To view this email as a web page, click here

   Home

Subscribe

Advertise

 

 

 

 

February 05, 2020___

Today's Rundown

Featured Story

GSK culls oncology hopeful, officially tosses out failed HIV vax

As GlaxoSmithKline announced it is splitting in two (with a consumer healthcare unit to become standalone), the British Big Pharma says its priority at GSK 2.0 will be R&D.

Top Stories

Novartis Oncology veterans reunite at Glenmark spinoff Ichnos

Gabriela Gruia, M.D., who oversaw regulatory affairs for Novartis’ oncology team, is Ichnos Sciences’ new chief development officer. She joins Alessandro Riva, M.D., who left the Swiss pharma for a stint at Gilead in 2017 and took Ichnos’ helm early last year.

Armed with Nestlé cash, Aimmune grabs experimental food allergy drug from Xencor

Aimmune has had a good few weeks: It’s just won approval for the first peanut allergy drug at the FDA, then got a $200 million boost from Nestlé, and today it’s using that cash to license a new drug from Xencor.

MaaT bags €18M to test microbiome modulators in cancer patients

MaaT Pharma has raised an €18 million ($20 million) series B round. The financing equips MaaT to wrap up a phase 2 trial of its lead microbiome therapy in graft-versus-host disease while expanding into solid tumors. 

After Ebola success, Regeneron turns antibody capabilities against 2019-nCoV 

Regeneron has teamed up with the U.S. Department of Health and Human Services (HHS) to develop a treatment for the coronavirus outbreak. The alliance will leverage Regeneron antibody technology that gave rise to an effective treatment for the Ebola virus. 

Verily plans digital eye care joint venture with Japan's Santen Pharma

Verily’s ophthalmology work is set to see new life through a joint venture with Japanese vision care company Santen Pharmaceutical.

Alleviating age-related cognitive decline by activating immune cells

Interleukins IL-33 and IL-5 are major culprits in the inflammatory responses associated with asthma. But researchers at Albany Medical College just found that leveraging the ability of these two signaling molecules to link to a type of immune cell in the brain might alleviate age-related cognitive decline and help treat neurodegenerative diseases.

GlaxoSmithKline's spinoff plan is here—and it may not be limited to consumer health

GlaxoSmithKline made clear it intended to spin off its consumer health joint venture with Pfizer when the partners first unveiled the deal. Now, the British drugmaker has officially started a two-year journey toward that split, which may take prescription dermatology along with it.

Resources

[Whitepaper] Regulatory agencies provide insights and concerns for eConsent study

To conduct a successful trial, do you need to understand the global eConsent Regulatory landscape?

[Whitepaper] Fusing Specifications and Design for Data Collection Casebooks with Veeva Vault EDC

Learn how data management teams at ICON, Bioforum, and Vertex Pharmaceuticals are creating the spec and casebook in a single step, reducing study build times and effort by over 50%.

[Whitepaper] Assessing the Financial Impact of Translational Pharmaceutics®

Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms.

[Presentation] Flexible Manufacturing Strategies

Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible.

[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.

[Executive Summary] Clinical Supplies - Made to Order

Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric.

[Whitepaper] Digital Twins: Creating Digital Operations Today to Deliver Business Value Tomorrow

This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future.

[Q&A] Embarking Upon the Commercial Manufacturing Journey for a Biologic

In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.

Events