Fri.Aug 13, 2021

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FDA authorizes third coronavirus vaccine dose for immunocompromised people

Bio Pharma Dive

A CDC advisory panel is expected to vote on Friday to recommend the additional dose, after which certain people with weakened immune systems can receive a third shot of Pfizer's or Moderna's vaccine.

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Forget COVID, diabetes is a national emergency

World of DTC Marketing

SUMMARY: Treating Americans with diabetes now costs more than the U.S. Navy’s annual budget. And the world’s richest nation is losing this battle — even before COVID. 85 percent of people with diabetes are overweight. While not all diabetes cases are linked to weight gain, overeating and eating too much is still the main cause of type 2 diabetes.

Genetics 187
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CDC advisory board unanimously backs third dose of Pfizer, Moderna vaccine for immunocompromised people

Bio Pharma Dive

People with weakened immune systems could start receiving an additional shot as early as this weekend. The panel's vote followed the FDA's authorization on Thursday.

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Mattel Introduces 6 Women in Science Barbie Dolls to Inspire Next Generation Girls

XTalks

British vaccine developer, Sarah Gilbert, has been honored with a Barbie doll. This one-of-a-kind doll looks just like her with long auburn hair, oversized black glasses and wears a pantsuit. Gilbert is a professor at Oxford University who helped lead the development of the Oxford/AstraZeneca COVID-19 vaccine. She now shares the honor of having her own Barbie doll with celebrities such as Marilyn Monroe, Eleanor Roosevelt and Beyoncé.

Scientist 116
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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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Shaping the future of ovarian cancer diagnosis with femtech

pharmaphorum

Israeli femtech start-up GinaLife is developing a platform of biomarker strategies supported by artificial intelligence and data science for the early detection of problems in women’s health. CEO and co-founder Inbal Zafir-Lavie tells pharmaphorum more. Six years ago, research scientist Inbal Zafir-Lavie tragically lost her 38-year-old sister Hava Zafir to colorectal cancer.

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FDA approval for Xywav for idiopathic hypersomnia in adults

Pharma Times

First and only FDA-approved treatment for the neurological sleep disorder

More Trending

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Health Secretary asks CMA to review high cost of PCR travel tests

Pharma Times

Sajid Javid has requested a rapid high-level review of the market for PCR travel tests

Marketing 123
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FDA authorises COVID-19 booster jabs for at-risk people

pharmaphorum

The FDA has cleared the use of third dose of either the Pfizer/BioNTech or Moderna COVID-19 vaccines for people with weakened immune systems, but stopped short of recommending a broader booster campaign. The emergency use authorisation (EUA) for the two mRNA-based vaccines has been amended so they can be used for solid organ transplant recipients or those with conditions that impair their immunity, who are at greater risk of severe disease. “Other individuals who are fully vaccinated are a

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Moderna's COVID-19 vaccine maintains antibodies to six months, study shows

Pharma Times

Variants studied included Alpha, Beta, Gamma, Delta, Epsilon and Iota

Antibody 129
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Three Factors to Determine the Best e-Support Services Provider for Your Brand

Drug Channels

Today’s guest post comes from Stacey Little, Senior Vice President of Business Development and Marketing at AssistRx. Stacey discusses how a patient support vendor can help specialty pharmacy patients attain prior authorizations and access critical therapies. She offers three criteria that manufacturers can use to evaluate e-support services providers.

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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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Dog coat patterns have ancient origin

Scienmag

Dogs come in all shapes and sizes, but variations in color patterns provide some of their most distinctive characteristics. A newly released study sheds light on a subset of these patterns, unexpectedly leading to new questions about long-held tenets of dog evolution. The study, co-authored by Professor Danika Bannasch, the Maxine Adler Endowed Chair in […].

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New patent for Boehringer Ingelheim drug PRADAXA

Drug Patent Watch

Annual Drug Patent Expirations for PRADAXA Pradaxa is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from three suppliers. There are five patents…. The post New patent for Boehringer Ingelheim drug PRADAXA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Sunny White

Pharma Marketing Network

Sunny drives the promotion of global brands for pharmaceutical, biotech and medical. device. She founded Xavier Creative House (XCH), a healthcare marketing agency that. builds BOLD and EVOCATIVE designs, pushing the edge of creativity. Sunny is the point person for positioning your brand into a “Powerhouse.” As, CEO, she leads Operations and Client Management utilizing a wealth of experience gained from her roles in communications, compliance, and sales in rapid-growth companies.

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New patent expiration for Genzyme Corp drug CAPRELSA

Drug Patent Watch

Annual Drug Patent Expirations for CAPRELSA Caprelsa is a drug marketed by Genzyme Corp and is included in one NDA. It is available from one supplier. There are four patents…. The post New patent expiration for Genzyme Corp drug CAPRELSA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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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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What To Do As A CRA During Your First IMV For A Study in Clinical Research

Clinical Trial Gurus

Interim Monitoring Visits are the most common type of monitoring visit that a clinical research associate will conduct throughout the course of her career. In this video I discuss how to handle your first Interim Monitoring Visit when you encounter this situation!

