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Today's Rundown

Featured Story

Merck KGaA pens $1B upfront, biobucks pact with Debiopharm for next-gen cancer asset

Germany’s Merck, looking to beef up its cancer pipeline and move beyond its checkpoint inhibitor Bavencio in the future, has signed up to in-license a late-stage oncology assert from Swiss biotech Debiopharm.

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Top Stories

OrbiMed collects $3.5B for a trio of life sciences, healthcare funds

OrbiMed banked $3.5 billion in its latest raise, a sum that will be divided among three private investment funds, including one focused on early-stage companies in North America and Europe and a second aimed at companies of various stages in Asia.

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FDA accepts gefapixant for review in cough, positioning Merck to get head start on Bayer and Bellus

The FDA has accepted a filing for approval of Merck’s P2X3 receptor antagonist gefapixant for review. Merck is seeking approval on the basis of phase 3 trials that linked the oral drug to improvements in several measures of chronic cough symptoms but confirmed tolerability concerns.

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Sponsored: Analysis of Humanized Mice with Myeloid Cell Engraftment

Humanized immune system mice are revolutionary tools for the development of oncology therapeutics, but their use has been limited for some applications by impaired human myeloid cell differentiation.

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China startup Suzhou Medilink Therapeutics nabs $50M for hot R&D cancer field

Using antibody-drug conjugate tech against cancer targets has become hot property in recent years, and a new Chinese biotech is cashing in on the craze.

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Tenaya grabs $106M top-up to push heart disease gene therapies to the clinic

With another $106 million in the bank, heart-focused Tenaya Therapeutics is ready to talk targets. The series C funding will propel several preclinical programs toward the clinic, including a gene therapy for hypertrophic cardiomyopathy, as well as set up a site in the Bay Area to manufacture vectors to deliver its treatments.

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SalioGen raises $20M to validate non-viral gene therapy platform

SalioGen Therapeutics has raised $20 million to validate a platform designed to eliminate barriers to the use of gene therapies. The series A will support preclinical validation of mammal-derived enzyme saliogase in the creation of in vivo gene therapies for familial hypercholesterolemia and inherited macular degeneration.

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New approaches to treating cancer with off-the-shelf immune-stimulating bispecific antibodies

Three Johns Hopkins research groups designed bispecific antibodies so they simultaneously bind to tumor antigens and T cells, resulting in drugs that could offer off-the-shelf immuno-oncology to a wide variety of cancer patients, they argued. The drugs showed promising efficacy in preclinical models.

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Rebus Biosystems launches spatial transcriptomics analysis platform

Rebus Biosystems has launched what it describes as its new “spatial omics” system, designed to give researchers a closer look at the output of individual cells across tissue samples.

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Johnson & Johnson's COVID-19 vaccine scores FDA authorization, adding key third shot to U.S. supply

A month after Johnson & Johnson's COVID-19 vaccine posted positive data in a phase 3 study, the shot is ready for prime time. After a key FDA panel unanimously endorsed the vaccine late Friday, the agency signed off on its emergency use Saturday.

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Enrollment Showcase

Specialize Your Career in Pharmaceutical Outcomes

Learn about the Top 5-Ranked UF College of Pharmacy’s online graduate programs in pharmaceutical outcomes & policy. Select from five specializations, including the new pharmaceutical value assessment & communication option. Over half of graduates progress to a new role within one year. Register now.

Resources

eBook: Optimize Trial Performance with AI-enabled Technology & Advanced Analytics

Unlock competitive advantage with AI and advanced analytics.

Whitepaper: The Crush: How COVID-19 Is Impacting Mature Brand Revenue & Long-Term Value

Mature brands lost billions in revenue and value during COVID, but with the right strategy, pharma can rebound and reignite revenue. Learn How.

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

Download our whitepaper to learn how BC Platforms has leveraged our technical expertise to offer robust and comprehensive solutions to maximize RWD ROI.

Free Infographic: The Future of Vaccine Development

Involved in vaccine development? Check out this timely infographic detailing the history of vaccines, key development milestones, and what challenges remain.

Whitepaper: 2021 Outlook for Cell-Based Therapies in Oncology: CAR-T Expansion & Beyond

A look ahead at how cell-based therapies in oncology will advance during 2021-22: research, regulatory, and commercial milestones.

Whitepaper: Seasonal Vaccine Manufacturing

While service directories are filled with CMOs claiming vaccine fill-finish experience, the logistical challenges resulting from seasonal product are unique and it is important that outsourcing partners can ensure quality and on-time delivery.

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: 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.

Content Hub: Emerging Biotech Resource Center

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

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.

Research: Premier Research Resource Hub

Browse the latest learnings and insights from our clinical development professionals.

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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