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September 07, 2018

Welcome to FierceLifeSci Weekly Digest, your roundup of the biggest and most popular stories from each of our publications.

Featured Story

Former GSK cancer scientist admits attempt to steal trade secrets

A scientist who worked at GlaxoSmithKline’s R&D unit in Philadelphia has pleaded guilty to attempting to steal confidential research and funnel it to conspirators in China.

Top Stories Of The Week

Fosun Pharma ‘massively’ fakes API production data and bribes regulators, whistleblower says

In probably the third Chinese drug scandal in two months after Zhejiang Huahai’s tainted valsartan API and Changchun Changsheng Life Sciences’ fabricated vaccine production data exposé, Fosun Pharma has allegedly falsified a large number of production and testing records.

As Brexit costs mount, Pfizer estimates $100M to adapt its supply chain

In yet another indication of what the burden of Brexit will be for drug manufacturers, Pfizer has said that it has tallied its costs to revise its manufacturing and supply chain at about $100 million.

Theranos bleeds dry, company to dissolve: WSJ

Theranos, the one-time Silicon Valley biotech star valued at more than $9 billion, has ultimately run out of money, employees and time. It will formally disband in the coming months, according to an email to shareholders obtained by The Wall Street Journal.

Sangamo slides on first genome-editing trial results

Sangamo’s big chance to show it has a safe and efficient gene-editing technique to rival CRISPR has come—and the initial response has been a little mixed.

Novartis finally unloads 300 troubled U.S. generics to India’s Aurobindo for $1B

Novartis has inked its deal to sell a big chunk of its Sandoz U.S. business. The deal relieves Novartis of a troubled franchise—including some easy-to-copy generics and several manufacturing plants—while boosting buyer Aurobindo to the second-largest generics player by prescriptions in the U.S.

Thwarting cancer by targeting cell survival and growth

Some cancer cells become resistant to treatments, while others simply grow so fast that drugs can’t keep up with them. Two studies out this week suggest potential methods for treating hard-to-beat tumors by targeting the mechanisms by which they survive and proliferate.

Novartis’ and Gilead’s CAR-Ts, Alnylam’s Onpattro and others rack up EU approvals

After the FDA pulled off several nods last week, its European counterpart has matched up with its own party of drug approvals. As Gilead and Novartis won key green lights for their CAR-Ts, Jazz, Ultragenyx and Alnylam also earned their own go-ahead stamps this week.

Suono Bio gets Fujifilm investment for its second-generation drug delivery tech, names new CEO

Japan’s Fujifilm is investing in Suono Bio’s second-generation drug delivery technology that uses speedy, formulation-independent application of therapeutics that include biologics and gene therapies.

Pediatric experts call for flu shots over AstraZeneca's nasal vaccine this year

Pediatric experts have recommended injected vaccines over AstraZeneca's FluMist for the upcoming season. The recommendation from the American Academy of Pediatrics comes after CDC officials endorsed AstraZeneca's nasal vaccine for this year's flu season.

Resources

[Whitepaper] Choosing the Best Sterile Dosage Form for Your Phase I Clinical Supply Needs

When developing a parenteral, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages.

[Whitepaper] Scale-Up and Technical Transfer for Lyophilized Products

Baxter BioPharma Solutions’ whitepaper offers a method to address the challenges of tech transfer for lyophilized products from lab-scale to commercial-scale.

[Whitepaper] Addressing the Special Commercial Challenges in Rare Diseases

A whitepaper outlining the key commercial challenges facing rare disease products, and how biopharmaceutical companies can overcome them.

[Webinar] Enabling precision medicine with Tableau and AWS

Inova is using the capabilities of Tableau on AWS to identify biomarkers for personalized treatment intended to improve health outcomes for children.

[Case Study] Identification of an Unknown Leachable Species from BFS Vials

In this case study, an unknown leachable species was detected by GC-MS analysis of an alkaline drug product (pH approximately 10.5) that was packaged in a novel self- contained plastic Blow Fill Seal (BFS) vial.

[Webinar] Build a holistic data management strategy for Life Sciences

Reltio and IQVIA provide holistic data management solutions for traditional pharma, emerging biotech, and consumer health companies, on AWS.

[Webinar] Safeguard your Life Sciences data with Druva and AWS

Life Sciences organizations are embracing cloud-based Master Data Management (MDM) to modernize the organization of critical data.

[Paid Marketplace] Stability Testing & Storage

Catalent provides world class stability services to ease your critical path to success.

[eBook] 2018 Weekly Compendium

The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry.

[Whitepaper] Evolving Approaches to Drug Value Assessment in Global Markets

The window of market exclusivity continues to narrow dramatically in the global marketplace. Given this demanding environment, your global market access team faces increasing urgency to get the value proposition right at the time of launch.

[eLearning] BIOAVAILABILITY 101

Develop a basic understanding of principles and concepts of bioavailability of oral drugs.

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