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June 22, 2018

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

Featured Story

Feds charge Theranos’ Elizabeth Holmes with wire fraud

A federal grand jury has indicted Theranos CEO Elizabeth Holmes and former COO Sunny Balwani for several counts of wire fraud and conspiracy to commit wire fraud.

Top Stories Of The Week

Doctors worry Shingrix side effects will put patients off their second dose

Patients might be hesitant to return for their second Shingrix dose if they experience side effects, according to doctors.

FDA hits Ziopharm CAR-T trial with clinical hold

The FDA has placed a clinical hold on Ziopharm Oncology’s phase 1 CAR-T trial. Ziopharm wants to run the study to assess CAR-T cells manufactured at the point of care, but the FDA is demanding more CMC information before allowing it to proceed.

Sarepta leaps 50% on early data for Duchenne gene therapy

The data, taken from three patients, showed a 38% increase in a muscle protein that boys with DMD usually lack.

What's next for embattled Allergan? Depends on pipeline performance, analysts say

Allergan is in the middle of making some moves to revive its struggling shares. And what’s next may depend on how some closely watched pipeline products perform in the months to come, analysts say.

Gene therapy with 'off switch' restores hand movement in rats with spinal cord injury

Researchers from King's College London designed a gene therapy that can be switched off once it has treated a spinal cord injury, addressing concerns of uncontrolled gene expression down the line.

Cannes Lions Health: Merck, Novartis, Pfizer and 15 more pharmas nab shortlist honors

Here’s some irony for you: Pharma creative award submissions to the Cannes International Festival of Creativity are at a record low, but a bigger-than-ever lineup of pharma companies made the Lions Health short list.

10 years after a rejection, Merck returns to the FDA with a Gardasil 9 age expansion bid

Merck won the FDA “priority review” designation for an application to expand Gardasil 9 into older populations up to 45 years old, about 10 years after the agency struck down a similar attempt for its older version of Gardasil.

Drug shortages again on the rise after 5 years of improvements, FDA says

After five years of declines in the number of new drug shortages in the U.S., they jumped to 39 last year from 26 in the two preceding years. And while that is a far cry from the peak of more than 250 registered in 2011, the FDA acknowledges that many of the current shortages have been for critical drug products and “are having a tangible impact on patients.”

Optimapharm opens first U.S. office in New York, appoints Americas VP

The European contract research organization Optimapharm has expanded its operations to the U.S., opening a new office in New York City and appointing a VP for business development in the Americas.

Enrollment Showcase

SBMI Now Offering an Online Graduate Program in Bioinformatics

UTHealth SBMI now offers a M.S. track in clinical and translational bioinformatics.

Resources

[Survey] 2018 eClinical Technology Solutions Survey

Take this anonymous 10-minute survey to share your thoughts on leading eClinical technology solutions and earn up to $55 honoraria. Take the survey now!

[Whitepaper] Is the pharma business model ready for precision medicine?

Blue Latitude Health explores the commercial barriers and new stakeholder connections for pharma companies developing precision medicines, and reveals how to grasp novel opportunities in the new era of healthcare.

[Whitepaper] Getting to First-in-Human Clinical Trials: A Make-or-Break Milestone for Small Biopharmas

“Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market faster. Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for these cash-strapped companies whose hopes hinge upon one or two molecules. Read how CDMOs are responding to this pressure.

[Whitepaper] Digitizing the Global Life Sciences Supply Chain: The Critical Role of Digital Transaction Management

Life science companies are experiencing a significant transformation in how they bring new products to market.

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