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March 05, 2020___

Today's Rundown

Featured Story

Servier bags expanded rights to Cellectis' CD19 CAR-Ts

Cellectis has revised its deal with Servier, granting its partner worldwide rights to all its CD19 CAR-T therapies in return for €25 million ($27.6 million) and the control of candidates against five additional targets.

Top Stories

Makena mess, CEO exit; now, AMAG loses CMO as pipeline comes into sharper focus

AMAG Pharmaceuticals is losing its CEO, likely having a drug pulled off the market by the FDA and has cut more than 100 staffers; as it turns more deeply to its pipeline, the person in charge of that is now leaving.

PsiOxus lures Lillie from Merck to fill CMO position

PsiOxus Therapeutics has hired Tom Lillie away from Merck to work as its chief medical officer. Lillie’s arrival coincides with the initiation of a phase 1 trial of PsiOxus’ quadrivalent viral gene therapy vector.

Novartis taps Orionis to pursue 'historically elusive targets'

Novartis has entered into a four-year research collaboration with Orionis Biosciences. The agreement tasks Orionis with applying its technologies to “historically elusive targets” in multiple therapeutic areas.

MacroGenics chief medical officer hits the exit

Just a month after getting its BLA accepted by the FDA for its next-gen breast cancer hopeful, MacroGenics’ SVP of clinical development and CMO Jon Wigginton, M.D., is set to leave the company later this month.

Can CAR-T cells built with scorpion venom kill glioblastoma tumors?

Scientists at City of Hope have designed a novel chimeric antigen receptor (CAR) based on chlorotoxin (CLTX), a toxin found in scorpion venom. The novel CAR-T cell therapy successfully killed glioblastoma tumors with minimal off-target events and will now be ushered into clinical testing.

FDA bans electric shock devices for conditioning against aggressive behaviors

The FDA has exercised a rarely used authority to completely ban a product from the market: the use of electric shock devices for conditioning a person against self-harm or aggressive behaviors.

UPDATED Coronavirus tracker: Moderna vaccine trial starts enrolling; California in state of emergency

Moderna's vaccine is nearly set for testing as investigators recruit trial participants in the Seattle area. The biotech's CEO, Stephane Bancel, has pledged to be "thoughtful" about the price. Meanwhile, the U.S. House of Representatives passed a major spending bill that includes billions for R&D and $300 million to purchase potential vaccines and therapeutics for the public.

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[Video] FierceBiotech Sits Down With H1

Biopharma companies don't want to go to market with a product no one knows about. H1 has homed in on the often time-consuming research and engagement phases that companies must ace for a successful launch, said Ariel Katz, co-founder of H1.

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This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market.

[Video] FierceBiotech Sits Down With Accenture

Kevin Julian, senior managing director of Accenture’s life sciences practice, recently sat down with FierceBiotech to discuss market trends and Accenture’s new technology platform, INTIENT. 

[Whitepaper] Achieving Differentiation in the Complex Oncology Market

White paper describing how a biopharma company can successfully differentiate an oncology product when the clinical profile alone is not enough to get the job done.

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[Executive Summary] Overcoming Manufacturing Challenges for Accelerated Drug Development

Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project.

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Events