissioner Janet Woodcock shared her thoughts on pandemic issues and outlined FDA modernization plans in a recent Q&A session with the Alliance for a Stronger FDA (Alliance).

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Assessment of Methylene Chloride–Related Fatalities in the United States, 1980-2018

JAMA Internal Medicine

This case series analyzes characteristics of methylene chloride–related fatalities in the United States from 1980 to 2018.

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Anixa Hits FDA Speedbump for Ovarian Cancer CAR-T Trial Approval

BioSpace

The government agency is asking for more information before approving a clinical study on the company’s Chimeric Antigen Receptor-T cell therapy (CAR-T).

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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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Videoconferences more exhausting when participants don’t feel group belonging

Scienmag

Being on video didn’t impact feelings of fatigue, study finds Videoconferences may be less exhausting if participants feel some sense of group belonging, according to new research published by the American Psychological Association. As remote work and the use of videoconferences have dramatically increased during the coronavirus pandemic, more people are fatigued from meeting through […].

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Fauci Says J&J Vaccine Likely to Resume by Friday

BioSpace

The vaccine distribution has been paused in the country because of six or seven cases of rare blood clots.

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Under 30 and sexually active? It’s a good idea to get tested for chlamydia and gonorrhea

Scienmag

Canadian Task Force on Preventive Health Care recommends routine screening Anyone sexually active under age 30 should be offered testing for chlamydia and gonorrhea, according to a new guideline from the Canadian Task Force on Preventive Health Care published in CMAJ (Canadian Medical Association Journal). Chlamydia and gonorrhea are the most commonly reported sexually transmitted […].

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Lyndra Therapeutics' Once-Per-Week Schizophrenia Treatment Shines in Phase II

BioSpace

A Phase II schizophrenia treatment is showing promise for patients diagnosed with this complex and chronic brain disorder.

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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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European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma

BioTech 365

European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma Approval … Continue reading →

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Sponsored | Business Transformation during a Pandemic: Q&A about Jubilant Biosys’ bold plans wit.

BioSpace

This is by far the most exciting time in our history as Jubilant Biosys, and certainly the most exciting message Biosys has ever announced simply because of the sheer scale of transformation that we’ve taken on. It’s massive, very achievable, and ultimately truly transformative for us as colleagu.

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NUMBER OF SHARES AND VOTING RIGHTS OF INNATE PHARMA AS OF APRIL 1, 2021

BioTech 365

NUMBER OF SHARES AND VOTING RIGHTS OF INNATE PHARMA AS OF APRIL 1, 2021 NUMBER OF SHARES AND VOTING RIGHTS OF INNATE PHARMA AS OF APRIL 1, 2021 Marseille, France, April 19, 2021 (GLOBE NEWSWIRE) — Pursuant to the article … Continue reading →

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Drug Patent Expirations for the Week of April 18, 2021

Drug Patent Watch

ZYDELIG (idelalisib) Gilead sciences inc Patent: 6,800,620 Expiration: Apr 24, 2021 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com…. The post Drug Patent Expirations for the Week of April 18, 2021 appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 40
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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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Number of Shares and Voting Rights of Innate Pharma as of April 1, 2021

BioTech 365

Number of Shares and Voting Rights of Innate Pharma as of April 1, 2021 Number of Shares and Voting Rights of Innate Pharma as of April 1, 2021 MARSEILLE, France, April 19, 2021 (GLOBE NEWSWIRE) — Pursuant to the article … Continue reading →

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Pharmaceutical companies with the most ‘New Patient Population’ drugs

Drug Patent Watch

This chart shows the companies which have received the most New Patient Population exclusivities in the past five years. New Patient Populations are one of the categories for which the…. The post Pharmaceutical companies with the most ‘New Patient Population’ drugs appeared first on DrugPatentWatch - Make Better Decisions.

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Nyxoah Announces Submission of Draft Registration Statement For Proposed Public Listing in the United States

BioTech 365

Nyxoah Announces Submission of Draft Registration Statement For Proposed Public Listing in the United States Nyxoah Announces Submission of Draft Registration Statement For Proposed Public Listing in the United States REGULATED INFORMATIONINSIDE INFORMATION Nyxoah Announces Submission of Draft Registration Statement … Continue reading →

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COVID – “Tell us the truth”

World of DTC Marketing

QUICK READ: According to the Times 89% of all media stories on COVID have been negative. While less tan 5% of people who get COVID will require hospitalization both Democrats and Republicans believe that number is a lot higher. The simple reason why there are so many scare headlines around COVID is that they lead to traffic which means higher ad revenue for publishers.

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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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Relief Comments on Certain Statements Made by NeuroRx, Inc. in the Amended Form S-4 Filing of Big Rock Partners Acquisition Corp.

BioTech 365

EQS Group-News: RELIEF THERAPEUTICS Holdings AG / Key word(s): Miscellaneous 19.04.2021 / 07:00 Relief Comments on Certain Statements Made by NeuroRx, Inc. in the Amended Form S-4 Filing of Big Rock Partners Acquisition Corp.

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Cosmo announces the start of trading of its shares on XETRA

BioTech 365

Cosmo Pharmaceuticals N.V. / Key word(s): Miscellaneous 19-Apr-2021 / 06:00 GMT/BST Release of an ad hoc announcement pursuant to Art. 53 KR The issuer is solely responsible for the content of this announcement.

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My Vaccine Program (MVP) Combines Best-of-Breed Technologies to Address Consumer Engagement, Vaccine Hesitancy and Safety Surveillance Related to COVID-19

BioTech 365

My Vaccine Program (MVP) Combines Best-of-Breed Technologies to Address Consumer Engagement, Vaccine Hesitancy and Safety Surveillance Related to COVID-19 My Vaccine Program (MVP) Combines Best-of-Breed Technologies to Address Consumer Engagement, Vaccine Hesitancy and Safety Surveillance Related to COVID-19 As COVID … Continue reading →

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Lyndra Therapeutics Presents Promising Phase 2 Data on Once-Weekly Oral Risperidone Treatment, LYN-005, in Development for Schizophrenia

BioTech 365

Lyndra Therapeutics Presents Promising Phase 2 Data on Once-Weekly Oral Risperidone Treatment, LYN-005, in Development for Schizophrenia Lyndra Therapeutics Presents Promising Phase 2 Data on Once-Weekly Oral Risperidone Treatment, LYN-005, in Development for Schizophrenia Data demonstrate LYN-005 quickly reaches therapeutic … Continue reading →

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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.