To view this email as a web page, click here

Today's Rundown

Featured Story

AstraZeneca, Oxford restart stalled COVID-19 test as Pfizer ramps up trial numbers for its vaccine

Just under a week after it stopped its key phase 3 pandemic vaccine test, AstraZeneca and the University of Oxford have been given the green light to restart in the U.K.

read more

Top Stories

Merck to pay Seattle $1.6B for ADC work, as ex partner Immunomedics nabs the big bucks buyout

Merck has struck a deal to develop Seattle Genetics’ antibody-drug conjugate ladiratuzumab vedotin. The agreement will see Merck pay $600 million and make a $1 billion investment in Seattle Genetics in return for the chance to embark on a joint development program.

read more

Where are they now? Tracking down 2010’s Fierce 15

Over the years, more than 250 companies have been named as finalists in the annual Fierce 15 competition. Before we unveil the 2020 crop of winners, let’s look back 10 years to the class of 2010 and see how the intervening decade has been for them.

read more

Sponsored: Fierce Innovation Awards — Life Sciences Edition 2020: Winners Announcement!

The Fierce Innovation Awards: Life Sciences Edition have come to a close and we're pleased to announce the 2020 award winners!

read more

FDA rejects Mallinckrodt's kidney drug over risk-benefit doubts

The FDA has rejected Mallinckrodt’s request for approval of terlipressin in a rare type of progressive kidney failure. Mallinckrodt suffered the setback despite hitting its primary endpoint in phase 3 and winning the backing of an advisory committee in a split decision.

read more

Next-gen T-cell cancer player Neogene raises $110M with help from some big-name players

A new neoantigen T-cell player has launched with Neogene nabbing a major $110 million series A.

read more

Boehringer’s schizophrenia med boosts cognition in phase 2

Boehringer Ingelheim’s schizophrenia hopeful hit the mark in a phase 2 study, helping patients overcome cognitive impairment that can affect everyday tasks, such as remembering important dates or solving problems. The treatment, BI 425809, works by inhibiting a protein called glycine transporter type 1, or Gly-T1.

read more

Frequency's hearing loss treatment shows long-term promise

Frequency Therapeutics’ hearing loss treatment showed early signs of efficacy last year, with some patients showing improvements after a few months. Now, as the biotech plugs away at a phase 2a study, it’s reporting new data showing the drug’s effects lasting as far out as 21 months.

read more

Nanospectra Bio nets Sirtex backing for gold nanoparticle prostate cancer therapy

Sirtex Medical, maker of a radioactive microsphere implant for treating liver tumors, has made a strategic investment in the developer of a prostate cancer therapy featuring laser-charged gold particles, Nanospectra Biosciences.

read more

BridgeBio's Navire preps SHP2 blocker for lung cancer trial after positive mouse study

Drugs to treat EGFR-mutated non-small cell lung cancer (NSCLC) are effective, but patients often become resistant to them. MD Anderson researchers teamed with BridgeBio’s Navire Pharma to develop an SHP2 inhibitor and are reporting that the drug caused tumors to shrink in models of drug-resistant NSCLC.

read more

Resources

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.

Events