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Today's Rundown

Featured Story

Merck-partnered Janux seeks $100M IPO on preclinical promise of bispecific pipeline

Janux Therapeutics has filed to raise up to $100 million in an IPO. The Merck-partnered biotech wants the money to take a clutch of T-cell engager drug candidates into phase 1 clinical trials.

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Top Stories

BeiGene's Novartis-partnered PD-1 drug hits goal in phase 3

A phase 3 clinical trial of BeiGene’s anti-PD-1 antibody in patients with nasopharyngeal cancer (NPC) has met its primary endpoint. The success at the interim analysis tees BeiGene up to expand use of the Novartis-partnered drug into a disease that is relatively common in its native China.

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Roivant, in an unexSPACted twist, wants to bring Immunovant back into the fold

Roivant Sciences inked a SPAC deal to go public earlier this month, but it’s not getting off the SPAC track just yet. The company wants to reacquire Immunovant, one of its subsidiaries, which went public in late 2019 through a different SPAC.

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Left out of SPAC pack, BioTheryX raises $92M in rare series E to hold over until potential end of year IPO

Clinical stage biopharmaceutical company BioTheryX, focused on protein degradation, decided against the blank-check route and could begin IPO preparations in the 4th quarter in line with clinical milestones.

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RenBio joins bigwigs Eli Lilly, Regeneron in hunt for next gen COVID-19 antibodies after $24M financing

A year and a half ago, the disease targeted by RenBio's lead asset did not even exist in humans, but now the upstart biotech is emerging from stealth with a COVID-19 antibody hopeful and $24 million in financing to go up against Big Pharma in the battle for a variant-busting treatment. 

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ASCO: Johnson & Johnson's bispecific lung cancer combo shows promise as Tagrisso backup, but the Big Pharma wants more

Johnson & Johnson's cancer combo of amivantamab and lazertinib spurred a response in 36% of patients with a difficult type of non-small cell lung cancer that has relapsed, a result the healthcare giant says could position the therapy as an alternative to tough-to-tolerate chemotherapy.

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ASCO: Boehringer, OSE offer promising glimpse of the immuno-oncology drug at the heart of their $1.4B deal

BI and OSE unveiled data from a phase 1 trial of BI 765063, a SIRP-alpha inhibitor, reporting that 45% of evaluable patients derived some clinical benefit from the drug. BI 765063  is among an emerging class of immuno-oncology drugs that target “don’t eat me” signaling, which is a strategy used by tumors to escape immune destruction.

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Fierce Pharma Asia—Lilly-Innovent's PD-1 review; Takeda-Bayer patent settlement; Novo's Hummingbird investment

Eli Lilly and Innovent Biologics will face an FDA advisory committee for their PD-1 application in lung cancer. Takeda and Bayer put to rest their hemophilia patent infringement lawsuit. Novo Holdings led a $125 million series C in Singapore's Hummingbird Bioscience. And more.

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Chutes & Ladders—Another Novartis exec answers the biotech call, this time for gene therapy startup Tevard

Novartis has lost another NIBR exec to the call of biotech. Blueprint Medicines has added another BMS vet to its roster. And Iovance quietly announced its CEO's departure Wednesday.

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Resources

Guide: Your Guide to Overcome Inconsistent Clinical Data Standards

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: 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.

Events