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Today's Rundown

    

Thank you to Janssen Oncology for sponsoring Fierce Biotech's ASCO coverage.

 

 

Featured Story

MorphoSys inks not one but 2 billion-dollar deals including Constellation Pharma buy valued at $1.7B

It’s a meteor shower of billion-dollar deals for MorphoSys today. The cancer- and autoimmune-disease-focused biotech will buy Constellation Pharmaceuticals in a deal valued at $1.7 billion. But that’s not all: MorphoSys has also inked a funding partnership with Royalty Pharma worth a staggering $1.425 billion upfront that will support financing of the Constellation deal.

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Top Stories

Immunovant's plan to restart IMVT-1401 development falls flat as CMO makes an exit

Call it a double whammy for Immunovant. The clinical-stage biotech hit another roadblock with its lead drug candidate, IMVT-1401, just as Chief Medical Officer Rita Jain makes an abrupt exit after five months with the company.

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NRx hopes 'guided missile' COVID-19 antiviral will get FDA clearance on 2nd attempt

The FDA told NRx Pharmaceuticals to try again in September when they attempted to obtain authorization for a COVID-19 therapy. Now, the biotech thinks they have the data they need to finally get the nod. Radnor, Pennsylvania-based NRx filed for emergency use authorization yesterday with the FDA for aviptadil-acetate, or Zyesami, to be used in COVID-19 patients with respiratory failure. 

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Genmab joins with Bolt to develop bispecific immune stimulators 

Genmab and Bolt Biotherapeutics have teamed up to develop bispecific immune-stimulating antibody conjugates. The collaboration brings together Genmab’s bispecific capabilities with Bolt’s innate immune stimulant platform to create a new type of immuno-oncology drug.

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After SPAC up, Renovacor staffs up with ex-MyoCardia CMO to lead clinical development

In the lead-up to going public later this year, preclinical biotech Renovacor is doing some renovating. The early-stage cardiovascular and central nervous system biotech today said former MyoKardia Chief Medical Officer Marc Semigran, M.D., would step into the same position at Renovacor. Semigran, who was also senior vice president of medical science at MyoKardia through its $13.1 billion exit to Bristol Myers Squibb last year, will manage and direct Renovacor’s global pipeline.

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Lyra Therapeutics taps LianBio to bring sinusitis med to Asia

As Lyra Therapeutics shepherds its rhinosinusitis program through the clinic, it’s getting a little help from LianBio. Lyra picks up $12 million upfront in exchange for the exclusive license to develop and commercialize the treatment in China and other Asian markets. Though the upfront fee is modest, Lyra stands to receive up to $135 million down the line.

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AB halts masitinib trials after discovering heart disease worry

AB Science has halted clinical trials of masitinib after identifying a potential risk of ischemic heart disease. The cessation of enrollment and treatment initiation deals yet another blow to a drug that has suffered a long string of regulatory setbacks.

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With new CEO, Veracyte outlines €260M deal for French test maker HalioDx and global cancer testing expansion

On the first day for its new CEO, Veracyte is keeping him busy, unveiling an acquisition that aims to dramatically widen the company’s global footprint in cancer diagnostics. The new buy, HalioDx, will serve as a beachhead in Europe and mark its first foray into immuno-oncology testing and kit manufacturing.

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On a roll, Moderna taps Thermo Fisher for fill-finish duties and Lonza for booster shot manufacturing

Moderna has tasked Thermo Fisher Scientific with fill-finish, labeling and packaging duties for its mRNA COVID-19 vaccine at Thermo Fisher’s commercial manufacturing site in Greenville, North Carolina. Meanwhile, Swiss CDMO Lonza will also build a new line at a site in the Netherlands to help produce booster shots.

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Resources

Whitepaper: How to Launch a Successful BYOD Strategy in Any Phase

For faster deployment, improved patient engagement, and better-quality data — go where your patients are. GO BYOD with Lunexis™ from Clinical Ink.

Paid Marketplace: Story of Success: Ashfield Healthcare Empowers Field Sales to Grow Market Share based on Data

Discover how Ashfield Healthcare uses the power of data and analytics to enable pre-call planning, inform sales rep actions and drive higher market share for its target pharmaceutical products.

eBook: Improving Diversity and Inclusion in Clinical Trials

Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning the barriers to participation and the strategies to overcome them.

Whitepaper: Closed Cell Processing System Benefits for Cell & Gene Therapy

Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Optimized automation of certain steps of the workflow may decrease hands-on time and the cost of the cell manufacturing process.

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.

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

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. 

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.

Events