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February 04, 2020___

Today's Rundown

Featured Story

Bristol-Myers forms fibrotic disease biotech, bags buyout option

Bristol-Myers Squibb has created a fibrotic and inflammatory disease biotech through its partnership with BioMotiv. The biotech, Anteros Pharmaceuticals, starts life with materials from Bristol-Myers to support development of small molecules and the potential to land a takeover by the Big Pharma.

Top Stories

A16z unveils $750M fund to bankroll startups at intersection of tech, medicine

Four years after Andreessen Horowitz raised its first bio fund, the VC shop is launching its third biotech- and healthcare-focused fund. At $750 million, Bio Fund III is a16z’s biggest fund of its kind yet, and it will bankroll early-stage companies, though General Partner Jorge Conde said it will “selectively” participate in more mature companies, too.

After bagging $200M-plus in 2019, Passage Bio guns for $125M IPO

Despite pulling off two megarounds in 2019, Passage Bio is returning to the funding well—but this time, it’s going public. The company filed for a $125 million IPO, which will bankroll its three lead gene therapy programs in dementia, Krabbe disease and rare childhood disease GM1 gangliosidosis.

FDA wins legal dispute with Vanda over partial clinical hold

The FDA has won a legal dispute with Vanda Pharmaceuticals over a partial clinical hold it imposed on tradipitant. Vanda took the FDA to court in the belief the agency's demand ran counter to scientific evidence but failed to convince the U.S. District Court for the District of Columbia.

After losing its CMO last summer, CytomX Therapeutics finally nabs a replacement

Rachel Humphrey, M.D., quietly and abruptly left CytomX Therapeutics last August as its chief medical officer; now, the cancer biotech has finally hired a new CMO.

Abbott to test its heart device against lifetime blood thinners for reducing stroke risk

Abbott plans to launch a head-to-head study that puts its structural heart device up against a newer generation of blood thinners, testing its ability to lower the risk of strokes in people with atrial fibrillation.

High hopes dashed: HIV vaccine made from GSK, Sanofi components flops massive study

Researchers had high hopes for an HIV vaccine candidate made up of components supplied by GlaxoSmithKline and Sanofi. But several years into the study, researchers took a peek at the data in January. It wasn't working.

The 10 most-anticipated drug launches of 2020

We've assembled a list of the top 10 most-anticipated new drug launches of 2020 based on estimated global sales in 2024. Of those 10, eight could break the blockbuster barrier in four short years—putting a new batch of heavy hitters in pharma's ranks.

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