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Today's Rundown

Featured Story

Trump pushes for preelection fast-tracked approval of AstraZeneca COVID-19 vaccine: report

President Donald Trump is considering fast-tracking the authorization of AstraZeneca’s COVID-19 vaccine to ensure a jab is available in time for the November election, according to the Financial Times. The mooted plan is to allow AstraZeneca to gain emergency use authorization on the basis of a 10,000-subject U.K. clinical trial. 

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Top Stories

Novartis’ PD-1 combo flops in phase 3 melanoma test

Novartis’ experimental PD-1 blocker came up short in a phase 3 study combining it with its melanoma-fighting duo Tafinlar and Mekinist. Tafinlar, a BRAF inhibitor, and Mekinist, a MEK inhibitor, are already approved to treat melanoma patients with a specific BRAF mutation, but Novartis thought adding a checkpoint inhibitor might help it work even better.

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Bristol Myers to buy Forbius in hunt for Opdivo-enhancing drugs

Bristol Myers Squibb has struck a deal to buy Forbius for its portfolio of TGF-beta inhibitors. The takeover will give Bristol Myers control of a clinical-phase inhibitor of TGF-beta 1 and 3 that Forbius is developing to increase the activity of immune checkpoint inhibitors.

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Sponsored: Improve outcomes for TIL therapies by tackling process challenges

The efficacy of TIL therapies depends on how the original tumor samples are collected, harvested, and processed.

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Pipeline report: Alzheimer’s disease, from amyloid and tau to gene therapies and beyond

Billions of research dollars have gone into discovering the underlying mechanisms in Alzheimer's disease and seeking drugs that can disrupt the pathogenic steps that lead to the destruction of neurons, but it’s a hugely long and expensive process.

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Yumanity backs onto Wall Street via Proteostasis merger

On the heels of a Big Pharma deal worth up to $500 million, Yumanity Therapeutics is merging its way onto Wall Street. The neuro-focused biotech is joining up with Proteostasis, which once planned to move a cystic fibrosis drug into the clinic this year but is now looking for someone to buy its pipeline.

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Aslan hopes to roar again as Dupixent rival test resumes after COVID-19 chaos

Singapore-based Aslan Pharmaceuticals is hitting go again on its stalled dermatitis study.

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From 'party drug' to PTSD treatment: ATAI launches EmpathBio to develop MDMA-based therapy

Drugs for post-traumatic stress disorder don’t work for everyone. EmpathBio, ATAI Life Sciences’ latest company, is looking to fill that gap with treatments based on the “party drug” MDMA in hopes they will work better as add-ons for patients with PTSD who are undergoing psychotherapy than antidepressants, such as Zoloft and Paxil, do.

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AstraZeneca taps RenalytixAI for personalized kidney medicine initiative at Mount Sinai

AstraZeneca has enlisted RenalytixAI to help it develop precision medicine strategies for managing patients with chronic diseases of the cardiovascular system, kidneys and metabolism.

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Functioning liver cells regenerate in pig lymph nodes, and a human trial is coming

Pitt researchers demonstrated that pigs can grow functioning auxiliary livers in their abdominal lymph nodes after their own hepatocytes are isolated and injected into them. Startup LyGenesis is working to bring the method into human clinical trials later this year.

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FDA's emergency nod for convalescent plasma sparks questions of whether it's bowing to Trump

Hospitalized COVID-19 patients in the U.S. have another treatment option in the U.S. after the FDA’s emergency authorization for convalescent plasma on Sunday. But the decision prompted pushback from experts who questioned the data and wondered whether the FDA is acting under pressure from President Donald Trump. 

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Enrollment Showcase

Bioscience Certificate Pathways Advancing Knowledge, Skills, & Careers

Taught by experienced professionals, Biotility’s online short courses provide the knowledge and practical skills valued by the bioscience industry. Enhance your career through coursework in one of our certificate pathways, including Document Management, Operations Management, and Quality Management. Learn more.

Resources

Whitepaper: Top 7 Data Points from Medical Claim Forms to Drive Market Development

Traditionally, pharma companies use a combination of prescription data & internal sales reports to look for potential buyers. Such practice provides only a LIMITED VIEW without competitor information.

Whitepaper: New data models to gain insight on medication adherence

Download the whitepaper by Optum to see how novel data platforms can uncover hidden insights on medication adherence helping life sciences companies maximize product utilization.

Report: Decentralized Trials - Where Does the Industry Stand?

Patient-facing digital technologies are playing an important role in clinical trials for new drugs and medical devices, to the point where conducting virtual trials is becoming mainstream. But terms like remote trials, direct-to-patient trials, hybrid trials, decentralized trials, and more all add to the confusion of what makes a trial "virtual."

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Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better.

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Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients.

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In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management.

Whitepaper: Learn How Collaboration (Not Competition) Will Bring Better Pediatric Medicines to Market

Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research.

Case Study: Establishing Parameters for Success

Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study.

Fact Sheet: Forecasting to Optimize Clinical Trial Supply Management

Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study.

eBook: Expecting the Unexpected: Strategies for Efficient Clinical Supply Management and Forecasting

Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study.

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