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Today's Rundown

Featured Story

Sarepta cites 'overburdened' FDA as factor in DMD gene therapy delay

Burdens placed on the FDA by COVID-19 and the rapid proliferation of cell and gene therapies are a factor in the recent setback to Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) prospect, according to CEO Douglas Ingram.

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Top Stories

First order of business for brand-new C4 Therapeutics chief Hirsch: A $100M IPO

Andrew Hirsch is wasting no time at his new role running C4 Therapeutics, and, just days after getting the top job, the biotech is gunning for an initial public offering.

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Celltrion passes early safety trial for anti-COVID-19 antibody as key tests await

Vaccines get all the headlines, but the use of antibodies to both treat and prevent SARS-CoV-02 infection is an equally major part of the COVID-19 arsenal.

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Eye disease biotech Orasis Pharmaceuticals nabs $30M for phase 3, sales activities

A year after a positive readout and two years since its series B round, Orasis has raised a further $30 million.

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Phase 3 migraine flop squashes Satsuma's stock price

A phase 3 trial of Satsuma Pharmaceuticals’ acute treatment for migraine has missed its co-primary endpoints. The nasally administered formulation did no better than placebo, sending Satsuma’s stock down 76%.

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Opdivo trial offers new insights into how immuno-oncology drugs could be enhanced

By analyzing tumor samples from a study of Bristol Myers Squibb's Opdivo in melanoma patients, a research team led by UCLA scientists showed that inducing interferon signaling could be part of a combination approach to enhancing immuno-oncology drugs.

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20-second coronavirus screening test piloted at U.K.'s Heathrow airport

Two British companies are preparing to launch a simple COVID-19 saliva screening test that aims to provide an accurate result within 20 seconds—following its first uses at London’s Heathrow airport, one of the busiest in the world.

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FiercePharmaAsia—AbbVie, I-Mab's $2B CD47 deal; COVID-19 vaccine trial pause; Baidu's AI biotech plan

AbbVie has put $2 billion on the table for I-Mab's anti-CD47 antibody drug. Serum Institute of India has put a hold on its clinical trial of AstraZeneca's COVID-19 vaccine. Chinese tech giant Baidu is in talks to raise $2 billion to launch a biotech that will use AI for drug discovery and diagnostics. And more.

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Chutes & Ladders—Bind's ex-CEO Hirsch washes up at C4 in helmsman role

C4 taps ex-Bind CEO Hirsch to head role; Lumen names Spigarelli to CMO post; Spruce brings on Invidior's Dias as CMO.

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Resources

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

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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.

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

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.

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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