​​​​​​​Synlogic backs onto Nasdaq by merging with Mirna

​​​​​​​Synlogic has landed a Nasdaq listing and an $82 million cash pile by simultaneously pulling off a reverse merger with Mirna Therapeutics and a series C round. The activity tees up the Jose Carlos Gutierrez-Ramos, Ph.D.-helmed synthetic biology startup to push its lead candidate into the clinic in the coming months.

Cambridge, Massachusetts-based Synlogic turned to a mix of new and existing investors including Arctic Aurora LifeScience, Atlas Venture, CLI Ventures, New Enterprise Associates (NEA) and OrbiMed for the $42 million series C. That round comes 15 months after Synlogic pulled in $40 million in a series B. And, when combined with the cash Mirna has left from its failed tilt at drug development, gives the company $82 million to fuel its move into the clinic.

READ MORE Synlogic backs onto Nasdaq by merging with Mirna

G1 pitches IPO to advance lung and breast cancer candidates

G1 Therapeutics thinks it has a winner on its hands with CDK4/6 inhibitor trilaciclib and is embarking on an initial public offering to give it the resources it needs to bring it to market.

The Research Triangle Park biotech says it is hoping to raise around $115 million from the IPO, which comes a little over a year after G1 raised $47 million in a venture round on the strength of some early-stage data for its lead drug.

Going public signals G1's increasing confidence  in trilaciclib (G1T28), which is in the same class as Pfizer's Ibrance (palbociclib)—the first drug of this type to reach the market in 2015 and already a $2 billion-a-year blockbuster—and Novartis' new entrant Kisqali (ribociclib). Eli Lilly is also nipping at the CDK4/6leaders' heels with its abemaciclib prospect, due to report late-stage data shortly.

READ MORE G1 pitches IPO to advance lung and breast cancer candidates

Bayer cancer drug boards path to speedy approval at FDA

The FDA has granted priority review status to Bayer’s copanlisib, setting the PI3K inhibitor up to speed through the regulatory process in 6 months or less. Bayer secured the privileged position on the strength of data from a midphase trial in patients with non-Hodgkin lymphoma (NHL).

Landing the regulatory status means Bayer will learn whether the FDA shares its enthusiasm for copanlisib within 6 months, rather than the 10 months the agency typically takes to review drugs. The precedent set by other cancer drugs with priority review status suggests the FDA may make a decision about copanlisib in less than 6 months if it is particularly bowled over by the data.

READ FULL STORY HERE- Bayer cancer drug boards path to speedy approval at FDA

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.

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

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.

Read more here- AstraZeneca sues exec Luke Miels after his defection to GlaxoSmithKline

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

Biotech pioneer and former Genzyme CEO Henri Termeer dies

The biotech industry is mourning the loss of one of the sector's founding fathers after the death of Genzyme founder Henri Termeer at the age of 71.

According to the Boston Globe, Termeer died after collapsing at his home in Marblehead, Massachusetts, on Friday night.

Termeer was at the helm of Genzyme for nearly 30 years, joining the company in 1983 and rising quickly to the role of CEO before it was acquired by Sanofi in 2011 for more than $20 billion. He is credited with not only transforming the small company into one of the world's leading biotech companies but also playing a leading role in working out how to develop a business model that opened up the market for rare and orphan disease therapies—to the benefit of patients and shareholders alike.

Biotech pioneer and former Genzyme CEO Henri Termeer dies