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September 24, 2019___

Today's Rundown

Featured Story

Little Abeona gets big setback with FDA clinical hold on pivotal phase 3

Just under a year ago, Abeona Therapeutics rejected its CEO; now, it’s the biotech’s turn to be spurned, as the FDA has slapped the company with a clinical hold.

Top Stories

Placebo-drug mix-up adds subplot to Helixmith phase 3 failure

A phase 3 trial of Helixmith’s DNA plasmid gene therapy in painful diabetic peripheral neuropathy missed its primary endpoint. Helixmith noted people in the placebo cohort received the experimental therapy as a potential explanation for the failure.

Bayer, Boston academics form joint lab to research lung disease

Bayer, Brigham and Women's Hospital (BWH) and Massachusetts General Hospital have teamed up to work on treatments for chronic lung diseases. They will work out of a joint lab in Boston that will receive more than $30 million over the next five years.

Takeda’s CMV med outshines Roche’s Valcyte in phase 2

Takeda’s cytomegalovirus drug, maribavir, beat Roche’s Valcyte at clearing the virus from patients’ blood in a phase 2 study. The study compared the drugs in patients with CMV infection after receiving an organ transplant or a stem cell transplant, a group that's particularly vulnerable to the virus.

Quiet biotech Amphivena nabs $62M funding round

Little-known and super quiet biotech Amphivena has grabbed a strong and healthy $62 million series C round funding haul.

New CRISPR approach could improve gene and cell therapies

Biomedical engineers at Duke are developing a new CRISPR system designed to alter the epigenome, which they believe could address some of the shortcomings of CRISPR-Cas9 and be used to perform many different genome engineering tasks simultaneously.

FDA device head Shuren talks about getting to 2-week 510(k) reviews

Speaking at the annual MedTech Conference hosted by industry trade association AdvaMed, CDRH Director Jeffrey Shuren outlined a few of the initiatives the FDA has planned to help accelerate its 510(k) review timelines.

Novartis is first to recall generic Zantac after confirming suspected carcinogen

Novartis quickly pivoted from suspending distribution of its generic Zantac drugs to recalling them from the U.S. after determining they contain a suspected carcinogen. It is likely to be the first of a wave of recalls.

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Events