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January 02, 2020___

Today's Rundown

Featured Story

With 45 new drug approvals in 2019, ‘friendly’ FDA is here to stay

It looks like drug approvals have well and truly bounced back. 2019’s total of 45 approvals may not have hit the record high posted in 2018, but it fits into a general upward trend. Some pin that on a “friendlier” FDA, while others think it is the natural outcome of the maturation of new treatment approaches.

Top Stories

After Audentes buy, acquisitive Astellas snaps up CAR-T biotech

Parker Institute-backed biotech Xyphos has been bought out by Japanese pharma Astellas as it looks to bolster its cancer pipeline.

Rise, Sir Pangalos! AstraZeneca R&D lead knighted

One of AstraZeneca’s top research leaders has been knighted in the U.K.’s New Year 2020 Honours list.

Wave tanks again as Huntington's clinical trial data underwhelm

Data from a phase 1b/2a trial have raised doubts about whether Wave Life Sciences’ Huntington’s disease drug can compete with Roche and Ionis’ rival candidate. The results wiped 50% off Wave’s share price, adding to losses it suffered when it dumped a Duchenne muscular dystrophy program earlier in December. 

Melinta files for bankruptcy in another dark day for antibiotics

Melinta Therapeutics has filed for Chapter 11 bankruptcy. Deerfield is set to take control of Melinta as payment for the $140 million loan it extended to the antibiotics business.

Amid AdComm rejection, Correvio Pharma hit with FDA complete response letter

Correvio Pharma is not having a happy holiday. After being hit by an FDA AdComm rejection a few weeks back, its heart drug has now also been denied approval by the FDA.

CRISPR baby scientist He Jiankui sentenced to 3 years in prison

He Jiankui, the Chinese scientist who gained international notoriety one year ago by claiming to use CRISPR to create the world’s first gene-edited babies, has been sentenced to three years in prison, according to a report from China’s state news agency, Xinhua.

Sensyne Health pairs with Roche for AI trial work

Oxford, U.K.-based clinical trial artificial intelligence tech company Sensyne Health has signed a new research project deal with Swiss major Roche.

Sanofi beat out 3 suitors and one last-minute bid in its pricey $2.5B Synthorx buyout

When Sanofi picked up biotech Synthorx for a cool $2.5 billion in December, it paid a rich premium to enter an increasingly competitive space for IL-2 immunotherapies. But in the face of stiff competition, sometimes a blow-away bid is what it takes to win the day.

Enrollment Showcase

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Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career.  Learn more.

Resources

[Whitepaper] Telemedicine: Facilitating Clinical Trial Participation

Download this white paper and read the expert feedback that snapIoT has gathered from industry thought leaders on the evolution, evaluation, and use of telemedicine solutions in clinical trials.

[Whitepaper] Are We Transforming in the Right Way? Why Launches Can’t Be Distracted By Empty Promises.

How are your launch strategies can convert “innovation” into value for patients?

[Whitepaper] Why Partner with CSP’s to Validate Mission Critical Apps in the Cloud?

Why companies leverage the expertize of industry focused cloud service providers to design and build quality systems and facilitate the FDA Validation of Mission Critical Apps in the Cloud.

[Whitepaper] How to Protect your Supply Chain from Security and Compliance Threats Utilizing On-Dose Authentication Technologies

Learn more: Best practices for defending supply chain security and compliance by efficiently managing product authentication.

[Whitepaper] The Unexpected Key to Building Value in Drug Discovery and Development

Small or emerging pharmaceutical and biotech companies pursuing novel molecules and targets have two important goals: achieve clinical success and attract new rounds of funding. While there’s never a guarantee of either, certain actions can influence the outcome in your favor.

[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.

[Whitepaper] Q2 2019 Life Sciences M&A notes and trends

Get your copy of the Q2 2019 Life Sciences M&A notes and trends to understand the mergers and acquisitions (M&A) activity in the life sciences sector which drove 136 new M&A deals and provides a forward look to 2020 activity ahead.

[Whitepaper] What You Need to Know to Avoid Costly Delays in Your API Scale-Up

Are you facing costly delays in your API scale-up?

[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.

[Whitepaper] Modernizing clinical trials with Amazon Web Services (AWS)

From IoT to data management to high-performance computing and machine learning, leading life sciences organizations are using Amazon Web Services (AWS) to develop scalable, global, predictable, and secure solutions to modernize clinical trials while mitigating risks

[Whitepaper] The Impact of Step-Therapy Policies on Patients

Download this complimentary paper that explores the practice of step therapy and its impact on key stakeholders in the US healthcare system.

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