Gottlieb tells staffers FDA can help—indirectly—to cut medicine prices

New FDA Commissioner Scott Gottlieb delivered his first address to agency workers yesterday, and tackling high drug prices featured prominently in the speech.

The speech trod some territory that will be familiar to those paying attention to President Trump's pronouncements on the future of the FDA, with efforts to reduce medicine pricing and improve the efficiency at the agency sitting alongside pledges to reduce smoking rates and tackle the greatest immediate challenge" of rampant opioid abuse.

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Editas delays IND for Allergan-partnered CRISPR program

Editas Medicine has delayed the target date for filing an IND for its lead candidate. The setback to the Allergan-partnered CRISPR program stems from delays at a third-party manufacturer working on Leber congenital amaurosis treatment LCA10.

Cambridge, Massachusetts-based Editas had planned to file an IND for LCA10 by the end of the year. Now Editas has delayed that major moment in its short history and that of the broader CRISPR field until the middle of next year. The delay stems from a misstep in the production of a material used in the manufacture of the adeno-associated viral (AAV) vectors Editas will use to deliver its gene editing payloads.

“AAV manufacturing requires several steps to happen in perfect sequence for things to all come together. And we’re using several external contractors to perform these steps. We have to produce the input material that all comes together to then create the AAV in a cell culture systems,” Editas CTO Vic Meyer told investors.

Read ore here Editas delays IND for Allergan-partnered CRISPR program

AstraZeneca sues exec Luke Miels after his defection to GlaxoSmithKline

GlaxoSmithKline's poaching of pharma industry veteran Luke Miels from AstraZeneca in January was billed as an early win success for incoming CEO Emma Walmsley, who scrambled to replace global pharma president Abbas Hussain and other departing execs.

Fast-forward to the present, and the appointment has opened a can of worms. Bloomberg reported that Miels is currently on "gardening leave" from AZ after facing a lawsuit from his current employer alleging breach of employment.

AZ wants Miels to honor the terms of the contract he signed as executive VP of its European pharma business and has taken to the courts to try to force him to do so, according to the newswire.

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Intellia moves closer to clinic with CRISPR tech

Intellia Therapeutics has taken another step toward human trials of its gene editing technology after reporting new data in animal models.

The CRISPR specialist says it has been able to show for the first time that it is able to not only achieve long-term suppression of a gene using its gene-editing CRISPR/Cas9 drug, in this case the sequence coding for serum transthyretin (TTR) protein, but also demonstrate a dose-dependent reduction in the activity of the target gene in a second animal species.

New data from studies in mice show that a previously reported 97% reduction in TTR—driven by 70% gene editing efficiency working in mouse livers—lasts for up to six months from a single dose. Meanwhile, a study in rats showed a similar dose-dependent reduction in the TTR gene, and crucially evidence of comparable activity in a second species as Intellia builds the case to move to the clinic.

Read more here- Intellia moves closer to clinic with CRISPR tech