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Today's Rundown

Featured Story

Novartis' asciminib bests Pfizer's Bosulif in phase 3 leukemia trial

Novartis’ asciminib has outperformed Pfizer’s Bosulif in a phase 3 chronic myeloid leukemia study, moving it closer to winning approval of a candidate designed to address drug resistance and intolerance.

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Top Stories

FDA commish finding his feet, COVID-19, and chaotic communication hitting speedy approvals

The FDA’s accelerated approvals program is on shaky ground after a series of surprise rejections, poor communication and COVID-19-focused staff.

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Moderna’s COVID-19 vaccine triggers immune response in older adults

As seen in 45 younger adults, the middle dose of Moderna’s COVID-19 vaccine triggered the production of neutralizing antibodies against SARS-CoV-2, the virus that causes COVID-19, in 10 patients aged 56 to 70 and 10 patients over 71. The patients’ antibody levels were two to three times higher than those seen in patients who recovered from the disease.

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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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Dyne Therapeutics gunning for $100M IPO weeks after a $115M raise

The story of 2020 biotech startups will be told in terms of free-flowing cash, wide open public markets and early promise.

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Kinnate bags $98M to push next-gen targeted cancer meds into the clinic

Targeted treatments have been a game changer for cancer patients with tumor-driving mutations like ALK or EGFR. But the reality is, this group of patients is pretty small—and even then, their tumors often develop resistance to targeted drugs, or the drugs may not work at all. Kinnate Biopharma is looking to change that, and it’s just raised $98 million to do so.

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Kura hires Tagrisso lead to take cancer drugs deeper into clinic

Kura Oncology has hired Stephen Dale as chief medical officer. The appointment gives Kura a chance to tap into the experience of the person who oversaw development of Tagrisso as it drives its cancer prospect tipifarnib through the clinic.

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Acadia adds pain meds to the pipeline with $52.5M CerSci buyout

Acadia Pharmaceuticals has seen its share of ups and downs as it tries to add indications to antipsychotic Nuplazid, its sole marketed drug. Now, it’s expanding its scope and adding a clutch of new pipeline hopefuls through a buyout that’s worth $52.5 million upfront but that could net CerSci shareholders $887 million in milestones.

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Medtronic reports 44% drop in quarterly income as it begins to recover from COVID-19

Over the past quarter, Medtronic’s net income dropped nearly 44% compared to the same period last year—but that still outpaced what many expected, considering the wide-ranging effects of the coronavirus pandemic.

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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."

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