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Today's Rundown

Featured Story

AstraZeneca's cancer R&D exec Ferté joins Relay to run its lead asset as another bluebird exec jumps ship

Last month we found out, via Twitter, that AstraZeneca’s Charles Ferté, M.D., Ph.D., senior director and global project leader of oncology R&D, was leaving the Big Pharma, but we didn’t know for where.

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Top Stories

Avrobio plans head-to-head Fabrazyme trial after FDA changes path to market

Avrobio has updated its Fabry disease gene therapy R&D plans in light of the FDA’s conversion of Sanofi’s Fabrazyme to full approval. The conversion deprives Avrobio of the chance to seek accelerated approval using its current phase 2, leading the biotech to plan to pit AVR-RD-01 against Fabrazyme in a new head-to-head clinical trial.

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Roivant catches the SPAC wave to Wall Street in $611M deal

As Roivant Sciences gears up its “next chapter,” the company is heading for the public markets by merging with a special purpose acquisition company, or SPAC, and raising $611 million in the process.

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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 Affinia prepares for clinic with $110M financing

Affinia Therapeutics, a biotech developing adeno-associated virus vectors and gene therapies, has raked in $110 million through a series B financing to move its programs into the clinic.

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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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Astellas quietly cuts Cytokinetics R&D pact as $450M-plus in biobucks goes up in smoke

Japanese pharma Astellas has culled a muscle disease research pact with Cytokinetics, two years after a partnered med between the two flopped in a midstage test.

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KalVista bulks up executive team with CMO addition as angioedema franchise grinds to launch

KalVista Pharmaceuticals will bring on Paul Audhya, M.D., as chief medical officer as the Cambridge, Massachusetts-based biotech works to get a clinical trial for its hereditary angioedema franchise back on track.

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Aceragen bags Enzyvant drug and $35M, plots fast path to market

Enzyvant has sold its preclinical Farber disease therapy to Aceragen. NovaQuest Capital Management is funding the newly founded Aceragen, setting the biotech up to enter the clinic and go on to seek approval.

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FDA clears augmented reality smartglasses for guiding knee replacement surgeries

Built into a pair of glasses worn by the surgeon, a camera helps judge the alignment of instruments and the joint itself within their field of view, without requiring changes in conventional surgical techniques.

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The top 20 drugs by worldwide sales in 2020

While the global sales rankings of Big Pharma's superstar drugs naturally feature the biggest names in the business, new meds often pop up or old drugs exit the scene. And the moves within the list from year to year illustrate many of the trends shaping pharma on a daily basis. 

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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: Top 5 Benefits of a Cloud ELN

Discover the benefits of a cloud-native ELN that delivers better performance, security, connectivity, total cost of ownership PLUS sub-second search results through even the largest data volumes.

Content Hub: How to improve the virtual work you do every day

We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met.

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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