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Checking the Mirror: How We’re Doing at Diversifying Intouch

Intouch Solutions

A little over a year ago, in the wake of the civil unrest and protests sparked by the murder of Minneapolis resident George Floyd, more than 600 Black advertising professionals called for industry leaders to take real steps to diversify their companies. Shortly after, Intouch answered the call. In July 2020, our director of inclusion, Antonio Rivera, sent out a company-wide email stating that Intouch would rise to the challenge: “In early June last year, the 600 & Rising campaign inspi

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Companion Animal Veterinary Vaccines Global Market Report 2021: Inactivated, Live Attenuated, Recombinant – Long-term Forecast to 2025 & 2030 – ResearchAndMarkets.com

BioTech 365

Companion Animal Veterinary Vaccines Global Market Report 2021: Inactivated, Live Attenuated, Recombinant – Long-term Forecast to 2025 & 2030 – ResearchAndMarkets.

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Which pharmaceutical companies have the most SPCs in Italy?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Italy. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating…. The post Which pharmaceutical companies have the most SPCs in Italy? appeared first on DrugPatentWatch - Make Better Decisions.

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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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Employee Elected Director to step down from the board of Zealand Pharma A/S

BioTech 365

Employee Elected Director to step down from the board of Zealand Pharma A/S Employee Elected Director to step down from the board of Zealand Pharma A/S Company announcement No.

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Reimagining Clinical Trials: Why are Virtual Clinical Trials Becoming the New Normal?

Delveinsight

Clinical trials are an essential part of the drug development process. Worldwide, more than 2 million clinical trials are registered and the number is steadily increasing over the past several years. While clinical trials are pivotal to analyze the efficacy of any new therapy or drug, every year, a lot is spent on clinical trials. The cost of patient enrolling, recruitment, and retention come up to cost several billion US dollars worldwide.

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Rani Therapeutics Announces Closing of its Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

BioTech 365

Rani Therapeutics Announces Closing of its Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares Rani Therapeutics Announces Closing of its Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares SAN JOSE, … Continue reading →

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FDA Authorizes Third Dose – Some Implications

Eye on FDA

What does “fully vaccinated” mean today? In the face of the widening spread of the SARS-Cov-2 variant, the rise in breakthrough cases, and data that suggests a slight waning effect over time of vaccines, FDA acted yesterday to protect some of the most vulnerable by amending the Emergency Use Authorization of the mRNA vaccines. People who have had organ transplants and people who are immunocompromised may now get a third dose.

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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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Entera Bio to Report Business and Financial Results for the Quarter ended June 30, 2021, on August 16, 2021

BioTech 365

Entera Bio to Report Business and Financial Results for the Quarter ended June 30, 2021, on August 16, 2021 Entera Bio to Report Business and Financial Results for the Quarter ended June 30, 2021, on August 16, 2021 BOSTON and … Continue reading →

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Biophytis Announces the Issue of 4,950,000 New Shares in a Capital Increase Reserved for NEGMA and the Performance of the Judgments of March 16, 2021 and July 16, 2021

BioTech 365

Biophytis Announces the Issue of 4,950,000 New Shares in a Capital Increase Reserved for NEGMA and the Performance of the Judgments of March 16, 2021 and July 16, 2021 Biophytis Announces the Issue of 4,950,000 New Shares in a Capital … Continue reading →

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XORTX Therapeutics Calls Special Meeting of Shareholders

BioTech 365

XORTX Therapeutics Calls Special Meeting of Shareholders XORTX Therapeutics Calls Special Meeting of Shareholders CALGARY, Alberta, Aug. 13, 2021 (GLOBE NEWSWIRE) — XORTX Therapeutics Inc.

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California Health and Wellness Assisting Members Across Tehama County during State of Emergency

BioTech 365

California Health and Wellness Assisting Members Across Tehama County during State of Emergency California Health and Wellness Assisting Members Across Tehama County during State of Emergency SACRAMENTO, Calif.–(BUSINESS WIRE)–In response to Gov.

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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.

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Cybin Inc. Announces 2021 First Quarter Financial Results and Business Highlights

BioTech 365

Cybin Inc. Announces 2021 First Quarter Financial Results and Business Highlights Cybin Inc. Announces 2021 First Quarter Financial Results and Business Highlights — Boosts current cash position to C$82.5M to progress clinical pipeline and business initiatives — TORONTO–(BUSINESS WIRE)–Cybin Inc.

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FDA Approves Merck’s Hypoxia-Inducible Factor-2 Alpha (HIF-2?) Inhibitor WELIREG™ (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors

BioTech 365

FDA Approves Merck’s Hypoxia-Inducible Factor-2 Alpha (HIF-2?) Inhibitor WELIREG™ (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors FDA Approves Merck’s Hypoxia-Inducible Factor-2 Alpha (HIF-2?

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Global Fibroblast Growth Factor Receptor Inhibitor Drug Market to 2026 – Opportunity & Clinical Trials Insights – ResearchAndMarkets.com

BioTech 365

Global Fibroblast Growth Factor Receptor Inhibitor Drug Market to 2026 – Opportunity & Clinical Trials Insights – ResearchAndMarkets.com Global Fibroblast Growth Factor Receptor Inhibitor Drug Market to 2026 – Opportunity & Clinical Trials Insights – ResearchAndMarkets.

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Life Science Tools Market Size, Share & Trends Analysis Report 2021 – ResearchAndMarkets.com

BioTech 365

Life Science Tools Market Size, Share & Trends Analysis Report 2021 – ResearchAndMarkets.com Life Science Tools Market Size, Share & Trends Analysis Report 2021 – ResearchAndMarkets.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.