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Today's Rundown

Featured Story

Inovio is going after the 'impossible tumor' left in the dust of new cancer meds

Inovio is hoping to change outcomes for patients with glioblastoma using a new DNA medicine combination of INO-5401, INO-9012 and Regeneron-Sanofi’s PD-1 inhibitor Libtayo.

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Top Stories

Galapagos cuts pipeline, targets €150M in savings after setbacks

Galapagos is dumping pipeline programs and targeting €150 million ($181 million) in savings as it seeks to bounce back from a bruising nine months. The Belgian biotech is pulling out of metabolic diseases and osteoarthritis R&D to focus on its core therapeutic areas. 

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Talaris pulls off $150M IPO to tackle organ rejection, autoimmune disorders

Another day, another biotech IPO. This time, its cell therapy player Talaris Therapeutics, which raised $150 million in a Nasdaq debut to fuel its lead asset, an off-the-shelf cell therapy it hopes will transform the standard of care in organ transplant, as well as some disorders of the blood, immune system and metabolism.

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Sponsored: Mitotech brings novel approach to treating eye disorders

Mitotech focuses its clinical development efforts on ophthalmology, hoping to deliver its mitochondria targeted therapies to patients suffering from age-related as well as rare genetic eye diseases.

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Gene therapy biotech Gyroscope finds unnavigable seas on IPO market

Gyroscope Therapeutics has taken a spin around the IPO market, only to find there is no path forward to reach the NASDAQ at this time.

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Sponsored: Risk Mitigation in Direct-to-Patient Clinical Trials

The COVID-19 pandemic has made society very aware of the need to be flexible in the approach to daily life. Use and acceptance of DTP has grown due to the pandemic, and sponsors quickly began to rethink their Direct-to-Patient (DTP) approach as patients increasingly requested that their study drugs be shipped to their homes.

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Adcomm experts split on whether to approve ChemoCentryx's avacopan

The question of whether to approve ChemoCentryx’s vasculitis drug avacopan has divided a panel of experts convened by the FDA. Ten experts voted that the benefit-risk profile supports approval, while the other eight voted against authorizing the drug on the strength of the available evidence.

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CRISPR therapeutics, Nkarta pen new cutting-edge cancer tech research pact

Two next-gen biotech pioneers in natural killer cell therapies and gene editing are coming together to battle cancer.

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Science 37 taps a SPAC to go public, with siteless trial specialist valued at a cool $1B

Science 37 had a good year in 2020, using its hybrid trial approach to help companies navigate their way through a pandemic; it’s now hoping to top 2020 with a major public listing in 2021.

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Chutes & Ladders—Former Merck R&D chief Perlmutter takes reins at Eikon, applying Nobel-winning tech to drug discovery

Former Merck R&D lead Perlmutter has landed at Eikon Therapeutics, which is using Nobel-winning tech to overhaul drug discovery. Jaguar Gene Therapy has enlisted a new chief medical officer. And a second Novartis oncology R&D exec has jumped ship for the world of biotech.

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Fierce Pharma Asia—BeiGene touts Q1, PARP inhibitor nod; Astellas culls muscle disease pact

BeiGene more than doubled product sales in the first quarter and won a conditional China nod for self-developed PARP inhibitor pamiparib. Astellas ended a licensing deal with Cytokinetics in muscle disease. Mundipharma is seeking bidders for its China business. And more.

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Resources

Guide: How to Establish a Successful Clinical Data Standards Program

Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials.

Whitepaper: Unlocking the True Value of Digital Therapeutics Through Partnerships

As clinical treatment options become more patient-centric, digital therapeutics provide forward-looking biopharma players the opportunity to augment the value of their offerings to stakeholders.

Whitepaper: The Journey to a Global Modular Content Strategy

One top 10 pharma outlines three key steps to launching a modular content strategy to generate localized content faster.

E-Book: 7 Keys to Success in Europe

This 77-page e-book explores 7 keys to success that any biopharma company needs to keep in mind as it enters Europe.

Executive Brief: Seven Secrets to Patient Experience Breakthroughs: Improving the Patient Experience and Study Retention

The average clinical trial spends $40,000 per patient. Yet despite these high costs, most trials struggle to retain patients.

Article: Make the right move at every step of the drug commercialization process

Developing a quality product and getting it approved for distribution is not enough to guarantee commercial success.

eBook: The New Standard: Virtual Study Training in Clinical Trials

The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – learn more today.

Report: New research indicates an accelerated shift to decentralized clinical trials

New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19.

Content Hub: Process Intensification Resource Center

A one-stop hub for Cytiva resources to support process intesification

Whitepaper: COVID-19 Survey report: The Lasting Impact on Outsourcing Decisions

How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond?

Content Hub: Emerging Biotech Resource Center

A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule

Whitepaper: Roche to pick up GenMark Diagnostics in $1.8B infectious disease testing deal

Roche has inked a $1.8 billion, all-cash deal for GenMark Diagnostics, to acquire its molecular tests designed to screen patient samples for multiple infections simultaneously.

Content Hub: Remarque Systems Resource Hub

Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. 

Whitepaper: New Data: A Better Way to Run CHO Cell Culture Experiments

Find out how upstream bioprocess scientists can use Culture Biosciences’ bioreactor system and real-time data visualizations to get faster insights and get their product to market more quickly.

Whitepaper: Overcoming the hurdles of Real-World Data Access through a federated global network

Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights.

Report: New research indicates an accelerated shift to decentralized clinical trials

New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19.

Executive Summary: Manufacturing Strategies to Effectively Industrialize Autologous Cell Therapies

Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.

eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase.

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: 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.

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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