To view this email as a web page, click here

   Home

Subscribe

Advertise

 

 

 

 

February 07, 2020___

Today's Rundown

Featured Story

Sanofi C-suite explains Regeneron deal 'simplification,' ramping up its pipeline

It’s been a busy year for Sanofi: It’s been rejigging deals with the likes of Regeneron and bought out a biotech in the form of Synthorx.

Top Stories

After Dravet hiccup, Zogenix's Fintepla prevails in phase 3 Lennox-Gastaut test

After a rocky ride, Zogenix’s Fintepla turned up encouraging phase 3 data in a second type of rare childhood epilepsy. The drug beat placebo at cutting seizure frequency for patients with Lennox-Gastaut syndrome who typically experience dozens of seizures each month. In addition, more patients taking Fintepla saw their monthly seizures reduce by half than patients on placebo.

Diffusion CSO and co-founder Gainer set to resign next month

Diffusion Pharmaceuticals’ co-founder and chief scientific officer John Gainer is set to leave the drug development company. Gainer invented the trans bipolar carotenoid family of molecules worked on by Diffusion but is now planning to leave the company next month.

Another Takeda/Shire R&D exec jumps ship as Pharvaris nabs Peng Lu as its new CMO

After getting off a $66 million series B in September last year, hereditary angioedema (HAE) specialist Pharvaris has taken on a seasoned HAE developer to help lead its pipeline.

Chiesi creates Boston rare disease unit ahead of Fabry launch

Chiesi Farmaceutici has set up a rare disease unit in Boston. The division will develop treatments for patients with rare lysosomal storage, hematological and ophthalmological disorders.

GenapSys raises $75M to bring its tabletop DNA sequencer to Asia amid coronavirus outbreak

Just months after collecting $90 million to support the launch of its compact DNA sequencing hardware, GenapSys has raised another $75 million to finance its global expansion with its eyes set on the Asia-Pacific market and the expanding coronavirus outbreak.

How blocking a 'first responder' in blood vessels could prevent heart disease

A research team led by the University of Oxford has discovered a molecular “first responder” in endothelial cells that detects blood-flow stress. Targeting the shape of this force detector could reduce harmful plaques in arteries and therefore holds promise for preventing serious heart diseases, they argue.

EuroBiotech Report—Sanofi's MS data, Roche in SMA, MaaT, GeNeuro and GSK

In this week's EuroBiotech Report, Sanofi hits goal in phase 2 MS trial, Roche posts pivotal SMA data and MaaT bags €18 million for microbiome trials. 

FiercePharmaAsia—Remdesivir patent in coronavirus; Takeda plant sale; Glenmark spinoff hire

The ongoing coronavirus outbreak in China has triggered a weird patent case around Gilead's remdesivir. Takeda is looking to sell a Shire biologics plant, and it doesn't expect U.S. Natpara supply for another year. Glenmark's biotech spinoff Ichnos hired Novartis exec as its chief development officer. And more.

Chutes & Ladders—Aerie taps former Allergan exec as new VP

Aerie nabs former Allergan exec Senchnya as VP of medical affairs; Novartis' Basson takes CMO role at Boston; Hannah tapped as CMO at CytomX.

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