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Today's Rundown

Featured Story

Trump accuses FDA of playing politics with last-minute COVID-19 plasma delay

As the months tick down before the November election, President Donald Trump is seemingly under increasing pressure to find vaccines and treatments for COVID-19.

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Top Stories

Bristol Myers inks lease to consolidate Cambridge R&D sites, join Sanofi at new development

Bristol Myers Squibb has taken out a lease on a 360,000-square-foot site in Massachusetts. Securing the facility, which is walking distance from Kendall Square, will enable Bristol Myers to combine its two existing Cambridge R&D sites into a single location.

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Turning Point posts data on rival to Roche's Rozlytrek, targets speedy approval

Turning Point Therapeutics has posted early phase 2 data on ALK inhibitor repotrectinib that suggest it may pose a threat to Roche’s Rozlytrek. Buoyed by the data, Turning Point is tweaking the trial with a view to pulling forward a filing for FDA approval.

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Sponsored: Why Ethical Procurement Matters for Human Biospecimens

While the response to COVID-19 and other disease indications drives science forward, regulatory guidelines that ensure the safe and ethical treatment of patients continues to be critically important.

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Inhibrx pulls off $119M IPO on its 2nd go-around

Inhibrx may have called off its first IPO attempt last fall, but its second go has proved much more fruitful. The antibody specialist raised $119 million in its Wall Street debut, far eclipsing the $75 million it originally sought last year. The funds will support phase 1 studies for multiple antibody candidates.

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No IPO? No problem: Alzheon bags $47M NIH grant to bankroll Alzheimer's trial

Alzheon has been trying to go public for years, calling off its IPO in April 2018 and aborting its second attempt in January last year. Now, public markets be damned, the company is moving forward with a phase 3 study of its lead Alzheimer’s program thanks to a $47 million grant from the National Institutes of Health.

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Qiagen launches new tools for tracking coronavirus mutations and strains

Qiagen launched new tools to capture and track emerging mutations in the novel coronavirus, which can lead to new strains that may change how the world responds to the COVID-19 pandemic.

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Immune-evading cells with PD-L1 control diabetes in mice

Scientists at the Salk Institute created functional, three-dimensional human islet-like organoids that restored glucose control in mice without triggering immune rejection. The trick was to induce the expression of the PD-L1 immune checkpoint protein.

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CureVac in 'advanced' talks with EU to supply 225M coronavirus vaccine doses

Officials in Europe have engaged some of the world's largest biopharma companies in COVID-19 vaccine supply talks, but now Germany’s CureVac is moving into advanced supply negotiations with the union. The deal, which is contingent on the vaccine succeeding in testing, would potentially allow for the purchase of 405 million doses.

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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.

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."

Whitepaper: Navigating the Changing Clinical Trial Landscape

The research conducted here is to help understand and solve the top challenges in clinical operations, to remove barriers that are slowing down our ability to bring new drugs to market as quickly as possible to patients waiting in need.

Whitepaper: Choosing the Best Sterile Dosage Form for Your Phase I Clinical Supply Needs

How to select the right dosage form for your Phase I clinical supply.

Whitepaper: Quality by Design: A Holistic Approach to Drug Development

Quality by Design (QbD) reduces risk within drug development, while bringing therapies to market quicker.

Webcast: DRUG ABUSE LIABILITY ASSESSMENT: Are you taking an integrated approach?

Two informative webcasts will present practical and methodological approaches to preclinical drug abuse liability assessment

Executive Summary: Keys to a Successful Rapid Commercial Launch

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.

Whitepaper: More Powerful Analytics Capabilities

Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI.

eBook: Navigating the Insulin Affordability Act

Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all.

Whitepaper: Reducing the Complexity and Costs of Channel Planning and Logistics

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

Whitepaper: The Art of Recognizing Clinical Supply Risk Factors

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.

Events