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December 13, 2019___

Today's Rundown

Featured Story

Analysts ponder what Sarepta's whirlwind approval means for Biogen—are all bets off?

After being hit with an FDA rejection for Sarepta Therapeutics' second Duchenne muscular dystrophy drug back in the summer, it looked like a long road, tinged with more than a hint of political intrigue, for it to be approved.

Top Stories

Biogen chalks up another failure, but investors' eyes remain firmly on Alzheimer's

Amid all the talk about aducanumab and whether it can be approved in Alzheimer’s disease next year in a classic phoenix from the flames tail, Biogen has served up another trial flop.

Gritstone posts 'one of the most potent immunogenic-responses for a neoantigen vaccine'

Early data out of former Fierce 15 winner Gritstone Oncology have been heralded as a big win for the early-stage biotech by analysts.

Tory landslide election victory sets U.K. on path to Brexit

A thumping election win for the Conservative Party has positioned the U.K. to push ahead with plans to leave the EU. The new parliamentary arithmetic gives Boris Johnson the numbers to pass the withdrawal agreement and take the U.K. out of the EU, although what will happen after that remains a mystery.

Anixa delays CAR-T trial in bid to boost efficacy

Anixa Biosciences has delayed a planned IND filing by 12 months to buy time to improve its CAR-T candidate. The delay will enable Anixa to perform additional genetic engineering intended to boost the efficacy of the treatment in ovarian cancer.

New cancer drug targets emerge from massive protein analysis

Baylor researchers scoured all of the proteins present in 500 diverse cancers and made a surprising discovery: All of those cancers, it turns out, can be slotted into 10 subtypes, each of which is driven by a common set of proteins. The data may lead to new ideas for drug development in ovarian, breast, colon, renal and uterine cancers, they believe.

EuroBiotech Report—Sanofi inks Synthorx deal, Roche data, Leo's Dupixent rival and Ipsen

In this week's EuroBiotech Report, Sanofi inks $2.5B Synthorx takeover and posts sutimlimab data, Roche shares bispecific results and more.

FiercePharmaAsia—AZ, Daiichi's HER2 data win; J&J, Legend's CAR-T; Samsung BioLogics fraud probe

AstraZeneca and Daiichi Sankyo turned up "impressive" efficacy data for their antibody-drug conjugate. Janssen and Legend Biotech’s CAR-T therapy cleared multiple myeloma in 69% of patients in phase 1. South Korea jailed Samsung execs for burying evidence linked to a BioLogics fraud probe.

Chutes & Ladders—Pyxis signs on Pfizer spinoff founder Sullivan

Pyxis brings on SpringWorks founder Sullivan; Insitro hires chief data officer Batzoglou; Frinzi to step down from J&J Vision.

Resources

[Executive Summary] Clinical Supplies - Made to Order

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

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[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

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This global landscape study identifies and assesses innovative funding models for cancer and other high-cost chronic NCDs across Africa, Asia, Europe, Latin America and Middle East. The study aims to enable readers to better understand the possibilities that innovative funding models bring to bridge the current and future funding gap, while stressing the key success factors that enable sustainability and success such as stakeholder collaboration.

[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.

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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] Why Companies Leverage the Cloud to Smooth the Path to FDA Approval

See why visionaries outsource the design and management of the infrastructure allowing their scientists to innovate.

[Whitepaper] Medical Affairs 2025 Excellence in the Era of Precision Medicine

Medical Affairs 2025 brings together leading perspectives from AstraZeneca, Bristol-Myers Squibb, Merck, Lilly, and other innovative life sciences organizations on key challenges impacting medical affairs and a roadmap for success in the coming decade.

[Whitepaper] IBM Clinical Development: Key solutions for more efficient clinical research

IBM’s highlighted solutions reside in a security-rich cloud environment—home for capturing, managing and analyzing clinical study data with control, accuracy and confidence. These solutions lay the groundwork for further integration with IBM® Watson® cognitive technology.

[Whitepaper] How Big is the US Market for Medical Devices and Technologies?

Inpatient View and Outpatient View are powered by robust data assets and use sophisticated projection methodologies to help ensure accuracy of reporting.

[Whitepaper] The importance of early key opinion leader outreach in the biologics and biosimilars marketplace

Acknowledging various stakeholder networks, as well as recognizing variances within the regulatory environment, we believe, is essential for companies looking to uncover the right decision-makers in support of biologics or biosimilars. Learn more.

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

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[Video] Demand Led Services and Clinical Supply Efficiency

Watch a short video on demand led supply model. It is designed to meet the needs of patients, clinical sites, clinical team and sponsors and results in shorter lead time, less waste, less stock out risk and no booklet labels.

[eBook] Strategies for Efficient Clinical Supply Management and Forecasting

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Events