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Editor's note: Fierce Biotech will not publish on Monday in observance of the Labor Day holiday. We'll be back in your inbox on Tuesday, Sept. 8. Have a great weekend everyone.

Today's Rundown

Featured Story

AbbVie puts $2B on the table for I-Mab cancer collab as biotech nabs $418M raise

It’s a good day for Shanghai-based I-Mab, which has penned a $2 billion upfront-biobucks R&D deal with AbbVie while also nabbing $418 million from investors.

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Top Stories

Vertex's success kills off Savara's experimental cystic fibrosis drug hopes

Texas-based biotech Savara is killing off a midstage test of its investigational cystic fibrosis hopeful Molgradex after a new winner-takes-all competitor from Vertex.

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Pfizer, BioNTech 'quietly' usher a 5th COVID-19 jab into the clinic: analyst

BioNTech and partner Pfizer have been working on four vaccine candidates against COVID-19, snagging FDA fast-track tags for two of them and pushing one into a 30,000-patient phase 3 study. Now, the duo is adding a fifth shot on goal, slated to enter a phase 1/2 study this month.

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Lixte plans Nasdaq uplisting to accelerate blood cancer trial

OTC-listed Lixte Biotechnology has filed to uplist to Nasdaq, raising $11 million in the process. The uplisting comes as Lixte seeks to accelerate enrollment in a phase 1b/2 myelodysplastic syndrome that is lagging behind expectations. 

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Rain bags $63M, ex-Daiichi cancer drug to mount pivotal push

Rain Therapeutics has raised $63 million and licensed a Daiichi Sankyo cancer drug to accelerate its progress into pivotal development. Licensing the ex-Daiichi small molecule sets Rain up to go after a target a who’s who of leading drug developers have pursued without success. 

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Insilico's weeks-old aging research spinout Deep Longevity picked up by Regent Pacific

After officially launching this July, Deep Longevity—a spinout venture from the prolific AI molecule designer Insilico Medicine—has found a new owner in Hong Kong investment firm Regent Pacific.

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Using CRISPR to improve viral vectors for gene therapy

To overcome preexisting immunity that cripples the adenovirus vectors used in gene therapy and vaccines, scientists at the University of Pittsburgh created a CRISPR-based system that briefly suppresses the genes that cause the problem. The method improved gene therapy uptake in mice and is being developed by startup SafeGen.

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FiercePharmaAsia—Biocon, Mylan's Lantus copy; Samsung rides COVID demand; Adlai Nortye's C round

Mylan and Biocon plans to launch their Lantus copy as the lowest-priced basal insulin on the U.S. market. Samsung Biologics got ambitious about its expansion plan amid rising demand from the pandemic. China's Adlai Nortye net $100 million in series C to advance its oncology pipeline. And more.

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Chutes & Ladders—Bristol Myers Squibb vet Noumani will head R&D at Blueprint Medicines

Blueprint taps Noumani as head of R&D; Nocion names Silber as CMO; Abbvie vet Olson jumps over to Magenta.

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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] 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.

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.

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