Mon.Aug 30, 2021

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Moderna founder's next big play in RNA raises $440 million

Bio Pharma Dive

Just a few months out of stealth mode, Laronde and its "endless RNA" technology have caught the attention of well-known investors like Fidelity, T. Rowe Price Associates and Invus.

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Lumiio streamlines data collection, changing the face of global health collaboration

Pharma Mirror

CALGARY, AB: Reliable, consistent, and applicable data is a key feature of well-executed research and the development of new treatments. For some diseases and disorders, possible study participants are spread out across the world, preventing effective research and slowing down the process of improving quality of life for the people who need them most.Lumiio is determined to change this.

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FDA scrutiny, Merck approval lead Roche to pull Tecentriq in breast cancer

Bio Pharma Dive

While FDA advisers voted in April to keep Tecentriq available for use in triple-negative breast cancer, the Swiss pharma said changes in how the disease is treated spurred it to withdraw the indication.

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How the UAE is Growing Climate-Proof Food in the Desert

XTalks

Desert farming has existed for thousands of years , but one center in Dubai has created desert farming equipped to handle rising temperatures and extreme weather events. While these climate change-induced factors tend to make farming difficult and disrupt food distribution, Dubai’s International Center of Biosaline Agriculture (ICBA) is creating solutions to boost local food production in the driest and hottest conditions.

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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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FDA restarts distribution of Lilly's COVID-19 drug in 22 states

Bio Pharma Dive

Use of the treatment had been halted due to weakened efficacy versus an early coronavirus variant. Now, with delta widely prevalent and demand for antibody treatments surging, Lilly's therapy will be available again.

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Ivermectin Demand Surges Though It Doesn’t Work for Covid-19

NY Times

Prescriptions for ivermectin have jumped to more than 88,000 per week, some pharmacists are reporting shortages and people are overdosing on forms of the drug meant for horses.

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More Trending

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Revive Therapeutics reports progress with Phase III COVID-19 trial

Outsourcing Pharma

A leader from the rare and infectious disease treatment specialist talks about ongoing research into a potential treatment for mild-to-moderate COVID-19.

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Study: COVID-19 Deaths Likely Due to Extremely High Viral Load

BioSpace

?A new study on COVID-19 behavior has found that patients affected by the virus might have died due to a buildup of coronavirus directly in the lungs and not because of a secondary infection.

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CAR T therapy focused Umoja hits manufacturing capability linked milestone

BioPharma Reporter

Seattle-based Umoja Biopharma, a company looking to reprogram immune cells in-vivo to create next-generation immunotherapies for the treatment of solid tumors and hematologic malignancies, has started work on its new development and manufacturing facility in Colorado.

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Cancer Patients Want Warp Speed Given to Oncology Research Next

BioSpace

While the speed of science is both lauded and mistrusted by near-equal parts of the population, the over 22 million Americans with cancer are now saying, “Wait, what about us?

Research 100
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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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UK consortium lands grant to construct digital supply chain

Outsourcing Pharma

FarmaTrust is helping assemble a collective of public and private firms working on solutions for smart manufacturing and creating medicines of the future.

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Startup Runs with Old Novartis Muscle Loss Drug to Fight Obesity

BioSpace

Newly launched Versanis Bio is aiming to turn a Novartis drug that was once developed to help with muscle loss and weakness into an anti-obesity treatment.

Drugs 105
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Self-injecting pill could offer oral administration for monoclonal antibodies, insulin and other drugs

BioPharma Reporter

A new type of self-injecting capsule could deliver medications at comparable levels to those given via injection, according to a preclinical study.

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New patent for Bionpharma Inc drug NAPROXEN SODIUM

Drug Patent Watch

Annual Drug Patent Expirations for NAPROXEN+SODIUM Naproxen Sodium is a drug marketed by Bionpharma Inc, Catalent, Puracap Pharm Llc, Actavis Labs Fl Inc, Able, Amneal Pharms Ny, Aurobindo Pharma Ltd,…. The post New patent for Bionpharma Inc drug NAPROXEN SODIUM appeared first on DrugPatentWatch - Make Better Decisions.

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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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Outgoing Moderna CMO Lands Seat on Teva Pharmaceuticals Board of Directors

BioSpace

Teva announced the appointment in a filing with the U.S. Securities and Exchange Commission. Zaks will serve on the board’s Science and Technology Committee.

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Venous Thromboembolism Market Quadrant Growth to Balloon UP

Delveinsight

Venous thromboembolism (VTE) is a condition that is characterized by the development of blood clots in the veins. The condition includes Deep vein thrombosis (DVT) which occurs when a blood clot forms in a deep vein of the lower legs or pelvic area. However, in some cases, the blood clots from pelvic areas may break loose and travel to the lungs through the right side of the heart, known as Pulmonary embolism (PE).

