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Today's Rundown

Featured Story

Regeneron's COVID-19 antibody cocktail curbs virus, speeds recovery in early data

The first data are in for Regeneron’s COVID-19 antibody cocktail—and they’re encouraging. The top dose of the treatment lowered virus levels and relieved symptoms more quickly than placebo in patients infected with COVID-19 but not sick enough to be hospitalized.

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Top Stories

Moderna's COVID-19 vaccine spurs immune response in older adults

Moderna has published data from adults aged 56 years and older who received its COVID-19 vaccine. Results from the small cohort suggest the vaccine triggers comparable immune responses in younger and older adults.

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Pfizer funnels $200M into CStone, licences late-stage cancer med in China

CStone Pharmaceuticals has seen a $200 million investment from U.S. Big Pharma Pfizer and nabbed a China license for its PD-L1 asset sugemalimab.

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Alnylam phase 3 links lumasiran to 'clinically significant' improvement in infants

A phase 3 trial has linked Alnylam’s lumasiran to a “clinically significant” decline in a substance that drives negative outcomes in children with a rare kidney disease. The top-line readout comes months before the FDA is due to rule on whether to approve the RNAi therapeutic in older patients. 

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Takeda, Ovid plot next steps for rare epilepsy med after mixed phase 2 data

Barely four years after Takeda and Ovid joined forces on a rare epilepsy drug, the duo are unveiling data for a pair of new indications. The drug, soticlestat, cut down on seizure frequency in a small pilot study of patients with CDKL5 deficiency and duplication 15q syndrome.

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Myovant's relugolix falls short in metastatic prostate cancer with FDA verdict looming

Last fall, Myovant’s prostate cancer drug outshone the standard of care at keeping patients’ testosterone levels down, a phase 3 showing that teed up an FDA filing. Now, as the agency ponders the case, the company is unveiling data for patients with metastatic disease—and they’re not so rosy.

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Ironwood puts GERD hopeful on the chopping block along with 100 staffers after flop

Ironwood had once hyped this drug as a $2 billion-a-year asset, but IW-3718 has failed to live up to its high expectations, failing a phase 3 program and thrown out onto the garbage pile.

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FDA authorizes Hologic's high-throughput COVID-19 test for wider screening of people showing no symptoms

The agency also gave the company’s diagnostic, run on the high-throughput Panther Fusion laboratory platform, a green light for pooled testing.

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Resources

Whitepaper: Position Your Pharmaceutical Lab for Success

Want to leapfrog lengthy LIMS deployments and position your pharmaceutical lab for success? Find out how with LabVantage Solutions.

Whitepaper: 16 Biopharma Leaders Tell How COVID-19 Will Change Customer Engagement

Senior executives from 16 biopharma companies share their thoughts on how COVID-19 will change how the industry engages with its customers.

Whitepaper: Five Imperatives for Becoming More Patient-Centric

Achieving patient centricity depends on evolving how evidence is generated.

Whitepaper: Why Your Business Needs a Ransomware Strategy To Avoid Being Hacked!

Cybercriminals Are Actively Exploiting The Coronavirus Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become The Next Ransomware Headline -- Make These Changes Now!

Whitepaper: Leverage Technology to Expedite Master Protocol Trials

This white paper addresses the complexity of basket and umbrella designs, and how modern technology is critical to run flexible, agile and quality-driven trials.

Whitepaper: The Chronic Microcap Trap: How Launch Is the Escape for True Growth

How independent drug launch and commercialization can lead to higher market capitalization.

Whitepaper: Antibody-Drug Conjugates: Catalysts for Chemistry

Download our white paper to learn more about the growth trends, complex anatomy and intricacies of developing these armed antibodies, as well as AMRI’s approach to their discovery and development.

Whitepaper: How to Successfully Manage Regulatory and Financial Compliance Risk

Avoid severe compliance penalties by staying on top of evolving laws.

Whitepaper: Accelerating the Development of Orphan Drugs for Rare Diseases

This white paper will discuss four principal CMC challenges for the developers of orphan drugs, and the potential solutions which are emerging. Download now >>

Case Study: QED Therapeutics accelerates launch of rare cancer drug into niche market with analytics-driven insights

In 2020, QED Therapeutics launched first-in-class infigratinib for cholangiocarcinoma (CCA). Learn how the launch team precisely identified and characterized eligible patients by taking an evidence-based approach to its commercial strategy.

Whitepaper: A Guide to Improving Your R&D Data Maturity

Life science R&D generates a LOT of data. Learn how to make sense of it and harness its potential with this step-by-step guide.

Whitepaper: How Broadening the Analysis of Compound Factors Allows for Predictive Solubility Solutions

Don’t oversimplify your solubility challenges.

Whitepaper: Reducing Site Workload for Better, Faster, Safer Clinical Trials

Download this free whitepaper to learn how to execute fast, high-quality clinical trials through eSource for studies that boost efficiency for both sponsors and sites.

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.

Whitepaper: Achieving a Successful Drug Product Technology Transfer

Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.

Whitepaper: Avoid Fallout From Incompatibility Between Your API And Its Formulation

Download the whitepaper to learn more.

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.

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.

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.

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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