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In the pipeline: What the next wave of COVID-19 vaccines could look like

BioPharma Reporter

We take a look at some of the COVID-19 vaccine candidates moving through clinical trials.

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J&J's HIV Vaccine Fails to Protect High-Risk African Women in Trial

BioSpace

Johnson & Johnson announced failed Imbokodo Phase IIb trial in HIV. The study evaluated the company’s investigational HIV vaccine regimen in young women in sub-Saharan Africa.

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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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The Intolerable Wait for a Kids’ Vaccine

NY Times

As children's hospital beds fill up, the F.D.A. shouldn't delay. .

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AIDS Healthcare Foundation Targets Moderna for "Pandemic Profiteering"

BioSpace

Today, activists with the AIDS Healthcare Foundation are setting up to protest in front of Moderna’s Cambridge headquarters.

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CRC Sets Up A LinkedIn Profile and Gets Hired As A CRA: Clinical Research Is Booming!

Clinical Trial Gurus

This clinical research coordinator who happens to be a former employee of mine became a clinical research associate earlier this year. This interview documents how this went down!

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Renovacor’s Marc Semigran Transitioned to Industry to Put Patients First

BioSpace

The burgeoning genetic capabilities were instrumental in causing Semigran to transition into the biotech industry.

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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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Vertex boosts cell and genetic therapies toolkit in deal worth up to $1.2bn with Arbor

BioPharma Reporter

Boston-based company, Vertex, has signed a deal to use Arbor Biotechnologiesâ CRISPR gene-editing technology to develop novel cell therapies for the treatment of serious diseases.

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The Intolerable Wait for a Kids’ Vaccine

NY Times

As children's hospital beds fill up, the F.D.A. shouldn't delay. .

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Announcing The ClinEssentials Giveaway

ECRG Media's Clinical Research Podcast

Announcing The ClinEssentials Giveaway To be entered in the giveaway. Comment on Youtube on Wednesday's, the full interview video in order to be entered in the giveaway. 3 Lucky winners will be chosen! Check out Tiffany Here: www.linkedin.com/in/tiffany-ashton-013277215 [link] Don't forget to Subscribe for new content! Merch: [link] [link] eliteclinicalgroup@gmail.com Podcast: [link] [link] eliteclinicalgroup@gmail.com Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link] Gl

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A drug costing less than €2 a day helps in.

The Pharma Data

Metoprolol, a drug widely used to treat cardiovascular disease, is beneficial when administered to COVID-19patients. This is the finding of a study by investigators at the Centro Nacional de Investigaciones Cardiovasculares (CNIC), published today in the Journal of the American College of Cardiology (JACC). The most severe form of COVID-19 is severe respiratory failure, which requires intubation and is associated with a high mortality rate.

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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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Announcing The ClinEssentials Giveaway

ECRG Media's Clinical Research Podcast

Announcing The ClinEssentials Giveaway. To be entered in the giveaway. Comment on Youtube on Wednesday's, the full interview video in order to be entered in the giveaway. 3 Lucky winners will be chosen! Check out Tiffany Here: www.linkedin.com/in/tiffany-ashton-013277215. [link]. Don't forget to Subscribe for new content! Merch: [link] [link] eliteclinicalgroup@gmail.com Podcast: [link] [link] eliteclinicalgroup@gmail.com Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link]

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Novartis Leqvio®* (inclisiran) analyses show effective and sustained LDL-C reduction.

The Pharma Data

Separate post hoc analyses of pooled Phase III ORION-9, -10 and -11 data show twice-yearly** Leqvio ® (inclisiran) consistently reduced low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD) with established cerebrovascular disease (CeVD) 1 and polyvascular disease (PVD) 2. Overall, Leqvio was well-tolerated, with a safety profile similar to placebo and consistent with the overall pooled population from the combined trials 1 – 3.

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New patent expiration for Vertex Pharms drug INCIVEK

Drug Patent Watch

Annual Drug Patent Expirations for INCIVEK Incivek is a drug marketed by Vertex Pharms and is included in one NDA. There are three patents protecting this drug. This drug has…. The post New patent expiration for Vertex Pharms drug INCIVEK appeared first on DrugPatentWatch - Make Better Decisions.

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ABROCITINIB AND DUPILUMAB FOR MODERATE TO SEVERE ATOPIC DERMATITIS

The Pharma Data

-JADE DARE trial met co-primary and key secondary endpoints and demonstrated a safety profile consistent with previous studies-. today announced that JADE DARE (B7451050), a 26-week, randomized, double-blind, double-dummy, active-controlled, multi-center Phase 3 study, met its co-primary and key secondary efficacy endpoints. The study showed that abrocitinib was statistically superior compared to dupilumab in each evaluated efficacy measure and had a safety profile consistent with previous studi

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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.